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

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Paragraph-level year-over-year comparison of Sight Sciences, 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.

+549 added−541 removedSource: 10-K (2026-03-04) vs 10-K (2025-03-07)

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

549 paragraphs added · 541 removed · 421 edited across 2 sections

Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

192 edited+54 added−36 removed346 unchanged
Biggest changeWe have based these estimates on assumptions that may prove to be wrong, including our assumptions that OMNI revenue will grow, procedures in which our OMNI technology is used will continue to be adequately reimbursed, our TearCare procedure will receive sustainable and attractive reimbursement, and we will receive a significant non-appealable damages award in our litigation opposite Alcon, If one or more of these assumptions are not met, we could utilize our available capital resources sooner than we expect. 40 We expect to continue to invest in clinical trials or investigations that are designed to provide clinical evidence of the safety and efficacy of our products, the growth of our sales and marketing organization, and research and development of product improvements and future products, including certain pharmaceutical product candidates, which will continue to increase our expenses.
Biggest changeWe expect to continue to invest in clinical trials or investigations that are designed to provide clinical evidence of the safety and efficacy of our products, the growth of our sales and marketing organization, and research and development of product improvements and future products, including certain pharmaceutical product candidates, which will continue to increase our expenses.
We began selling VISCO360 and TRAB360, commercial predicate devices to OMNI, in 2015, TearCare in 2019 and SION in 2022, and therefore do not have a long history operating as a commercial company. Currently, we are highly dependent on the success of OMNI.
We began selling VISCO360 and TRAB360, commercial predicate devices to OMNI, in 2015, TearCare in 2019 and SION in 2022, and therefore do not have a long history operating as a commercial company. Currently, we are highly dependent on the success of OMNI and TearCare.
Doing business internationally involves a number of risks, including: • Difficulties in staffing and managing our international operations; • Multiple, conflicting and changing laws and regulations such as tax laws, privacy laws, export and import restrictions, employment laws, regulatory requirements and other governmental approvals, permits and licenses; • Reduced or varied protection for intellectual property rights in some countries; • Obtaining regulatory clearance, certification or approval where required for our products in various countries; • Requirements to maintain data and the processing of that data on servers located within such countries; • Complexities associated with managing multiple payor reimbursement regimes, government payors or patient self-pay systems; • Limits on our ability to penetrate international markets if we are required to manufacture our products locally; • Financial risks, such as longer payment cycles, difficulty collecting accounts receivable, foreign tax laws and complexities of foreign value-added tax systems, the effect of local and regional financial pressures on demand and payment for our products and exposure to foreign currency exchange rate fluctuations; • Restrictions on the site-of-service for use of our products and the economics related thereto for physicians, providers and payors; • Changes in foreign currency exchange rates and costs associated with hedging against such changes; • Natural disasters, political and economic instability, including wars, such as the current military conflict between Russia and Ukraine and the crisis in the Middle East, terrorism, political unrest, outbreak of disease, boycotts, curtailment of trade and other market restrictions; and 46 • Regulatory and compliance risks that relate to maintaining accurate information and control over activities subject to regulation under the United States Foreign Corrupt Practices Act of 1977 ("FCPA"), U.K.
Doing business internationally involves a number of risks, including: • Difficulties in staffing and managing our international operations; • Multiple, conflicting and changing laws and regulations such as tax laws, privacy laws, export and import restrictions, employment laws, regulatory requirements and other governmental approvals, permits and licenses; • Reduced or varied protection for intellectual property rights in some countries; • Obtaining regulatory clearance, certification or approval where required for our products in various countries; • Requirements to maintain data and the processing of that data on servers located within such countries; • Complexities associated with managing multiple payor reimbursement regimes, government payors or patient self-pay systems; • Limits on our ability to penetrate international markets if we are required to manufacture our products locally; • Financial risks, such as longer payment cycles, difficulty collecting accounts receivable, foreign tax laws and complexities of foreign value-added tax systems, the effect of local and regional financial pressures on demand and payment for our products and exposure to foreign currency exchange rate fluctuations; • Restrictions on the site-of-service for use of our products and the economics related thereto for physicians, providers and payors; • Changes in foreign currency exchange rates and costs associated with hedging against such changes; • Natural disasters, political and economic instability, including wars, such as the current military conflict between Russia and Ukraine and the crisis in the Middle East, terrorism, political unrest, outbreak of disease, boycotts, curtailment of trade and other market restrictions; and • Regulatory and compliance risks that relate to maintaining accurate information and control over activities subject to regulation under the United States Foreign Corrupt Practices Act of 1977 ("FCPA"), U.K.
These fluctuations may occur due to a variety of factors, many of which are outside of our control, including the following: • The level of demand for our products which may vary significantly; • Changes in coverage and reimbursement policies with respect to the procedures in which our products and our competitors' products are used, and potential future products that compete with our products; • Results of clinical trials or investigations involving the use of our products; • Regulatory decisions or announcements, including product recalls, and product labeling and reimbursement determinations; • Expenditures that we may incur to acquire, develop or commercialize additional products and technologies; • Sales and marketing efforts and expenses; • Pricing pressures; • The rate at which we grow our sales force and the speed at which newly hired salespeople become effective; 38 • The degree of competition in our industry and any change in the competitive landscape of our industry, including consolidation among our competitors or future partners; • Positive or negative coverage in the media or clinical publications of our products or products of our competitors or our industry; • The timing of customer orders or medical procedures using our products and the number of available selling days in any quarterly period, which can be impacted by holidays, the mix of products sold and the geographic mix of where products are sold; • The timing and cost of, and level of investment in, research, development, licenses, regulatory approval, commercialization activities, acquisitions and other strategic transactions, or other significant events relating to our products, which may change from time to time; • The costs of enforcing and defending our intellectual property rights, whether through litigation or otherwise; • The cost of manufacturing our products, which may vary depending on the quantity of production and the terms of our agreements with third-party suppliers; and • Future accounting pronouncements or changes in our accounting policies.
These fluctuations may occur due to a variety of factors, many of which are outside of our control, including the following: • The level of demand for our products which may vary significantly; • Changes in coverage and reimbursement policies with respect to the procedures in which our products and our competitors' products are used, and potential future products that compete with our products; • Results of clinical trials or investigations involving the use of our products; • Regulatory decisions or announcements, including product recalls, and product labeling and reimbursement determinations; • Expenditures that we may incur to acquire, develop or commercialize additional products and technologies; • Sales and marketing efforts and expenses; • Pricing pressures; • The rate at which we grow our sales force and the speed at which newly hired salespeople become effective; • The degree of competition in our industry and any change in the competitive landscape of our industry, including consolidation among our competitors or future partners; • Positive or negative coverage in the media or clinical publications of our products or products of our competitors or our industry; • The timing of customer orders or medical procedures using our products and the number of available selling days in any quarterly period, which can be impacted by holidays, the mix of products sold and the geographic mix of where products are sold; • The timing and cost of, and level of investment in, research, development, licenses, regulatory approval, commercialization activities, acquisitions and other strategic transactions, or other significant events relating to our products, which may change from time to time; • The costs of enforcing and defending our intellectual property rights, whether through litigation or otherwise; • The cost of manufacturing our products, which may vary depending on the quantity of production and the terms of our agreements with third-party suppliers; and • Future accounting pronouncements or changes in our accounting policies.
Risks Related to Our Common Stock The price of our common stock may fluctuate substantially or may decline regardless of our operating performance and you could lose all or part of your investment The market price of our common stock may be highly volatile and may fluctuate or decline substantially as a result of a variety of factors, some of which are beyond our control or are related in complex ways, including: • Changes in analysts’ estimates, investors’ perceptions, recommendations by securities analysts or our failure to achieve analysts’ estimates; • Changes in reimbursement coverage by current or potential payors, including new or updated local or national coverage determinations by one or more MACs; • Actual or anticipated quarterly variations in our or our competitors’ results of operations; • Periodic fluctuations in our revenue, which could be due in part to the way in which we recognize revenue; • The trading volume of our common stock; • General market conditions and other factors unrelated to our operating performance or the operating performance of our competitors; • Changes in operating performance and stock market valuations of other technology companies generally, or those in the medical device industry in particular; • Actual or anticipated changes in regulatory oversight of our products; • The results of our clinical trials; 59 • The loss of key personnel, including changes in our board of directors or management; • Product recalls or other problems associated with our products; • Legislation or regulation of our market; • Lawsuits threatened or filed against us; • The announcement of new products or product enhancements by us or our competitors; • Announced or completed acquisitions of businesses or technologies by us or our competitors; • Announcements related to patents issued to us or our competitors and related litigation; and • Developments in our industry.
Risks Related to Our Common Stock The price of our common stock may fluctuate substantially or may decline regardless of our operating performance and you could lose all or part of your investment The market price of our common stock may be highly volatile and may fluctuate or decline substantially as a result of a variety of factors, some of which are beyond our control or are related in complex ways, including: • Changes in analysts’ estimates, investors’ perceptions, recommendations by securities analysts or our failure to achieve analysts’ estimates; • Changes in reimbursement coverage by current or potential payors, including new or updated local or national coverage determinations by one or more MACs; • Actual or anticipated quarterly variations in our or our competitors’ results of operations; • Periodic fluctuations in our revenue, which could be due in part to the way in which we recognize revenue; • The trading volume of our common stock; • General market conditions and other factors unrelated to our operating performance or the operating performance of our competitors; • Changes in operating performance and stock market valuations of other technology companies generally, or those in the medical device industry in particular; • Actual or anticipated changes in regulatory oversight of our products; • The results of our clinical trials; • The loss of key personnel, including changes in our board of directors or management; • Product recalls or other problems associated with our products; • Legislation or regulation of our market; • Lawsuits threatened or filed against us; • The announcement of new products or product enhancements by us or our competitors; • Announced or completed acquisitions of businesses or technologies by us or our competitors; • Announcements related to patents issued to us or our competitors and related litigation; and • Developments in our industry.
The success of any new product offering or product enhancements to our solutions will depend on several factors, including our ability to: • Maintain strong relationships with ECPs; • Assemble sufficient resources to acquire or discover additional products; • Properly identify and anticipate physician and patient needs; 37 • Develop and introduce new products and product enhancements in a timely manner; • Receive adequate and equitable coding, coverage and reimbursement for procedures performed with our products; • Avoid infringing upon, misappropriating or otherwise violating the intellectual property rights of third parties; • Demonstrate, if required, the safety and efficacy of new products with data from preclinical studies and clinical trials or investigations; • Obtain the necessary regulatory clearances, certifications or approvals for expanded indications, new products or product modifications; • Comply with the requirements of FDA and similar foreign regulatory authorities regarding the marketing of new devices or modified products; • Produce new products in commercial quantities at an acceptable cost; • Provide adequate training to potential users of our products; and • Develop an effective and dedicated sales and marketing team.
The success of any new product offering or product enhancements to our solutions will depend on several factors, including our ability to: • Maintain strong relationships with ECPs; • Assemble sufficient resources to acquire or discover additional products; • Properly identify and anticipate physician and patient needs; • Develop and introduce new products and product enhancements in a timely manner; • Receive adequate and equitable coding, coverage and reimbursement for procedures performed with our products; • Avoid infringing upon, misappropriating or otherwise violating the intellectual property rights of third parties; • Demonstrate, if required, the safety and efficacy of new products with data from preclinical studies and clinical trials or investigations; • Obtain the necessary regulatory clearances, certifications or approvals for expanded indications, new products or product modifications; • Comply with the requirements of FDA and similar foreign regulatory authorities regarding the marketing of new devices or modified products; • Produce new products in commercial quantities at an acceptable cost; • Provide adequate training to potential users of our products; and • Develop an effective and dedicated sales and marketing team.
Our failure to comply with applicable regulatory requirements could result in enforcement action by the FDA, state or foreign regulatory authorities, which may include any of the following sanctions or consequences: • Untitled letters, warning letters or adverse publicity; • Fines, injunctions, consent decrees and civil penalties; • Recalls, termination of distribution, administrative detention, or seizure of our products; • Customer notifications or repair, replacement or refunds; • Operating restrictions or partial suspension or total shutdown of production; • Delays in or refusal to grant our requests for future clearances or approvals or foreign clearance, certification or approval of new products, new intended uses, or modifications to existing products; • Withdrawals or suspensions of 510(k) clearances or certifications or Class I registrations, or requirements for new 510(k) or PMA clearances, certifications, or approvals, resulting in prohibitions on sales of our products pending such further clearance or certification; • FDA refusal to issue certificates to foreign governments needed to export products for sale in other countries; and • Criminal prosecution.
Our failure to comply with applicable regulatory requirements could result in enforcement action by the FDA, state or foreign regulatory authorities, which may include any of the following sanctions or consequences: • Untitled letters, warning letters or adverse publicity; • Fines, injunctions, consent decrees and civil penalties; • Recalls, termination of distribution, administrative detention, or seizure of our products; • Customer notifications or repair, replacement or refunds; • Operating restrictions or partial suspension or total shutdown of production; • Delays in or refusal to grant our requests for future clearances or approvals or foreign clearance, certification or approval of new products, new intended uses, or modifications to existing products; • Withdrawals or suspensions of 510(k) clearances or certifications or Class I registrations, or requirements for new 510(k) or PMA clearances, certifications, or approvals, resulting in prohibitions on sales of our products pending such further clearance or certification; • FDA refusal to issue certificates to foreign governments needed to export products for sale in other countries; and 53 • Criminal prosecution.
The healthcare laws and regulations that may affect our ability to operate include the following: • The federal Anti-Kickback Statute, which prohibits, among other things, individuals and entities from knowingly and willfully soliciting, offering, receiving or providing remuneration (including any kickback, bribe or rebate), directly or indirectly, in cash or in kind, to induce either the referral of an individual or furnishing or arranging for a good or service, for which payment may be made, in whole or in part, under federal healthcare programs, such as Medicare and Medicaid; • The federal and state civil and criminal false claims laws and civil monetary penalties laws, including the federal civil False Claims Act, which prohibit, among other things, individuals and entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, state Medicaid programs, other third-party payors, or other federal healthcare programs that are false or fraudulent; • The federal Civil Monetary Penalties Law, which prohibits, among other things, individuals and entities from offering or transferring remuneration to a federal healthcare beneficiary that a person knows or should know is likely to influence the beneficiary’s decision to order or receive items or services reimbursable by the government from a particular provider or supplier; • HIPAA, which created additional federal criminal statutes that prohibit, among other things, executing a scheme to defraud any healthcare benefit program and making false statements relating to healthcare matters; • Federal disclosure laws, such as the Physician Payments Sunshine Act, which require certain applicable manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or CHIP to report annually to the CMS information related to payments and other transfers of value to physicians, which is defined broadly to include other healthcare providers, and teaching hospitals, and to report annually ownership and investment interests held by physicians and their immediate family members; • HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, and their respective implementing regulations, which impose requirements on certain covered healthcare providers, health plans and healthcare clearinghouses as well as their business associates that perform services for them that involve individually identifiable health information, relating to the privacy, security and transmission of individually identifiable health information without appropriate authorization, including mandatory contractual terms as well as directly applicable privacy and security standards and requirements; • The FDCA, which prohibits, among other things, the adulteration or misbranding of drugs, biologics and medical devices; • Federal and state laws and regulations regarding billing and claims payment applicable to our products and regulatory agencies enforcing those laws and regulations; and • Analogous state and foreign law equivalents of each of the above federal laws, such as anti-kickback and false claims laws, which may apply to items or services reimbursed by any third-party payor, including commercial insurers or patients; state laws that require device companies to comply with the industry’s voluntary compliance guidelines and the applicable compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; state laws that require device manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm customers, foreign and state laws, including the GDPR, governing the privacy and security of personal (including health) information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts; and state laws related to insurance fraud in the case of claims involving private insurers.
The laws and regulations that may affect our ability to operate include the following: • The federal Anti-Kickback Statute, which prohibits, among other things, individuals and entities from knowingly and willfully soliciting, offering, receiving or providing remuneration (including any kickback, bribe or rebate), directly or indirectly, in cash or in kind, to induce either the referral of an individual or furnishing or arranging for a good or service, for which payment may be made, in whole or in part, under federal healthcare programs, such as Medicare and Medicaid; • The federal and state civil and criminal false claims laws and civil monetary penalties laws, including the federal civil False Claims Act, which prohibit, among other things, individuals and entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, state Medicaid programs, other third-party payors, or other federal healthcare programs that are false or fraudulent; • The federal Civil Monetary Penalties Law, which prohibits, among other things, individuals and entities from offering or transferring remuneration to a federal healthcare beneficiary that a person knows or should know is likely to influence the beneficiary’s decision to order or receive items or services reimbursable by the government from a particular provider or supplier; • HIPAA, which created additional federal criminal statutes that prohibit, among other things, executing a scheme to defraud any healthcare benefit program and making false statements relating to healthcare matters; • Federal disclosure laws, such as the Physician Payments Sunshine Act, which require certain applicable manufacturers of drugs, devices, biologics and medical supplies for which payment is available under 55 Medicare, Medicaid or CHIP to report annually to the CMS information related to payments and other transfers of value to physicians, which is defined broadly to include other healthcare providers, and teaching hospitals, and to report annually ownership and investment interests held by physicians and their immediate family members; • HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, and their respective implementing regulations, which impose requirements on certain covered healthcare providers, health plans and healthcare clearinghouses as well as their business associates that perform services for them that involve individually identifiable health information, relating to the privacy, security and transmission of individually identifiable health information without appropriate authorization, including mandatory contractual terms as well as directly applicable privacy and security standards and requirements; • The FDCA, which prohibits, among other things, the adulteration or misbranding of drugs, biologics and medical devices; • Federal and state laws and regulations regarding billing and claims payment applicable to our products and regulatory agencies enforcing those laws and regulations; and • Analogous state and foreign law equivalents of each of the above federal laws, such as anti-kickback and false claims laws, which may apply to items or services reimbursed by any third-party payor, including commercial insurers or patients; state marketing-compliance and gift-ban laws; state laws that require device companies to comply with the industry’s voluntary compliance guidelines and the applicable compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; state laws that require device manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm customers, foreign and state laws, including the GDPR, governing the privacy and security of personal (including health) information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts; and state laws related to insurance fraud in the case of claims involving private insurers.
If our operations are found to be in violation of any of the federal, state and foreign laws described above or any other current or future fraud and abuse or other healthcare laws and regulations that apply to us, we may be subject to significant penalties, including significant criminal, civil, and administrative penalties, damages, fines, exclusion from participation in government programs, such as Medicare and Medicaid, imprisonment, contractual damages, reputation harm and disgorgement and we could be required to curtail, restructure or cease our operations.
If our operations are found to be in violation of any of the federal, state and foreign laws described above or any other current or future fraud and abuse or other healthcare laws and regulations that apply to us, we may be subject to significant penalties, including significant criminal, civil, and administrative penalties, damages, fines, exclusion from 56 participation in government programs, such as Medicare and Medicaid, imprisonment, contractual damages, reputation harm and disgorgement and we could be required to curtail, restructure or cease our operations.
In addition, notwithstanding their subsequent withdrawal in late December 2023, the publication of the Prior LCDs, as amended, by five of the seven MACs in June 2023, which would have rendered canaloplasty followed by trabeculotomy (ab interno), a procedure associated with our OMNI technology, investigational and thus non-covered in these MAC jurisdictions, adversely affected our business and prospects and resulted in a substantial decline in the market price of our common stock.
In addition, notwithstanding their subsequent withdrawal in late December 2023, the publication of the Prior LCDs, as amended, by five 58 of the seven MACs in June 2023, which would have rendered canaloplasty followed by trabeculotomy (ab interno), a procedure associated with our OMNI technology, investigational and thus non-covered in these MAC jurisdictions, adversely affected our business and prospects and resulted in a substantial decline in the market price of our common stock.
District Court for the District of Delaware (C.A. No. 1:21-cv-01317) (the “Court”) alleging that Ivantis, Inc. (“Ivantis”) directly and indirectly infringes our U.S. Patent Nos. 8,287,482, 9,370,443, 9,486,361, and 10,314,742 by making, using, selling, and offering for sale the Hydrus® Microstent. Our complaint sought money damages and injunctive relief.
District Court for the District of Delaware (C.A. No. 1:21-cv-01317) (the “Court”) alleging that Ivantis, Inc. (“Ivantis”) directly and indirectly infringes our U.S. Patent Nos. 8,287,482, 9,370,443, 48 9,486,361, and 10,314,742 by making, using, selling, and offering for sale the Hydrus® Microstent. Our complaint sought money damages and injunctive relief.
If physicians elect to use our products in manners outside of the intended uses that have been cleared, authorized, or certified, then such off-label use of our products may result in outcomes and adverse events that are sight threatening, necessitate medical or surgical intervention to preclude permanent impairment of vision, or result in a permanent impairment of vision, potentially leading to product liability claims.
If physicians elect to use our products in manners outside of the intended uses that have been cleared, authorized, or 41 certified, then such off-label use of our products may result in outcomes and adverse events that are sight threatening, necessitate medical or surgical intervention to preclude permanent impairment of vision, or result in a permanent impairment of vision, potentially leading to product liability claims.
If we identify future material weaknesses in our internal controls over financial reporting or fail to meet the demands that will be placed upon us as a public company, including the requirements of the Sarbanes-Oxley Act, we may be unable to accurately report our financial results or report them within the timeframes required by law or stock exchange regulations.
If we identify material weaknesses in our internal controls over financial reporting or fail to meet the demands that will be placed upon us as a public company, including the requirements of the Sarbanes-Oxley Act, we may be unable to accurately report our financial results or report them within the timeframes required by law or stock exchange regulations.
Product liability claims could cause us to incur significant legal fees and deductibles and claims in excess of our insurance coverage would be paid out of cash reserves, harming our financial condition and operating results. 43 We have a significant amount of debt, which may affect our ability to operate our business and secure additional financing in the future.
Product liability claims could cause us to incur significant legal fees and deductibles and claims in excess of our insurance coverage would be paid out of cash reserves, harming our financial condition and operating results. We have a significant amount of debt, which may affect our ability to operate our business and secure additional financing in the future.
Any of these events could negatively impact the number of procedures using our implants that are performed and have a material adverse effect on our business, financial condition, results of operations, or cash flows. 48 Risks Related to Our Intellectual Property Our success will depend on our, and our licensors’, ability to obtain, maintain and protect our intellectual property rights.
Any of these events could negatively impact the number of procedures using our implants that are performed and have a material adverse effect on our business, financial condition, results of operations, or cash flows. Risks Related to Our Intellectual Property Our success will depend on our, and our licensors’, ability to obtain, maintain and protect our intellectual property rights.
Historical clinical results, including interim results, are not necessarily predictive of future clinical results, and we cannot assure you that the results reported in these studies will be consistent with, or better than, currently available clinical data. In addition, our competitors and other third parties may conduct clinical trials of our products without our participation.
Historical clinical results, including interim results, 31 are not necessarily predictive of future clinical results, and we cannot assure you that the results reported in these studies will be consistent with, or better than, currently available clinical data. In addition, our competitors and other third parties may conduct clinical trials of our products without our participation.
If the FDA, other regulator, or notified body, inspect or audit any of our manufacturers’ facilities and discovers compliance problems, we may have to cease manufacturing and product distribution until we can take the appropriate remedial steps to correct the audit findings. Any of the actions noted above could significantly and negatively affect supply of our products.
If the FDA, other regulator, or notified body, inspect or audit any of our manufacturers’ facilities and discovers compliance problems, we may have to cease manufacturing and product distribution until we can take the 54 appropriate remedial steps to correct the audit findings. Any of the actions noted above could significantly and negatively affect supply of our products.
Non-compliance with the above requirements would also prevent us from selling our products in these three countries. We may incur significant liability if it is determined that we are promoting off-label uses of our products in violation of federal and state regulations in the United States or elsewhere.
Non-compliance with the above requirements would also prevent us from selling our products in these three countries. 52 We may incur significant liability if it is determined that we are promoting off-label uses of our products in violation of federal and state regulations in the United States or elsewhere.
For instance, competitors may price their products significantly below ours, or bundle their products in a manner that is attractive to ECPs, which may result in decreased use or adoption of our products by ECPs, notwithstanding that our products may offer superior safety and efficacy. Adoption of our products depends upon appropriate physician training, practice and patient selection.
For instance, competitors may price their products significantly below ours or bundle their products in a manner that is attractive to ECPs, which may result 30 in decreased use or adoption of our products by ECPs, notwithstanding that our products may offer superior safety and efficacy. Adoption of our products depends upon appropriate physician training, practice and patient selection.
Furthermore, even if our patents are found to be valid and infringed, a court may refuse to grant injunctive relief against the infringer and instead grant us monetary damages and/or ongoing royalties. Such monetary compensation may be insufficient to adequately offset the damage to our business caused by the infringer’s competition in the market.
Furthermore, even if our patents and trademarks are found to be valid and infringed, a court may refuse to grant injunctive relief against the infringer and instead grant us monetary damages and/or ongoing royalties. Such monetary compensation may be insufficient to adequately offset the damage to our business caused by the infringer’s competition in the market.
Further, under the FDA’s medical device reporting regulations and similar foreign regulations, we are required to maintain appropriate quality systems and report incidents in which our product may have caused or contributed to serious 55 injury or death in which our product malfunctioned and, if the malfunction were to recur, would likely cause or contribute to serious injury or death.
Further, under the FDA’s medical device reporting regulations and similar foreign regulations, we are required to maintain appropriate quality systems and report incidents in which our product may have caused or contributed to serious injury or death in which our product malfunctioned and, if the malfunction were to recur, would likely cause or contribute to serious injury or death.
Once a permanent CPT code ("Category I CPT code") is established for a service, CMS establishes payment levels under Medicare, while other payors may establish rates and coverage rules independently. Canaloplasty followed by trabeculotomy procedures using OMNI are typically billed using the Category I CPT code 66174, which describes canaloplasty.
Once a permanent CPT code ("Category I CPT code") is established for a service, CMS establishes national payment levels under Medicare, while other payors may establish rates and coverage rules independently. Canaloplasty followed by trabeculotomy procedures using OMNI are typically billed using the Category I CPT code 66174, which describes canaloplasty.
An inability to incorporate technologies or features that are important 51 or essential to our products could have a material adverse effect on our business, financial condition and results of operations, and may prevent us from selling our products. In addition, we may lose valuable intellectual property rights or personnel.
An inability to incorporate technologies or features that are important or essential to our products could have a material adverse effect on our business, financial condition and results of operations, and may prevent us from selling our products. In addition, we may lose valuable intellectual property rights or personnel.
We seek to protect such proprietary information, in part, through confidentiality agreements with our employees, collaborators, contractors, advisors, consultants and other third parties and invention assignment agreements with our employees. 50 We cannot guarantee that we have entered into such agreements with each party that has or may have had access to our trade secrets or proprietary information.
We seek to protect such proprietary information, in part, through confidentiality agreements with our employees, collaborators, contractors, advisors, consultants and other third parties and invention assignment agreements with our employees. We cannot guarantee that we have entered into such agreements with each party that has or may have had access to our trade secrets or proprietary information.
Regulatory changes could result in restrictions on our ability to continue or expand our operations, higher than anticipated costs, or lower than 54 anticipated sales. Even after we have obtained the proper regulatory clearance to market a device, we have ongoing responsibilities under FDA regulations and applicable foreign laws and regulations.
Regulatory changes could result in restrictions on our ability to continue or expand our operations, higher than anticipated costs, or lower than anticipated sales. Even after we have obtained the proper regulatory clearance to market a device, we have ongoing responsibilities under FDA regulations and applicable foreign laws and regulations.
Our business practices and relationships with providers are subject to scrutiny under these laws. We may also be subject to privacy and security regulation related to patient, customer, 56 employee and other third-party information by both the federal government and the states and foreign jurisdictions in which we conduct our business.
Our business practices and relationships with providers are subject to scrutiny under these laws. We may also be subject to privacy and security regulation related to patient, customer, employee and other third-party information by both the federal government and the states and foreign jurisdictions in which we conduct our business.
Should a carrier encounter delivery performance issues such as loss, damage or destruction of any systems, it would be costly to replace such systems in a timely manner and such occurrences may damage our reputation and lead to decreased demand for our solutions and increased cost and expense to our business.
Should a carrier encounter delivery performance issues such as loss, damage or destruction of any systems, it would be costly to replace such 38 systems in a timely manner and such occurrences may damage our reputation and lead to decreased demand for our solutions and increased cost and expense to our business.
Recent patent reform legislation could increase the uncertainties and costs surrounding the prosecution of patent applications and the enforcement or defense of issued patents. In 2011, the Leahy-Smith America Invents Act ("Leahy-Smith Act") was signed into law. The Leahy-Smith Act includes a number of significant changes to U.S. patent law.
Recent patent reform legislation could increase the uncertainties and costs surrounding the prosecution of patent applications and the enforcement or defense of issued patents. In 2011, the Leahy-Smith America Invents Act ("Leahy-Smith 47 Act") was signed into law. The Leahy-Smith Act includes a number of significant changes to U.S. patent law.
It is possible that conflicts may arise with our collaborators, such as conflicts concerning the achievement of performance milestones, or the interpretation of significant terms under any agreement, such as those related to financial obligations or the ownership or control of intellectual property developed during the collaboration.
It is possible that conflicts may arise with our collaborators, such as conflicts concerning the achievement of performance 40 milestones, or the interpretation of significant terms under any agreement, such as those related to financial obligations or the ownership or control of intellectual property developed during the collaboration.
Due to the breadth of these laws, the narrowness of statutory exceptions and regulatory safe harbors 57 available, and the range of interpretations to which they are subject, it is possible that some of our current or future practices might be challenged under one or more of these laws.
Due to the breadth of these laws, the narrowness of statutory exceptions and regulatory safe harbors available, and the range of interpretations to which they are subject, it is possible that some of our current or future practices might be challenged under one or more of these laws.
Our competitors may have longer operating histories, more established products and distribution networks, lower product prices or greater resources than we do, and may be able to develop or market treatments that are safer, more effective or gain greater acceptance in the marketplace than our products.
Our competitors may have longer operating histories, more established products and distribution networks, lower product prices or greater resources than we do, and may be able to develop or market products that are safer, more effective or gain greater acceptance in the marketplace than our products.
If new or updated LCDs, national coverage determinations, or other material coverage updates or determinations are published that could or would adversely affect coverage for procedures involving our OMNI technology, our business and prospects would be further adversely affected and our financial condition and results of operation could suffer.
If new or updated LCDs, national coverage determinations, or other material coverage or reimbursement updates or determinations are published that could or would adversely affect coverage for procedures involving our OMNI technology, our business and prospects would be further adversely affected and our financial condition and results of operation could suffer.
Further, our sales results are dependent in large part on the efforts and effectiveness of our sales and marketing personnel, and underperformance in these functions, whether though sub-optimal marketing campaigns, problematic sales representative performance or otherwise, may adversely impact our product sales and reputation.
Further, our sales results are dependent in large part on the efforts and effectiveness of our sales and marketing personnel, and underperformance in 34 these functions, whether though sub-optimal marketing campaigns, problematic sales representative performance or otherwise, may adversely impact our product sales and reputation.
Similarly, if competitive products are priced significantly lower than our products or are considered to offer greater ease of use than our products, then ECPs may elect to use these competitive products, even if we believe that other considerations such as clinical efficacy favor our products.
Similarly, if competitive products are priced significantly lower than our products or are considered to offer greater ease of use than our products, then ECPs may elect to use these competitive products, even if we believe that other considerations such as clinical efficacy favor our 26 products.
Compliance with environmental laws and regulations could be expensive, and the failure to comply with these laws and regulations could subject us to significant liability. Our research and development operations involve the use of hazardous substances, such as isopropyl alcohol and various adhesives.
Compliance with environmental laws and regulations could be expensive, and the failure to comply with these laws and regulations could subject us to significant liability. 57 Our research and development operations involve the use of hazardous substances, such as isopropyl alcohol and various adhesives.
Inventory levels in excess of customer demand may result in a portion of our inventory becoming obsolete or expiring, as well as inventory write-downs or write-offs, which would negatively impact our gross margins and impair the strength of our brand.
Inventory levels in excess of customer demand may result in a portion of our inventory becoming obsolete or expiring, as well as inventory write-downs or write-offs, which would negatively impact our gross margins and impair the strength of 35 our brand.
Furthermore, many of our competitors devote a considerably greater amount of funds to their research and development programs than we do, and those that do not may be acquired by larger companies that could allocate greater resources to research and development programs.
Furthermore, many of our competitors devote a considerably greater amount of funds to their research and development programs than we do, and those that do not may be acquired by larger companies that could allocate greater resources to research and 36 development programs.
Any further modification to these products or their intended uses may require us to submit new regulatory filings, including new 510(k) premarket notifications to obtain 52 clearance, or PMA submissions to obtain FDA approval prior to implementing the change.
Any further modification to these products or their intended uses may require us to submit new regulatory filings, including new 510(k) premarket notifications to obtain clearance, or PMA submissions to obtain FDA approval prior to implementing the change.
In particular, sales, marketing and business arrangements in the healthcare 58 industry, including the sale of medical devices, are subject to extensive laws and regulations intended to prevent fraud, misconduct, kickbacks, self-dealing and other abusive practices.
In particular, sales, marketing and business arrangements in the healthcare industry, including the sale of medical devices, are subject to extensive laws and regulations intended to prevent fraud, misconduct, kickbacks, self-dealing and other abusive practices.
For example, the OECD is leading work on proposals, commonly referred to as “BEPS 2.0,” which, if and to the extent implemented, 47 would make important changes to the international tax system.
For example, the OECD is leading work on proposals, commonly referred to as “BEPS 2.0,” which, if and to the extent implemented, would make important changes to the international tax system.
We also could suffer severe penalties, including criminal and civil penalties, disgorgement, and other remedial measures, including further changes or enhancements to our procedures, policies, and controls, as well as potential personnel changes and disciplinary actions.
We also could suffer severe penalties, including criminal and civil penalties, disgorgement, and other remedial measures, 46 including further changes or enhancements to our procedures, policies, and controls, as well as potential personnel changes and disciplinary actions.
Risks Related to Government Regulation Our products, business practices, and operations are subject to extensive government regulation and oversight in the United States and elsewhere. Our products are regulated as medical devices by the FDA and foreign regulatory authorities.
Risks Related to Government Regulation 50 Our products, business practices, and operations are subject to extensive government regulation and oversight in the United States and elsewhere. Our products are regulated as medical devices by the FDA and foreign regulatory authorities.
In June 2023, for instance, five of the seven Medicare Administrative Contractors (“MACs”) published proposed local coverage determinations (the “Prior LCDs”) that identified certain non-implantable MIGS procedures as investigational and not reasonable and necessary in the jurisdictions where these MACs administer Medicare Part B benefits, including adult canaloplasty in combination with trabeculotomy (ab interno), a procedure performed with OMNI and for which it is indicated.
In November 2023, for instance, five of the seven Medicare Administrative Contractors (“MACs”) published proposed local coverage determinations (the “Prior LCDs”) that identified certain non-implantable MIGS procedures as investigational and not reasonable and necessary in the jurisdictions where these MACs administer Medicare Part B benefits, including adult canaloplasty in combination with trabeculotomy (ab interno), a procedure performed with OMNI and for which it is indicated.
Any failure to meet customer and patient expectations and any resulting negative perceptions or publicity could harm our reputation and future sales and therefore adversely affect our business, financial condition and results of operations.
Any failure to meet 29 customer and patient expectations and any resulting negative perceptions or publicity could harm our reputation and future sales and therefore adversely affect our business, financial condition and results of operations.
The EU MDR includes significant additional premarket and post-market requirements, and manufacturers of medical devices are required by the EU MDR to collect post-marketing 32 clinical data in relation to their CE Marked medical devices.
The EU MDR includes significant additional premarket and post-market requirements, and manufacturers of medical devices are required by the EU MDR to collect post-marketing clinical data in relation to their CE Marked medical devices.
We compete, or plan to compete, with medical device and pharmaceutical companies that develop and commercialize products for eye conditions, including Glaukos, AbbVie, Novartis, Alcon, Johnson & Johnson, Nova Eye Medical, and New World Medical.
We compete, or plan to compete, with medical device and pharmaceutical companies that develop and commercialize products for eye conditions, including Glaukos, AbbVie, Novartis, Alcon, Johnson & Johnson, Iantrek, Nova Eye Medical, and New World Medical.
The methods used in, and the facilities used for, the manufacture of our products must comply with the FDA’s QSR and, subject to transitional provisions, the EU Medical Device Regulation (“EU MDR”), both of which are complex regulatory schemes that cover the procedures and documentation of the design, testing, production, process controls, quality assurance, labeling, packaging, handling, storage, distribution, installation, servicing and shipping of medical devices.
The methods used in, and the facilities used for, the manufacture of our products must comply with the FDA’s QMSR and, subject to transitional provisions, the EU Medical Device Regulation (“EU MDR”), both of which are complex regulatory schemes that cover the procedures and documentation of the design, testing, production, process controls, quality assurance, labeling, packaging, handling, storage, distribution, installation, servicing and shipping of medical devices.
If the nature and quality of the long-term data does not meet ECPs’ expectations, or if the long-term data indicates that our products are not as safe or effective as other treatment options or as current short-term data would suggest, physicians may recommend alternative treatments for their patients and our products may not become widely adopted, which will negatively affect our business, financial condition and results of operations.
If the nature and quality of the long-term data does not meet ECPs’ expectations, or if the long-term data indicates that our products are not as safe or effective as other treatment options or as data would suggest, physicians may recommend alternative treatments for their patients and our products may not become widely adopted, which will negatively affect our business, financial condition and results of operations.
The Final LCDs allow for continued coverage of canaloplasty and goniotomy procedures performed with our OMNI and SION technologies in these five MAC jurisdictions.
The Final LCDs allow for continued coverage of canaloplasty and goniotomy procedures performed with our OMNI and SION technologies in these five MAC 24 jurisdictions.
We have received 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. We can provide no assurance that we will be found to remain in compliance with the QSR or ISO standards upon a regulator’s review.
We have received 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. We can provide no assurance that we will be found to remain in compliance with the QMSR or ISO standards upon a regulator’s review.
In order to generate future growth, we plan to continue to expand and leverage our commercial infrastructure to increase our customer base and increase adoption by existing customers to drive our growth.
In order to generate future growth, we plan to expand and leverage our commercial infrastructure to increase our customer base and increase adoption by existing customers to drive our growth.
Patent Nos. 8,287,482, 9,370,443, and 11,389,328. In December 2024, the Court held an in-person hearing to hear the parties’ oral arguments on their post-trial briefings at the conclusion of which, the Court ordered the parties to engage in non-binding mediation.
Patent Nos. 8,287,482, 9,370,443, and 11,389,328. In December 2024, the Court held an in-person hearing to brief the parties’ oral arguments on their post-trial briefings at the conclusion of which, the Court ordered the parties to engage in non-binding mediation.
Our long-term growth depends on our ability to continue to capture market share, enhance our products, maintain appropriate product reimbursement, expand our indications and develop and commercialize additional products in a timely manner. If we fail to identify, acquire and develop other products, we may be unable to grow our business.
Our long-term growth depends on our ability to continue to capture market share, enhance our products, maintain appropriate product reimbursement, expand our indications and develop and commercialize additional products in a timely manner. If we fail to identify, acquire and develop other products as needed, we may be unable to grow our business.
The notified body will then 53 assess the planned changes and verify whether they affect the products’ ongoing conformity with the EU MDR.
The notified body will then assess the planned changes and verify whether they affect the products’ ongoing conformity with the EU MDR.
For example, in the third quarter of 2024, certain reimbursement advice published by the United Kingdom’s National Health Service has rendered untenable the code that had previously been relied upon as applicable to procedures performed with our OMNI technology.
For example, in the third quarter of 2024, certain reimbursement advice published by the United Kingdom’s National Health Service (NHS) had rendered untenable the code that had previously been relied upon as applicable to procedures performed with our OMNI technology.
Any decline in the amount that payors reimburse our customers for procedures that use our Surgical Glaucoma products or in the amount that customers are willing to pay or that payors reimburse for procedures that use TearCare in the future, could make it difficult for customers to continue using, or to adopt, our products and could create additional pricing pressure for us.
Any decline in the amount that payors reimburse our customers for procedures that use our Interventional Glaucoma products or in the amount that customers are willing to pay or that payors reimburse for procedures that use TearCare in the future, could make it difficult for customers to continue using, or to adopt, our products and could create additional pricing pressure for us.
In June 2023, for instance, five MACs published the Prior LCDs, which proposed to identify certain non-implantable MIGS procedures as investigational and not reasonable and necessary in the jurisdictions where these MACS administer Medicare Part B benefits, including but not limited to adult canaloplasty in combination with trabeculotomy ab interno, a procedure performed with OMNI and for which it is indicated.
In June 2023, for instance, five MACs published the Prior LCDs, which identified certain non-implantable MIGS procedures as investigational and not reasonable and necessary in the jurisdictions where these MACS administer Medicare Part B benefits, including but not limited to adult canaloplasty in combination with trabeculotomy ab interno, a procedure performed with OMNI and for which it is indicated.
In early March 2025, we and Alcon informed the Court that we had not resolved our dispute through mediation and asked the Court to decide the parties’ post-trial motions and enter a judgement, which judgement will be subject to appeal.
In early March 2025, we and Alcon informed the Court that we had not resolved our dispute through mediation and asked the Court to decide the parties’ post-trial motions and enter a judgment, which judgment will be subject to appeal.
We have experienced recent declines in the number of ECPs undergoing training on the use of OMNI, which means that fewer physicians than we had anticipated are being trained regarding appropriate patient selection and OMNI surgical techniques. If we are not able to stabilize and return our physician training rates to a robust growth trajectory, our business could suffer.
We have experienced recent declines in the number of ECPs undergoing training on the use of OMNI, which means that fewer physicians are being trained regarding appropriate patient selection and OMNI surgical techniques. If we are not able to stabilize and return our physician training rates to a robust growth trajectory, our business could suffer.
We rely extensively on IT systems, networks and services, including internet sites, data hosting and processing facilities and tools, physical security systems and other hardware, software and technical applications and platforms, some of which are managed, hosted, provided and/or used by third parties or their vendors, to assist in conducting our business.
We rely extensively on IT systems, networks and services, including internet sites, data hosting and processing facilities and tools, physical security systems and other hardware, software and technical applications and platforms, including artificial intelligence (AI) tools, some of which are managed, hosted, provided and/or used by third parties or their vendors, to assist in conducting our business.
As a public company, we are required to comply with the SEC’s rules implementing Sections 302 and 404 of the Sarbanes-Oxley Act, which require management to certify financial and other information in our quarterly and annual reports and provide an annual management report on the effectiveness of controls over financial reporting.
As a public company, we are required to comply with the SEC’s rules implementing Sections 302 and 404 of the Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley Act”), which require management to certify financial and other information in our quarterly and annual reports and provide an annual management report on the effectiveness of controls over financial reporting.
We also believe that ECPs and payers will give added weight to outcomes data derived from randomized controlled trials, which are considered to be the “gold standard” for proving efficacy of a treatment or intervention; while our TearCare SAHARA trial is an RCT, we have not completed an RCT for our OMNI technology, which may prove to be a competitive disadvantage as compared to competitive products with positive RCT data.
We also believe that ECPs and payers will give added weight to outcomes data derived from randomized controlled trials, which are considered to be the “gold standard” for proving efficacy of a treatment or intervention; while our TearCare SAHARA trial is an RCT, we have not completed an RCT for our OMNI technology, which can be a reimbursement and competitive disadvantage as compared to competitive products with positive RCT data.
In addition, the manufacture of future products may require modification of the current production processes or unique production processes, the identification of new suppliers for specific components, sub-assemblies and materials or the development of new manufacturing technologies.
In addition, the manufacture of future products may require modification of our current production processes, the identification of new suppliers for specific components, sub-assemblies and materials, or the development of new manufacturing processes or technologies.
Even if we are able to raise awareness among ECPs, they may be slow to change their medical treatment practices and may be hesitant to select our products for a variety of reasons, including: 27 • Lack of adequate, equitable third-party payor coverage or reimbursement, or changes in (or new) third-party payor coverage or reimbursement policies or determinations that adversely affect coverage for procedures involving OMNI; • Availability of lower-priced competitive products; • Unwillingness to alter historical practice patterns to incorporate OMNI use in Standalone procedures into their practices; • Lack of experience with our products and concerns that we are relatively new to market; • Perceived liability risk generally associated with the use of new products and treatment options; • Lack, or perceived lack, of sufficient clinical evidence, including with respect to an absence of OMNI randomized controlled trial data, clinical data on long-term outcomes, supporting clinical benefits of our products or the cost-effectiveness of our products over existing treatments; • The failure of key ophthalmologist and optometrist leaders to support and recommend our products; • Perceptions that our products are unproven; • ECPs’ long-standing relationships with companies, distributors and salespeople that sell competing products; • Competitive activities, including new product introductions, pricing tactics, and negative selling efforts from providers of alternative treatments; • ASC and ECP preferences for procedures that may be more profitable than those performed with our products, or for competitive products that are lower priced and thus offer greater profit margins in procedures in which our products are used; • Challenges of integrating TearCare into established ophthalmologic and optometric practices in light of ECP practice patterns and preferences, lack of awareness of our TearCare system and its capabilities, and lack of appropriate, equitable reimbursement for procedures involving our TearCare system; and • Perceptions regarding the time commitment and skill development that may be required to gain familiarity and proficiency with our OMNI and TearCare products.
Even if we are able to raise awareness among ECPs, they may be slow to change their medical treatment practices and may be hesitant to select our products for a variety of reasons, including: • Lack of adequate, equitable third-party payor coverage or reimbursement, or changes in (or new) third-party payor coverage or reimbursement policies or determinations that adversely affect coverage for Interventional Glaucoma and Interventional Dry Eye procedures; • Availability of lower-priced competitive products, especially competitive products with equivalent or superior reimbursement; • Unwillingness to alter historical practice patterns to incorporate OMNI use in Standalone Procedures into their practices; • Lack of experience with our products; • Perceived liability risk generally associated with the use of new products and treatment options; • Lack, or perceived lack, of sufficient clinical evidence, including with respect to an absence of OMNI randomized controlled trial data, clinical data on long-term outcomes, supporting clinical benefits of our products or the cost-effectiveness of our products over existing treatments; • The failure of key ophthalmologist and optometrist leaders to support and recommend our products; • Perceptions that our products are unproven; • ECPs’ long-standing relationships with companies, distributors and salespeople that sell competing products; • Competitive activities, including new product introductions, pricing, coding and coverage tactics, and negative selling efforts from providers of equivalent or alternative treatments; • ASC and ECP preferences for procedures that may be more profitable than those performed with our products, or for competitive products that are lower priced and thus offer greater profit margins in procedures in which our products are used; • Challenges of integrating TearCare into established ophthalmologic and optometric practices in light of ECP practice patterns and preferences, lack of awareness of our TearCare system and its capabilities, and lack of appropriate, equitable reimbursement for procedures involving our TearCare system; and • Perceptions regarding the time commitment and skill development that may be required to gain familiarity and proficiency with our Interventional Glaucoma and Interventional Dry Eye products.
Historically, we have sold our TearCare system components to customers on a limited cash-pay basis to drive customer awareness and acceptance in advance of reimbursement.
Historically, we have sold our TearCare system components to customers on a limited basis to drive customer awareness and acceptance in advance of reimbursement.
One of the major hurdles to adoption of our products will be overcoming established treatment patterns, which will require educating ECPs and supportive clinical data.
One of the major hurdles to adoption of our Interventional Glaucoma products will be overcoming established treatment patterns, which will require educating ECPs and supportive clinical data.
If patients are not willing to pay for procedures in which TearCare is used, or if third-party payors continue to decline to provide coverage and reimbursement, or provide insufficient levels of coverage and reimbursement, it would have a negative impact on ECPs’ adoption of TearCare and sales of TearCare, which could adversely affect our business and results of operations.
If patients are not willing to pay for procedures in which TearCare is used, or if third-party payors other than FCSO and Novitas continue to decline to provide coverage and reimbursement, or provide insufficient levels of reimbursement, it would have a negative impact on ECPs’ adoption of TearCare and sales of TearCare, which could adversely affect our business and results of operations.
Development of our products for expanded indications depends upon positive clinical data, and the safety and efficacy of our products for the intended uses for which we intend to seek clearance, certification or approval are not yet supported by long-term clinical data, which could delay or prevent clearance by the FDA (or other foreign authorities or notified bodies) or limit sales, and our products might prove to be less safe or effective than initially thought.
Development of our products for expanded indications depends upon positive clinical data, and applicable regulatory authorities may determine that the safety and efficacy of our products for the intended uses for which we intend to seek clearance, certification or approval are not yet supported by long-term clinical data, which could delay or prevent clearance by the FDA (or other foreign authorities or notified bodies) or limit sales, and our products might prove to be less safe or effective than initially thought.
Moreover, any uncertainty with respect to coverage or coding may impact management’s ability to accurately forecast results. We also derive revenue from sales of TearCare to ECPs and eye care clinics, which bill all or a portion of the costs and fees associated with treatments and products to patients or, on a limited basis, to third-party payors.
Moreover, any uncertainty with respect to coverage or coding may impact management’s ability to accurately forecast results. We also derive revenue from sales of TearCare to ECPs and eye care clinics, which bill all or a portion of the costs and fees associated with treatments and products to third-party payors.
Additionally, while software and other of our proprietary works may be protected under copyright law, we have chosen not to register any copyrights in these works, and instead, primarily rely on protecting our software as a trade secret. In order to bring a copyright infringement lawsuit in the United States, the copyright must be registered.
Additionally, while software and other of our proprietary works may be protected under copyright law, we have chosen not to register any copyrights in these works, and instead, primarily rely on protecting our software as a trade secret. In order to bring a copyright infringement lawsuit in the United States or obtain statutory damages, the copyright must be registered.
Adverse determinations against us in defending against infringement could subject us to significant liabilities to third parties, require us to seek licenses from third parties and prevent us from manufacturing, selling or using the product, any of which could severely harm our business.
Adverse determinations against us in defending against infringement could subject us to significant liabilities to third parties, require us to seek licenses from third parties, prevent us from using the infringing trademark in our business, or prevent us from manufacturing, selling or using the infringing product, any of which could severely harm our business.
In addition, a number of factors, including some outside of our control, may render our products less competitive, economically impracticable or obsolete and contribute to fluctuations in our financial results, including: • Our ability to obtain and maintain reimbursement coverage for procedures in which our products are used; • Changes in reimbursement rates or coverage restrictions instituted by government or commercial payors, such as the coverage limitations on multiple MIGS procedures done at the same time as a cataract surgery included in the Final LCDs; • The results of our clinical trials or investigations, including perceived inadequacy or insufficiency of evidence supporting the clinical benefits or cost-effectiveness of our products, and the publication of any long-term clinical data that may suggest or conclude that our products are less safe or effective than initially thought; • Positive or negative media coverage, or public, patient and/or physician perception, of our products or competing products and treatments; • Safety or effectiveness concerns that arise regarding our products’ currently authorized uses or uses for which we are developing our products; • The effectiveness of our marketing and sales efforts, including our ability to have a sufficient number of qualified sales representatives to sell our products; • Unanticipated delays in product development or launches; • Our ability to raise additional capital on acceptable terms, or at all, to support the commercialization of our products; • Our ability to achieve and maintain compliance with legal and regulatory requirements applicable to our products; • Our ability, and the ability of our licensors, to obtain, maintain, protect and enforce our intellectual property rights; • Our third-party manufacturers’ ability to supply our products in a timely manner, in accordance with our specifications, and in compliance with applicable regulatory requirements; and • Introduction of new products or alternative treatments that compete with our products.
In addition, a number of factors, including some outside of our control, may render our products less competitive, economically impracticable or obsolete and contribute to fluctuations in our financial results, including: • Our ability to obtain and maintain reimbursement coverage for procedures in which our products are used; • Changes in reimbursement rates or coverage restrictions instituted by government or commercial payors, such as the coverage limitations on multiple MIGS procedures done at the same time as a cataract surgery included in the Final LCDs, or coverage limitations on our TearCare procedure; • The results of our clinical trials or investigations, including perceived inadequacy or insufficiency of evidence supporting the clinical benefits or cost-effectiveness of our products, and the publication of any long-term clinical data that may suggest or conclude that our products are less safe or effective than initially thought; • Positive or negative media coverage, or public, patient and/or physician perception, of our products or competing products and treatments; • Safety or effectiveness concerns that arise regarding our products’ currently authorized uses or uses for which we are developing our products; • The effectiveness of our marketing and sales efforts, including our ability to have a sufficient number of qualified sales representatives to sell our products; • Unanticipated delays in product development or launches; • Our ability to raise additional capital on acceptable terms, or at all, to support the commercialization of our products; • Our ability to achieve and maintain compliance with legal and regulatory requirements applicable to our products; • Our ability, and the ability of our licensors, to obtain, maintain, protect and enforce our intellectual property rights; • Our third-party manufacturers’ ability to supply our products in a timely manner, in accordance with our specifications, and in compliance with applicable regulatory requirements; and • Introduction of new products or alternative treatments that compete with our products. 25 Our business is dependent upon the broad adoption and continued use of our products by eyecare professionals and patients.
Although the Prior LCDs were withdrawn before becoming effective, the Final LCDs that became effective in November 2024 contain certain restrictions on billing for MIGS procedures that will likely have an adverse impact on our OMNI sales results.
Although the Prior LCDs were withdrawn before becoming effective, the Final LCDs that became effective in November 2024 contain certain restrictions on billing for MIGS procedures that have had an adverse impact on our OMNI sales results.
In February 2022, we received further communications from the FDA regarding the appropriateness of the marketing and distribution of our legacy TearCare Systems as a 510(k)-exempt device without premarket notification to and authorization from the FDA.
For example, in February 2022, we received communications from the FDA regarding the appropriateness of the marketing and distribution of our legacy TearCare Systems as a 510(k)-exempt device without premarket notification to and authorization from the FDA.
Our continued growth will be driven in part by capture of market share from our competitors through a combination of factors, including competitive positioning, increasing ECP acceptance and use of OMNI for Standalone Procedures, re-engagement of customer accounts that decrease or cease utilization of our products, engagement of new customer accounts, and robust ECP training on our products to drive product awareness and acceptance.
Our continued growth will be driven in large part by growth of TearCare revenues in reimbursed jurisdictions, and capture of market share from our competitors through a combination of factors, including competitive positioning, increasing ECP acceptance and use of OMNI for Standalone Procedures, re-engagement of customer accounts that decrease or cease utilization of our products, engagement of new customer accounts, and robust ECP training on our products to drive product awareness and acceptance.
We are pursuing reimbursement coverage for TearCare so ECPs can bill all or a portion of the costs and fees associated with this product to various third-party payors, including Medicare, Medicaid, private commercial insurance companies, health maintenance organizations, and other healthcare-related organizations, and then bill patients for any applicable deductibles or co-payments.
We are pursuing broad reimbursement coverage for TearCare so that ECPs can bill all or a portion of the costs and fees associated with this product to a larger swath of third-party payors, including Medicare, Medicaid, private commercial insurance companies, health maintenance organizations, and other healthcare-related organizations, and then bill patients for any applicable deductibles or co-payments.
Further, if we choose to, or are required to, conduct additional studies, equivocal or unfavorable results from such studies or experience could lead to a reduction in the rate of coverage and reimbursement by both public and private third-party payors for procedures that are performed with our products, slow market adoption of our products by ECPs, significantly reduce our ability to achieve expected revenue and prevent us from being profitable. 33 We rely on third parties to manufacture and supply our products.
Further, if we choose to, or are required to, conduct additional studies, equivocal or unfavorable results from such studies or experience could lead to a reduction in the rate of coverage and reimbursement by both public and private third-party payors for procedures that are performed with our products, slow market adoption of our products by ECPs, significantly reduce our ability to achieve expected revenue and prevent us from being profitable.
Our business strategy depends on our ability to manufacture our current and future products in sufficient quantities, on terms that are acceptable to us, and on a timely basis to meet customer demand, while adhering to product quality standards, complying with regulatory quality system requirements, and managing manufacturing costs.
Our business strategy depends on our ability to manufacture our current and future products in sufficient quantities, on terms acceptable to us, and on a timely basis to meet customer demand, while adhering to product quality standards, complying with regulatory requirements, and managing manufacturing and import costs.
For example, the services of Paul Badawi, our Chief Executive Officer, David Badawi, our Chief Technology Officer, Alison Bauerlein, our Chief Financial Officer, and Matthew Link, our Chief Commercial Officer, are essential to driving innovation and adoption of our products, executing on our corporate strategy and ensuring the continued operations and integrity of financial reporting within our company.
For example, the services of Paul Badawi, our Chief Executive Officer, David Badawi, our Chief Technology Officer and Alison Bauerlein, our Chief Operating Officer, are essential to driving innovation and adoption of our products, executing on our corporate strategy and ensuring the continued operations and integrity of financial reporting within our company.
The success of our products depends in part on the skill of the ECPs utilizing and administering products to treat patients and on their adherence to our stated patient selection criteria and the proper techniques that we provide in training sessions. We train ECPs on the correct use of OMNI and SION.
The success of our products depends in part on the skill of the ECPs utilizing and administering products to treat patients and on their adherence to our stated patient selection criteria and the proper techniques that we provide in training sessions. We train ECPs on the correct use of our Interventional Glaucoma products.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeBalance Sheet Components Property and Equipment, Net Property and equipment, net consist of the following (in thousands): As of December 31, 2024 2023 Tools and equipment $ 1,991 $ 2,010 Computer equipment and software 37 37 Furniture and fixtures 402 323 Leasehold improvements 38 38 Construction in process 1,218 859 3,686 3,267 Less: Accumulated depreciation ( 2,106 ) ( 1,627 ) Property and equipment, net $ 1,580 $ 1,640 Depreciation expense was $ 0.5 million and $ 0.6 million for the years ended December 31, 2024 and 2023 respectively. 89 Accrued and Other Current Liabilities Accrued and other current liabilities consist of the following (in thousands): As of December 31, 2024 2023 Accrued expenses $ 2,113 $ 1,639 Current portion of lease liabilities 533 573 Short term interest payable 344 375 Other accrued liabilities 1,107 1,187 Total accrued and other current liabilities $ 4,097 $ 3,774 Other Noncurrent Liabilities Other noncurrent liabilities consist of the following (in thousands): As of December 31, 2024 2023 Noncurrent portion of lease liabilities $ 473 $ 914 Other noncurrent liabilities 19 38 Long term interest payable — 1,524 Total other noncurrent liabilities $ 492 $ 2,476 Note 5.
Biggest changeBalance Sheet Components Property and Equipment, Net Property and equipment, net consist of the following (in thousands): 88 As of December 31, 2025 2024 Tools and equipment $ 2,215 $ 1,991 Computer equipment and software 37 37 Furniture and fixtures 461 402 Leasehold improvements 38 38 Construction in process 1,260 1,218 4,011 3,686 Less: Accumulated depreciation ( 2,401 ) ( 2,106 ) Property and equipment, net $ 1,610 $ 1,580 Depreciation expense was $ 0.3 million and $ 0.5 million for the years ended December 31, 2025 and 2024 respectively.
Net Cash Provided by Financing Activities Net cash provided by financing activities for the year ended December 31, 2024 was $5.0 million, consisting primarily of proceeds from the Hercules Loan Agreement, partially offset by costs associated with refinancing the term loan agreement.
Net cash provided by financing activities for the year ended December 31, 2024 was $5.0 million, consisting primarily of proceeds from the Hercules Loan Agreement, partially offset by costs associated with refinancing the term loan agreement.
Our historical cash outflows have been primarily been associated with cash used for operating activities such as sales, marketing and commercialization of our products, research and development activities, regulatory and market access activities, intellectual property portfolio expansion and enforcement, capital expenditures and debt service costs.
Our historical cash outflows have primarily been associated with cash used for operating activities such as sales, marketing and commercialization of our products, research and development activities, regulatory and market access activities, intellectual property enforcement and portfolio expansion, capital expenditures and debt service costs.
Due to the Company's historical operating performance and the recorded cumulative net losses in prior fiscal periods, the net deferred tax assets have been fully offset by a valuation allowance. The Company recognizes uncertain income tax positions at the largest amount that is more likely than not to be sustained upon audit by relevant taxing authority.
Due to the Company's 85 historical operating performance and the recorded cumulative net losses in prior fiscal periods, the net deferred tax assets have been fully offset by a valuation allowance. The Company recognizes uncertain income tax positions at the largest amount that is more likely than not to be sustained upon audit by relevant taxing authority.
As a result, we intend to continue to invest in product development, market access, sales and marketing, clinical studies, and education initiatives. Because of these and other factors, we expect to continue to incur net losses for at least the next several years, and we may seek additional debt and equity financing to fund our operations and planned growth.
As a result, we intend to continue to invest in product development, market access, sales and marketing, clinical studies, and education initiatives. Because of these and other factors, we expect to continue to incur net losses for at least the next several years, and we may seek additional debt and/or equity financing to fund our operations and planned growth.
Additionally, the Company is subject to customary affirmative 90 and negative covenants, including covenants that limit or restrict the ability of the Company to, among other things, incur indebtedness, grant liens, merge or consolidate, make investments, dispose of assets, make acquisitions, pay dividends or make distributions, repurchase stock and enter into certain transactions with affiliates, in each case subject to certain exceptions.
Additionally, the Company is subject to customary affirmative and negative covenants, including covenants that limit or restrict the ability of the Company to, among other things, incur indebtedness, grant liens, merge or consolidate, make investments, dispose of assets, make acquisitions, pay dividends or make distributions, repurchase stock and enter into certain transactions with affiliates, in each case subject to certain exceptions.
The Company uses its reasonable judgment, based on the available information, and records a provision against amounts due to reduce the receivable to the amount that is expected to be collected. These specific provisions are reevaluated and adjusted as additional information is received that impacts the amount reserved. To date, the Company has not experienced material credit-related losses.
The Company uses its reasonable judgment, based on the available information, and records a provision against amounts due to reduce the receivable to the amount that is expected to be collected. These specific provisions are reevaluated and adjusted as additional information is received that impacts the amount reserved. To date, the Company has not 82 experienced material credit-related losses.
The non-cash charges primarily consisted of $17.1 million related to stock-based compensation, $1.0 million of noncash loss on debt extinguishment, $0.8 of accretion of debt discount and debt issuance costs, $0.7 million of depreciation and amortization, and $0.6 million of noncash operating lease expense.
The non-cash charges primarily consisted of $17.1 million related to stock-based compensation, $1.0 million of noncash loss on debt 71 extinguishment, $0.8 million of accretion of debt discount and debt issuance costs, $0.7 million of depreciation and amortization, and $0.6 million of noncash operating lease expense.
For stock options granted to a grantee who, at the time the option is granted, owned stock representing more than 10% of the voting power of all classes of stock of the Company (or any parent or subsidiary of the Company), the term of the stock option may be granted for periods of up to five years.
For stock options granted to a grantee who, at the time the option is granted, owned stock representing more than 10% of the voting power of all classes of stock of the Company (or any parent or subsidiary of the Company), the term may be up to five years.
The fair value of the common stock 85 warrants was calculated using the Black-Scholes option pricing method and are recorded at fair value upon issuance in additional paid-in capital in the consolidated balance sheets. These common stock warrants are not remeasured after the issuance date.
The fair value of the common stock warrants was calculated using the Black-Scholes option pricing method and are recorded at fair value upon issuance in additional paid-in capital in the consolidated balance sheets. These common stock warrants are not remeasured after the issuance date.
The three levels of the fair value hierarchy are as follows: 88 Level 1—Inputs are quoted prices (unadjusted) in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date.
The three levels of the fair value hierarchy are as follows: Level 1—Inputs are quoted prices (unadjusted) in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date.
Under the 2021 Plan, the Company has the ability to issue incentive stock options ("ISOs"), nonqualified stock options ("NSOs"), stock appreciation rights, dividend equivalent rights, restricted stock awards, and RSUs. Stock options under the 2021 Plan can typically be granted for periods of up to ten years.
Under the 2021 Plan, the Company has the ability to issue incentive stock options ("ISOs"), nonqualified stock options ("NSOs"), stock appreciation rights, dividend equivalent rights, restricted stock awards, and restricted stock units ("RSUs"). Stock options under the 2021 Plan can typically be granted for periods of up to ten years.
Clinical studies have demonstrated that treating MGD by liquefying and removing clogged meibum is the most effective method to eliminate obstructions and restore the lipid layer 69 of tear film, thereby preventing premature evaporation of tears.
Clinical studies have demonstrated that treating MGD by liquefying and removing clogged meibum is the most effective method to eliminate obstructions and restore the lipid layer of tear film, thereby preventing premature evaporation of tears.
Notes to Consolidated Fin ancial Statements (Unaudited) Note 1. The Company and Nature of Business Description of Business Sight Sciences, Inc. (the “Company”) was incorporated in the State of Delaware in 2010 and is headquartered in Menlo Park, California.
Notes to Consolidated Fin ancial Statements Note 1. The Company and Nature of Business Description of Business Sight Sciences, Inc. (the “Company”) was incorporated in the State of Delaware in 2010 and is headquartered in Menlo Park, California.
The most significant 83 estimates relate to the allowance for credit losses, inventory excess and obsolescence, the selection of useful lives of property and equipment, determination of the fair value of stock option grants, and provisions for income taxes and contingencies.
The most significant estimates relate to the allowance for credit losses, inventory excess and obsolescence, the selection of useful lives of property and equipment, determination of the fair value of stock option grants, and provisions for income taxes and contingencies.
The CODM does not review operating expenses separately for its segments, as the Company does not allocate operating expenses, with many operating costs shared between the segments, and therefore, this is not considered when allocating resources and assessing performance.
The CODM does not review operating expenses separately for its segments, as the Company does not allocate operating expenses, with many operating costs shared between the segments, and therefore, this is not considered when allocating resources and 98 assessing performance.
Fair Value of Financial Instruments The Company’s financial instruments typically consist of cash and cash equivalents, accounts receivable, accounts payable, accrued and other current liabilities, common stock warrants, and short-term and long-term debt.
Fair Value of Financial Instruments The Company’s financial instruments typically consist of cash, cash equivalents, restricted cash, accounts receivable, accounts payable, accrued and other current liabilities, common stock warrants, and short-term and long-term debt.
Components of Our Results of Operations Revenue We currently derive the majority of our U.S. revenue from the sale of our OMNI and SION products to ASCs and HOPDs and from the sales of our TearCare products to ECPs.
Components of Our Results of Operations Revenue We currently derive the majority of our U.S. revenue from the sale of our OMNI and SION products to ASCs and HOPDs and from the sale of our TearCare products to ECPs.
The Company's cash equivalents are comprised of U.S. treasury securities that are classified as held-to-maturity and recorded at amortized cost in the financial statements, and money market accounts. The Company states accounts receivable, accounts payable, and accrued and other current liabilities at their carrying value, which approximates fair value due to the short time to the expected receipt or payment.
The Company's cash equivalents are comprised of U.S. treasury securities that are classified as held-to-maturity and recorded at amortized cost in the financial statements, and money market accounts. The Company records accounts receivable, accounts payable, and accrued and other current liabilities at their carrying value, which approximates fair value due to the short time to the expected receipt or payment.
TearCare is a proprietary, interventional, dry eye device designed to melt and facilitate the comprehensive removal of meibomian gland obstructions and restore gland functionality and healthy oil production for adult patients with evaporative dry eye disease due to meibomian gland dysfunction (“MGD”) when used in conjunction with manual expression of the meibomian glands, enabling clearance of gland obstructions by physicians to address the leading cause of dry eye disease.
TearCare is a proprietary, interventional, dry eye device designed to melt and facilitate the comprehensive removal of meibomian gland obstructions and restore gland functionality and healthy oil production for adult patients with evaporative dry eye disease due to meibomian gland disease when used in conjunction with manual expression of the meibomian glands, enabling clearance of gland obstructions by physicians to address the leading cause of dry eye disease.
Our TearCare customers typically purchase a TearCare System which consists of one or more TearCare SmartHubs® (“SmartHubs”), multiple single-use TearCare SmartLids® (“SmartLids”) and other accessories. After utilizing their initial inventory, customers can reorder SmartLids as needed. No single customer accounted for 10% or more of our revenue for the years ended December 31, 2024 and 2023.
Our TearCare customers typically purchase a TearCare System which consists of one or more TearCare SmartHubs® (“SmartHubs”), multiple single-use TearCare SmartLids® (“SmartLids”) and other accessories. After utilizing their initial inventory, customers can reorder SmartLids as needed. No single customer accounted for 10% or more of our revenue for the years ended December 31, 2025 and 2024.
Our Security Operations Center provides comprehensive, around the clock, cyber threat detection and response capabilities. • Third-Party Software Risk Assessment: W e complete security audits on all third-party platforms prior to selection. • Incident Response Plan: Our Incident Response Plan includes the investigation steps and notifications required on all actual and suspected information security incidences • Cybersecurity Training Programs: Our training program is multi-faceted and focused on awareness of new techniques that threat actors utilize both in the corporate environment, as well as their personal lives.
Our Security Operations Center provides comprehensive, around the clock, cyber threat detection and response capabilities. • Third-Party Software Risk Assessment: We complete security audits on all third-party platforms prior to selection. • Incident Response Plan: Our Incident Response Plan includes the investigation steps and notifications required on all actual and suspected information security incidences • Cybersecurity Training Programs: Our training program is multi-faceted and focused on awareness of new techniques that threat actors utilize both in the corporate environment, as well as their personal lives.
Opinion on the Financial Statements We have audited the accompanying consolidated balance sheets of Sight Sciences, Inc. and subsidiaries (the "Company") as of December 31, 2024 and 2023, the related consolidated statements of operations and comprehensive loss, stockholders' equity, and cash flows, for each of the two years in the period ended December 31, 2024, and the related notes (collectively referred to as the "financial statements").
Opinion on the Financial Statements We have audited the accompanying consolidated balance sheets of Sight Sciences, Inc. and subsidiaries (the "Company") as of December 31, 2025 and 2024, the related consolidated statements of operations and comprehensive loss, stockholders' equity, and cash flows, for each of the two years in the period ended December 31, 2025, and the related notes (collectively referred to as the "financial statements").
Fair value is determined through various valuation techniques, including discounted cash flow models, quoted market values, and third-party independent appraisals, as considered necessary. The Company did no t record any impairment of long-lived assets for the years ended December 31, 2024 and 2023.
Fair value is determined through various valuation techniques, including discounted cash flow models, quoted market values, and third-party independent appraisals, as considered necessary. The Company did no t record any impairment of long-lived assets for the years ended December 31, 2025 and 2024.
Based on this evaluation, our principal executive officer and principal financial and accounting officer concluded that as of December 31, 2024, our disclosure controls and procedures were effective at the reasonable assurance level. Management's Annual Report on Internal Control over Financial Reporting Our management is responsible for establishing and maintaining adequate internal control over financial reporting.
Based on this evaluation, our principal executive officer and principal financial and accounting officer concluded that as of December 31, 2025, our disclosure controls and procedures were effective at the reasonable assurance level. Management's Annual Report on Internal Control over Financial Reporting Our management is responsible for establishing and maintaining adequate internal control over financial reporting.
In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2024 and 2023, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2024, in conformity with accounting principles generally accepted in the United States of America .
In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2025 and 2024, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2025, in conformity with accounting principles generally accepted in the United States of America.
Changes in Internal Control over Financial Reporting There were no changes in our internal control over financial reporting identified in management's evaluation pursuant to Rule 13a-15(d) of the Exchange Act during the fiscal year ended December 31, 2024, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Changes in Internal Control over Financial Reporting There were no changes in our internal control over financial reporting identified in management's evaluation pursuant to Rule 13a-15(d) of the Exchange Act during the fiscal year ended December 31, 2025, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Payment terms, typically 30 days, are offered to customers and do not include a significant financing component. The Company extends credit to customers based upon their financial condition and credit history and generally require no collateral. The Company does not have any contract balances related to product sales.
Payment terms, typically 30 days, are offered to customers and do not include a significant financing component. The Company extends credit to customers based upon their financial condition and credit history and generally requires no collateral. The Company does not have any contract balances related to product sales.
The term of the indemnification period lasts as long as a director may be subject to any proceeding arising out of acts or omissions of such director in such capacity. The maximum amount of potential future indemnification is unlimited; however, the Company currently holds director liability insurance.
The term of the indemnification period lasts as long as a director or officer may be subject to any proceeding arising out of acts or omissions of such director or officer in such capacity. The maximum amount of potential future indemnification is unlimited; however, the Company currently holds director and officer liability insurance.
Given the earlier stage of TearCare’s commercial development, we expect our Dry Eye segment’s gross margins to be lower than our Surgical Glaucoma segment’s gross margins for the near- and medium-term due to the allocation of fixed labor and overhead costs to the segment's cost of goods sold.
Given the earlier stage of TearCare’s commercial development, we expect our Interventional Dry Eye segment’s gross margins to be lower than our Interventional Glaucoma segment’s gross margins for the near- and medium-term due to the allocation of fixed labor and overhead costs to the segment's cost of goods sold.
These annual increases are equal to the lesser of (i) 5% of the aggregate number of shares of common stock outstanding on the final day of the immediately preceding calendar year and (ii) such smaller number of shares of common stock as determined by the Board, subject to certain limitations.
These annual increases are equal to the lesser of (i) 5% of the aggregate number of shares of common stock outstanding on the final day of the immediately preceding calendar year and (ii) such smaller number of shares of common stock as determined by the Company's board of directors (the "Board"), subject to certain limitations.
The Hercules Loan Agreement contains a floating rate equal to the greater of 10.35% or the Prime Rate plus 2.35%, with the initial interest rate under the agreement of 10.85%. As of December 31, 2024, the balance outstanding under the agreement is $40.0 million and the interest rate was 10.35%.
The Hercules Loan Agreement contains a floating rate equal to the greater of 10.35% or the Prime Rate plus 2.35%, with the initial interest rate under the agreement of 10.85%. As of December 31, 2025, the balance outstanding under the agreement is $40.0 million and the interest rate was 10.35%.
Any failure to generate increased revenue, achieve improved gross margins, or control operating costs could require the Company to raise additional capital through equity or debt financing. Such additional financing may not be available on acceptable terms, or at all.
Any failure to generate increased revenue, achieve improved gross profit, or control operating costs could require the Company to raise additional capital through equity or debt financing. Such additional financing may not be available on acceptable terms, or at all.
O ur initial product development has focused on the treatment of two of the world’s most prevalent and underserved eye diseases, glaucoma and dry eye disease (“DED”). We have commercialized products in each of our two reportable operating segments, Surgical Glaucoma and Dry Eye.
O ur initial product development has focused on the treatment of two of the world’s most prevalent and underserved eye diseases, glaucoma and dry eye disease (“DED”). We have commercialized products in each of our two reportable operating segments, Interventional Glaucoma and Interventional Dry Eye.
As the Company reported a net loss for the years ended December 31, 2024 and 2023, basic net loss per share is the same as diluted net loss per share as the inclusion of potentially dilutive shares would have been antidilutive if included in the calculation.
As the Company reported a net loss for the years ended December 31, 2025 and 2024, basic net loss per share is the same as diluted net loss per share as the inclusion of potentially dilutive shares would have been antidilutive if included in the calculation.
Shares of common stock are offered during two offering periods annually, each running for six-months, with the first offering period typically beginning in the second quarter, and the second offering period typically beginning in the fourth quarter. The purchase of shares for participants in the ESPP occurs at the conclusion of each offering period.
Shares of common stock are offered during two offering periods annually, each running for nine months, with the first offering period typically beginning in the second quarter, and the second offering period typically beginning in the fourth quarter. The purchase of shares for participants in the ESPP occurs at the conclusion of each offering period.
Based upon the balance outstanding, a hypothetical 1.0% (100 basis points) change in interest rates would not have a material impact on our financial statements. 76 Ite m 8. Financial Statements and Supplementary Data.
Based upon the balance outstanding, a hypothetical 1.0% (100 basis points) change in interest rates would not have a material impact on our financial statements. 74 Ite m 8. Financial Statements and Supplementary Data.
The disclosure in this Item 9A should be read in conjunction with such 101 certifications for a more complete understanding of our disclosure controls and procedures and internal control over financial reporting. It em 9B.
The disclosure in this Item 9A should be read in conjunction with such 100 certifications for a more complete understanding of our disclosure controls and procedures and internal control over financial reporting. It em 9B.
Additionally, we are subject to customary affirmative and negative covenants, including covenants that limit or restrict the ability of us to, among other things, incur indebtedness, grant liens, merge or consolidate, make investments, dispose of assets, make acquisitions, pay dividends or make distributions, repurchase stock and enter into certain transactions with affiliates, in each case subject to certain exceptions.
Additionally, we are subject to customary affirmative and negative covenants, including covenants that limit or restrict our ability to, among other things, incur indebtedness, grant liens, merge or consolidate, make investments, dispose of assets, make acquisitions, pay dividends or make distributions, repurchase stock and enter into certain transactions with affiliates, in each case subject to certain exceptions.
As of December 31, 2024, there are no additional ASUs issued and not yet adopted that are expected to have a material impact on the Company's financial statements and related disclosures. Note 3.
As of December 31, 2025, there are no additional ASUs issued and not yet adopted that are expected to have a material impact on the Company's financial statements and related disclosures. Note 3.
Equity Incentive Plans 2011 Stock Option Plan and 2021 Equity Incentive Plan In 2011, the Company approved the 2011 Stock Option Plan (the “2011 Plan”) that provided for the granting of stock options to employees and nonemployees of the Company. In July 2021, the board of directors and stockholders adopted and approved the 2021 Incentive Award Plan, (the “2021 Plan”).
Equity Incentive Plans 2011 Stock Option Plan and 2021 Equity Incentive Plan In 2011, the Company approved the 2011 Stock Option Plan (the “2011 Plan”) that provided for the grant of stock options to employees and nonemployees of the Company. In July 2021, the board of directors and stockholders adopted and approved the 2021 Incentive Award Plan, (the “2021 Plan”).
The product portfolio for the Dry Eye segment consists of the TearCare® System ("TearCare") for ophthalmologists and optometrists.
The product portfolio for the Interventional Dry Eye segment consists of the TearCare® System ("TearCare") for ophthalmologists and optometrists.
The financial statements as of December 31, 2024 and 2023, do not include any assets or liabilities that are measured at fair value on a nonrecurring basis. Note 4.
The financial statements as of December 31, 2025 and 2024, do not include any assets or liabilities that are measured at fair value on a nonrecurring basis. Note 4.
The ISOs and NSOs will be granted at a price per share not less than the fair value at the date of grant. The exercise price of a stock option granted to a 10% stockholder shall be not less than 110% of the grant date fair value of the shares.
The ISOs and NSOs are granted at a price per share not less than the fair value at the date of grant. The exercise price of a stock option granted to a 10% stockholder shall be not less than 110% of the grant date fair value of the shares.
As of December 31, 2024, a full valuation allowance for deferred tax assets was recorded as management believes it is not more likely than not that all of the deferred tax assets will be realized.
As of December 31, 2025, a full valuation allowance for deferred tax assets was recorded as management believes it is not more likely than not that all of the deferred tax assets will be realized.
The amount of revenue that is recognized is based on the transaction price, which represents the invoiced amounts and includes estimates of variable consideration, such as discounts, where applicable.
The amount of revenue that is recognized is based on the transaction price, which represents the invoiced amounts and includes estimates of variable consideration, such as discounts or rebates, where applicable.
The Company is also subject to certain minimum cash and revenue covenants under the Hercules Loan Agreement. The Company was in compliance with all covenants as of December 31, 2024.
The Company is also subject to certain minimum cash and revenue covenants under the Hercules Loan Agreement. The Company was in compliance with all covenants as of December 31, 2025.
The exercise price will be calculated using the five-day volume-weighted average stock price as of such date. The unissued warrants do not meet the requirements for classification in equity, and are recorded as liabilities in other noncurrent liabilities in the financial statements.
The exercise price will be calculated using the five-day volume-weighted average stock price as of the issuance date. The unissued warrants do not meet the requirements for classification as equity and are recorded as other noncurrent liabilities in the consolidated financial statements.
We may seek additional sources of liquidity and capital resources through equity or debt financings, such as additional securities offerings or through borrowings under a new or existing credit facility. There can be no assurance that such transactions will be available to us on favorable terms, if at all.
We may in the future need to seek additional sources of liquidity and capital resources through equity or debt financings, such as additional securities offerings or through borrowings under a new or existing credit facility. There can be no assurance that such transactions will be available to us on favorable terms, if at all.
This insurance allows the transfer of risk associated with the Company’s exposure and may enable it to recover a portion of any future amounts paid. The Company believes that the fair value of these indemnification obligations is minimal. Accordingly, the Company has not recognized any liabilities relating to these obligations as of December 31, 2024 and 2023. Note 7.
This insurance allows the transfer of risk associated with the Company’s exposure and may enable it to recover a portion of any future amounts paid. The Company believes that the fair value of these indemnification obligations is minimal. Accordingly, the Company has not recognized any liabilities relating to these obligations as of December 31, 2025 and 2024.
Recent Sales of Unregistered Securities from Registered Securities There were no sales of unregistered equity securities during the fiscal year ended December 31, 2024 that were not previously reported in a Quarterly Report on Form 10-Q or Current Report on Form 8-K. Issuer Repurchases of Equity Securities None. It em 6. [Reserved.] 65 It em 7.
Recent Sales of Unregistered Securities from Registered Securities There were no sales of unregistered equity securities during the fiscal year ended December 31, 2025 that were not previously reported in a Quarterly Report on Form 10-Q or Current Report on Form 8-K. Issuer Repurchases of Equity Securities None. It em 6. [Reserved.] 63 It em 7.
Revenue recognized during the years ended December 31, 2024 and 2023 relates entirely to the sale of the Company’s products within the Surgical Glaucoma and Dry Eye segments. These sales are primarily to hospitals, medical centers, and eyecare professionals ("ECPs") throughout the United States. Sales are generally made through sales representatives and distributors.
Revenue recognized during the years ended December 31, 2025 and 2024 relates entirely to the sale of the Company’s products within the Interventional Glaucoma and Interventional Dry Eye segments. These sales are primarily to hospitals, medical centers, and eyecare professionals ("ECPs") throughout the United States. Sales are generally made through sales representatives and distributors.
The allowance for credit losses was $ 0.7 million and $ 1.2 million as of December 31, 2024 and 2023, respectively. 84 Inventory, net Inventory represents raw materials and finished goods purchased from third-party suppliers and manufacturers. Inventory is valued at the lower of cost or net realizable value.
The allowance for credit losses was $ 0.2 million and $ 0.7 million as of December 31, 2025 and 2024, respectively. Inventory, net Inventory represents raw materials and finished goods purchased from third-party suppliers and manufacturers. Inventory is valued at the lower of cost or net realizable value.
Of the Company's federal net operating loss carryovers, $ 14.8 million was generated before January 1, 2018 and is subject to a 20-year carryforward period. The remaining $ 254.4 million can be carried forward indefinitely but is subject to an 80 % taxable income limitation.
Of the Company's federal net operating loss carryovers, $ 14.8 million was generated before January 1, 2018 and is subject to a 20-year carryforward period. The remaining $ 308.5 million can be carried forward indefinitely but is subject to an 80 % taxable income limitation.
The pre-2018 federal and certain state net operating losses will begin to expire in 2031 and 2032, respectively, if not utilized. As of December 31, 2024 and 2023, the Company has federal research and development income tax credit carryforwards of approximately $ 2.8 million and $ 1.9 million, respectively.
The pre-2018 federal and certain state net operating losses will begin to expire in 2031 and 2032, respectively, if not utilized. As of December 31, 2025 and 2024, the Company has federal research and development income tax credit carryforwards of approximately $ 2.8 million and $ 2.8 million, respectively.
We believe in the importance of continued strategic investment in initiatives that: • further demonstrate our products’ clinical effectiveness and safety to potential customers, patients, payors and regulators, including (i) establishing OMNI and SION as standards of care of interventional glaucoma treatment among MIGS-trained surgeons, (ii) developing the Standalone Market Segment with a focus on pseudophakic patients whose IOP is not well-controlled on two or more medications and who are at risk of disease progression, and (iii) pursuing coverage and equitable reimbursement for TearCare; • enhance our commercial capabilities and expertise, including resources dedicated to sales, marketing and education; • ensure the broadest possible patient access to the treatment alternatives that our products are cleared to offer; • enhance and improve upon our existing product technologies; • develop our existing international markets and expand into new international markets; and • allow us to create transformational and interventional technology innovation with new products, devices or drugs, in glaucoma and ocular surface disease or in new eye disease areas.
We believe in the importance of continued strategic investment in initiatives that: • further demonstrate our products’ clinical effectiveness and safety to potential customers, patients, payors and regulators, including (i) establishing OMNI and SION as standards of care of Interventional Glaucoma treatment among MIGS-trained surgeons, (ii) developing a standalone Interventional Glaucoma market segment with a focus on pseudophakic patients whose IOP is not well-controlled on two or more medications and who are at risk of disease progression, and (iii) increasing customer advocacy and pursuing reimbursement including expanding coverage and/or payment for TearCare; • enhance our commercial capabilities and expertise, including resources dedicated to sales, marketing and education; • ensure the broadest possible patient access to the treatment alternatives that our products are cleared to offer; 65 • enhance and improve upon our existing product technologies; and • allow us to create transformational and interventional technology innovation with new products, devices or drugs, in glaucoma and ocular surface disease or in new eye disease areas.
Accounting Standards Not Yet Adopted In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. The ASU includes amendments requiring enhanced income tax disclosures, primarily related to standardization and disaggregation of rate reconciliation categories and income taxes paid by jurisdiction.
Recent Accounting Pronouncements Accounting Standards Adopted In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. The ASU includes amendments requiring enhanced income tax disclosures, primarily related to standardization and disaggregation of rate reconciliation categories and income taxes paid by jurisdiction.
The Term Loans accrue interest at a floating annual rate equal to the greater of 10.35 % or the Wall Street Journal prime rate plus 2.35 %, with the interest rate under the Term Loans equal to 10.35 % at December 31, 2024.
The Term Loans accrue interest at a floating annual rate equal to the greater of 10.35 % or the Wall Street Journal prime rate plus 2.35 %, with the interest rate equal to 10.35 % at December 31, 2025.
The Company’s unissued common stock warrants under the Hercules Loan Agreement are classified as liabilities in the consolidated balance sheets. These common stock warrants are remeasured at each reporting date using the BackSolve Method, with the gain or loss recorded in the Company’s consolidated statements of operations and comprehensive loss. See Note 5. Debt and Note 7.
The Company’s unissued common stock warrants under the Hercules Loan Agreement are classified as liabilities in the consolidated balance sheets. These common stock warrants are remeasured at each reporting date using the Black-Scholes option pricing method, with the gain or loss recorded in the Company’s consolidated statements of operations and comprehensive loss. See Note 5. Debt and Note 7.
For the years ended December 31, 2024 and 2023, there were no customers that represented 10 % or more of the Company's revenue. Cash and Cash Equivalents The Company considers all highly liquid investments with an original maturity of 90 days or less, when purchased, to be cash and cash equivalents.
For the years ended December 31, 2025 and 2024, there were no customers that represented 10 % or more of the Company's revenue or accounts receivable. Cash and Cash Equivalents and Restricted Cash The Company considers all highly liquid investments with an original maturity of 90 days or less, when purchased, to be cash and cash equivalents.
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS Report of Independent Registered Public Accounting Firm (PCAOB ID Number 34 ) 78 Consolidated Balance Sheets as of December 31, 2024 and 2023 79 Consolidated Statements of Operations and Comprehensive Loss for the Years ended December 31, 2024 and 2023 80 Consolidated Statements of Stockholders’ Equity for the Years ended December 31, 2024 and 2023 81 Consolidated Statements of Cash Flows for the Years ended December 31, 2024 and 2023 82 Notes to Consolidated Financial Statements 83 77 REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM To the stockholders and the Board of Directors of Sight Sciences, Inc.
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS Report of Independent Registered Public Accounting Firm (PCAOB ID Number 34 ) 76 Consolidated Balance Sheets as of December 31, 2025 and 2024 77 Consolidated Statements of Operations and Comprehensive Loss for the Years ended December 31, 2025 and 2024 78 Consolidated Statements of Stockholders’ Equity for the Years ended December 31, 2025 and 2024 79 Consolidated Statements of Cash Flows for the Years ended December 31, 2025 and 2024 80 Notes to Consolidated Financial Statements 81 75 REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM To the stockholders and the Board of Directors of Sight Sciences, Inc.
Except as described above, as of December 31, 2024 and 2023, the Company was not a party to any legal proceedings, regulatory matters, or other disputes or claims which, if determined adversely, would, individually or taken together, have a material adverse effect on the Company’s business, financial condition, operating results, liquidity, or future prospects.
Except as described above, as of December 31, 2025 the Company was not a party to any legal proceedings, regulatory matters, or other disputes or claims which, if determined adversely, it believes would, individually or taken together, have a material adverse effect on the Company’s business, financial condition, operating results, liquidity, or future prospects.
If the additional Term Loans are funded, the Company will be obligated to issue to the Lenders additional warrants to purchase common stock in an amount equal to 2.0 % of the funded balance of each tranche, divided by the exercise price on the date the Company draws funds from such tranche.
If the additional Term Loans are funded, the Company will be obligated to issue to the Lenders additional warrants to purchase common stock in an amount equal to 2.0 % of the funded balance of each tranche loan under the Hercules Loan Agreement, divided by the exercise price on the date the Company draws funds under such tranche loan.
For the years ended December 31, 2024 and 2023, the Company recorded stock-based compensation expense associated with the ESPP of $ 0.6 million and $ 0.6 million, respectively.
For the years ended December 31, 2025 and 2024, the Company recorded stock-based compensation expense associated with the ESPP of $ 0.4 million and $ 0.6 million, respectively.
The aggregate intrinsic value of stock options exercised was $ 0.9 million during the year ended December 31, 2024. The aggregate intrinsic value was calculated as the difference between the exercise prices of the underlying stock options and the estimated fair value of the common stock on the date of exercise.
The aggregate intrinsic value of stock options exercised, calculated as the difference between the exercise prices of the underlying stock options and the estimated fair value of the common stock on the date of exercise, was $ 2.9 million during the year ended December 31, 2025.
On December 10, 2024, upon the funding of the Tranche I(b) Loan, the Company issued additional warrants to the Lenders to purchase 26,095 shares of its common stock at an exercise price of $ 3.83 . Each warrant is exercisable for up to seven years from the date of issuance. The warrants are classified as equity.
On December 10, 2024, upon the funding of the Tranche I(b) Loan, the Company issued additional warrants to the Lenders to purchase 26,095 shares of its common stock at an exercise price of $ 3.83 per share. Each warrant is exercisable for up to seven years from the date of issuance.
On December 10, 2024, upon the funding of the Tranche 1(b) Drawdown, the Company issued additional warrants to the Lenders to purchase 26,095 shares of its common stock at an exercise price of $ 3.83 . Each warrant is exercisable for a period of seven years from the date of issuance.
On December 10, 2024, upon the funding of the Tranche I(b) Loan, the Company issued additional warrants to the Lenders to purchase 26,095 shares of its common stock at an exercise price of $ 3.83 per share. Each warrant is exercisable for a period of seven years from the date of issuance.
The Company has elected to avail themselves of this exemption and, therefore, will not be subject to the timeline for adopting new or revised accounting standards for public business entities that are not emerging growth companies, and will follow the transition guidance applicable to private companies.
The Company has elected to avail itself of this exemption and, therefore, is not subject to the timeline for adopting new or revised accounting standards for public business entities that are not emerging growth companies, and will follow the applicable transition guidance.
As of December 31, 2024 and 2023, the Company has state research and development income tax credit carryforwards of approximately $ 2.3 million and $ 1.7 million, respectively. The Federal income tax credits begin to expire in 2033. The California research and development credits can be carried forward indefinitely.
As of December 31, 2025 and 2024, the Company has state research and development income tax credit carryforwards of approximately $ 2.4 million and $ 2.3 million, respectively. The Federal income tax credits begin to expire in 2033. The California research and development credits can be carried forward indefinitely.
However, our gross margins could fluctuate from quarter to quarter due to a number of factors, including variations in product mix, changes in product reimbursement rates, transitions to new suppliers, introduction of new products by us or our competitors, adoption of new manufacturing processes and technologies, and responses to evolving macroeconomic, and geopolitical conditions, including the adoption of tariffs by the United States and China.
Our gross margins could fluctuate from quarter to quarter due to a number of factors, including variations in product mix, changes in product reimbursement rates or average selling prices, transitions to new suppliers, introduction of new products by us or our competitors, adoption of new manufacturing processes and technologies, and responses to evolving macroeconomic and geopolitical conditions, including the adoption of new or increased tariffs by the United States, China, and other countries.
Research and Development Expenses Research and development ("R&D") expenses consist primarily of costs associated with engineering, product development, clinical studies to develop and support our products, including clinical trial design, clinical trial site initiation and study costs, internal and external costs associated with our regulatory compliance and quality assurance functions, medical affairs, cost of products used for clinical trials and other costs associated with products and technologies – either new or enhancements of existing platforms – that are in development.
Research and Development Expenses Research and development ("R&D") expenses consist primarily of costs associated with engineering, product development, clinical studies to develop and support our products, including clinical trial design, clinical trial site initiation 68 and study costs, internal and external costs associated with our regulatory compliance and quality assurance functions, medical affairs, cost of products used for clinical trials and other costs associated with products and technologies that are in development.
The estimate of excess quantities requires the Company to exercise judgment and is primarily dependent on the Company’s estimates of future demand for the particular product. As of December 31, 2024 and 2023, the Company has reserves for excess and obsolete inventory of $ 0.3 million and $ 0.5 million.
The estimate of excess quantities requires the Company to exercise judgment and is primarily dependent on the Company’s estimates of future demand for the particular product. As of December 31, 2025 and 2024, the Company had reserves for excess and obsolete inventory of $ 0.3 million and $ 0.3 million.
We have dedicated meaningful resources to execute our commercial strategy as we reduce operating expenses and improve cost efficiencies to better align our operating structure for long-term, profitable growth.
We have dedicated meaningful resources to execute our commercial strategy, while also seeking to reduce operating expenses and improve cost efficiencies to better align our operating structure for long-term, profitable growth.
In general, we expect our gross margins to increase over the long term to the extent our production and ordering volumes increase and as we spread the fixed portion of our overhead costs over a larger number of units produced.
In general, we expect our gross profit to increase over time as our revenue increases, and we expect our gross margins to increase over the long term to the extent our production and ordering volumes increase and as we spread the fixed portion of our overhead costs over a larger number of units produced and sold.
Net Cash Used in Investing Activities Net cash used in investing activities in the years ended December 31, 2024 and 2023 was $0.4 million and $0.8 million, respectively, consisting of purchases of property and equipment.
Net Cash Used in Investing Activities Net cash used in investing activities in the years ended December 31, 2025 and 2024 was $0.2 million and $0.4 million, respectively, consisting of purchases of property and equipment.
Tranche 3 consists of $15.0 million available for us to draw through the interest only period in increments of $5.0 million, subject to the sole approval of Hercules' investment committee.
Tranche 3 consisted of $ 15.0 million available to draw through the interest only period in increments of $ 5.0 million, subject to the sole approval of Hercules' investment committee.
Our ability to establish OMNI as a standard of care for all POAG patients by continuing to grow its adoption and utilization in Combination Cataract Procedures and by pioneering the development of the market for interventional Standalone Procedures, with a focus on pseudophakic patients, will have a substantial impact on our future growth.
Our ability to establish OMNI as a standard of care for POAG patients by continuing to grow its adoption and utilization in Combination Cataract Procedures and by pioneering the development of the market for interventional Standalone Procedures, with a focus on pseudophakic patients, will have a substantial impact on our future growth. We introduced our SION Surgical Instrument in 2022.
Interest Rate Risk Our exposure to interest rate risk is principally confined to our cash and cash equivalents and our outstanding credit agreement. As of December 31, 2024, we had cash, cash equivalents and investments of $120.4 million, which consisted of bank deposits, money market funds, and U.S. treasury bills.
Interest Rate Risk Our exposure to interest rate risk is principally confined to our cash and cash equivalents and our outstanding credit agreement. As of December 31, 2025, we had cash, cash equivalents and investments of $92.0 million, which consisted of bank deposits, money market funds, and U.S. treasury bills.
Our gross margin has been, and we believe it will continue to be, affected by a variety of factors, including differences in segment gross margins, changes in average selling prices, changes in product reimbursement rates, product sales mix, production and ordering volumes, manufacturing costs, product yields, and headcount.
Our gross profit and gross margin have been, and we believe they will continue to be, affected by a variety of factors, including differences in segment gross profit and gross margins, changes in average selling prices, changes in product reimbursement rates, product sales mix, production and ordering volumes, manufacturing, tariff and freight costs, product yields, and headcount.
Operating lease expense and supplemental cash flow information related to operating leases for the years ended December 31, 2024 and 2023 were as follows (in thousands): Years Ended December 31, 2024 2023 Operating lease expense $ 783 $ 1,157 Cash paid for operating leases 741 1,158 New operating lease assets obtained in exchange for operating lease liabilities 124 849 Aggregate future minimum lease payments at December 31, 2024 under these noncancelable operating leases were as follows (in thousands): As of December 31, 2024 2025 618 2026 497 Total future minimum lease payments $ 1,115 Less: imputed interest ( 109 ) Present value of future minimum lease payments $ 1,006 Less: current portion of operating lease liability ( 533 ) Operating lease liabilities - noncurrent $ 473 Legal Proceedings On September 16, 2021, the Company filed suit in the U.S.
Operating lease expense and supplemental cash flow information related to operating leases for the years ended December 31, 2025 and 2024 were as follows (in thousands): Years Ended December 31, 2025 2024 Operating lease expense $ 585 $ 783 Cash paid for operating leases 618 741 New operating lease assets obtained in exchange for operating lease liabilities — 124 Aggregate future minimum lease payments at December 31, 2025 under these noncancelable operating leases were as follows (in thousands): As of December 31, 2025 2026 497 Total future minimum lease payments $ 497 Less: imputed interest ( 22 ) Present value of future minimum lease payments $ 475 Less: current portion of operating lease liability ( 475 ) Operating lease liabilities - noncurrent $ — Legal Proceedings On September 16, 2021, the Company filed suit in the U.S.

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