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What changed in RxSight, Inc.'s 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of RxSight, Inc.'s 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+591 added−590 removedSource: 10-K (2026-02-25) vs 10-K (2025-02-25)

Top changes in RxSight, Inc.'s 2025 10-K

591 paragraphs added · 590 removed · 486 edited across 8 sections

Item 1. Business

Business — how the company describes what it does

127 edited+10 added−40 removed216 unchanged
Biggest changeThe FDA regulates, among other things, product design and development, pre-clinical and clinical testing, manufacturing, packaging, labeling, storage, record keeping and reporting, clearance or approval, marketing, distribution, promotion, import and export, and post-marketing surveillance in the United States to assure the safety and effectiveness of medical products for their intended use. 14 FDA regulation of medical devices Unless an exemption applies, each new or significantly modified medical device we seek to commercially distribute in the United States will require either a premarket notification to the FDA requesting permission for commercial distribution under Section 510(k) of the FDCA, also referred to as a 510(k) clearance, or approval from the FDA of a PMA application.
Biggest changeFDA regulation of medical devices Unless an exemption applies, each new or significantly modified medical device we seek to commercially distribute in the U.S. will require either a premarket notification to the FDA requesting permission for commercial distribution under Section 510(k) of the FDCA, also referred to as a 510(k) clearance, or approval from the FDA of a PMA application.
Premium IOLs reduce the need for glasses relative to conventional IOLs but may impose trade-offs related to their ability to provide glasses-free near, intermediate and distance vision, as well as the potential for increased incidence of halos, glare and other side effects related to monofocal IOLs. Healthcare payors typically cover the full cost of conventional cataract procedures.
Premium IOLs reduce the need for glasses relative to conventional IOLs but may impose trade-offs related to their ability to provide glasses-free near, intermediate and distance vision, as well as the potential for increased incidence of halos, glare and other side effects relative to monofocal IOLs. Healthcare payors typically cover the full cost of conventional cataract procedures.
Since late 2021, we have included ActivShield technology on all LALs, which provides an extra layer of UV protection on the lens surface and reduces dependence on patient compliance with protective glasses. Key benefits of RxSight system for patients • Superior vision outcomes.
Since late 2021, we have included ActivShield technology on all LALs, which provides an extra layer of UV protection on the lens surface and reduces dependence on patient compliance with protective glasses. Key benefits of the RxSight system for patients • Superior vision outcomes.
Additionally, LAL patients reported a low rate of glare or halo, visual side effects that are frequently reported with premium IOLs. In 2024, we completed a 500-eye prospective, randomized, controlled multi-center Post Approval Study (“PAS”), which was a requirement of our Premarket Approval (“PMA”) approval.
Additionally, LAL patients reported a low rate of glare or halo, visual side effects that are frequently reported with premium IOLs. In 2024, we completed a 500-eye prospective, randomized, controlled multi-center Post Approval Study (“PAS”), which was a requirement of our Premarket Approval (“PMA”).
There can be no assurance that submission of an IDE will result in the ability to commence clinical trials, and although the FDA’s approval of an IDE allows clinical testing to go forward for a specified number of subjects, it does not bind the FDA to accept the results of the trial as sufficient to prove the product’s safety and effectiveness, even if the trial meets its intended success criteria.
There can be no assurance that submission of an IDE will result in the ability to commence clinical trials, and although the FDA’s approval of an IDE allows clinical testing to go forward for a specified number of subjects, it does not bind the FDA to accept the results of the clinical trial as sufficient to prove the product’s safety and effectiveness, even if the clinical trial meets its intended success criteria.
The FDA also may determine that additional tests or clinical trials are necessary, in which case the PMA approval may be delayed for several months or years while the trials are conducted and data is submitted in an amendment to the PMA, or the PMA is withdrawn and resubmitted when the data are available.
The FDA also may determine that additional tests or clinical trials are necessary, in which case the PMA approval may be delayed for several months or years while the clinical trials are conducted and data is submitted in an amendment to the PMA, or the PMA is withdrawn and resubmitted when the data are available.
The commencement or completion of any clinical trial may be delayed or halted, or be inadequate to support approval of a PMA application, for numerous reasons, including, but not limited to, the following: • The FDA or other regulatory authorities do not approve a clinical trial protocol or a clinical trial, or place a clinical trial on hold; • Patients do not enroll in clinical trials at the rate expected; • Patients do not comply with trial protocols; • Patient follow-up is not at the rate expected; • Patients experience adverse events; • Patients die during a clinical trial, even though their death may not be related to the products that are part of the trial; • Device malfunctions occur with unexpected frequency or potential adverse consequences; • Side effects or device malfunctions of similar products already in the market that change the FDA’s view toward approval of new or similar PMAs or result in the imposition of new requirements or testing; • Institutional review boards and third-party clinical investigators may delay or reject the trial protocol; • Third-party clinical investigators decline to participate in a trial or do not perform a trial on the anticipated schedule or consistent with the clinical trial protocol, investigator agreement, investigational plan, good clinical practices, the IDE regulations, or other FDA or IRB requirements; • Third-party investigators are disqualified by the FDA; • We or third-party organizations do not perform data collection, monitoring and analysis in a timely or accurate manner or consistent with the clinical trial protocol or investigational or statistical plans, or otherwise fail to comply with the IDE regulations governing responsibilities, records, and reports of sponsors of clinical investigations; • Third-party clinical investigators have significant financial interests related to us or our study such that the FDA deems the study results unreliable, or we or investigators fail to disclose such interests; • Regulatory inspections of our clinical trials or manufacturing facilities, which may, among other things, require us to undertake corrective action or suspend or terminate our clinical trials; • Changes in government regulations or administrative actions; • The interim or final results of the clinical trial are inconclusive or unfavorable as to safety or effectiveness; or 16 • The FDA concludes that our trial design is unreliable or inadequate to demonstrate safety and effectiveness.
The commencement or completion of any clinical trial may be delayed or halted, or be inadequate to support approval of a PMA application, for numerous reasons, including, but not limited to, the following: • The FDA or other regulatory authorities do not approve a clinical trial protocol or a clinical trial, or place a clinical trial on hold; • Patients do not enroll in clinical trials at the rate expected; • Patients do not comply with trial protocols; • Patient follow-up is not at the rate expected; • Patients experience adverse events; • Patients die during a clinical trial, even though their death may not be related to the products that are part of the clinical trial; • Device malfunctions occur with unexpected frequency or potential adverse consequences; • Side effects or device malfunctions of similar products already in the market that change the FDA’s view toward approval of new or similar PMAs or result in the imposition of new requirements or testing; • Institutional review boards may delay or reject the clinical trial protocol; 15 • Third-party clinical investigators decline to participate in a trial or do not perform a trial on the anticipated schedule or consistent with the clinical trial protocol, investigator agreement, investigational plan, good clinical practices, the IDE regulations, or other FDA or IRB requirements; • Third-party investigators are disqualified by the FDA; • We or third-party organizations do not perform data collection, monitoring and analysis in a timely or accurate manner or consistent with the clinical trial protocol or investigational or statistical plans, or otherwise fail to comply with the IDE regulations governing responsibilities, records, and reports of sponsors of clinical investigations; • Third-party clinical investigators have significant financial interests related to us or our study such that the FDA deems the study results unreliable, or we or investigators fail to disclose such interests; • Regulatory inspections of our clinical trials or manufacturing facilities, which may, among other things, require us to undertake corrective action or suspend or terminate our clinical trials; • Changes in government regulations or administrative actions; • The interim or final results of the clinical trial are inconclusive or unfavorable as to safety or effectiveness; or • The FDA concludes that our trial design is unreliable or inadequate to demonstrate safety and effectiveness.
While we depend on our suppliers to provide us and our customers with materials in a timely manner that meet our and their quality, quantity and cost requirements, vendors will miss delivery dates, extend delivery dates or in some circumstances cancel purchase orders because these suppliers may encounter problems during manufacturing for a variety of reasons, any of which could delay or impede their ability to meet our demand.
While we depend on our suppliers to provide us and our customers with materials in a timely manner that meet our and their quality, quantity and cost requirements, vendors will miss delivery dates, extend delivery dates or in some 10 circumstances cancel purchase orders because these suppliers may encounter problems during manufacturing for a variety of reasons, any of which could delay or impede their ability to meet our demand.
We believe our ability to compete effectively will be dependent on our ability to build the commercial infrastructure necessary to effectively and cost-efficiently drive awareness of the unique value of our RxSight system. In addition, patients who receive an LAL will be required to wear UV protective glasses until final lock-in which is approximately 4-5 weeks after surgery.
We believe our ability to compete effectively will be dependent on our ability to build the commercial infrastructure necessary to effectively and cost-efficiently drive awareness of the unique value of our RxSight system. 13 In addition, patients who receive an LAL will be required to wear UV protective glasses until final lock-in which is approximately 4-5 weeks after surgery.
The CPRA, which became effective January 1, 2023 created additional obligations with respect to certain data relating to consumers, 23 significantly expands the CCPA, including by introducing additional obligations such as data minimization and storage limitations, granting additional rights to consumers, such as correction of personal information and additional opt-out rights, and creates a new entity, the California Privacy Protection Agency, to implement and enforce the law.
The CPRA, which became effective January 1, 2023, created additional obligations with respect to certain data relating to consumers, significantly expands the CCPA, including by introducing additional obligations such as data minimization and storage limitations, granting additional rights to consumers, such as correction of personal information and additional opt-out rights, and creates a new entity, the California Privacy Protection Agency, to implement and enforce the law.
Any action brought against us for violations of these laws or regulations, even successfully defended, could cause us to incur significant legal expenses and divert our management’s attention from the operation of our business. Also, we may be subject to private “qui tam” actions brought by individual whistleblowers on behalf of the federal or state governments.
Any action brought against us for violations of these laws or regulations, even successfully defended, could cause us to incur significant legal expenses and divert our management’s attention from the operation of our business. Also, we may be 19 subject to private “qui tam” actions brought by individual whistleblowers on behalf of the federal or state governments.
In addition to personnel support, we also provide practices with marketing materials, such as patient brochures, literature and digital content for website and social media promotions. We also provide ongoing training related to new technology features and developments, as well as education on the patient benefits of our solution; • Strategically expanding our commercial organization and marketing activities.
In addition to personnel support, we also provide practices with marketing materials, such as patient brochures, literature and digital content for website and social media promotions. We also provide ongoing training related to new technology features and developments, as well as education on the patient benefits of our solution; 8 • Strategically expanding our commercial organization and marketing activities.
Since our initial FDA approval in November 2017 through December 31, 2024, we have received approximately 40 supplemental approvals that advance these objectives. In January 2023, the FDA approved our PMA supplement for our compact LDD with various modifications and it was approved in Canada in September 2024 and in Korea in February 2025.
Since our initial FDA approval in November 2017 through December 31, 2025, we have received approximately 40 supplemental approvals that advance these objectives. In January 2023, the FDA approved our PMA supplement for our compact LDD with various modifications, and it was approved in Canada in September 2024, and in South Korea in February 2025.
Although we take steps to protect our trade secrets and know-how, third parties may independently develop or otherwise gain access to our trade secrets and know-how. 13 For more information regarding risks related to our intellectual property, please see “Risk Factors-Risks related to Intellectual Property” in Part I, Item 1A of this Annual Report.
Although we take steps to protect our trade secrets and know-how, third parties may independently develop or otherwise gain access to our trade secrets and know-how. For more information regarding risks related to our intellectual property, please see “Risk Factors-Risks related to Intellectual Property” in Part I, Item 1A of this Annual Report.
The Food and Drug Administration Modernization Act of 1997 established a new route to market for low to moderate risk medical devices that are automatically placed into Class III due to the absence of a predicate device, called the “Request for Evaluation of Automatic Class III Designation,” or the de novo classification process.
The Food and Drug 14 Administration Modernization Act of 1997 established a new route to market for low to moderate risk medical devices that are automatically placed into Class III due to the absence of a predicate device, called the “Request for Evaluation of Automatic Class III Designation,” or the de novo classification process.
No. 11,083,568, which is estimated to expire in 2037. Pursuant to the agreement with QAD, Inc. (“QAD”) dated October 29, 2015 (the “QAD Agreement”), we received a nonexclusive, non-transferable, perpetual license to use certain QAD software at the physical location where we install the software.
No. 11,083,568, which is estimated to expire in 2037. Pursuant to the agreement with QAD, Inc. (“QAD”) dated October 29, 2015 (the “QAD Agreement”), we received a nonexclusive, non-transferable, perpetual license to use certain QAD software at the physical location where we install the 12 software.
Available Information Our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the SEC, and all amendments to these filings, can be obtained free of charge from our website at www.rxsight.com following our 24 filing of any of these reports with the SEC.
Available Information Our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the SEC, and all amendments to these filings, can be obtained free of charge from our website at www.rxsight.com following our filing of any of these reports with the SEC.
This creates an excess concentration of free macromers in the unexposed portion of the lens and sets up a diffusion gradient over which the unpolymerized macromers move from the concentrated area to the less concentrated area. Over the next one to two days, the unpolymerized macromers redistribute across 6 the lens to achieve a uniform distribution.
This creates an excess concentration of free macromers in the unexposed portion of the lens and sets up a diffusion gradient over which the unpolymerized macromers move from the concentrated area to the less concentrated area. Over the next one to two days, the unpolymerized macromers redistribute across the lens to achieve a uniform distribution.
The study compared effectiveness and safety of the LAL and a monofocal IOL. 335 eyes were implanted with the LAL and 165 eyes with a monofocal control IOL. Both safety endpoints were met. Regarding effectiveness, the monocular uncorrected distance visual acuity was 20/25 or better in 82.5% of LAL eyes compared to 50.6% of control eyes.
The study compared effectiveness and safety of the LAL and a monofocal IOL. 335 eyes were implanted with the LAL and 165 eyes with a monofocal control IOL. Both safety endpoints were met. Regarding effectiveness, the monocular uncorrected distance visual acuity was 20/20 or better in 82.5% of LAL eyes compared to 50.6% of control eyes.
The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making decisions. 17 Prior to approval of a PMA, the FDA may conduct inspections of the clinical trial data and clinical trial sites, as well as inspections of the manufacturing facility and processes.
The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making decisions. Prior to approval of a PMA, the FDA may conduct inspections of the clinical trial data and clinical trial sites, as well as inspections of the manufacturing facility and processes.
In our Food and Drug Administration (“FDA”) clinical trial, 70% of LAL patients achieved 20/20 or better uncorrected visual acuity without glasses, while in similar 1 trials of other premium IOLs, only about 40% of patients achieved this performance level.
In our Food and Drug Administration (“FDA”) clinical trial, 70% of LAL patients achieved 20/20 or better uncorrected visual acuity without glasses, while in similar trials of other premium IOLs, only about 40% of patients achieved this performance level.
With the RxSight system, the doctor performs a standard cataract procedure to implant the LAL, determines refractive error with patient input after healing is complete, then uses the LDD to reshape the LAL 5 to achieve the patients’ desired vision outcomes.
With the RxSight system, the doctor performs a standard cataract procedure to implant the LAL, determines refractive error with patient input after healing is complete, then uses the LDD to reshape the LAL to achieve the patients’ desired vision outcomes.
Designed for placement in the doctor’s office, the LDD is a combination of a standard slit lamp and a digital light projector. The slit lamp portion allows the doctor to see inside the patient’s eye and align the light beam with the LAL.
Designed for placement in the doctor’s office, the LDD is a combination of a standard slit 6 lamp and a digital light projector. The slit lamp portion allows the doctor to see inside the patient’s eye and align the light beam with the LAL.
We believe our technology offers a differentiated value proposition to doctors and patients, providing us an opportunity to grow our share in the premium 8 IOL market and increase the penetration of premium IOLs in the broader cataract surgery market.
We believe our technology offers a differentiated value proposition to doctors and patients, providing us an opportunity to grow our share in the premium IOL market and increase the penetration of premium IOLs in the broader cataract surgery market.
We have received International Organization for Standardization (“ISO”) 13485:2016 certification for our quality management system. ISO certification generally includes recertification audits every third year, scheduled annual surveillance 10 audits and periodic unannounced audits.
We have received International Organization for Standardization (“ISO”) 13485:2016 certification for our quality management system. ISO certification generally includes recertification audits every third year, scheduled annual surveillance audits and periodic unannounced audits.
In the study, 70.1% of LAL 9 subjects achieved monocular uncorrected distance visual acuity of 20/20 or better compared to 36.3% of the eyes implanted with the monofocal control IOL.
In the study, 70.1% of LAL subjects achieved monocular uncorrected distance visual acuity of 20/20 or better compared to 36.3% of the eyes implanted with the monofocal control IOL.
If the device presents a “significant risk” 15 to human health, as defined by the FDA, the sponsor must submit an IDE application to the FDA and obtain IDE approval prior to commencing the human clinical trials.
If the device presents a “significant risk” to human health, as defined by the FDA, the sponsor must submit an IDE application to the FDA and obtain IDE approval prior to commencing the human clinical trials.
Consequently, premium cataract procedures are between 10 and 15 times more profitable for the doctors and ophthalmology practices than conventional cataract procedures and are less impacted by changes in reimbursement rates.
Consequently, premium cataract procedures are between 10 and 15 times more profitable for the doctors and ophthalmology practices than 3 conventional cataract procedures and are less impacted by changes in reimbursement rates.
Certain suppliers have passed on higher prices, surcharges and expedited shipping fees to defray the higher commodity prices they are paying due to short supply and pushed out delivery dates.
Certain suppliers have passed on higher prices, surcharges and expedited shipping fees to defray the higher commodity prices they are paying due to short supply, pushed out delivery dates, and tariffs.
According to Market Scope, the global cataract IOL market is highly concentrated, with these top two players accounting for approximately 75% of the total U.S. premium cataract surgery market and approximately 60% of the global manufacturer market revenue. Our competitors are significantly larger than us with greater financial, marketing, sales and personnel resources, greater brand recognition and longer operating histories.
According to Market Scope, the global cataract IOL market is highly concentrated, with these top two players accounting for approximately 75% of the total U.S. premium cataract surgery market and approximately 70% of the global manufacturer market revenue. Our competitors are significantly larger than us with greater financial, marketing, sales and personnel resources, greater brand recognition and longer operating histories.
Any issued patents that we may own or in-license in the future may be challenged, invalidated, narrowed, held unenforceable, infringed or circumvented. As of December 31, 2024, our patent estate is directed to various aspects of our programs and technology, including our LAL and our LDD as well as lens adjustment procedure and other technology.
Any issued patents that we may own or in-license in the future may be challenged, invalidated, narrowed, held unenforceable, infringed or circumvented. As of December 31, 2025, our patent estate is directed to various aspects of our programs and technology, including our LAL and our LDD as well as lens adjustment procedure and other technology.
Further, the Company’s references to the URLs for these websites are intended to be inactive textual references only. We have used, and intend to continue to use, our investor relations website, press releases, public conference calls, and webcasts to disclose material non-public information and to comply with our disclosure obligations under Regulation FD. 25
Further, the Company’s references to the URLs for these websites are intended to be inactive textual references only. We have used, and intend to continue to use, our investor relations website, press releases, public conference calls, and webcasts to disclose material non-public information and to comply with our disclosure obligations under Regulation FD. 22
Toric lenses correct for astigmatism, a condition in which the cornea is not uniformly curved leading to distortion of near and distance vision. According to the 2024 Market Scope IOL Report, approximately 70% of the population has clinically significant astigmatism of 0.5 diopters or more.
Toric lenses correct for astigmatism, a condition in which the cornea is not uniformly curved leading to distortion of near and distance vision. According to the 2025 Market Scope IOL Report, approximately 70% of the population has clinically significant astigmatism of 0.5 diopters or more.
We believe the United States is the most compelling market given the large population of individuals over the age of 60 that are covered by health insurance, the concentrated base of cataract surgeons experienced with premium IOL offerings, the high gross domestic product per capita and the favorable U.S. healthcare reimbursement system, which has a well-established history of covering a portion of the cost for cataract surgery.
We believe the U.S.is a compelling market given the large population of individuals over the age of 60 that are covered by health insurance, the concentrated base of cataract surgeons experienced with premium IOL offerings, the high gross domestic product per capita and the favorable U.S. healthcare reimbursement system, which has a well-established history of covering a portion of the cost for cataract surgery.
Failure to comply with the applicable United States medical device regulatory requirements could result in, among other things, warning letters, untitled letters, fines, injunctions, consent decrees, civil penalties, unanticipated expenditures, repairs, replacements, refunds, recalls or seizures of products, operating restrictions, total or partial suspension of production, the FDA’s refusal to issue certificates to foreign governments needed to export products for sale in other countries, the FDA’s refusal to grant future premarket clearances or approvals, withdrawals or suspensions of current product clearances or approvals and criminal prosecution.
Failure to comply with the applicable U.S. medical device regulatory requirements could result in, among other things, warning letters, untitled letters, fines, injunctions, consent decrees, civil penalties, unanticipated expenditures, repairs, replacements, refunds, recalls or seizures of products, operating restrictions, total or partial suspension of production, the FDA’s refusal to issue certificates to foreign governments needed to export products for sale in other countries, the FDA’s refusal to grant future premarket clearances or approvals, withdrawals or suspensions of current product clearances or approvals and criminal prosecution.
Ongoing regulation by the FDA Even after the FDA permits a device to be marketed, numerous regulatory requirements apply, including but not limited to: • establishment registration and device listing; • the QSR, or Quality Management System Regulation (“QMSR”), which goes into effect in February 2026, which requires manufacturers, including third-party manufacturers, to follow stringent design, testing, production, control, supplier/contractor selection, complaint handling, documentation, and other quality assurance procedures during the manufacturing process; • labeling regulations, advertising and promotion requirements, restrictions on sale distribution or use of a device, each including the FDA general prohibition against the promotion of products for any uses other than those authorized by the FDA, which are commonly known as “off label” uses; • the Medical Device Reporting (“MDR”) regulation, which requires that manufactures report to the FDA if their device may have caused or contributed to a death or serious injury or if their device malfunctioned and the device or a similar 18 device marketed by the manufacturer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur; • medical device corrections and removal reporting regulations, which require that manufactures report to the FDA field corrections or removals if undertaken to reduce a risk to health posed by a device or to remedy a violation of the FDCA Act that may present a risk to health; • recall requirements, including a mandatory recall if there is a reasonable probability that the device would cause serious adverse health consequences or death; • an order of repair, replacement or refund; • device tracking requirements; and • post market study and surveillance requirements.
Ongoing regulation by the FDA Even after the FDA permits a device to be marketed, numerous regulatory requirements apply, including but not limited to: • establishment registration and device listing; 17 • the QMSR, which went into effect in February 2026, which requires manufacturers, including third-party manufacturers, to follow stringent design, testing, production, control, supplier/contractor selection, complaint handling, documentation, and other quality assurance procedures during the manufacturing process; • labeling regulations, advertising and promotion requirements, restrictions on sale distribution or use of a device, each including the FDA general prohibition against the promotion of products for any uses other than those authorized by the FDA, which are commonly known as “off label” uses; • the Medical Device Reporting (“MDR”) regulation, which requires that manufactures report to the FDA if their device may have caused or contributed to a death or serious injury or if their device malfunctioned and the device or a similar device marketed by the manufacturer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur; • medical device corrections and removal reporting regulations, which require that manufactures report to the FDA field corrections or removals if undertaken to reduce a risk to health posed by a device or to remedy a violation of the FDCA Act that may present a risk to health; • recall requirements, including a mandatory recall if there is a reasonable probability that the device would cause serious adverse health consequences or death; • an order of repair, replacement or refund; • device tracking requirements; and • post market study and surveillance requirements.
They create an elongated focal point that allows for a broader range of vision, although patients will still often require glasses for distance and near vision. EDOF lenses will still typically result in glare and halos, as well as reduced contrast vision, although generally less severe than those experienced with multifocal lenses; and 4 • Astigmatism-Correcting or Toric Lenses.
They create an elongated focal point that allows for a broader range of vision, although patients may still require glasses for distance and near vision. EDOF lenses will still typically result in glare and halos, as well as reduced contrast vision, although generally less severe than those experienced with multifocal lenses; and • Astigmatism-Correcting or Toric Lenses.
Additionally, some states also require medical device manufacturers and/or distributors doing business within the state to register with the state or apply for a state license, which could subject our facility to state inspection as well as FDA inspection on a routine basis for compliance with the QSR and any applicable state requirements.
Additionally, some states also require medical device manufacturers and/or distributors doing business within the state to register with the state or apply for a state license, which could subject our facility to state inspection as well as FDA inspection on a routine basis for compliance with the FDA's QMSR and any applicable state requirements.
We maintain a rigorous change control policy to assure that no product or process changes are implemented without our prior review and approval. Third-party reimbursement and patient billing Dual aspect payment model In the United States, the CMS has determined that the additional refractive correction provided by astigmatism correcting and presbyopia correcting (premium) IOLs is not a covered benefit.
We maintain a rigorous change control policy to assure that no product or process changes are implemented without our prior review and approval. Third-party reimbursement and patient billing Dual aspect payment model In the U.S., the CMS has determined that the additional refractive correction provided by astigmatism correcting and presbyopia correcting (premium) IOLs is not a covered benefit.
Generally, in the United States, issued patents are granted a term of 20 years from the earliest claimed non-provisional or Patent Cooperation Treaty (“PCT”) filing date. In certain instances, a patent term can be adjusted to recapture a portion of delay by the 12 U.S.
Generally, in the U.S., issued patents are granted a term of 20 years from the earliest claimed non-provisional or Patent Cooperation Treaty (“PCT”) filing date. In certain instances, a patent term can be adjusted to recapture a portion of delay by the U.S.
Obtaining FDA marketing authorization, de novo down-classification, or approval for medical devices is expensive and uncertain, and may take several years, and generally requires significant scientific and clinical data. Investigational device process In the United States, absent certain limited exceptions, human clinical trials intended to support medical device clearance or approval require an IDE application.
Obtaining FDA marketing authorization, de novo down-classification, or approval for medical devices is expensive and uncertain, and may take several years, and generally requires significant scientific and clinical data. Investigational device process In the U.S., absent certain limited exceptions, human clinical trials intended to support medical device clearance or approval require an IDE application.
Key growth drivers include the increasing number of patients who prefer to be glasses-free, technological innovations, increased access to healthcare and rising disposable income; and • In the United States, there are approximately 9,000 ophthalmic surgeons that perform cataract surgery, including approximately 3,500 to 4,000 that perform roughly 60% of premium IOL cataract procedures.
Key growth drivers include the increasing number of patients who prefer to be glasses-free, technological innovations, increased access to healthcare and rising disposable income; and • In the U.S., there are approximately 9,500 ophthalmic surgeons that perform cataract surgery, including approximately 3,500 to 4,000 that perform roughly 60% of premium IOL cataract procedures.
These problems can lead to explants, in which patients undergo another procedure to remove the multifocal IOL and replace it with another type of IOL. In FDA studies for the Alcon Panoptix, J&J Symfony and Alcon Vivity lenses, 48.8%, 59.2% and 17.0% of subjects, respectively, reported being bothered by halos postoperatively; and • Corrects residual refractive error .
These problems can lead to explants, in which patients undergo another procedure to remove the multifocal IOL and replace it with another type of IOL. In FDA studies for the Alcon Panoptix and J&J Symfony, 48.8% and 59.2% of subjects, respectively, reported being bothered by halos postoperatively; and • Corrects residual refractive error .
To achieve broad awareness of the RxSight system among cataract surgeons, we also conduct various marketing programs, including promotions at industry and society conferences, podium presentations, social media, and educational webinars focused on the differentiated benefits of our RxSight system. Our RxSight system has regulatory approval in the U.S., Europe, Canada, Mexico and Korea.
To achieve broad awareness of the RxSight 9 system among cataract surgeons, we also conduct various marketing programs, including promotions at industry and society conferences, podium presentations, social media, and educational webinars focused on the differentiated benefits of our RxSight system. Our RxSight system has regulatory approval in the U.S., Europe, Canada, Mexico, Singapore, Australia and South Korea.
Manufacturing, sales, promotion and other activities following product clearance or approval are subject to regulation by numerous regulatory authorities in the United States in addition to the FDA, including the CMS, other divisions of the Department of Health and Human Services, the Department of Justice, the Consumer Product Safety Commission, the Federal Trade Commission, the Occupational Safety & Health Administration, the Environmental Protection Agency, and state and local governments.
Manufacturing, sales, promotion and other activities following product clearance or approval are subject to regulation by numerous regulatory authorities in the U.S. in addition to the FDA, including the CMS, other divisions of the Department of Health and Human Services, the Department of Justice, the Consumer Product Safety Commission, the Federal Trade Commission, the Occupational Safety & Health Administration, the Environmental Protection Agency, and state and local governments.
Prior to surgery, patients can opt for either a spherical monofocal IOL, which usually results in improved vision but requires glasses for best vision, or a premium IOL, which also corrects for astigmatism and/or presbyopia, thereby reducing spectacle dependence.
Prior to surgery, patients can opt for either a spherical monofocal IOL, which usually results in improved vision but may require glasses for best vision, or a premium IOL, which also corrects for astigmatism and/or presbyopia, thereby reducing spectacle dependence.
In the United States, the procedure is commonly performed in an outpatient setting, such as an Ambulatory Surgery Center (“ASC”), by an ophthalmologist specializing in cataract surgery and often requires only 5 to 15 minutes to complete. In most cases, surgery begins with removal of the cataractous lens through a process known as phacoemulsification.
In the U.S., the procedure is commonly performed in an outpatient setting, such as an Ambulatory Surgery Center (“ASC”), by an ophthalmologist specializing in cataract surgery and often requires only 5 to 15 minutes to complete. In most cases, surgery begins with removal of the cataractous lens through a process known as phacoemulsification.
Further details on certain segments of our patent portfolio, including our owned and exclusively in-licensed issued patents and patent applications, are included below. • Our current LAL: Some of the patents directed to our current LAL include, for example, U.S. Pat. No. 10,470,874, which is estimated to expire in 2026, U.S. Pat.
Further details on certain segments of our patent portfolio, including our owned and exclusively in-licensed issued patents and patent applications, are included below. • Our current LAL: Some of the patents directed to our current LAL include, for example, U.S. Pat. No. 10,874,505, which is estimated to expire in 2033, U.S. Pat.
Employees and human capital As of December 31, 2024, we had 498 full-time employees. All of our employees are full-time and none of our employees are represented by a labor union or covered under a collective bargaining agreement. Our human capital resources objectives include, as applicable, identifying, recruiting, retaining, incentivizing and integrating our existing and new employees, advisors and consultants.
Employees and human capital As of December 31, 2025, we had 461 full-time employees. All of our employees are full-time and none of our employees are represented by a labor union or covered under a collective bargaining agreement. Our human capital resources objectives include, as applicable, identifying, recruiting, retaining, incentivizing and integrating our existing and new employees, advisors and consultants.
As of 2017, CMS has recognized the LAL as an astigmatism correcting (premium) IOL, making it eligible for the dual aspect payment model. Most commercial payers mirror the Medicare rulings, but this can vary by payor. 11 Procedure coding and payment In the United States, we primarily sell our LAL products to ambulatory surgical centers (“ASCs”) and occasionally to hospitals.
As of 2017, CMS has recognized the LAL as an astigmatism correcting (premium) IOL, making it eligible for the dual aspect payment model. Most commercial payers mirror the Medicare rulings, but this can vary by payor. Procedure coding and payment In the U.S., we primarily sell our LAL products to ambulatory surgical centers (“ASCs”) and occasionally to hospitals.
Changes in healthcare policy, including changes in the implementation or the repeal of the ACA in the United States, could increase our costs, decrease our revenue and impact sales of and reimbursement and coverage for our current and future products. Since its enactment, there have been judicial and Congressional challenges to certain aspects of the ACA.
Changes in healthcare policy, including changes in the implementation or the repeal of the ACA in the U.S., could increase our costs, decrease our revenue and impact sales of and reimbursement and coverage for our current and future products. Since its enactment, there have been judicial and Congressional challenges to certain aspects of the ACA.
Corporate information We were incorporated in California on March 5, 1997 as Calhoun Vision, Inc. and changed our name to RxSight, Inc. in October 2016. We reincorporated in Delaware on July 6, 2021. Our principal executive offices are located at 100 Columbia, Aliso Viejo, California 92656. Our telephone number is (949) 521-7830. We maintain a website at www.rxsight.com.
Corporate information We were incorporated in California on March 5, 1997 as Calhoun Vision, Inc. and changed our name to RxSight, Inc. in October 2016. We reincorporated in Delaware on July 6, 2021. Our principal executive offices are located at 100 Columbia, Aliso Viejo, California 92656. Our telephone number is (949) 521-7830.
Since our initial FDA approval in November 2017 through December 31, 2024, we have received approximately 40 supplemental approvals. Recent enhancements include the addition of low diopter powers for the LAL+ ® , improvements to our manufacturing processes and improvements to the LDD software.
Since our initial FDA approval in November 2017 through December 31, 2025, we have received approximately 55 supplemental approvals. Recent enhancements include the addition of low diopter powers for the LAL+ ® , improvements to our manufacturing processes and improvements to the LDD software.
The U.S. and foreign patents issued or pending are estimated to expire from 2025 to 2044, without taking into account any possible patent term adjustments or extensions and assuming payment of all appropriate maintenance, renewal, annuity, and other governmental fees.
The U.S. and foreign patents issued or pending are estimated to expire from 2026 to 2045, without taking into account any possible patent term adjustments or extensions and assuming payment of all appropriate maintenance, renewal, annuity, and other governmental fees.
Any of the foregoing consequences could seriously harm our business and our financial results. United States health care reform Changes in healthcare policy could increase our costs and subject us to additional regulatory requirements that may interrupt commercialization of our current and future solutions.
Any of the foregoing consequences could seriously harm our business and our financial results. U.S. health care reform Changes in healthcare policy could increase our costs and subject us to additional regulatory requirements that may interrupt commercialization of our current and future solutions.
Class I devices are those for which safety and effectiveness can be reasonably assured by adherence to the FDA’s general controls for medical devices, which include compliance with the applicable portions of FDA’s current good manufacturing practices for devices, as reflected in of the Quality System Regulation, or QSR, establishment registration and device listing, reporting of adverse events and malfunctions, and appropriate, truthful and non-misleading labeling and promotional materials.
Class I devices are those for which safety and effectiveness can be reasonably assured by adherence to the FDA’s general controls for medical devices, which include compliance with the applicable portions of FDA’s current good manufacturing practices for devices, as reflected in the FDA's QMSR, establishment registration and device listing, reporting of adverse events and malfunctions, and appropriate, truthful and non-misleading labeling and promotional materials.
Our policy is to seek to protect our proprietary position by, among other methods, pursuing and obtaining patent protection in the United States and in jurisdictions outside of the United States related to our technology, inventions, improvements and products that are important to the development and implementation of our business.
Our policy is to seek to protect our proprietary position by, among other methods, pursuing and obtaining patent protection in the U.S. and in jurisdictions outside of the U.S. related to our technology, inventions, improvements and products that are important to the development and implementation of our business.
Government regulation Our products and operations are subject to extensive and ongoing regulation by the FDA under the Federal Food, Drug, and Cosmetic Act, (the “FDCA”) and its implementing regulations, as well as other federal, state and local regulatory authorities in the United States, as well as foreign regulatory authorities.
Government regulation Our products and operations are subject to extensive and ongoing regulation by the FDA under the Federal Food, Drug, and Cosmetic Act, (the “FDCA”) and its implementing regulations, as well as other federal, state and local regulatory authorities in the U.S., as well as foreign regulatory authorities.
In the United States, a healthcare payor (primarily Centers for Medicare and Medicaid Services (“CMS”)) typically provides reimbursement for a conventional cataract procedure of approximately $500 for a surgeon fee and approximately $1,000 for a facility fee, which includes the cost of a conventional monofocal IOL.
In the U.S., a healthcare payor (primarily Centers for Medicare and Medicaid Services (“CMS”)) typically provides reimbursement for a conventional cataract procedure of approximately $500 for a surgeon fee and approximately $1,000 for a facility fee, which includes the cost of a conventional monofocal IOL.
Our commercial efforts began in 2019 and have been primarily focused in the United States, where we are building a “razor and razor blade” business model to drive new customer adoption and ongoing LAL volume growth.
Our commercial efforts began in 2019, and have been primarily focused in the U.S., where we are building a “razor and razor blade” business model to drive new customer adoption and ongoing LAL volume growth.
The United States and some foreign jurisdictions are considering or have enacted a number of legislative and regulatory proposals to change the healthcare system in ways that could affect our ability to sell our products profitably.
The U.S. and some foreign jurisdictions are considering or have enacted a number of legislative and regulatory proposals to change the healthcare system in ways that could affect our ability to sell our products profitably.
The Acrysof and Tecnis families of IOLs are available in a monofocal Toric, multifocal Toric and EDOF Toric versions. The PC and Toric versions of these lenses represented over half of all premium multifocal IOLs sold in 2024. The rest of the market is shared between several smaller companies each with under 5% market share.
The Acrysof and Tecnis families of IOLs are available in a monofocal Toric, multifocal Toric and EDOF Toric versions. The Presbyopia-Correcting and Toric versions of these lenses represented over half of all premium multifocal IOLs sold in 2025. The rest of the market is shared between several smaller companies each with under 5% market share.
Generally, clinical trials for a significant risk device may begin once the IDE application is approved by the FDA and the study protocol and informed consent are approved by appropriate institutional review boards at the clinical trial sites.
Generally, clinical trials for a significant risk device may begin once the IDE application is approved by the FDA and the study protocol and informed consent are approved by appropriate institutional review boards for each clinical trial site.
In the United States, Medicare and private insurers typically cover the full cost of spherical IOL procedures, while premium IOL procedures require patients to pay an incremental out-of-pocket fee, typically ranging from $2,000 to $5,000 per eye depending on the specific premium IOL used.
In the U.S., Medicare and private insurers typically cover the full cost of spherical monofocal IOL procedures, while premium IOL procedures require patients to pay an incremental out-of-pocket fee, typically ranging from $2,000 to $5,000 per eye depending on the specific premium IOL used.
Our LDD is a UV projector medical device, which consists of an anterior segment biomicroscope, computer controllers for performing light treatments, and a biometrically designed patient interface and table. The optics are bonded into their mounts using epoxies, which are then oven cured, assembled into the main optical housing and optimized on a proprietary precision alignment station.
Our LDD is a UV projector medical device, which consists of an anterior segment biomicroscope, computer controllers for performing light treatments, and a biometrically designed patient interface and table. The optics are bonded into their mounts using epoxies, which are then oven cured, and are assembled into the main optical housing.
As a result, the coverage determination process can require manufacturers to provide additional support for the use of a product to each payor separately. This can be a time-consuming process, with no assurance that the dual aspect model will be applied consistently.
As a result, the coverage determination process can require manufacturers to provide additional support for the use of a product to each payor separately. This can be a time-consuming process, with no assurance that the dual aspect model will be applied consistently. 11 Reimbursement outside of the U.S.
Among policy makers and payors in the United States and elsewhere, there is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs, improving quality or expanding access.
Among policy makers and payors in the U.S. and elsewhere, there is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs, improving quality or expanding access.
This method would require a different billing methodology by us than is currently used in the United States, where light treatments are included with the purchase of the LAL.
This method would require a different billing methodology by us than is currently used in the U.S., where light treatments are included with the purchase of the LAL.
We are currently focused on driving awareness and penetration of our RxSight system in the premium cataract market, and primarily concentrating our near-term commercial efforts on the United States.
We are currently focused on driving awareness and penetration of our RxSight system in the premium cataract market, and primarily concentrating our near-term commercial efforts on the U.S.
Research and development expenses were $34.4 million, $29.1 million and $26.0 million for the years ended December 31, 2024, 2023 and 2022 respectively. Manufacturing and supply We currently manufacture, assemble, test, and ship our LAL and LDD in Aliso Viejo, California at our campus of four facilities which consist of an aggregate of approximately 150,000 total square feet.
Research and development expenses were $38.5 million, $34.4 million and $29.1 million for the years ended December 31, 2025, 2024 and 2023, respectively. Manufacturing and supply We currently manufacture, assemble, test, and ship our LAL and LDD in Aliso Viejo, California at our campus of five facilities which consist of an aggregate of approximately 150,000 total square feet.
In a recent RxSight customer survey conducted by Haffey & Company, 92% of doctors said they thought our RxSight system delivered the highest quality vision, 97% said they would recommend the LAL to others and 82% said they would select it for their own eyes.
In a recent RxSight customer survey conducted by Haffey & Company, 90% of doctors said they thought our RxSight system delivered the highest quality vision, 96% said they would recommend the LAL to others and 79% said they would select it for their own eyes.
Our RxSight system has regulatory approval in the U.S., Europe, Canada, Mexico and Korea. We may selectively pursue commercial expansion outside the United States, with a priority on markets where we see significant potential growth opportunities. New approvals may also be sought in large cataract markets with more complex regulatory environments such as Asia and Europe.
Our RxSight system has regulatory approval in the U.S., Europe, Canada, Mexico, Singapore, Australia and South Korea. We may selectively pursue commercial expansion outside the U.S., with a priority on markets where we see significant potential growth opportunities. New approvals may also be sought in large cataract markets with more complex regulatory environments.
As of February 7 th , 2025, the PAS was accepted by the FDA and they stated that “we fulfilled our Post Approval Study requirements.” The PAS subjects were randomized in a 2:1 ratio to receive either the LAL or a monofocal IOL. Study subjects were followed for six months.
As of February 7 th , 2025, the PAS was accepted by the FDA fulfilling our Post Approval Study requirements.” The PAS subjects were randomized in a 2:1 ratio to receive either the LAL or a monofocal IOL. Study subjects were followed for six months.
Our RxSight system has been shown to deliver excellent visual outcomes across a broad range of patient types and preferences. In our 2024 RxSight customer survey, 92% of respondents said they thought our RxSight system delivered the highest quality vision, 97% said they would recommend the LAL to others and 82% said they would select it for their own eyes.
Our RxSight system has been shown to deliver excellent visual outcomes across a broad range of patient types and preferences. In our 2025 RxSight customer survey, 90% of respondents said they thought our RxSight system delivered the highest quality vision, 96% said they would recommend the LAL to others and 78% said they would select it for their own eyes.
The growth of our business and sales organization and our expansion outside of the United States may increase the potential of violating these laws or our internal policies and procedures.
The growth of our business and sales organization and our expansion outside of the U.S. may increase the potential of violating these laws or our internal policies and procedures.
If the FDA disagrees with a manufacturer’s determination regarding whether a new premarket submission is required for the modification of an existing device, the FDA can require the manufacturer to cease marketing and/or recall the modified device until 510(k) clearance or approval of a PMA application is obtained. The manufacturer may also be subject to significant regulatory fines or penalties.
If the FDA disagrees with a manufacturer’s determination regarding whether a new premarket submission is required for the modification of an existing device, the FDA can require the manufacturer to cease marketing and/or recall the modified device until 510(k) clearance or approval of a PMA application is obtained.
No. 10,874,505, which is estimated to expire in 2033, and U.S. Pat. No. 11,266,495, which is estimated to expire in 2039. • Our LDD: Some of the patents directed to our LDD include, for example, U.S. Pat. No. 10,864,075, which is estimated to expire in 2038, and U.S. Pat.
No. 11,266,495, which is estimated to expire in 2039 and U.S. Pat. No. 12,102,524, which is estimated to expire in 2039. • Our LDD: Some of the patents directed to our LDD include, for example, U.S. Pat. No. 10,864,075, which is estimated to expire in 2038, and U.S. Pat.
Court of Appeals for the 5th Circuit upheld the District Court ruling that the individual mandate was unconstitutional and remanded the case back to the District Court to determine whether the remaining provisions of the ACA are invalid as well.
Court of Appeals for the 5th Circuit upheld the District Court ruling that the individual mandate was unconstitutional and remanded the case back to the District Court to determine whether the remaining provisions of the ACA are invalid as well. On March 2, 2020, the U.S.
Item 1. Business Overview We are a commercial-stage medical technology company dedicated to improving the vision of patients following cataract surgery. Our proprietary RxSight ® Light Adjustable Lens system (“RxSight system”) is the first and only commercially available premium cataract technology that enables doctors to customize and optimize visual acuity for patients after surgery.
Item 1. Business Overview RxSight, Inc. is a commercial-stage medical technology company dedicated to providing high-quality customized vision to patients following cataract surgery. Our proprietary RxSight ® Light Adjustable Lens system (“RxSight system”) is the first and only commercially available premium cataract technology that enables doctors to customize and optimize visual acuity for patients after surgery.
The most popular premium IOLs families approved for cataract treatment are toric and multifocal Acrysof and Tecnis IOL models. According to the Market Scope 2024 Premium Report Alcon and Johnson & Johnson are two of the top IOL manufacturers, with an estimated 2024 revenue share of the world-wide premium IOL market of approximately 44%, 24%, and 7% respectively.
The most popular premium IOLs families approved for cataract treatment are toric and multifocal Acrysof and Tecnis IOL models. According to the Market Scope 2025 Premium Cataract Surgery Market Report Alcon and Johnson & Johnson are two of the top IOL manufacturers, with an estimated 2025 revenue share of the world-wide premium IOL market of approximately 45% and 27%, respectively.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeAny provision of our amended and restated certificate of incorporation, amended and restated bylaws or Delaware law that has the effect of delaying or preventing a change in control could limit the opportunity for our stockholders to receive a premium for their shares of our capital stock and could also affect the price that some investors are willing to pay for our common stock. 76 Our bylaws provide that, unless the company consents in writing to an alternative forum, the Court of Chancery of the State of Delaware will be the exclusive forum for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
Biggest changeAny provision of our amended and restated certificate of incorporation, amended and restated bylaws or Delaware law that has the effect of delaying or preventing a change in control could limit the opportunity for our stockholders to receive a premium for their shares of our capital stock and could also affect the price that some investors are willing to pay for our common stock.
Additionally, the FDA’s clinical trial requirements, including the adequacy of the patient population studied and statistical powering, must be met. In addition, such foreign trials are subject to the applicable local laws of the foreign jurisdictions where the trials are conducted.
Additionally, the FDA’s clinical trial requirements, including the adequacy of the patient population studied and statistical powering, must be met. In addition, such foreign clinical trials are subject to the applicable local laws of the foreign jurisdictions where the clinical trials are conducted.
In addition, even if such clinical trials are successfully completed, we cannot guarantee that the FDA or foreign regulatory authorities will interpret the results as we do, and more trials could be required before we submit our products for approval.
In addition, even if such clinical trials are successfully completed, we cannot guarantee that the FDA or foreign regulatory authorities will interpret the results as we do, and more clinical trials could be required before we submit our products for approval.
Our business processes personal data, including some data related to health. When conducting clinical trials, we face risks associated with collecting trial participants’ data, especially health data, in a manner consistent with applicable laws and regulations, such as the Common Rule (“GCP”) guidelines, or FDA human subject protection regulations.
Our business processes personal data, including some data related to health. When conducting clinical trials, we face risks associated with collecting clinical trial participants’ data, especially health data, in a manner consistent with applicable laws and regulations, such as the Common Rule (“GCP”) guidelines, or FDA human subject protection regulations.
Risks related to reliance on third parties From time to time, we engage outside parties to perform services related to certain of our clinical studies and trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval for or commercialize our products.
Risks related to reliance on third parties From time to time, we engage outside parties to perform services related to certain of our clinical studies and clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval for or commercialize our products.
For example, the loss, corruption, or unavailability of preclinical study or clinical trial data from completed, ongoing, or planned trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data.
For example, the loss, corruption, or unavailability of preclinical study or clinical trial data from completed, ongoing, or planned clinical trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data.
Even if we are able to raise awareness, 31 doctors tend to be slow in changing their medical treatment practices and may be hesitant to select our products for recommendation to their patients for a variety of reasons, including: • long-standing relationships with competing companies and distributors that sell other products; • competitive response and negative selling efforts from providers of alternative products; • lack of experience with our products and concerns that we are relatively new to market; • lack or perceived lack of sufficient clinical evidence, including long-term data, supporting safety or clinical benefits; • time commitment and skill development that may be required to gain familiarity and proficiency with our products; • patient confusion regarding the wide range of commercially available premium IOL offerings and their ability to deliver promised results at near, middle and far distances without reliance on glasses; • patient reticence to select a premium IOL due to nonperformance and adverse side effects associated with competing products in the market; • patient non-compliance with the RxSight system requirement to wear protective glasses following surgery until the LAL is locked to avoid UV exposure and an unintended change to the LAL, resulting in patient dissatisfaction with the results and possible need to remove the LAL; and • an inability to generate patient referral due to dissatisfaction with results obtained through treatment with our products, the out-of-pocket cost of treatments using our products or otherwise.
Even if we are able to raise awareness, doctors tend to be slow in changing their medical treatment practices and may be hesitant to select our products for recommendation to their patients for a variety of reasons, including: • long-standing relationships with competing companies and distributors that sell other products; • competitive response and negative selling efforts from providers of alternative products; • lack of experience with our products and concerns that we are relatively new to market; • lack or perceived lack of sufficient clinical evidence, including long-term data, supporting safety or clinical benefits; • time commitment and skill development that may be required to gain familiarity and proficiency with our products; • patient confusion regarding the wide range of commercially available premium IOL offerings and their ability to deliver promised results at near, middle and far distances without reliance on glasses; • patient reticence to select a premium IOL due to nonperformance and adverse side effects associated with competing products in the market; • patient non-compliance with the RxSight system requirement to wear protective glasses following surgery until the LAL is locked to avoid UV exposure and an unintended change to the LAL, resulting in patient dissatisfaction with the results and possible need to remove the LAL; and • an inability to generate patient referral due to dissatisfaction with results obtained through treatment with our products, the out-of-pocket cost of treatments using our products or otherwise.
The FDA can delay, limit or deny clearance or approval of a device for many reasons, including: • our inability to demonstrate to the satisfaction of the FDA or the applicable regulatory entity or notified body that our products are safe or effective for their intended uses; • the disagreement of the FDA or the applicable foreign regulatory body with the design, conduct or implementation of our clinical trials or the analyses or interpretation of data from pre-clinical studies or clinical trials; • serious and unexpected adverse device effects experienced by participants in our clinical trials; • the data from our pre-clinical studies and clinical trials may be insufficient to support clearance or approval, where required; • our inability to demonstrate that the clinical and other benefits of the device outweigh the risks; • an advisory committee, if convened by the applicable regulatory authority, may recommend against approval of our application or may recommend that the applicable regulatory authority require, as a condition of approval, additional preclinical studies or clinical trials, limitations on approved labeling or distribution and use restrictions, or even if an advisory committee, if convened, makes a favorable recommendation, the respective regulatory authority may still not approve the product; • the applicable regulatory authority may identify significant deficiencies in our manufacturing processes, facilities or analytical methods or those of our third-party contract manufacturers; • the potential for approval policies or regulations of the FDA or applicable foreign regulatory bodies to change significantly in a manner rendering our clinical data or regulatory filings insufficient for clearance or approval; and 57 • the FDA or foreign regulatory authorities may audit our clinical trial data and conclude that the data is not sufficiently reliable to support approval or clearance.
The FDA can delay, limit or deny clearance or approval of a device for many reasons, including: • our inability to demonstrate to the satisfaction of the FDA or the applicable regulatory entity or notified body that our products are safe or effective for their intended uses; • the disagreement of the FDA or the applicable foreign regulatory body with the design, conduct or implementation of our clinical trials or the analyses or interpretation of data from pre-clinical studies or clinical trials; • serious and unexpected adverse device effects experienced by participants in our clinical trials; • the data from our pre-clinical studies and clinical trials may be insufficient to support clearance or approval, where required; • our inability to demonstrate that the clinical and other benefits of the device outweigh the risks; • an advisory committee, if convened by the applicable regulatory authority, may recommend against approval of our application or may recommend that the applicable regulatory authority require, as a condition of approval, additional preclinical studies or clinical trials, limitations on approved labeling or distribution and use restrictions, or even if an advisory committee, if convened, makes a favorable recommendation, the respective regulatory authority may still not approve the product; • the applicable regulatory authority may identify significant deficiencies in our manufacturing processes, facilities or analytical methods or those of our third-party contract manufacturers; • the potential for approval policies or regulations of the FDA or applicable foreign regulatory bodies to change significantly in a manner rendering our clinical data or regulatory filings insufficient for clearance or approval; and • the FDA or foreign regulatory authorities may audit our clinical trial data and conclude that the data is not sufficiently reliable to support approval or clearance.
These provisions, among other things: • establish a classified Board of Directors so that not all members of our board are elected at one time; • permit only the Board of Directors to establish the number of directors and fill vacancies on the board; • provide that directors may only be removed “for cause” and only with the approval of two-thirds of our stockholders; • authorize the issuance of “blank check” preferred stock that our board could use to implement a stockholder rights plan (also known as a poison pill); • eliminate the ability of our stockholders to call special meetings of stockholders; • prohibit stockholder action by written consent, which requires all stockholder actions to be taken at a meeting of our stockholders; • prohibit cumulative voting; • authorize our Board of Directors to amend the bylaws; • establish advance notice requirements for nominations for election to our board or for proposing matters that can be acted upon by stockholders at annual stockholder meetings; and • require a super-majority vote of stockholders to amend some provisions described above.
These provisions, among other things: • establish a classified Board of Directors so that not all members of our board are elected at one time; • permit only the Board of Directors to establish the number of directors and fill vacancies on the board; • provide that directors may only be removed “for cause” and only with the approval of two-thirds of our stockholders; 71 • authorize the issuance of “blank check” preferred stock that our board could use to implement a stockholder rights plan (also known as a poison pill); • eliminate the ability of our stockholders to call special meetings of stockholders; • prohibit stockholder action by written consent, which requires all stockholder actions to be taken at a meeting of our stockholders; • prohibit cumulative voting; • authorize our Board of Directors to amend the bylaws; • establish advance notice requirements for nominations for election to our board or for proposing matters that can be acted upon by stockholders at annual stockholder meetings; and • require a super-majority vote of stockholders to amend some provisions described above.
We may experience numerous unforeseen events during, or because of, the clinical trial process that could delay or prevent us from receiving regulatory clearance or approval for new products, modifications of existing products, or new indications for existing products, including: • successful and timely completion of nonclinical studies or clinical development of our products, as well as the associated costs, including any unforeseen costs we may incur as a result of clinical trial delays; • enrollment in our clinical trials may be slower than we anticipate, or we may experience high screen failure rates in our clinical trials, resulting in significant delays; • our clinical trials may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional clinical and/or preclinical testing which may be expensive and time-consuming; • trial results may not meet the level of statistical significance required by the FDA or other regulatory authorities; • the FDA or similar foreign regulatory authorities may find that one or more of our products is not sufficiently safe for investigational use in humans; • the FDA or similar foreign regulatory authorities may interpret data from preclinical testing and clinical trials in different ways than we do; • there may be delays or failure in obtaining approval of our clinical trial protocols from the FDA or other regulatory authorities; • there may be delays in obtaining institutional review board approvals or governmental approvals to conduct clinical trials at prospective sites; 35 • the FDA or similar foreign regulatory authorities may find our or our suppliers’ manufacturing processes or facilities unsatisfactory; • the FDA or similar foreign regulatory authorities may change their review policies or adopt new regulations that may negatively affect or delay our ability to bring a product to market or receive approvals or clearances to treat new indications; • we may have trouble in managing multiple clinical sites; • we may have trouble finding patients to enroll in our trials; • we may experience delays in agreeing on acceptable terms with third-party research organizations and trial sites that may help us conduct the clinical trials; and • we, or regulators, may suspend or terminate our clinical trials because the participating patients are being exposed to unacceptable health risks.
We may experience numerous unforeseen events during, or because of, the clinical trial process that could delay or prevent us from receiving regulatory clearance or approval for new products, modifications of existing products, or new indications for existing products, including: • successful and timely completion of nonclinical studies or clinical development of our products, as well as the associated costs, including any unforeseen costs we may incur as a result of clinical trial delays; • enrollment in our clinical trials may be slower than we anticipate, or we may experience high screen failure rates in our clinical trials, resulting in significant delays; • our clinical trials may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional clinical and/or preclinical testing which may be expensive and time-consuming; • clinical trial results may not meet the level of statistical significance required by the FDA or other regulatory authorities; • the FDA or similar foreign regulatory authorities may find that one or more of our products is not sufficiently safe for investigational use in humans or may interpret data from preclinical testing and clinical trials in different ways than we do; • there may be delays or failure in obtaining approval of our clinical trial protocols from the FDA or other regulatory authorities; • there may be delays in obtaining institutional review board approvals or governmental approvals to conduct clinical trials at prospective sites; • the FDA or similar foreign regulatory authorities may find our or our suppliers’ manufacturing processes or facilities unsatisfactory; • the FDA or similar foreign regulatory authorities may change their review policies or adopt new regulations that may negatively affect or delay our ability to bring a product to market or receive approvals or clearances to treat new indications; 33 • we may have trouble in managing multiple clinical sites; or • may have trouble finding patients to enroll in our clinical trials; • we may experience delays in agreeing on acceptable terms with third-party research organizations and clinical trial sites that may help us conduct the clinical trials; and • we, or regulators, may suspend or terminate our clinical trials because the participating patients are being exposed to unacceptable health risks.
Collaborations are subject to numerous risks, which may include that: • collaborators have significant discretion in determining the efforts and resources that they will apply to collaborations; • collaborators may not pursue development and commercialization of our products or may elect not to continue or renew development or commercialization programs based on trial or test results, changes in their strategic focus due to the acquisition of competitive products, availability of funding or other external factors, such as a business combination that diverts resources or creates competing priorities; • collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our current and future products; • a collaborator with marketing, manufacturing and distribution rights to one or more products may not commit sufficient resources to or otherwise not perform satisfactorily in carrying out these activities; • we could grant exclusive rights to our collaborators that would prevent us from collaborating with others; • collaborators may not properly maintain or defend our intellectual property rights or may use our intellectual property or proprietary information in a way that gives rise to actual or threatened litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential liability; • disputes may arise between us and a collaborator that causes the delay or termination of the research, development or commercialization of our current or future products or that results in costly litigation or arbitration that diverts management attention and resources; • collaborations may be terminated, and, if terminated, may result in a need for additional capital to pursue further development or commercialization of the applicable current or future products; 52 • collaborators may own or co-own intellectual property covering our products that results from our collaborating with them, and in such cases, we would not have the exclusive right to develop or commercialize such intellectual property; and • a collaborator’s sales and marketing activities or other operations may not be in compliance with applicable laws resulting in civil or criminal proceedings.
Collaborations are subject to numerous risks, which may include that: • collaborators have significant discretion in determining the efforts and resources that they will apply to collaborations; • collaborators may not pursue development and commercialization of our products or may elect not to continue or renew development or commercialization programs based on clinical trial or test results, changes in their strategic focus due to the acquisition of competitive products, availability of funding or other external factors, such as a business combination that diverts resources or creates competing priorities; • collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our current and future products; • a collaborator with marketing, manufacturing and distribution rights to one or more products may not commit sufficient resources to or otherwise not perform satisfactorily in carrying out these activities; • we could grant exclusive rights to our collaborators that would prevent us from collaborating with others; • collaborators may not properly maintain or defend our intellectual property rights or may use our intellectual property or proprietary information in a way that gives rise to actual or threatened litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential liability; • disputes may arise between us and a collaborator that causes the delay or termination of the research, development or commercialization of our current or future products or that results in costly litigation or arbitration that diverts management attention and resources; • collaborations may be terminated, and, if terminated, may result in a need for additional capital to pursue further development or commercialization of the applicable current or future products; • collaborators may own or co-own intellectual property covering our products that results from our collaborating with them, and in such cases, we would not have the exclusive right to develop or commercialize such intellectual property; and • a collaborator’s sales and marketing activities or other operations may not be in compliance with applicable laws resulting in civil or criminal proceedings.
For example, the GDPR, which was adopted by the EU and became effective in May 2018, applies extraterritorially and imposes several stringent requirements for controllers and processors of personal data, including, for example, higher standards for obtaining consent from individuals to process their personal data, more robust disclosures to individuals and a strengthened individual data rights regime, shortened timelines for data breach notifications, limitations on retention of information, increased requirements pertaining to special categories of personal data and pseudonymized (i.e., key-coded) data and additional obligations when we contract third-party processors in connection with the processing of the personal data.
For example, the GDPR, 65 which was adopted by the EU and became effective in May 2018, applies extraterritorially and imposes several stringent requirements for controllers and processors of personal data, including, for example, higher standards for obtaining consent from individuals to process their personal data, more robust disclosures to individuals and a strengthened individual data rights regime, shortened timelines for data breach notifications, limitations on retention of information, increased requirements pertaining to special categories of personal data and pseudonymized (i.e., key-coded) data and additional obligations when we contract third-party processors in connection with the processing of the personal data.
Any disruption, degradation, or other security breach, incident, or other event that results in loss or unavailability of or damage to our data or systems, system downtime or other disruptions, or in inappropriate disclosure or other processing of confidential or personal data, could adversely impact us and our customers, potentially resulting in, among other things, financial losses, loss of customers or business, our inability to transact business, adverse impact on our reputation, actual or alleged violations of applicable privacy, data protection, security and other laws, regulatory fines, penalties, litigation, reputational damage, reimbursement, or additional compliance and regulatory costs.
Any disruption, degradation, or other security breach, incident, or other event that results in loss or unavailability of or damage to our data or systems, system downtime or other disruptions, or in inappropriate disclosure or other processing of confidential or personal data, could adversely impact us and our customers, potentially resulting in, among other things, financial losses, loss of customers or business, our inability to transact business, 34 adverse impact on our reputation, actual or alleged violations of applicable privacy, data protection, security and other laws, regulatory fines, penalties, litigation, reputational damage, reimbursement, or additional compliance and regulatory costs.
Our future liquidity and capital funding requirements will depend on numerous factors, including: • our sales growth; • our research and development efforts; • our sales and marketing activities; • our success in leveraging future strategic partnerships; • working capital investments, primarily in inventories and accounts receivable; • our ability to borrow or raise additional funds through future debt or equity offerings to finance our operations; • the outcome, costs and timing of any clinical trial results for our current or future products; • the emergence and effect of competing or complementary products; • the availability and amount of reimbursement for procedures using our products; • our ability to maintain, expand, enforce and defend our intellectual property portfolio, including the amount and timing of any payments we may be required to make, or that we may receive, in connection with the licensing, filing, prosecution, maintenance, defense and enforcement of any patents or other intellectual property rights; 28 • our ability to retain our current employees and the need and ability to hire additional management, sales, research and development, scientific and customer support personnel; • the terms and timing of any collaborative, licensing or other arrangements that we have or may establish; • operating and finance lease payments for our facilities; and • the extent to which we acquire or invest in businesses, products or technologies.
Our future liquidity and capital funding requirements will depend on numerous factors, including: • our sales growth; • our research and development efforts; • our sales and marketing activities; • our success in leveraging future strategic partnerships; • working capital investments, primarily in inventories and accounts receivable; • our ability to borrow or raise additional funds through future debt or equity offerings to finance our operations; • the outcome, costs and timing of any clinical trial results for our current or future products; • the emergence and effect of competing or complementary products; • the availability and amount of reimbursement for procedures using our products; • our ability to maintain, expand, enforce and defend our intellectual property portfolio, including the amount and timing of any payments we may be required to make, or that we may receive, in connection with the licensing, filing, prosecution, maintenance, defense and enforcement of any patents or other intellectual property rights; • our ability to retain our current employees and the need and ability to hire additional management, sales, research and development, scientific and customer support personnel; • the terms and timing of any collaborative, licensing or other arrangements that we have or may establish; • operating and finance lease payments for our facilities; and 25 • the extent to which we acquire or invest in businesses, products or technologies.
Regardless of the merits or eventual outcome, liability claims may result in: • decreased demand for our products; • injury to our reputation; • initiation of investigations by regulators; • costs to defend the related litigation; • a diversion of management’s time and our resources; • substantial monetary awards to trial participants or patients; • product recalls, withdrawals or labeling, marketing or promotional restrictions; • loss of revenue; • exhaustion of any available insurance and our capital resources; and • the inability to market and sell our products.
Regardless of the merits or eventual outcome, liability claims may result in: • decreased demand for our products; • injury to our reputation; • initiation of investigations by regulators; • costs to defend the related litigation; • a diversion of management’s time and our resources; • substantial monetary awards to clinical trial participants or patients; • product recalls, withdrawals or labeling, marketing or promotional restrictions; • loss of revenue; • exhaustion of any available insurance and our capital resources; and • the inability to market and sell our products.
Major changes include: • reclassification of some products; • greater emphasis on clinical data; • data transparency, including publication of clinical trial data and safety summaries; • defined content and structure for technical files to support registration; • unique device identification system; • greater burden on post-market surveillance and clinical follow-up; • reduction of adverse event reporting time from 30 to 15 days after the event; • delayed review times; and • more power to notified bodies.
Major changes include: • reclassification of some products; • greater emphasis on clinical data; • data transparency, including publication of clinical trial data and safety summaries; • defined content and structure for technical files to support registration; • unique device identification system; • greater burden on post-market surveillance and clinical follow-up; • reduction of adverse event reporting time from 30 to 15 days after the event; • delayed review times; and 62 • more power to notified bodies.
We have a 63 compliance program, a Code of Conduct and associated policies and procedures, but it is not always possible to identify and deter misconduct by our employees and other third parties, and the precautions we take to detect and prevent noncompliance may not be effective in protecting us from governmental investigations for failure to comply with applicable fraud and abuse or other healthcare laws and regulations.
We have a compliance program, a Code of Conduct and associated policies and procedures, but it is not always possible to identify and deter misconduct by our employees and other third parties, and the precautions we take to detect and prevent noncompliance may not be effective in protecting us from governmental investigations for failure to comply with applicable fraud and abuse or other healthcare laws and regulations.
Any violation of the FCPA or other applicable anti-bribery, anti-corruption or anti-money laundering laws could result in whistleblower complaints, adverse media coverage, investigations, loss of export privileges, severe criminal or civil sanctions and, in the case of the FCPA, 71 suspension or debarment from U.S. government contracts, which could have a material and adverse effect on our business, financial condition and results of operations.
Any violation of the FCPA or other applicable anti-bribery, anti-corruption or anti-money laundering laws could result in whistleblower complaints, adverse media coverage, investigations, loss of export privileges, severe criminal or civil sanctions and, in the case of the FCPA, suspension or debarment from U.S. government contracts, which could have a material and adverse effect on our business, financial condition and results of operations.
If we fail these inspections or fail to meet these regulatory standards, it could have a material adverse effect on our business, financial condition and results of operations. 72 We depend upon third parties, including single and sole source suppliers, to manufacture certain components and subcomponents of the RxSight system making us vulnerable to supply disruptions and price fluctuations.
If we fail these inspections or fail to meet these regulatory standards, it could have a material adverse effect on our business, financial condition and results of operations. We depend upon third parties, including single and sole source suppliers, to manufacture certain components and subcomponents of the RxSight system making us vulnerable to supply disruptions and price fluctuations.
Our certificate of incorporation authorizes our Board of Directors, without the approval of our stockholders, to issue shares of our preferred stock, subject to limitations prescribed by applicable law, rules and regulations and the provisions of our amended and restated certificate of incorporation, as shares of preferred stock in series, to establish from time to time the number of shares to be included in each such series and to fix the designation, powers, preferences and rights of the shares of each such 77 series and the qualifications, limitations or restrictions thereof.
Our certificate of incorporation authorizes our Board of Directors, without the approval of our stockholders, to issue shares of our preferred stock, subject to limitations prescribed by applicable law, rules and regulations and the provisions of our amended and restated certificate of incorporation, as shares of preferred stock in series, to establish from time to time the number of shares to be included in each such series and to fix the designation, powers, preferences and rights of the shares of each such series and the qualifications, limitations or restrictions thereof.
Our continued success depends on our ability to: • continue to develop innovative, proprietary products that address significant clinical needs in a manner that is safe and effective for patients and easy-to-use for doctors; • obtain and maintain regulatory clearances or approvals; • demonstrate safety and effectiveness in our sponsored and third-party clinical trials; • expand our sales force across key markets to increase doctors’ awareness; • obtain and maintain coverage and adequate reimbursement for procedures using our products; • attract and retain skilled research, development, sales and clinical personnel; • cost-effectively manufacture, market and sell our products; • provide doctors with a sufficient return on investment as compared to alternative premium IOL procedures that justifies the upfront cost of our LDD; and • obtain, maintain, enforce and defend our intellectual property rights and operate our business without infringing, misappropriating or otherwise violating the intellectual property rights of others.
Our continued success depends on our ability to: • continue to develop innovative, proprietary products that address significant clinical needs in a manner that is safe and effective for patients and easy-to-use for doctors; • obtain and maintain regulatory clearances or approvals; • demonstrate safety and effectiveness in our sponsored and third-party clinical trials; • expand our sales and clinical teams across key markets to increase doctors’ awareness; • obtain and maintain coverage and adequate reimbursement for procedures using our products; • attract and retain skilled research, development, sales and clinical personnel; • cost-effectively manufacture, market and sell our products; • provide doctors with a sufficient return on investment as compared to alternative premium IOL procedures that justifies the upfront cost of our LDD; and • obtain, maintain, enforce and defend our intellectual property rights and operate our business without infringing, misappropriating or otherwise violating the intellectual property rights of others.
Delays in product introductions could have a material adverse effect on our business, financial condition and results of operations. In addition, many medical device companies are consolidating to create new companies with greater market power. As the medical device industry consolidates, competition to provide goods and services to industry participants will become more intense.
Delays in product introductions could have a material adverse effect on our business, financial condition and results of operations. 30 In addition, many medical device companies are consolidating to create new companies with greater market power. As the medical device industry consolidates, competition to provide goods and services to industry participants will become more intense.
Our network security controls are comprised of administrative, physical and technical controls, which include, but are not limited to, the implementation of firewalls, anti-virus protection, patches, log monitors, routine 36 backups, off-site storage, network audits and other routine updates and modifications. We also routinely monitor and develop our internal information technology systems to address risks to our information systems.
Our network security controls are comprised of administrative, physical and technical controls, which include, but are not limited to, the implementation of firewalls, anti-virus protection, patches, log monitors, routine backups, off-site storage, network audits and other routine updates and modifications. We also routinely monitor and develop our internal information technology systems to address risks to our information systems.
While we have conducted diligence with respect to such acquisitions, because we did not participate in the development or prosecution of much of the acquired intellectual property, we cannot guarantee that our diligence efforts identified and/or remedied all issues related to such intellectual property, including potential ownership errors, potential errors during prosecution of such intellectual property, and potential encumbrances that could limit our ability to enforce such intellectual property rights.
While we have conducted diligence with respect to such acquisitions, because we did not participate in the development or prosecution of much of the acquired intellectual property, we cannot guarantee that our diligence efforts identified and/or remedied all issues related to such 43 intellectual property, including potential ownership errors, potential errors during prosecution of such intellectual property, and potential encumbrances that could limit our ability to enforce such intellectual property rights.
If the 60 FDA or a comparable foreign regulatory authority disagrees and requires new clearances or approvals for these modifications, we may be required to recall and to stop selling or marketing such products as modified, which could harm our operating results and require us to redesign such products. In these circumstances, we may be subject to significant enforcement actions.
If the FDA or a comparable foreign regulatory authority disagrees and requires new clearances or approvals for these modifications, we may be required to recall and to stop selling or marketing such products as modified, which could harm our operating results and require us to redesign such products. In these circumstances, we may be subject to significant enforcement actions.
For any products that we may develop in the future, complying with these new regulations may result in Europe being less attractive as a “first market” destination. Marketing authorization timelines will become more 66 protracted and the costs of operating in Europe will increase. A significantly more costly path to regulatory compliance is anticipated.
For any products that we may develop in the future, complying with these new regulations may result in Europe being less attractive as a “first market” destination. Marketing authorization timelines will become more protracted and the costs of operating in Europe will increase. A significantly more costly path to regulatory compliance is anticipated.
Moreover, any significant delays in our product launches may significantly impede our ability to enter or compete in a given market and may reduce the sales that we are able to generate from these products. We may experience delays in any phase 33 of a product development, including during research and development, clinical trials, regulatory review, manufacturing and marketing.
Moreover, any significant delays in our product launches may significantly impede our ability to enter or compete in a given market and may reduce the sales that we are able to generate from these products. We may experience delays in any phase of a product development, including during research and development, clinical trials, regulatory review, manufacturing and marketing.
We may not be able to successfully integrate any acquired personnel, operations and technologies, or effectively manage the combined business following an acquisition. Acquisitions could also result in dilutive issuances of equity securities, 38 the use of our available cash, or the incurrence of debt, which could harm our operating results.
We may not be able to successfully integrate any acquired personnel, operations and technologies, or effectively manage the combined business following an acquisition. Acquisitions could also result in dilutive issuances of equity securities, the use of our available cash, or the incurrence of debt, which could harm our operating results.
In addition, the patent prosecution process is expensive, time-consuming and complex, and we may not be able to file, prosecute, maintain, enforce or license all necessary or desirable patent applications at a reasonable cost, in a timely manner, or in all jurisdictions where protection may be commercially advantageous, or we may not be able to protect our intellectual property at all.
In addition, the patent prosecution process is expensive, time-consuming and complex, and we may not be able to file, prosecute, maintain, enforce or license all necessary or desirable patents and patent applications at a reasonable cost, in a timely manner, or in all jurisdictions where protection may be commercially advantageous, or we may not be able to protect our intellectual property at all.
Uncertainties resulting from the initiation and continuation of patent and other intellectual property litigation or other proceedings could have a material adverse effect on our business, financial condition and results of operations. 49 Because of the expense and uncertainty of litigation, we may not be in a position to enforce our intellectual property rights against third parties.
Uncertainties resulting from the initiation and continuation of patent and other intellectual property litigation or other proceedings could have a material adverse effect on our business, financial condition and results of operations. Because of the expense and uncertainty of litigation, we may not be in a position to enforce our intellectual property rights against third parties.
The FDA and the Federal Trade Commission, or FTC, also regulate the advertising, promotion and labeling of our products to ensure that the claims we make are consistent with our regulatory clearances and approvals, that there is adequate and reasonable scientific data to substantiate the claims and that our promotional labeling and advertising is neither false nor misleading in any respect.
The FDA and the Federal Trade Commission, or FTC, also regulate the advertising, promotion and labeling of our products to ensure that the claims we make are consistent with our regulatory clearances and approvals, that there is adequate and 54 reasonable scientific data to substantiate the claims and that our promotional labeling and advertising is neither false nor misleading in any respect.
In addition, such insurance may not be available to us in the future on economically reasonable terms, or at all. Further, our insurance may not cover all claims made against us and could have high deductibles in any event, and defending a suit, regardless of its merit, could be costly and divert management attention.
In addition, such insurance may not be available to us in the future on economically reasonable terms, or at all. Further, our insurance may not cover all 74 claims made against us and could have high deductibles in any event, and defending a suit, regardless of its merit, could be costly and divert management attention.
In any of these types of proceedings, a court or agency with jurisdiction may find our patents invalid, unenforceable or not infringed, in which case, our competitors and other third parties may then be able to market products and use manufacturing and analytical processes that are substantially similar to ours.
In any of these types of proceedings, a court or agency with jurisdiction may find our patents invalid, unenforceable or not 42 infringed, in which case, our competitors and other third parties may then be able to market products and use manufacturing and analytical processes that are substantially similar to ours.
Further, if patents, trademarks, copyrights, or trade secrets are successfully asserted against us, this may harm our business and result in injunctions preventing us from developing, manufacturing, marketing or selling our products, or result in 48 obligations to pay license fees, damages, attorney fees and court costs, which could be significant.
Further, if patents, trademarks, copyrights, or trade secrets are successfully asserted against us, this may harm our business and result in injunctions preventing us from developing, manufacturing, marketing or selling our products, or result in obligations to pay license fees, damages, attorney fees and court costs, which could be significant.
Consequently, a catastrophic event at our current facility or any future facilities could have a material adverse effect on our business, financial condition and results of operations. Furthermore, the current leases on our four facilities expire on January 31, 2031, with two options to extend for five years each.
Consequently, a catastrophic event at our current facility or any future facilities could have a material adverse effect on our business, financial condition and results of operations. Furthermore, the current leases on our facilities expire on January 31, 2031, with two options to extend for five years each.
These unauthorized products may compete with our products in such jurisdictions and take away our market share where 54 we do not have any issued or in-licensed patents and any future patent claims or other intellectual property rights may not be effective or sufficient to prevent them from so competing.
These unauthorized products may compete with our products in such jurisdictions and take away our market share where we do not have any issued or in-licensed patents and any future patent claims or other intellectual property rights may not be effective or sufficient to prevent them from so competing.
If the FDA or any applicable foreign regulatory authority does not accept such data, it would result in the need for additional trials, which would be costly and time-consuming and delay aspects of our business plan, and which may result in our products not receiving approval or clearance for commercialization in the applicable jurisdiction.
If the FDA or any applicable foreign regulatory authority does not accept such data, it would result in the need for additional clinical trials, which would be costly and time-consuming and delay aspects of our business plan, and which may result in our products not receiving approval or clearance for commercialization in the applicable jurisdiction.
We depend on these consultants and clinical investigators to conduct clinical studies and trials and monitor and analyze data from these studies and trials under the investigational plan and protocol for the study or trial and in compliance with applicable regulations and standards, such as GCP guidelines, the Common Rule, and FDA human subject protection regulations.
We depend on 67 these consultants and clinical investigators to conduct clinical studies and trials and monitor and analyze data from these studies and trials under the investigational plan and protocol for the study or trial and in compliance with applicable regulations and standards, such as GCP guidelines, the Common Rule, and FDA human subject protection regulations.
The inability to perform our research, development and manufacturing activities if our facilities become inoperable, combined with our limited inventory of materials and components and manufactured products, may cause doctors to discontinue using our products or harm our reputation, and we may be unable to re-establish relationships with such doctors in the future.
The inability to perform our research, development and manufacturing activities if our facilities 31 become inoperable, combined with our limited inventory of materials and components and manufactured products, may cause doctors to discontinue using our products or harm our reputation, and we may be unable to re-establish relationships with such doctors in the future.
If a regulatory agency discovers previously unknown problems with a product, such as adverse events of unanticipated severity or frequency, or problems with our facility where the product is manufactured or disagrees with the promotion, 59 marketing or labeling of a product, such regulatory agency may impose restrictions on that product or us, including requiring withdrawal of the product from the market.
If a regulatory agency discovers previously unknown problems with a product, such as adverse events of unanticipated severity or frequency, or problems with our facility where the product is manufactured or disagrees with the promotion, marketing or labeling of a product, such regulatory agency may impose restrictions on that product or us, including requiring withdrawal of the product from the market.
To counter infringement or unauthorized use, we may be required to file infringement claims, which can be expensive and time-consuming. Any claims we assert against perceived infringers could provoke these parties to assert counterclaims against us alleging that we infringe their intellectual property or alleging that our intellectual property is invalid or unenforceable.
To counter infringement or unauthorized use, we may be required to file infringement claims, which can be expensive and time-consuming. Any claims we assert against perceived 46 infringers could provoke these parties to assert counterclaims against us alleging that we infringe their intellectual property or alleging that our intellectual property is invalid or unenforceable.
If our potential licensors fail to prosecute, maintain, enforce and defend such patents, or lose rights to those patents or patent applications, the rights we have licensed may be reduced or eliminated, and our right to develop and commercialize any of our products that are subject of such licensed rights could be adversely affected.
If our potential licensors fail to prosecute, maintain, enforce and defend such patents, or lose rights to those patents or 47 patent applications, the rights we have licensed may be reduced or eliminated, and our right to develop and commercialize any of our products that are subject of such licensed rights could be adversely affected.
Further, it is possible that others will independently develop the same or similar technology or otherwise obtain access to our unpatented technology, and in such cases we could not assert any trade secret rights against such parties or those to whom they 53 communicate such trade secrets.
Further, it is possible that others will independently develop the same or similar technology or otherwise obtain access to our unpatented technology, and in such cases we could not assert any trade secret rights against such parties or those to whom they communicate such trade secrets.
If the FDA determines that our promotional materials or training constitute promotion of an off-label or other improper use, or that our internal policies and procedures are inadequate to prevent such off-label uses, it could subject us to regulatory or enforcement actions as discussed below.
If the FDA determines 55 that our promotional materials or training constitute promotion of an off-label or other improper use, or that our internal policies and procedures are inadequate to prevent such off-label uses, it could subject us to regulatory or enforcement actions as discussed below.
With respect to both in-licensed and owned intellectual property, we cannot predict whether the patent applications we and our licensors are currently pursuing will issue as patents in any particular jurisdiction or whether the claims 44 of any issued patents will provide sufficient protection from competitors.
With respect to both in-licensed and owned intellectual property, we cannot predict whether the patent applications we and our licensors are currently pursuing will issue as patents in any particular jurisdiction or whether the claims of any issued patents will provide sufficient protection from competitors.
Any supply interruption from our suppliers or failure to obtain additional suppliers for any of the components or subcomponents used in our products would limit our ability to manufacture our current and new products and could have a material adverse effect on our business, financial condition and results of operations.
Any supply interruption from our suppliers or failure to obtain additional suppliers for any of the 68 components or subcomponents used in our products would limit our ability to manufacture our current and new products and could have a material adverse effect on our business, financial condition and results of operations.
If we fail to obtain, maintain, protect and enforce our intellectual property, third parties may be able to compete more effectively against us, we may lose our technological or competitive advantage, or we may incur substantial litigation costs in our attempts to recover or restrict use of our intellectual property.
If we fail to obtain, maintain, protect and enforce our intellectual property, third parties may be able to compete more effectively against us, we may 41 lose our technological or competitive advantage, or we may incur substantial litigation costs in our attempts to recover or restrict use of our intellectual property.
Obtaining and maintaining regulatory approval of our current and future products in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our current and future products in other jurisdictions. The FDA and other comparable foreign regulatory authorities may not accept data from trials conducted in locations outside of their jurisdiction.
Obtaining and maintaining regulatory approval of our current and future products in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our current and future products in other jurisdictions. The FDA and other comparable foreign regulatory authorities may not accept data from clinical trials conducted in locations outside of their jurisdiction.
To the extent that the results of the trials are not satisfactory to the FDA or foreign regulatory authorities for support of a marketing application, we may be required to expend significant resources, which may not be available to us, to conduct additional trials in support of potential approval of our products.
To the extent that the results of the clinical trials are not satisfactory to the FDA or foreign regulatory authorities for support of a marketing application, we may be required to expend significant resources, which may not be available to us, to conduct additional clinical trials in support of potential approval of our products.
In addition, we may be subject to claims against us even if the apparent injury is due to the actions of others or the pre-existing health of the patient. For example, we rely on doctors in connection with the use of our products on patients.
In addition, we may be 37 subject to claims against us even if the apparent injury is due to the actions of others or the pre-existing health of the patient. For example, we rely on doctors in connection with the use of our products on patients.
Furthermore, our key component suppliers may not currently be or may not continue to be in compliance with applicable regulatory requirements, which may result in manufacturing delays for our products and cause our revenue to decline. The FDA has broad post-market and regulatory enforcement powers.
Furthermore, our key component suppliers may not currently be or may not continue to be in compliance with applicable regulatory requirements, which may result in manufacturing delays for our products and cause our revenue to decline. 58 The FDA has broad post-market and regulatory enforcement powers.
The publication of our privacy policies and other statements that provide notices and representations about privacy, data protection or security can subject us to potential government or legal action if they are found 70 to be deceptive, unfair or misrepresentative of our actual practices.
The publication of our privacy policies and other statements that provide notices and representations about privacy, data protection or security can subject us to potential government or legal action if they are found to be deceptive, unfair or misrepresentative of our actual practices.
Given that our proprietary position is based, in part, on our know-how and trade secrets, a competitor’s discovery of our trade secrets or other unauthorized use or disclosure would impair our competitive position and may have an adverse effect on our business and results of operations.
Given that our proprietary position is based, in part, on our know-how and trade secrets, a competitor’s discovery of our trade secrets or other unauthorized 44 use or disclosure would impair our competitive position and may have an adverse effect on our business and results of operations.
The FDA’s 510(k) clearance process usually takes from three to 12 months but may last longer. The process of obtaining a PMA generally takes from one to three years, or even longer, from the time the PMA is submitted to the FDA until an approval is obtained.
The FDA’s 510(k) clearance process usually takes from three to 12 months but may last longer. The process of obtaining a PMA generally takes from one to three years, or even 53 longer, from the time the PMA is submitted to the FDA until an approval is obtained.
Obtaining foreign approvals could result in significant delays, difficulties and costs for us and require additional trials and additional expenses. Regulatory requirements can vary widely from country to country and could delay the introduction of our products in those countries.
Obtaining foreign approvals could result in significant delays, difficulties and costs for us and require additional clinical trials and additional expenses. Regulatory requirements can vary widely from country to country and could delay the introduction of our products in those countries.
We have expanded, and expect to continue to expand, our organization, including expanding our sales and marketing capability and creating additional infrastructure to support our operations as a public company, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.
We have expanded, and may continue to expand, our organization, including expanding our sales and marketing capability and creating additional infrastructure to support our operations as a public company, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.
Global economic conditions could have an adverse effect on demand for our products, including on 79 our ability to predict future operating results and on our financial condition and operating results. If global economic conditions remain uncertain or deteriorate, it may materially impact our business, operating results and financial condition.
Global economic conditions could have an adverse effect on demand for our products, including on our ability to predict future operating results and on our financial condition and operating results. If global economic conditions remain uncertain or deteriorate, it may materially impact our business, operating results and financial condition.
Additional risks related to operating in foreign countries include: • differing regulatory requirements and reimbursement regimes in foreign countries, including changes to regulatory requirements and implementation of new regulations in foreign countries; • difficulties in compliance with non-U.S. laws and regulations; • unexpected changes in tariffs, trade barriers, price and exchange controls and other regulatory requirements; • trade protection measures, import or export licensing requirements, or other restrictive actions by U.S. or non-U.S. governments; • economic weakness, including inflation, or political instability in particular foreign economies and markets; 40 • compliance with tax, employment, immigration and labor laws for employees living or traveling abroad; • foreign taxes, including withholding of payroll taxes; • foreign currency fluctuations, which could result in increased operating expenses and reduced revenue, and other obligations incident to doing business in another country; • difficulties staffing and managing foreign operations; • workforce uncertainty in countries where labor unrest is more common than in the United States; • potential liability under the FCPA or comparable foreign regulations; • challenges enforcing our contractual and intellectual property rights, especially in those foreign countries that do not respect and protect intellectual property rights to the same extent as the United States; • production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and • business interruptions resulting from geo-political actions, including war and terrorism.
Additional risks related to operating in foreign countries include: • differing regulatory requirements and reimbursement regimes in foreign countries, including changes to regulatory requirements and implementation of new regulations in foreign countries; • difficulties in compliance with non-U.S. laws and regulations; • unexpected changes in tariffs, trade barriers, price and exchange controls and other regulatory requirements; • trade protection measures, import or export licensing requirements, or other restrictive actions by U.S. or non-U.S. governments; 38 • economic weakness, including inflation, or political instability in particular foreign economies and markets; • compliance with tax, employment, immigration and labor laws for employees living or traveling abroad; • foreign taxes, including withholding of payroll taxes; • foreign currency fluctuations, which could result in increased operating expenses and reduced revenue, and other obligations incident to doing business in another country; • difficulties staffing and managing foreign operations; • workforce uncertainty in countries where labor unrest is more common than in the U.S.; • potential liability under the FCPA or comparable foreign regulations; • challenges enforcing our contractual and intellectual property rights, especially in those foreign countries that do not respect and protect intellectual property rights to the same extent as the U.S.; • production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and • business interruptions resulting from geo-political actions, including war and terrorism.
Our failure or inability to devote adequate research and 34 development resources or compete effectively with the research and development programs of our current or future competitors could have a material adverse effect on our business, financial condition and results of operations.
Our failure or inability to devote adequate research and development resources or compete effectively with the research and development programs of our current or future competitors could have a material adverse effect on our business, financial condition and results of operations.
Furthermore, the 61 submission of these reports has been and could be used by competitors against us in competitive situations and cause customers to delay purchase decisions or cancel orders and would harm our reputation.
Furthermore, the submission of these reports has been and could be used by competitors against us in competitive situations and cause customers to delay purchase decisions or cancel orders and would harm our reputation.
The effects of the CCPA, CPRA and other laws relating to privacy, data protection and cybersecurity are potentially 69 significant, and may require us to modify our practices and policies and to incur substantial costs and expenses in an effort to comply.
The effects of the CCPA, CPRA and other laws relating to privacy, data protection and cybersecurity are potentially significant, and may require us to modify our practices and policies and to incur substantial costs and expenses in an effort to comply.
However, the risks and uncertainties identified in this subsection are not the only ones we face and are qualified in their entirety by reference to all of the risk factors described herein: Risks related to our business and products: • We have a limited operating history, and if we fail to effectively train our sales force, increase our sales and marketing capabilities, or develop broad brand awareness in a cost-effective manner, our growth will be impeded, and our business will suffer. • We have a history of net operating losses, and we expect to continue to incur losses in the future.
However, the risks and uncertainties identified in this subsection are not the only ones we face and are qualified in their entirety by reference to all of the risk factors described herein: Risks related to our business and products: • If we fail to effectively train our sales force, increase our sales and marketing capabilities, or develop broad brand awareness in a cost-effective manner, our growth will be impeded, and our business will suffer. • We have a history of net losses, and we expect to continue to incur losses in the future.
It is difficult to 51 monitor whether our predecessors or future licensors limit their use of the technology to these uses, and we could incur substantial expenses to enforce our rights to our licensed technology in the event of misuse.
It is difficult to monitor whether our predecessors or future licensors limit their use of the technology to these uses, and we could incur substantial expenses to enforce our rights to our licensed technology in the event of misuse.
These include allowing third-party submission of prior art to the USPTO during patent prosecution and additional procedures to challenge the validity of a patent by USPTO administered post-grant proceedings, including post-grant review, inter partes review and derivation proceedings.
These include 50 allowing third-party submission of prior art to the USPTO during patent prosecution and additional procedures to challenge the validity of a patent by USPTO administered post-grant proceedings, including post-grant review, inter partes review and derivation proceedings.
However, the FDA may not be able to continue its current inspection pace or may be unable to complete required inspections during the review period, which can delay clinical development and result in a complete response letter.
The FDA may not be able to continue its current inspection pace or may be unable to complete required inspections during the review period, which can delay clinical development and result in a complete response letter. .
Although our products have received regulatory approval or clearance from FDA in the United States for a particular patient population, they will be subject to ongoing regulatory requirements for manufacturing, labeling, packaging, storage, advertising, promotion, sampling, record-keeping, conduct of post-marketing studies and submission of safety, effectiveness and other post-market information, including both federal and state requirements in the United States and requirements of comparable non-U.S. regulatory authorities in any international markets we choose to enter.
Although our products have received regulatory approval or clearance from FDA in the U.S. for a particular patient population, they will be subject to ongoing regulatory requirements for manufacturing, labeling, packaging, storage, advertising, promotion, sampling, record-keeping, conduct of post-marketing studies and submission of safety, effectiveness and other post-market information, including both federal and state requirements in the U.S. and requirements of comparable non-U.S. regulatory authorities in any international markets we choose to enter.
As the UPC is a new court system, precedent is developing for the court, increasing the uncertainty of any litigation. Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
As the UPC is a new court system, precedent is developing for the court, increasing the uncertainty of any litigation. 51 Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
In addition, our corporate headquarters is located in Aliso Viejo, California, near major earthquake faults and fire zones, and the ultimate impact on us for being located near major earthquake 80 faults and fire zones and being consolidated in a certain geographical area is unknown.
In addition, our corporate headquarters is located in Aliso Viejo, California, near major earthquake faults and fire zones, and the ultimate impact on us for being located near major earthquake faults and fire zones and being consolidated in a certain geographical area is unknown.
We operate in four separate facilities, designated as a single manufacturing facility, and should any one of these facilities be significantly damaged or destroyed by natural or man-made disasters, such as earthquakes, and/or fires (both of which are prevalent in California) or other events, it could take months to relocate or rebuild, during which time our employees may seek other positions, our research, development and manufacturing would cease or be delayed and our products may be unavailable.
We operate in five separate facilities, designated as a single manufacturing facility, and should any one of these facilities be significantly damaged or destroyed by natural or man-made disasters, such as earthquakes, and/or fires (both of which are prevalent in California) or other events, it could take months to relocate or rebuild, during which time our employees may seek other positions, our research, development and manufacturing would cease or be delayed and our products may be unavailable.
Competitors, who may have greater financial, marketing and sales resources than we do, may be able to respond more quickly and effectively than we can to new or changing opportunities, technologies, standards or customer requirements.
Competitors, who may have greater financial, marketing and sales resources than we 35 do, may be able to respond more quickly and effectively than we can to new or changing opportunities, technologies, standards or customer requirements.
We may incorrectly determine that our products are not covered by a 46 third-party patent or may incorrectly predict whether a third party’s pending application will issue with claims of relevant scope.
We may incorrectly determine that our products are not covered by a third-party patent or may incorrectly predict whether a third party’s pending application will issue with claims of relevant scope.
In cases where data from foreign clinical trials are intended to serve as the basis for marketing approval in the United States, the FDA will generally not approve the application on the basis of foreign data alone unless (1) the data are applicable to the U.S. population and U.S. medical practice; (2) the trials are performed by clinical investigators of recognized competence and pursuant to current good clinical practices regulations; and (3) audits by regulatory authorities of the clinical data do not identify significant data integrity issues.
In cases where data from foreign clinical trials are intended to serve as the basis for marketing approval in the U.S., the FDA will generally not approve the application on the basis of foreign data alone unless (1) the data are applicable to the U.S. population and U.S. medical practice; (2) the clinical trials are performed by clinical investigators of recognized competence and pursuant to current good clinical practices regulations; and (3) audits by regulatory authorities of the clinical data do not identify significant data integrity issues.
We cannot predict the full impact of this decision, future judicial challenges brought against the FDA, or the nature or extent of government regulation that may arise from future legislation or administrative action.
We cannot predict the full impact of this decision, future judicial 56 challenges brought against the FDA, or the nature or extent of government regulation that may arise from future legislation or administrative action.
We are aware of certain characteristics and features of our RxSight system that may prevent widespread market adoption, including the fact that doctors would need to adopt a new procedure, and training for doctors will be required to enable them to effectively operate our products. 32 We face significant competition, and if we are unable to compete effectively, we may not be able to achieve or maintain significant market penetration or improve our results of operations.
We are aware of certain characteristics and features of our RxSight system that may prevent widespread market adoption, including the fact that doctors would need to adopt a new procedure, and training for doctors will be required to enable them to effectively operate our products. 29 We face significant competition, and if we are unable to compete effectively, we may not be able to achieve or maintain significant market penetration or improve our results of operations.
Patent terms may be inadequate to protect our competitive position on technology for an adequate amount of time. Patents have a limited lifespan. In the United States, if all maintenance fees are timely paid, the natural expiration of a patent is generally 20 years from its earliest claimed U.S. non-provisional or Patent Cooperation Treaty application filing date.
Patent terms may be inadequate to protect our competitive position on technology for an adequate amount of time. Patents have a limited lifespan. In the U.S., if all maintenance fees are timely paid, the natural expiration of a patent is generally 20 years from its earliest claimed U.S. non-provisional or Patent Cooperation Treaty application filing date.
There can be no assurance that the FDA or any applicable foreign regulatory authority will accept data from trials conducted outside of its applicable jurisdiction.
There can be no assurance that the FDA or any applicable foreign regulatory authority will accept data from clinical trials conducted outside of its applicable jurisdiction.
In addition to the factors discussed in “Part I, Item 1A, “Risk Factors,” and elsewhere in this report, these factors include: • announcement of our results of operations and updates regarding our business, including financial and operational guidance; • research published by securities or industry analysts about our business and prospects; • the timing and results of preclinical studies and clinical trials of our current and future products or those of our competitors; • the success of competitive products or announcements by potential competitors of their product development efforts; 73 • regulatory actions with respect to our products or our competitors’ products; • actual or anticipated changes in our growth rate relative to our competitors; • regulatory or legal developments in the United States and other countries; • developments or disputes concerning patent applications, issued patents or other intellectual property or proprietary rights; • the recruitment or departure of key personnel; • announcements by us or our competitors of significant acquisitions, strategic collaborations, joint ventures, collaborations or capital commitments; • actual or anticipated changes in estimates as to financial results, development timelines or recommendations by securities analysts; • fluctuations in the valuation of companies perceived by investors to be comparable to us; • market conditions in the medical device sector; • changes in the structure of healthcare payment systems; • share price and volume fluctuations attributable to inconsistent trading volume levels of our shares; • announcement or expectation of additional financing efforts; • sales of our common stock by us, our insiders or our other stockholders; and • general economic, industry and market conditions, including global and national events, such as the conflicts in Eastern Europe and the Middle East, and general economic downturns.
In addition to the factors discussed in “Part I, Item 1A, “Risk Factors,” and elsewhere in this report, these factors include: • announcement of our results of operations and updates regarding our business, including financial and operational guidance; • research published by securities or industry analysts about our business and prospects; • the success of competitive products or announcements by potential competitors of their product development efforts; • regulatory actions with respect to our products or our competitors’ products; • actual or anticipated changes in our growth rate, including relative to our competitors; • regulatory or legal developments in the U.S. and other countries; • developments or disputes concerning patent applications, issued patents or other intellectual property or proprietary rights; • the recruitment or departure of key personnel; • announcements by us or our competitors of significant acquisitions, strategic collaborations, joint ventures, collaborations or capital commitments; • the timing and results of preclinical studies and clinical trials of our current and future products or those of our competitors; • actual or anticipated changes in estimates as to financial results, development timelines or recommendations by securities analysts; • fluctuations in the valuation of companies perceived by investors to be comparable to us; • market conditions in the medical device sector; • changes in the structure of healthcare payment systems; • share price and volume fluctuations attributable to inconsistent trading volume levels of our shares; 69 • announcement or expectation of additional financing efforts; • sales of our common stock by us, our insiders or our other stockholders; and • general economic, industry and market conditions, including global and national events, such as the conflicts in Eastern Europe and the Middle East, and general economic downturns.
If we fail to comply with these regulatory requirements or to obtain and maintain required approvals, our target market will be reduced and 41 our ability to generate revenue will be diminished. Our inability to successfully enter all our desired international markets and manage business on a global scale could negatively affect our business, financial results and results of operations.
If we fail to comply with these regulatory requirements or to obtain and maintain required approvals, our target market will be reduced and 39 our ability to generate revenue will be diminished. Our inability to successfully enter all our desired international markets and manage business on a global scale could negatively affect our business, financial results and results of operations.
Changes in corporate tax rates, the realization of net deferred tax assets relating to our U.S. operations, the taxation of foreign earnings and the deductibility of expenses contained in the Tax Act or other tax reform legislation could have a material impact on the value of our deferred tax assets, could result in significant one-time charges in the current or future taxable years and could increase our future U.S. tax expense.
Changes in corporate tax rates, the realization of net deferred tax assets relating to our U.S. operations, the taxation of foreign earnings and the deductibility of expenses contained in the Tax Act or other tax reform legislation could have a material impact on the value of our deferred tax assets, could result in significant charges in the current or future taxable years and could increase our future U.S. tax expense.
Supreme Court overruled the Chevron doctrine, which gives deference to regulatory agencies’ statutory interpretations in litigation against federal government agencies where the law is ambiguous. This landmark Supreme Court decision may invite more stakeholders to bring lawsuits against the FDA and other federal agencies to challenge longstanding decisions and policies, which could lead to uncertainties in the industry.
Supreme Court overruled the Chevron doctrine, which gave deference to regulatory agencies’ statutory interpretations in litigation against federal government agencies where the law is ambiguous. This landmark Supreme Court decision may invite more stakeholders to bring lawsuits against the FDA and other federal agencies to challenge longstanding decisions and policies, which could lead to uncertainties in the industry.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeThese risk assessments include identification of reasonably foreseeable internal and external risks and the sufficiency of existing policies, procedures, systems, and safeguards in place to manage such risks. 81 Following these risk assessments, if necessary, we implement and maintain reasonable safeguards to minimize identified risks and regularly monitor the effectiveness of our safeguards.
Biggest changeWe conduct periodic risk assessments to identify cybersecurity threats that may affect information systems that may be vulnerable to cybersecurity threats. These risk assessments include identification of reasonably foreseeable internal and external risks and the sufficiency of existing policies, procedures, systems, and safeguards in place to manage such risks.
For additional information regarding whether any risks from cybersecurity threats have materially affected or are reasonably likely to materially affect our company, including our business strategy, results of operations, or financial condition, please refer to Item 1A, “Risk Factors,” in this report, including the risk factor entitled “We may experience a significant disruption in our information technology systems or breaches of data security” and “Unauthorized third parties may seek to access our devices or other products and services, or related devices, products, and services, and modify or use them in a way inconsistent with our FDA clearances and approvals, which may create risks to users.” As of the date of this report, we do not believe that we have experienced a material cybersecurity incident.
For additional information regarding whether any risks from cybersecurity threats have materially affected or are reasonably likely to materially affect our company, including our business strategy, results of operations, or financial condition, please refer to Item 1A, “Risk Factors,” in this report, including the risk factor entitled “Unauthorized third parties may seek to access our devices or other products and services, or related devices, products, and services, and modify or use them in a way inconsistent with our FDA clearances and approvals, which may create risks to users.” As of the date of this report, we do not believe that we have experienced a material cybersecurity incident
We use automated tools and trained personnel to maintain real-time threat monitoring and 24x7 alerting of all of our IT infrastructure and endpoints. We leverage various software tools, internal personnel and consultants to identify, triage, escalate and remediate threats.
Personnel tasked with managing cybersecurity risks periodically report to senior management and the Audit Committee. We use automated tools and trained personnel to maintain real-time threat monitoring and 24x7 alerting of all of our IT infrastructure and endpoints. We leverage various software tools, internal personnel and consultants to identify, triage, escalate and remediate threats.
We devote significant resources, including engaging experienced consultants and designate senior-level information technology management (“IT management”) to manage the risk assessment and mitigation process. Personnel tasked with managing cybersecurity risks periodically report to senior management and the Audit Committee.
Following these risk assessments, if necessary, we implement and maintain reasonable safeguards to minimize identified risks and regularly monitor the effectiveness of our safeguards. We devote significant resources, including engaging experienced consultants and designate senior-level information technology management (“IT management”) to manage the risk assessment and mitigation process.
Removed
We conduct periodic risk assessments to identify cybersecurity threats that may affect information systems that may be vulnerable to cybersecurity threats.

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeItem 2. Properties. We currently lease four facilities which includes our headquarters, manufacturing, research and development and administrative offices in Aliso Viejo, California. The facility leases are for approximately 150,000 square feet in the aggregate. The current leases on our four facilities expire on January 31, 2031, with two options to extend for five years each.
Biggest changeItem 2. Properties. We currently lease five facilities which includes our headquarters, manufacturing, research and development and administrative offices in Aliso Viejo, California. The facility leases are for approximately 150,000 square feet in the aggregate. The current leases on our five facilities expire on January 31, 2031, with two options to extend for five years each.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Biggest changeItem 3. Legal Proceedings. From time to time, we may become involved in litigation or other legal proceedings. We are not currently a party to any litigation or legal proceedings that, in the opinion of our management, are likely to have a material adverse effect on our business.
Biggest changeWe are not currently a party to any litigation or legal proceedings that, in the opinion of our management, are likely to have a material adverse effect on our business. Regardless of outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources, and other factors.
Removed
Regardless of outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources, and other factors.
Added
Item 3. Legal Proceedings. Securities Class Actions 77 On July 22, 2025, a putative securities class action complaint was filed in the U.S. District Court for the Central District of California against the Company and certain of its officers, captioned Makaveev v. RxSight, Inc., et al., No. 8:25-cv-01596.
Added
The lawsuit asserts claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and SEC Rule 10b-5, alleging that the defendants made materially false and misleading statements and omitted material adverse facts regarding demand for our products and financial guidance. On September 16, 2025, a related putative securities class action complaint was filed in the U.S.
Added
District Court for the Central District of California against us and certain of our officers, captioned Gémesi v. RxSight, Inc., et al., No. 25-cv-02093.
Added
On October 6, 2025, the court entered an order consolidating the Makaveev and Gémesi actions, appointing a lead plaintiff and approving selection of lead counsel, and re-captioning the case as In re RxSight Securities Litigation, No. 8:25-cv-01596-FWS-KES. . A consolidated, amended complaint was filed on December 12, 2025. Defendants’ motion to dismiss was filed on February 13, 2026.
Added
The plaintiffs seek unspecified compensatory and punitive damages, and reasonable costs and expenses, including attorneys’ fees. Shareholder Derivative Actions On August 18, 2025, a shareholder derivative action was filed in the U.S. District Court for the Central District of California against certain of our officers and directors, captioned Swift v. Kurtz, et al., Case No. 8:25-cv-01820-FWS-KES.
Added
The plaintiff purports to bring the action derivatively on behalf of us, and we are named as a nominal defendant. The complaint generally alleges that the defendants made false and misleading statements and omitted material adverse facts regarding declining sales, demand for our products, and financial guidance, and we lacked internal controls.
Added
The complaint asserts claims for alleged violations of Section 14(a) of the Exchange Act, as well as claims for alleged breaches of fiduciary duties, aiding and abetting, unjust enrichment, and waste of corporate assets.
Added
The complaint seeks unspecified damages on behalf of the Company, declaratory relief, a constructive trust, punitive damages, and an award of costs and expenses, including attorneys’ fees. On October 2, 2025, the court entered an order staying proceedings in the Swift action until a final resolution of the Securities Class Actions, including the exhaustion of any appeals.
Added
On October 10, 2025, a related shareholder derivative action was filed in the U.S. District Court for the Central District of California against certain of our officers and directors, captioned Yost v. Kurtz, et al., Case No. 8:25-cv-2295.
Added
The complaint asserts claims for alleged breaches of fiduciary duties, gross mismanagement, waste of corporate assets, unjust enrichment, aiding and abetting, insider trading, and alleged violations of Section 14(a) of the Exchange Act and seeks unspecified damages on behalf of us, declaratory relief, disgorgement, corporate governance reforms, and an award of costs and expenses, including attorneys’ fees.
Added
On November 13, 2025, the Court entered an order consolidating the Swift and Yost actions and staying the consolidated derivative action until the final resolution of the Securities Class Actions, including the exhaustion of any appeals.
Added
While it is too early to predict the outcome of the litigation or a reasonable range of potential losses and whether an adverse result would have a material adverse impact on our results of operations or financial position, we believe we have meritorious defenses, vehemently deny the allegations and intend to defend the case vigorously.
Added
Failure to obtain a favorable resolution of this lawsuit could have a material adverse effect on our business, results of operations and financial condition. From time to time, we may become involved in litigation or other legal proceedings.

Item 4. Mine Safety Disclosures

Mine Safety Disclosures — required of mining issuers

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Biggest changePrior to that time, there was no public market for our common stock. Stockholders As of February 14, 2025, there were approximately 110 registered stockholders of record of our common stock.
Biggest changePrior to that time, there was no public market for our common stock. Stockholders As of February 18, 2026, there were approximately 102 registered stockholders of record of our common stock.
Issuer purchases of equity securities None. 83 Stock Performance Graph This performance graph shall not be deemed “soliciting material” or to be “filed” with the SEC for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities under that Section, and shall not be deemed to be incorporated by reference into any filing of ours under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.
Issuer purchases of equity securities None. 79 Stock Performance Graph This performance graph shall not be deemed “soliciting material” or to be “filed” with the SEC for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities under that Section, and shall not be deemed to be incorporated by reference into any filing of ours under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.
Item 4. Mine Safety Disclosures. None 82 PART II It em 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. Market information and holders Our common stock has been publicly traded on the Nasdaq Global Market under the symbol “RXST” since July 30, 2021.
Item 4. Mine Safety Disclosures. None 78 PART II It em 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. Market information and holders Our common stock has been publicly traded on the Nasdaq Global Market under the symbol “RXST” since July 30, 2021.
The following graph compares the performance of our common stock for the periods indicated with the performance of the S&P Healthcare and Supplies Index, the Russell 2000 Index, and the NASDAQ Composite Index from July 30, 2021 to December 31, 2024.
The following graph compares the performance of our common stock for the periods indicated with the performance of the S&P Healthcare and Supplies Index, the Russell 2000 Index, and the NASDAQ Composite Index from July 30, 2021 to December 31, 2025.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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Biggest changeComprehensive loss is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources, including unrealized gains and losses on short-term investments and foreign currency translation adjustments. 88 Results of operations Comparison of the years ended December 31, 2024 and 2023 The following table summarizes our results of operations for the years ended December 31, 2024 and 2023, together with the dollar increase or decrease and percentage change in those items: Twelve Months Ended December 31, Change (in thousands, except percentages) 2024 2023 ($) (%) Sales $ 139,927 $ 89,077 $ 50,850 57.1 % Cost of sales 40,984 35,312 5,672 16.1 Gross profit $ 98,943 $ 53,765 $ 45,178 84.0 % Operating expenses: Selling, general and administrative 101,434 74,799 26,635 35.6 Research and development 34,367 29,051 5,316 18.3 Total operating expenses 135,801 103,850 31,951 30.8 Loss from operations $ (36,858 ) $ (50,085 ) $ 13,227 (26.4 )% Other income (expense), net: Interest expense (21 ) (3,308 ) 3,287 (99.4 ) Interest and other income 9,474 6,574 2,900 44.1 Loss on extinguishment of term loan — (1,769 ) 1,769 — Total other income (expense), net: 9,453 1,497 7,956 531.4 % Loss before income taxes (27,405 ) (48,588 ) 21,183 (43.6 ) Income tax expense 50 20 30 151.6 Net loss $ (27,455 ) $ (48,608 ) $ 21,153 (43.5 )% Other comprehensive income (loss) Unrealized gain on short-term investments 180 83 97 117.0 Foreign currency translation (loss) gain (9 ) 7 (16 ) (229.7 ) Total other comprehensive income (loss) 171 90 81 90.0 Comprehensive loss $ (27,284 ) $ (48,518 ) $ 21,234 (43.8 )% Sales Sales increased by $50.8 million, or 57.1%, to $139.9 million for the year ended December 31, 2024 from $89.1 million for the year ended December 31, 2023.
Biggest changeComprehensive loss is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources, including unrealized gains and losses on short-term investments and foreign currency translation adjustments. 84 Results of operations Comparison of the years ended December 31, 2025 and 2024 The following table summarizes our results of operations for the years ended December 31, 2025 and 2024, together with the dollar increase or decrease and percentage change in those items: Twelve Months Ended December 31, Change (in thousands, except percentages) 2025 2024 ($) (%) Sales $ 134,479 $ 139,927 $ (5,448 ) (3.9 )% Cost of sales 31,470 40,984 (9,514 ) (23.2 ) Gross profit $ 103,009 $ 98,943 $ 4,066 4.1 % Operating expenses: Selling, general and administrative 112,651 101,434 11,217 11.1 Research and development 38,549 34,367 4,182 12.2 Total operating expenses 151,200 135,801 15,399 11.3 Loss from operations $ (48,191 ) $ (36,858 ) $ (11,333 ) 30.7 % Other income (expense), net: Interest expense (19 ) (21 ) 3 (12.0 ) Interest and other income 9,332 9,474 (142 ) (1.5 ) Total other income (expense), net: 9,313 9,453 (139 ) (1.5 )% Loss before income taxes (38,878 ) (27,405 ) (11,472 ) 41.9 Income tax expense 66 50 16 31.3 Net loss $ (38,944 ) $ (27,455 ) $ (11,488 ) 41.8 % Other comprehensive income (loss) Unrealized gain on short-term investments (136 ) 180 (316 ) (175.7 ) Foreign currency translation (loss) gain 23 (9 ) 32 (352.5 ) Total other comprehensive income (loss) (113 ) 171 (284 ) (166.4 ) Comprehensive loss $ (39,057 ) $ (27,284 ) $ (11,772 ) 43.1 % Sales Sales decreased by $5.5 million, or (3.9)%, to $134.5 million in 2025 from $139.9 million in 2024.
Other SG&A expenses include sales commissions, travel expenses, promotional activities, marketing initiatives, market research and analysis, conferences and trade shows, training for doctors, professional services fees such as legal, patent registration costs, accounting, audit fees, (including costs for compliance with Section 404(b) of the Sarbanes-Oxley Act), tax fees, board of directors’ expenses, insurance costs, general corporate expenses and facilities-related expenses.
Other SG&A expenses include sales commissions, travel expenses, promotional activities, marketing initiatives, market research and analysis, conferences and trade shows, training for doctors, professional services fees such as legal, patent registration costs, accounting, audit fees (including costs for compliance with Section 404(b) of the Sarbanes-Oxley Act), tax fees, board of 83 directors’ expenses, insurance costs, general corporate expenses and facilities-related expenses.
Revenue recognition Our revenue is generated from the sale of LALs used in cataract surgery along with a specifically designed machine for delivering light to the eye, the LDD, to adjust the lens post-surgery. Revenue is recognized from sales of products in the U.S. Canada, Europe and Asia to ambulatory surgery centers, hospitals, and physician private practices.
Revenue recognition Our revenue is generated from the sale of LALs used in cataract surgery along with a specifically designed machine for delivering light to the eye, the LDD, to adjust the lens post-surgery. Revenue is recognized from sales of products in the U.S. Canada, Europe and Asia to ambulatory surgery centers, hospitals, physician private practices and distributors.
We calculate gross margin as gross profit/(loss) divided by sales. Our gross margin has been and will continue to be affected by a variety of factors, including average selling prices, product sales mix, production and ordering volumes, manufacturing costs, product yields, headcount and cost-reduction strategies.
We calculate gross margin as gross profit divided by sales. Our gross margin has been and will continue to be affected by a variety of factors, including average selling prices, product sales mix, production and ordering volumes, manufacturing costs, product yields, headcount and cost-reduction strategies.
Cost of sales Cost of sales consist of materials, labor and manufacturing overhead internally to produce our products as well as the cost of shipping and handling. Overhead costs include the cost of quality assurance, material procurement, inventory control, facilities, equipment and operations supervision and management and stock-based compensation.
Cost of sales Cost of sales consist of materials, labor and manufacturing overhead internally to produce our products as well as the cost of shipping and handling. Overhead costs include the cost of quality assurance, material procurement, inventory control, facilities, equipment and operations management and stock-based compensation.
Uncertain macroeconomic conditions including recent inflationary pressures and the rise in interest rates have created significant uncertainty in the U.S. economy and capital markets, which is expected to continue through 2025 and beyond and could negatively impact our financial results and liquidity.
Uncertain macroeconomic conditions including recent inflationary pressures and the rise in interest rates have created significant uncertainty in the U.S. economy and capital markets, which is expected to continue through 2026 and beyond and could negatively impact our financial results and liquidity.
See “Special Note Regarding Forward-Looking Statements.” Overview We are a commercial-stage medical technology company dedicated to providing high quality customized vision to patients following cataract surgery. Our proprietary RxSight® Light Adjustable Lens system (“RxSight system”) is the first and only commercially available premium cataract technology that enables doctors to customize and optimize visual acuity for patients after surgery.
See “Special Note Regarding Forward-Looking Statements.” Overview RxSight, Inc. is a commercial-stage medical technology company dedicated to providing high-quality customized vision to patients following cataract surgery. Our proprietary RxSight ® Light Adjustable Lens system (“RxSight system”) is the first and only commercially available premium cataract technology that enables doctors to customize and optimize visual acuity for patients after surgery.
We believe our RxSight system provides doctors and patients increased confidence and peace of mind by eliminating the high-stakes preoperative guesswork common to competitive premium IOLs and allowing patients to iterate their final vision characteristics with customized post-surgical adjustments. We compete primarily in the IOL market in the U.S.
We believe our RxSight system provides doctors and patients increased confidence and peace of mind by eliminating the high-stakes preoperative guesswork common to conventional premium IOLs and allowing patients to iterate their final vision characteristics with customized post-surgical adjustments. Currently, we primarily compete in the IOL market in the U.S.
The expansion of global lead times has resulted in the lack of availability of raw materials, including 93 semiconductors, computers, monitors electronic parts, metals, packaging, adhesives, chemicals, resins and subcontract painted components.
The expansion of global lead times has resulted in the lack of availability of raw materials, including 88 semiconductors, computers, monitors electronic parts, metals, packaging, adhesives, chemicals, resins and subcontract painted components.
Comparison of the years ended December 31, 2023 and 2022 A discussion of changes in our results of operations during the year ended December 31, 2023 compared to the year ended December 31, 2022 has been omitted from this Annual Report on Form 10-K, but may be found in “MD&A – Results of Operations – Comparison of the years ended December 31, 2023 and 2022” in Part II, Item 7 of the 2023 Form 10-K, which discussion is incorporated herein by reference and which is available free of charge on the SEC’s website at www.sec.gov.
Comparison of the years ended December 31, 2024 and 2023 A discussion of changes in our results of operations during the year ended December 31, 2024 compared to the year ended December 31, 2023, has been omitted from this Annual Report on Form 10-K, but may be found in “MD&A – Results of Operations – Comparison of the years ended December 31, 2024 and 2023” in Part II, Item 7 of the 2024 Form 10-K, which discussion is incorporated herein by reference and which is available free of charge on the SEC’s website at www.sec.gov.
Additionally, as a public company, we have incurred and expect to continue to incur increased costs for employee-related expenses, director and officer insurance premiums, audit fees, (including costs for compliance with Section 404(b) of the Sarbanes-Oxley Act), legal fees, investor relations fees, fees to members of our Board of directors and expenses for compliance with public-company reporting requirements.
Additionally, we have incurred and expect to continue to incur costs related to operating as a public company, such as director and officer insurance premiums, audit fees, costs for compliance with Section 404(b) of the Sarbanes-Oxley Act, legal fees, investor relations fees, fees to members of our Board of Directors, and expenses for compliance with public-company reporting requirements.
Funding requirements Our future liquidity and capital funding requirements will depend on numerous factors, including: • our sales growth, including potential international expansion; • our research and development efforts; • our sales and marketing activities; • working capital investments, primarily in inventories and accounts receivable; • our ability to raise additional funds or borrow to finance our operations; • the outcome, costs and timing of any clinical trial results for our current or future products; • the emergence and effect of competing or complementary products; • our ability to maintain, expand, enforce and defend our intellectual property portfolio, including the amount and timing of any payments we may be required to make, or that we may receive, in connection with the licensing, filing, prosecution, maintenance, defense and enforcement of any patents or other intellectual property rights; • our ability to retain our current employees and the need and ability to hire additional management, sales, research and development, scientific and customer support personnel; • the terms and timing of any collaborative, licensing or other arrangements that we have or may establish; • operating and finance lease payments for our facilities; and • the extent to which we acquire or invest in businesses, products or technologies.
Funding requirements Our future liquidity and capital funding requirements will depend on numerous factors, including: • our sales growth, including potential international expansion; • our research and development efforts; • our sales and marketing activities; • working capital investments, primarily in inventories and accounts receivable; • our ability to raise additional funds or borrow to finance our operations; • the outcome, costs and timing of any clinical trial results for our current or future products; • the emergence and effect of competing or complementary products; • our ability to maintain, expand, enforce and defend our intellectual property portfolio, including the amount and timing of any payments we may be required to make, or that we may receive, in connection with the licensing, filing, prosecution, maintenance, defense and enforcement of any patents or other intellectual property rights; • our ability to retain our current employees and the need and ability to hire additional management, sales, research and development, scientific and customer support personnel; • the terms and timing of any collaborative, licensing or other arrangements that we have or may establish; • operating and finance lease payments for our facilities; and • the extent to which we acquire or invest in businesses, products or technologies. 86 As of December 31, 2025, we had cash and cash equivalents of $19.9 million and short-term investments of $208.2 million.
If we determine that we need to raise additional funds, which may not be available to us when needed or on terms that we deem to be favorable.
If we determine that we need to raise additional funds, such capital may not be available to us when needed or on terms that we deem to be favorable.
Research and development expenses are expensed as incurred. We expect research and development expenses as a percentage of revenue to vary over time depending on the level and timing of our new product development efforts, as well as our clinical development, clinical trials and registries and other related activities.
Research and development expenses are expensed as incurred. We expect research and development expenses as a percentage of revenue to vary over time depending on the level and timing of our new product development efforts, as well as our clinical development, clinical trials and registries and other related activities. Interest expense Interest expense consist primarily of interest incurred on leases.
The LAL is a premium IOL which is partially reimbursable under Medicare, and in some cases by private payors. Premium IOLs are sold at a higher price point than conventional IOLs, as they provide refractive correction of vision unlike a conventional IOL that only replaces the natural lens with a clear lens (which is the standard for Medicare reimbursement).
The LAL is a premium IOL which is partially reimbursable under Medicare, and in some cases by private payors. Premium IOLs are sold at a higher price point than conventional IOLs as they provide refractive vision correction, whereas conventional IOLs simply replace the natural lens with a clear lens (which is the standard for Medicare reimbursement).
We may also opportunistically raise capital under advantageous 91 circumstances from time to time, such as the Public Offering, in order to support the expansion of our sales and operations in the U.S. and internationally and to pursue other business opportunities.
We may also opportunistically raise capital under advantageous circumstances from time to time to support the expansion of our sales and operations in the U.S. and internationally and to pursue other business opportunities.
In contrast, with the RxSight system, the surgeon implants the LAL during a standard cataract procedure, determines refractive error with patient input several weeks following surgery and then uses the LDD to modify the LAL with the precise visual correction needed to achieve the patient’s desired vision outcomes.
In contrast, with the RxSight system, the surgeon implants the LAL as they would in any other cataract procedure, determines refractive error with patient input several weeks following surgery and then uses the LDD to modify the LAL with the precise visual correction needed to achieve the patient’s desired vision outcomes.
Cost of sales also includes depreciation expense for production equipment and certain direct costs such as shipping costs and royalty and license fee expense. Shipping costs billed to customers are included in sales. We expect cost of sales to increase in absolute dollars as our revenue grows and more of our products are sold.
Cost of sales also includes depreciation expense for production equipment and certain direct costs such as shipping costs. Shipping costs billed to customers are included in sales. As we return to growth, we expect cost of sales to increase in absolute dollars as our revenue grows and higher volume of products are sold.
Cash used in investing activities Net cash used in investing activities for the year ended December 31, 2024 was $99.3 million, consisting of net purchases of short-term investments of $93.9 million and purchases of property and equipment of $5.4 million.
Net cash used in investing activities in 2024 was $99.3 million, consisting of net purchases of short-term investments of $93.9 million and purchases of property and equipment of $5.4 million.
Cash provided by financing activities Net cash provided by financing activities for the year ended December 31, 2024 was $123.3 million, consisting primarily of proceeds from issuances of common stock from our public offering of $108.1. million, and proceeds from issuance of common stock pursuant to equity compensation programs of $20.8 million, partially offset by tax payments for employee stock compensation of $4.8 million.
Cash provided by financing activities Net cash provided by financing activities in 2025 was $1.9 million, consisting primarily of proceeds from issuances of common stock pursuant to equity compensation programs of $3.9 million, partially offset by tax payments for employee stock compensation of $2.0 million. 87 Net cash provided by financing activities in 2024 was $123.3 million, consisting primarily of proceeds from issuances of common stock from our public offering of $108.1. million, and proceeds from issuance of common stock pursuant to equity compensation programs of $20.8 million, partially offset by tax payments for employee stock compensation of $4.8 million.
Summary statement of cash flows The following table sets forth the primary sources and uses of cash, cash equivalents, and restricted cash for each of the periods presented below (in thousands): For the Year Ended December 31, 2024 2023 Net cash (used in) provided by: Operating activities $ (16,946 ) $ (41,593 ) Investing activities (99,311 ) (22,129 ) Financing activities 123,319 61,524 Effect of foreign exchange rate on cash, cash equivalents and restricted cash (9 ) 6 Net increase (decrease) in cash, cash equivalents and restricted cash $ 7,053 $ (2,192 ) Cash used in operating activities Net cash used in operating activities for the year ended December 31, 2024 was $17.0 million consisting primarily of a net loss of $27.5 million, a change in operating assets and liabilities of $9.2 million, partially offset by non-cash stock-based compensation of $24.6 million, and depreciation and amortization of $3.6 million.
Summary statement of cash flows The following table sets forth the primary sources and uses of cash, cash equivalents, and restricted cash for each of the periods presented below (in thousands): For the Year Ended December 31, 2025 2024 Net cash (used in) provided by: Operating activities $ (15,511 ) $ (16,946 ) Investing activities 16,889 (99,311 ) Financing activities 1,863 123,319 Effect of foreign exchange rate on cash, cash equivalents and restricted cash 3 (9 ) Net increase in cash, cash equivalents and restricted cash $ 3,243 $ 7,052 Cash used in operating activities Net cash used in operating activities in 2025 was $15.5 million consisting primarily of a net loss of $38.9 million, a change in operating assets and liabilities of $4.9 million, partially offset by non-cash stock-based compensation of $31.6 million, and depreciation and amortization of $3.3 million.
For the years ended December 31, 2024 and 2023, revenue from contracts with customers consisted of the following (in thousands): Year Ended December 31, 2024 2023 LDD (including training) $ 39,704 $ 32,091 LAL 96,497 54,092 Service warranty, service contracts, and accessories 3,726 2,894 $ 139,927 $ 89,077 For the year ended December 31, 2024 and 2023 we did not have any one customer who individually accounted for more than 10% of revenue.
For the years ended December 31, 2025 and 2024, revenue from contracts with customers consisted of the following (in thousands): Year Ended December 31, 2025 2024 LDD (including training) $ 20,669 $ 39,704 LAL 108,062 96,497 Service warranty, service contracts, and accessories 5,748 3,726 $ 134,479 $ 139,927 For the year ended December 31, 2025 and 2024 we did not have any one customer who individually accounted for more than 10% of revenue.
Revenue is recognized for LALs upon customer notification that the LALs have been implanted in a patient. Our LDD contracts contain multiple performance obligations bundled into one transaction price, with all obligations generally satisfied within one year.
Outside the U.S., generally, LALs are held at distributor sites and distributor customer locations, with revenue recognized for LALs upon the distributor notification that the LALs have been implanted in a patient or upon shipment to the distributor. Our LDD contracts contain multiple performance obligations bundled into one transaction price, with all obligations generally satisfied within one year.
As of December 31, 2024, we had cash and cash equivalents of $16.7 million, short-term investments of $220.5 million, and an accumulated deficit of $622.1 million. We believe that our current cash, cash equivalents and short-term investments through the date of filing of this report will be sufficient to fund our operations for at least the next 12 months.
We believe that our current cash, cash equivalents and short-term investments through the date of filing of this report will be sufficient to fund our operations for at least the next 12 months.
As of December 31, 2024, we had cash and cash equivalents of $16.7 million, short-term investments of $220.5 million, and accumulated deficit of $622.1 million. For the years ended December 31, 2024 and 2023, our net losses from operations were $36.9 and $50.1 million, respectively.
As of December 31, 2025, we had cash and cash equivalents of $19.9 million, short-term investments of $208.2 million, and accumulated deficit of $661.0 million. For the years ended December 31, 2025 and 2024, our net losses from operations were $48.2 and $36.9 million, respectively.
Our commercial efforts began in late 2019 and have been primarily focused in the United States, where we are building a “razor and razor blade” business model to drive new customer adoption and ongoing LAL volume growth.
RxSight, Netherlands has a registered branch in the United Kingdom and a wholly owned subsidiary located in Germany (“RxSight Germany”). Our commercial efforts began in 2019, and have been primarily focused in the U.S., where we are building a “razor and razor blade” business model to drive new customer adoption and ongoing LAL volume growth.
As our manufacturing volume of the LAL increases and the percentage of revenue from the LAL increases as a percentage of sales, we expect gross margin may continue to improve. 87 Operating expenses Selling, general and administrative expenses Selling, general and administrative (“SG&A”), expenses consist primarily of personnel-related expenses, including wages, incentive bonuses, stock-based compensation and benefits related to administrative, selling and marketing functions, education programs for doctors, commercial operations and analytics, finance, information technology and human resource functions.
Operating expenses Selling, general and administrative expenses Selling, general and administrative (“SG&A”), expenses consist primarily of personnel-related expenses, including wages, incentive bonuses, stock-based compensation and benefits related to administrative, selling and marketing functions, education programs for doctors, commercial operations and analytics, finance, information technology and human resource functions.
Our gross margin could fluctuate from quarter to quarter as we introduce new products, and as we adopt new manufacturing processes and technologies.
Our gross margin could fluctuate from quarter to quarter as we introduce new products, increase or decrease units of production for both the LDD and LAL and as we adopt new manufacturing processes and technologies.
This increase was primarily attributable to an increase in selling and marketing personnel costs of $19.4 million due mainly to additional headcount of 44, increased sales commissions, incentive bonuses and employee benefits of $9.4 million, $3.2 million of increased stock-based compensation expense, $3.7 million in additional marketing study costs, and new customer acquisition costs, in each case when compared to the year ended December 31, 2023.
This increase was primarily attributable to an increase in selling and marketing costs of $10.0 million, personnel costs of $1.9 million, $2.4 million of increased stock-based compensation expense, $3.9 million in additional marketing study costs, and $1.7 million in new customer acquisition costs, in each case when compared to 2024.
Cost of sales Cost of sales increased by $5.7 million, or 16.1%, to $41.0 million for the year ended December 31, 2024 from $35.3 million for the year ended December 31, 2023, primarily due to the increase in the number of LALs and LDDs sold during the period.
Cost of sales Cost of sales decreased by $9.5 million, or (23.2)%, to $31.5 million for the year ended December 31, 2025 from $41.0 million for the year ended December 31, 2024, primarily due to the decreased number of LDDs sold during the period.
We believe that over time, our adjustable lens solution can be used to address a broad range of cataract surgery patients, including those that would otherwise elect for a conventional cataract procedure today.
We believe our adjustable lens solution can be used to address a broad range of cataract surgery patients, including those that would otherwise elect for a conventional cataract procedure today. We will undertake additional clinical studies to expand the existing body of evidence related to the safety and effectiveness of our current and future generations of products.
Net cash used in operating activities for the year ended December 31, 2023 was $41.6 million consisting primarily of a net loss of $48.6 million, a change in operating assets and liabilities of $9.1 million, partially offset by non-cash stock-based compensation of $15.7 million, and depreciation and amortization of $4.1 million.
Net cash used in operating activities in 2024 was $17.0 million consisting primarily of a net loss of $27.5 million, a change in operating assets and liabilities of $9.2 million, partially offset by non-cash stock-based compensation of $24.6 million, and depreciation and amortization of $3.6 million.
Comprehensive loss All components of comprehensive loss, including net loss, are reported in the consolidated financial statements in the period in which they are recognized.
Interest and other income, net Interest and other income, net consist primarily of interest income earned on our short-term investments and cash equivalents. Comprehensive loss All components of comprehensive loss, including net loss, are reported in the consolidated financial statements in the period in which they are recognized.
Components of results of operations Sales Our sales consist of the sale of LALs used in cataract surgeries, the LDDs for delivering light to the LALs to adjust the lens post-surgery, as needed, and service and accessories. Revenue is derived from sales of products primarily in the United States.
LAL sales increased by 11,560 units when compared to the prior year, primarily due to the larger LDD installed base. Components of results of operations Sales Our sales consist of LALs used in cataract surgeries, the LDDs for delivering light to the LALs to adjust the lens post-surgery, as needed, and service and accessories.
Because of these and other factors, we expect to continue to incur net losses and negative cash flows from operations in the near future. Key business metrics We regularly review several operating and financial metrics to evaluate our business, measure our performance, identify trends affecting our business, formulate our business plan and make strategic decisions.
Key business metrics We regularly review several operating and financial metrics to evaluate our business, measure our performance, identify trends affecting our business, formulate our business plan and make strategic decisions.
Revenue for such service agreements will be recognized over the term of each contract.
After the first year, service contracts can be purchased separately on a standalone basis. Revenue for such service agreements will be recognized ratably over the term of each contract.
We generated sales of $139.9 million and had a net loss of $27.5 million for the year ended December 31, 2024, compared to sales of $89.1 million and net loss of $48.6 million for the year ended December 31, 2023.
We generated sales of $134.5 million and had a net loss of $38.9 million in 2025, compared to sales of $139.9 million and net loss of $27.5 million in 2024.
Our LDD, as is typical of many medical device capital equipment products, has a lower gross margin than the IOL, as the material cost of the LDD is significant, representing approximately 50% of the total cost to manufacture.
Our LDD, as is typical of many medical device capital equipment products, has a lower gross margin, as the material cost of the LDD is a significant portion of the total cost to manufacture. In addition, we do not mark up our LDD substantially because LDDs, once sold, can generate LAL procedures.
Revenue is recognized for LALs upon customer notification that the LALs have been implanted in a patient or when title transfers to the distributor in a limited number. The timing of revenue recognition for LDD transactions and LAL transactions requires management judgment. Revenue recognition is reasonably likely to have a material impact on our financial condition and results of operations.
The timing of revenue recognition for LDD transactions and LAL transactions requires management judgment. Revenue recognition is reasonably likely to have a material impact on our financial condition and results of operations. Indemnification agreements We enter into standard indemnification arrangements in the ordinary course of business.
We designed our RxSight system to address the shortcomings of competitive premium IOL technologies and provide a solution that doctors can trust to improve visual outcomes and achieve high levels of patient satisfaction. Competitive premium IOLs require patients to specify their visual priorities before surgery and be willing to accept various optical trade-offs associated with those choices.
We designed our RxSight system to address limitations of conventional premium IOL technologies by providing doctors with a more precise and adaptable method for achieving desired visual outcomes for their patients. Conventional premium IOLs require patients to select their visual priorities before surgery and accept the optical trade-offs inherent in those choices.
To continue to 85 strengthen our competitive position in the premium IOL market, our research and development activities are focused primarily on programs that improve clinical outcomes, improve customer experience, expand our indications for use, reduce manufacturing costs and lifecycle management.
Our Customer Success Organization is focused on providing this support to our customers. Our near-term research and development activities are focused on enhancements to the RxSight system to improve clinical outcomes, enhance customer experience, expand our indications for use, reduce manufacturing costs and support lifecycle management.
This increase was primarily attributable to $2.9 million in increased facility costs due to increased research and development infrastructure, $2.2 million in increased personnel costs which includes stock-based compensation and $0.4 million in increased clinical study costs.
This increase was primarily attributable to $2.6 million in research and development activities, including the allocation of manufacturing resources and headcount, $2.7 million in increased personnel costs which includes stock-based compensation, offset by a $1.3 million decrease in clinical study and other costs.
Net cash used in investing activities for the year ended December 31, 2023 was $22.1 million, consisting of net purchases of short-term investments of $17.3 million and purchases of property and equipment of $4.8 million.
Cash used in investing activities Net cash provided by investing activities in 2025 was $16.9 million, consisting of net maturities of short-term investments of $20.7 million offset by purchases of property and equipment of $3.8 million.
We plan to grow our business primarily by expanding the size of our LDD installed base and driving increased utilization of our LAL through heightened awareness of the superior clinical outcomes that our RxSight system provides patients.
We plan on growing our business by increasing LAL adoption, expanding our LDD installed base, and driving heightened awareness of what we believe to be superior clinical outcomes that our RxSight system provides patients. We have found that ensuring clinicians understand our technology, are well-trained in its use, and understand the number of patients our technology can benefit, increases utilization.
Once a patient has selected a competitive premium IOL, the surgeon must rely on a series of preoperative diagnostic tests and predictive formulae to choose the appropriate lens power. If the doctor’s prediction isn’t exact, the patient may experience suboptimal results that could necessitate a subsequent corneal refractive procedure or certain other compromises in order to reach vision targets.
Surgeons must rely on a series of preoperative measurements and predictive formulae to determine the appropriate lens power. If the selected power is not optimal, the patient may experience less-than-ideal results that could require a subsequent corneal refractive procedure or other corrective measures to achieve intended vision targets.
We recognize LDD revenue primarily at the point in time at installation and customer acceptance of the LDD is satisfied. LALs are generally held at customer sites on consignment. In limited instances distributors may purchase small quantities of our products primarily to support clinical studies outside the U.S.
We recognize LDD revenue primarily at the point in time at installation and customer acceptance of the LDD is satisfied. LALs are generally held at customer sites on consignment. Revenue is recognized for LALs upon customer notification that the LALs have been implanted in a patient or upon shipment to an international distributor.
In addition, the list price for and average selling price of our LDD are priced reasonably because LDDs, once sold, generate LAL procedures. Our LAL gross margin is higher, with low material cost but high fixed overhead costs.
Our LAL gross margin is higher, with low material cost but high fixed overhead costs.
Selling, general and administrative expenses Selling, general and administrative expenses increased by $26.6 million, or 35.6%, to $101.4 million for the year ended December 31, 2024, from $74.8 million for the year ended December 31, 2023.
Selling, general and administrative expenses Selling, general and administrative expenses increased by $11.2 million, or 11.1%, to $112.7 million in 2025, from $101.4 million in 2024.
The RxSight system is comprised of our RxSight Light Adjustable Lens™ (“LAL™” and “LAL+ ® ”, collectively the “LAL”), RxSight Light Delivery Device (“LDD™”), and accessories. Our LAL's are premium intraocular lens (“IOL”) made of proprietary photosensitive material that changes shape in response to specific patterns of ultraviolet (“UV”) light generated by our LDD.
The LAL is a premium intraocular lens (“IOL”) made from the proprietary silicone-based photosensitive material that undergoes controlled changes in refractive power when exposed to specific ultraviolet (“UV”) light patterns generated by the LDD.
We will expand our marketing efforts with additional print and digital, social media and other customer tools to expand their local advertising. We will also continue to make significant investments in research and development and clinical expenses to make enhancements in our current products.
While we continue to make investments in our sales and marketing organization, including personnel in clinical applications, practice development, sales and technical service personnel, we also intend to expand our marketing efforts through additional print and digital, social media, education and other customer tools to drive further adoption of the RxSight system.
We believe the number of LDDs installed and, LALs implanted are indicators of our ability to drive adoption and generate revenue. We believe these are important metrics for our business.
We believe the number of LDDs installed and LALs implanted are the strongest indicators of the adoption of our technology and our ability to generate revenue. We monitor average monthly utilization, which we define as the number of LALs implanted during a quarter divided by the LDD installed base at the end of the prior quarter.
Gross margin increased to 70.7% in the year ended December 31, 2024 from 60.4% in 2023 primarily due to improved operating leverage, favorable product mix from a greater percentage of revenue from LAL sales and increased margins on our LDD due to lower material costs from the introduction of our compact LDD during the third quarter of 2023.
Gross margin increased to 76.6% in 2025 from 70.7% in 2024, primarily due to favorable product mix from a greater percentage of revenue from LAL sales, with LAL revenue comprising 80% of revenue in 2025, compared to 69% of revenue in 2024.
Our United States commercial organization includes a direct sales team of LDD sales personnel and LAL account managers, as well as clinical specialists, field service engineers and marketing personnel. Our sales efforts are concentrated on the roughly 3,500 to 4,000 U.S. cataract surgeons that perform approximately 60% of all premium IOL procedures.
Our sales efforts are concentrated on the approximately 3,500 to 4,000 U.S. cataract surgeons that perform approximately 60% of all premium IOL procedures. As of December 31, 2025, we have established an installed base of 1,134 LDDs in ophthalmology practices and, since our inception through December 31, 2025, surgeons have implanted approximately 300,000 LALs.
See Note 11 – Leases in the Notes to the consolidated financial statements included in this report. Our four facility operating leases are our only material contractual obligations. For an additional description of these contractual obligations and commitments, see Note 11 – Leases in the Notes to the consolidated financial statements included in this annual report.
Contractual Obligations and Commitments For a discussion of our contractual obligations and commitments, refer to Part II, Item 8, Note 12, “Commitments and Contingencies” in our notes to the consolidated financial statements in this Annual Report on Form 10-K.
Net cash provided by financing activities for the year ended December 31, 2023 was $61.5 million, consisting primarily of proceeds from issuances of common stock from our public offering of $54.1 million, proceeds from issuance of common stock for at-the-market offerings of $42.4 million and proceeds from issuance of common stock of $9.5 million pursuant to equity compensation programs, partially offset by a net paydown of the June 2023 LSA Oxford term debt of $40.0 million. 92 Critical accounting policies, significant judgments and use of estimates Our management’s discussion and analysis of our financial condition and results of operations are based on our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”).
Critical accounting policies, significant judgments and use of estimates Our management’s discussion and analysis of our financial condition and results of operations are based on our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the U.S. of America (“GAAP”).
The increase was due to incremental sales of 43,182 LALs primarily due to continued penetration in existing customers, an increased LDD installed base of 305 and incremental sales of 39 LDDs from strong adoption of our RxSight technology by practices and doctors.
The lower LDD sales were partially offset by increased LAL sales of 11,560 units, or 12%, when compared to the same period in 2024, which was primarily due to the net increase in our LDD installed base. The reduction in LDD sales was due to slower adoption of RxSight technology among practices and doctors in 2025 as compared to 2024.
Removed
Our RxSight system has regulatory approval in the U.S., Europe, Canada, Mexico and Korea. We may selectively pursue commercial expansion in these or other geographies that accept these approvals in the future, with a priority on markets where we see significant potential opportunities.
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The RxSight system is comprised of our RxSight Light Adjustable Lens ® (LAL ® /LAL+ ® , collectively the “LAL”), RxSight Light Delivery Device™ (“LDD™”) and related accessories.
Removed
New approvals may also be sought in large foreign cataract markets with more complex regulatory processes such as Asia and Europe. We are a Delaware corporation headquartered in Aliso Viejo, California with one wholly owned subsidiary located in Amsterdam, Netherlands. The wholly owned subsidiary has a registered branch in the United Kingdom and a wholly owned subsidiary located in Germany.
Added
Our RxSight system is approved in the U.S. and several foreign countries for improving uncorrected visual acuity by adjusting the LAL power to correct residual postoperative refractive error. Outside of the U.S., we presently have approval in Europe, Canada, Mexico, Singapore, Australia and South Korea, and we intend to seek additional approvals in the future to broaden our international presence.
Removed
As of December 31, 2024, we had established an installed base of 971 LDDs in ophthalmology practices and, since our inception though December 31, 2024, surgeons have implanted over 195,000 LALs. We believe this business model provides an attractive and concentrated market opportunity addressable with a focused sales force.
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In non-U.S. markets, reimbursement and healthcare payment systems vary significantly by country. Some have instituted price ceilings on specific products and therapies.
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We intend to continue to make significant investments in our sales and marketing organization. We believe selectively increasing the number of sales representatives, practice development personnel and clinical trainers will help facilitate further adoption of our products among existing customer accounts as well as broaden awareness of our products to new accounts.
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In many countries, analogous determinations to the dual aspect CMS ruling have been made, allowing for partial coverage of the cataract procedure by national health systems, with patients paying out of pocket for refractive services associated with the premium IOL. In other countries, similar dual billing is not allowed.
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Our near-term research and development activities are focused on enhancements to the RxSight system to improve the patient and doctor experience, expand the range of patients that can be treated, as well as expand the RxSight system indications and drive adoption.
Added
While we are growing our presence outside the U.S., we do not anticipate meaningful near-term sales from these non-U.S. regions. We are a Delaware corporation headquartered in Aliso Viejo, California with two wholly owned subsidiaries located in Hong Kong (“RxSight, Hong Kong”) and in Amsterdam, Netherlands (“RxSight, Netherlands”).
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Additional development and clinical studies that are designed to provide clinical evidence of the safety and effectiveness of our existing and future generations of products are also anticipated.
Added
We believe this business model provides an attractive and concentrated market opportunity addressable with a focused sales force. Our commercial organization includes LDD sales personnel, LAL account managers, clinical specialists, field service engineers, and marketing personnel.
Removed
We intend to continue to make investments in our sales and marketing organization, primarily sales representatives, clinical applications specialists and technical service personnel to support new customers and upgrades and LAL account managers to facilitate adoption of use of our LALs among existing accounts.
Added
We recently completed a full realignment of our U.S. commercial organization by integrating our clinical and sales teams into a single unified Customer Success Organization. We believe this new structure will not only help us better support our existing customers, but it will also position us for the next phase of adoption.
Removed
We may not yet be able to accurately assess seasonality and other trends, and we will continue to evaluate our business in the future using these and other financial metrics as we observe trends in our business. Our quarterly and annual financial results may fluctuate as a result of a variety of factors many of which are outside our control.
Added
Each integrated team within the Customer Success Organization is responsible for a defined group of doctors and practices, managing the 81 customer experience from onboarding through long-term LAL utilization growth. The majority of employees in our approximately 200-person commercial organization are in the Customer Success Organization.
Removed
For example, it is not uncommon in our industry to experience seasonally weaker sales during the summer months and end-of-year holiday season. We may be affected by other seasonal trends in the future, including severe weather (which can impact the number of elective procedures performed), particularly as our business matures.
Added
Because of our ongoing investment in our business and products and these and other factors, we expect to continue to incur net losses and negative cash flows from operations for the near future.
Removed
Additionally, this seasonality may be reflected to a much lesser extent, and sometimes may not be immediately apparent, in our revenue. To the extent we experience this seasonality, it may cause fluctuations in our operating results and financial metrics and make forecasting our future operating results and financial metrics more difficult.
Added
Our results are influenced by several key factors, including: (i) growth in our LDD installed base, which enables LALs to be implanted; (ii) the utilization of that installed base for LAL procedures, measured by the number of LALs implanted per installed LDD; (iii) product mix between LALs and LDDs, which affects our overall gross margins; (iv) manufacturing cost trends; and (v) seasonal and external factors that may affect cataract surgery volumes.
Removed
We believe the number of LDDs sold in each quarter and our LDD installed base at the end of each period are important metrics as they represent an installed base into which we can sell our LALs.
Added
This fluctuates due to seasonality, practice ramp, and external disruptions (including severe weather events). 2025 2024 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 LDDs Sold 73 40 25 25 66 78 78 83 Installed Base at End of Period 1,044 1,084 1,109 1,134 732 810 888 971 2025 2024 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 LALs Sold 27,579 27,380 26,045 28,611 20,218 24,214 24,554 29,069 During 2025, we sold 163 LDDs, which was a decrease of 142 LDDs when compared to the prior year due to slower adoption of our RxSight technology by practices and doctors.
Removed
We also believe the number of LALs sold (reported as implanted in a patient) in each quarter is an important metric indicative of adoption and utilization of our RxSight system. 2024 2023 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 LDDs Sold 66 78 78 83 56 67 66 77 Installed Base at End of Period 732 810 888 971 456 523 589 666 2024 2023 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 LALs Sold 20,218 24,214 24,554 29,069 10,523 12,622 13,657 18,071 86 During 2024, we had increased LDD sales of 39 and increased LAL sales of 43,182 when compared to 2023 from strong adoption of our RxSight technology by practices and doctors combined with an increased LDD installed base.
Added
Revenue is derived from sales of products mainly in the U.S. and select international markets. Customers are primarily comprised of ophthalmic practices (LDD sales) and ambulatory surgery centers (LAL sales). We recently completed a full realignment of our U.S. commercial organization by integrating our clinical and sales 82 teams into a single unified Customer Success Organization.

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Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

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Biggest changeInterest Fluctuation Rate Risk We had cash and cash equivalents and short-term investments of $237.2 million as of December 31, 2024, which consisted of $220.5 million in highly liquid money market and U.S. Treasury securities with maturities of twelve months or less. The primary goals of our investment policy are liquidity and capital preservation.
Biggest changeInterest Fluctuation Rate Risk We had cash and cash equivalents and short-term investments of $228.1 million as of December 31, 2025, which consisted of $208.2 million in highly liquid money market and U.S. Treasury securities with maturities of twelve months or less. The primary goals of our investment policy are liquidity and capital preservation.
If overall interest rates had increased or decreased by 1.00% (100 basis points), our interest income would not have been materially affected during the years ended December 31, 2024 or December 31, 2023.
If overall interest rates had increased or decreased by 1.00% (100 basis points), our interest income would not have been materially affected during the years ended December 31, 2025 or December 31, 2024.
A hypothetical 1.00% (100 basis points) increase in interest rates would not have materially impacted the fair value of our marketable securities as of December 31, 2024 and December 31, 2023.
A hypothetical 1.00% (100 basis points) increase in interest rates would not have materially impacted the fair value of our marketable securities as of December 31, 2025 and December 31, 2024.
Foreign Currency Exchange Risk As of December 31, 2024, we have de minimis amounts of revenue and expenses that are denominated in currencies other than U.S. dollars. 94
Foreign Currency Exchange Risk As of December 31, 2025, we have de minimis amounts of revenue and expenses that are denominated in currencies other than U.S. dollars. 89

Other RXST 10-K year-over-year comparisons