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What changed in ESTABLISHMENT LABS HOLDINGS INC.'s 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of ESTABLISHMENT LABS HOLDINGS 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.

+469 added−455 removedSource: 10-K (2026-02-27) vs 10-K (2025-02-28)

Top changes in ESTABLISHMENT LABS HOLDINGS INC.'s 2025 10-K

469 paragraphs added · 455 removed · 367 edited across 6 sections

Item 1. Business

Business — how the company describes what it does

141 edited+31 added−41 removed125 unchanged
Biggest changeThese companies have greater financial resources for sales, marketing and product development, broader established relationships with health care providers and third-party payers, and larger and more established distribution networks. In some instances, our competitors also offer products that include features that we do not currently offer in all geographies.
Biggest changeOur major competitors in the silicone breast implant marketplace are either publicly traded companies or divisions or subsidiaries of publicly traded companies with significantly more market share and resources than we have. These companies have greater financial resources for sales, marketing and product development, broader established relationships with healthcare providers and third-party payers, and larger and more established distribution networks.
We demonstrate our confidence in Motiva Implants with the Motiva Always Confident Warranty, which offers patients a free replacement for any Motiva Implant that ruptures, for the life of the product. We also replace any implant which is replaced due to capsular contracture of Baker Grade III or IV severity at any time in the first 10 years post-implantation.
We demonstrate our confidence in Motiva Implants with the Motiva Always Confident Warranty, which offers patients a free replacement for any Motiva Implant that ruptures, for the life of the product. We also replace any implant which is replaced due to capsular contracture of Baker Grade III or IV severity at any time in the first 10 years of post-implantation.
Both of our facilities in Coyol Free Zone are Carbon Neutral certified by the Costa Rican Ministry of Environment, Energy, and Telecommunications, based on the implementation of efficiency-aimed actions such as the reduction of energy consumption through the acquisition of more efficient equipment; the combined use of solar panels, ice banks, and battery storage units; and the avoidance of fossil fuels for our operations.
Both of our facilities in the Coyol Free Zone are Carbon Neutral certified by the Costa Rican Ministry of Environment, Energy, and Telecommunications, based on the implementation of efficiency-aimed actions such as the reduction of energy consumption through the acquisition of more efficient equipment; the combined use of solar panels, ice banks, and battery storage units; and the avoidance of fossil fuels for our operations.
All these components are also critical to maintain integrity of the product throughout its shelf-life and all these suppliers must be qualified and materials must be validated prior to being approved for manufacturing activities.
All these components are also critical to maintain the integrity of the product throughout its shelf-life, and all of these suppliers must be qualified, and all materials must be validated prior to being approved for manufacturing activities.
Ergonomix2 incorporates the latest innovations, including our most advanced ultra-high purity chemistries for enhanced device safety mechanical properties and improved patient ergonomics. Ergonomix2 also features our patented SmoothSilk surface technology, which is the basis of Motiva Implants’ low inflammatory characteristics that have contributed to the lowest capsular contracture rates in the industry.
Ergonomix2 incorporates the latest innovations, including our most advanced ultra-high purity chemistries designed for enhanced device safety mechanical properties and improved patient ergonomics. Ergonomix2 also features our patented SmoothSilk surface technology, which is the basis of Motiva Implants’ low inflammatory characteristics that have contributed to the lowest capsular contracture rates in the industry.
We employ a multi-faceted marketing strategy that includes social media engagement, conferences, advertisements and education. Intellectual Property Our success depends at least in part upon our ability to protect our core technology and intellectual property. To accomplish this, we rely on a combination of intellectual property rights, including patents, trade secrets and trademarks, as well as customary contractual protections.
We employ a multi-faceted marketing strategy that includes social media engagement, influencers, conferences, advertisements and education. Intellectual Property Our success depends at least in part upon our ability to protect our core technology and intellectual property. To accomplish this, we rely on a combination of intellectual property rights, including patents, trade secrets and trademarks, as well as customary contractual protections.
This allows us to adapt to specific needs or new developments in our field. Manufacturing and Suppliers Facilities We manufacture our products in ISO-13485-certified manufacturing facilities located in the Coyol Free Zone office park in Costa Rica, a park populated by a number of international medical device companies and granted tax-advantaged status by the government of Costa Rica.
This allows us to adapt to specific needs or new developments in our field. Manufacturing and Suppliers Facilities We manufacture our products in ISO-13485-certified manufacturing facilities located in the Coyol Free Zone office park in Alajuela, Costa Rica, a park populated by a number of international medical device companies and granted tax-advantaged status by the government of Costa Rica.
ITEM 1. BUSINESS Overview We are a medical technology company focused on improving patient safety and aesthetic outcomes, initially in the breast aesthetics and reconstruction market. We initially incorporated in Costa Rica in 2004 and subsequently reorganized under a parent holding company in the British Virgin Islands in 2013.
ITEM 1. BUSINESS Overview We are a global medical technology company focused on improving patient safety and aesthetic outcomes, initially in the breast aesthetics and reconstruction market. We initially incorporated in Costa Rica in 2004 and subsequently reorganized in 2013 under a parent holding company in the British Virgin Islands.
In particular, if our products become eligible for reimbursement by federal health care programs (directly or indirectly) in the United States, our business activities could be subject to scrutiny and enforcement under one or more U.S. federal or state health care fraud and abuse laws and regulations, including: 24 Table of Contents • The federal Anti-Kickback Law, which prohibits, among other things, knowingly or willingly offering, paying, soliciting or receiving remuneration, directly or indirectly, in cash or in kind, for the referral of an individual for the furnishing of an item or service, or to induce or reward the purchasing, leasing, ordering or arranging for or recommending the purchase, lease or order of any health care items or service for which payment may be made, in whole or in part, by federal healthcare programs such as Medicare and Medicaid. • The federal civil False Claims Act, which prohibits, among other things, individuals or entities from knowingly presenting, or causing to be presented, a false or fraudulent claim for payment of government funds or knowingly making, using or causing to be made or used, a false record or statement material to an obligation to pay money to the government or knowingly concealing or knowingly and improperly avoiding, decreasing or concealing an obligation to pay money to the federal government. • The fraud provisions of HIPAA, which impose criminal liability for knowingly and willfully executing a scheme to defraud any healthcare benefit program, including private third-party payors, and prohibit knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement or representation, or making or using any false writing or document knowing the same to contain any materially false fictitious or fraudulent statement or entry, in connection with the delivery of or payment for healthcare benefits, items or services. • Analogous state and local laws and regulations, such as state anti-kickback and false claims laws, which may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers; state and foreign laws that require medical technology companies to comply with the device industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare providers; and state laws and local ordinances that require identification or licensing of sales representatives.
In particular, if our products become eligible for reimbursement by federal healthcare programs (directly or indirectly) in the United States, our business activities could be subject to scrutiny and enforcement under one or more U.S. federal or state healthcare fraud and abuse laws and regulations, including: • The federal Anti-Kickback Law, which prohibits, among other things, knowingly or willingly offering, paying, soliciting or receiving remuneration, directly or indirectly, in cash or in kind, for the referral of an individual for the furnishing of an item or service, or to induce or reward the purchasing, leasing, ordering or arranging for or recommending the purchase, lease or order of any healthcare items or service for which payment may be made, in whole or in part, by federal healthcare programs such as Medicare and Medicaid. • The federal civil False Claims Act, which prohibits, among other things, individuals or entities from knowingly presenting, or causing to be presented, a false or fraudulent claim for payment of government funds or knowingly making, using or causing to be made or used, a false record or statement material to an obligation to pay money to the government or knowingly concealing or knowingly and improperly avoiding, decreasing or concealing an obligation to pay money to the federal government. • The fraud provisions of HIPAA, which impose criminal liability for knowingly and willfully executing a scheme to defraud any healthcare benefit program, including private third-party payors, and prohibit knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement or representation, or making or using any false writing or document knowing the same to contain any materially false fictitious or fraudulent statement or entry, in connection with the delivery of or payment for healthcare benefits, items or services. • Analogous state and local laws and regulations, such as state anti-kickback and false claims laws, which may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers; state and foreign laws that require medical technology companies to comply with the device industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare providers; and state laws and local ordinances that require identification or licensing of sales representatives.
An abstract presented in 2017 by researchers at Montana State University showed less accumulation of both bacteria and biofilm on SmoothSilk in vitro when compared to smoother and textured surfaces. Biofilm formed on implant surfaces increases the risk of bacteria accumulation and capsule formation.
An abstract presented in 2017 by researchers at Montana State University showed less accumulation of both bacteria and biofilm on SmoothSilk surface in vitro when compared to smoother and textured implant surfaces. Biofilm formed on implant surfaces increases the risk of bacteria accumulation and capsule formation.
We are also subject to periodic inspections and audits by various international regulatory and notified bodies, and we believe our past performance in these audits reflects the strength of our quality system and manufacturing controls.
We are also subject to periodic inspections and audits by various international regulatory and notified bodies, and we believe our past performance in these audits reflects the strength of our Quality Management System and manufacturing controls.
The FDA’s guidance document “Saline, Silicone Gel, and Alternative Breast Implants” also states that manufacturers seeking approval of breast implants will be subject to post-approval requirements, which may include, but are not limited to, long-term follow-up of the core clinical study patients, conduct new enrollment post-approval studies, participation in a patient registry or other studies, training programs for physicians and surgeons, and periodic reporting requirements.
The FDA’s guidance document “Saline, Silicone Gel, and Alternative Breast Implants” also states that manufacturers seeking approval of breast implants will be subject to post-approval requirements, which may include, but are not limited to, long-term follow-up of the core clinical study patients, conduction of new enrollment post-approval studies, participation in a patient registry or other studies, training programs for physicians and surgeons, and periodic reporting requirements.
In the United States, the Motiva Health Initiative also covers implant replacement for late forming seroma and double capsule complication within 10 years post-implantation and provides financial assistance for surgical costs related to BIA-ALCL. An extended warranty is available for an additional cost, covering up to $15,000 for surgical expenses based on specific circumstances.
In the United States, the Motiva Health Program also covers implant replacement for late forming seroma and double capsule complication within 10 years post-implantation and provides financial assistance for surgical costs related to BIA-ALCL. An extended warranty is available for an additional cost, covering up to $15,000 for surgical expenses based on specific circumstances.
These include: • establishment registration and device listing with the FDA; • QSR requirements, which require manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation and other quality assurance procedures during all aspects of the design and manufacturing process; • labeling regulations and FDA prohibitions against the promotion of ‘‘off-label’’ uses of cleared or approved products, as well as other requirements related to promotional activities; • clearance or approval of product modifications to cleared or approved devices, where warranted; • medical device reporting regulations, which require that a manufacturer report to the FDA if a device it markets may have caused or contributed to a death or serious injury, or has malfunctioned and the device or a similar device that it markets would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur; • correction, removal and recall reporting regulations, which require that manufacturers report to the FDA field corrections and product recalls or removals if undertaken to reduce a risk to health posed by the device or to remedy a violation of the FDC Act that may present a risk to health; • the FDA’s recall authority, whereby the agency can order device manufacturers to recall from the market a product that is in violation of governing laws and regulations; • post-market surveillance activities and regulations, which apply when deemed by the FDA to be necessary to protect the public health or to provide additional safety and effectiveness data for the device; and • any post-market restrictions or conditions imposed by the FDA on a specific device.
These include: • establishment registration and device listing with the FDA; • QMSR requirements, which require manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation and other quality assurance procedures during all aspects of the design and manufacturing process; • labeling regulations and FDA prohibitions against the promotion of “off-label” uses of cleared or approved products, as well as other requirements related to promotional activities; • clearance or approval of product modifications to cleared or approved devices, where warranted; • medical device reporting regulations, which require that a manufacturer report to the FDA if a device it markets may have caused or contributed to a death or serious injury or has malfunctioned and the device or a similar device that it markets would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur; • correction, removal and recall reporting regulations, which require that manufacturers report to the FDA field corrections and product recalls or removals if undertaken to reduce a risk to health posed by the device or to remedy a violation of the FDC Act that may present a risk to health; • the FDA’s recall authority, whereby the agency can order device manufacturers to recall from the market a product that is in violation of governing laws and regulations; • post-market surveillance activities and regulations, which apply when deemed by the FDA to be necessary to protect the public health or to provide additional safety and effectiveness data for the device; and • any post-market restrictions or conditions imposed by the FDA on a specific device.
If the FDA determines that we failed to comply with applicable regulatory requirements, it can take a variety of compliance or enforcement actions, which 23 Table of Contents may result in sanctions including (but not limited to) Warning Letters, fines, injunctions, consent decrees and civil penalties, customer notifications or repair, replacement, refunds, recall, detention or seizure of our products, operating restrictions, partial suspension or total shutdown of production, refusal to grant export approval, or criminal prosecution.
If the FDA determines that we failed to comply with applicable regulatory requirements, it can take a variety of compliance or enforcement actions, which may result in sanctions including (but not limited to) Warning Letters, fines, injunctions, consent decrees and civil penalties, customer notifications or repair, replacement, refunds, recall, detention or seizure of our products, operating restrictions, partial suspension or total shutdown of production, refusal to grant export approval, or criminal prosecution.
The three-year, by-patient, Kaplan-Meier risk rates of first occurrence of complications for patients (95% confidence interval) in the primary augmentation cohort were as follows: Primary Augmentation 3-year (N=451), 95% CI Capsular contracture (Baker Grade III/IV) 0.5% Rupture, suspected or confirmed; MRI cohort (1) 0.6% Breast pain 0.9% Infection 0.9% Implant removal, with or without replacement 1.8% Any reoperation (2) 6.8% Any complication (3) 9.6% Kaplan-Meier risk rates were the primary method of analysis for the above data.
The five-year, by-patient, Kaplan-Meier risk rates of first occurrence of complications for patients (95% confidence interval) in the primary augmentation cohort were as follows: Primary Augmentation 5-year (N=451), 95% CI Capsular contracture (Baker Grade III/IV) 0.5% Rupture, suspected or confirmed; MRI cohort (1) 0.6% Breast pain 1.2% Infection 0.9% Implant removal, with or without replacement 3.1% Any reoperation (2) 8.8% Any complication (3) 12.0% Kaplan-Meier risk rates were the primary method of analysis for the above data.
To obtain 510(k) clearance, the submitted 510(k) notice must demonstrate that the proposed device is “substantially equivalent” to a predicate device already on the market; a predicate device is a legally marketed device that is not subject to PMA approval. The FDA’s 510(k) clearance process usually takes from three to twelve months, but it can take longer.
To obtain 510(k) clearance, the submitted 510(k) notice must demonstrate that the proposed device is “substantially equivalent” to a predicate device (i.e., a legally marketed device that is not subject to PMA approval) already on the market. The FDA’s 510(k) clearance process usually takes from three to twelve months, but it can take longer.
Following these inspections, the FDA may assert noncompliance with QSR requirements on a Form 483, which is a report of observations from an inspection, or by way of “untitled letters” or “warning letters” that could cause us or any third-party manufacturers to modify certain activities.
Following these inspections, the FDA may assert noncompliance with QMSR requirements on a Form 483, which is a report of observations from an inspection, or by way of “untitled letters” or “warning letters” that could cause us or any third-party manufacturers to modify certain activities.
For more information, please refer to Section 1A “Risk Factors”. Working towards a more sustainable future by reducing our environmental footprint is important to us. Our manufacturing facilities are certified as Carbon Neutral by the Costa Rican Ministry of Environment, Energy, and Telecommunications, or MINAE.
For more information, please refer to Section 1A “Risk Factors”. Working toward a more sustainable future by reducing our environmental footprint is important to us. Our manufacturing facilities are certified as Carbon Neutral by the Costa Rican Ministry of Environment, Energy, and Telecommunications, or MINAE.
The older facility has approximately 28,000 square feet of office space and production areas which are capable of producing over 400,000 implants a year, with state-of-the-art support systems for sustaining production, including an ice-bank system for cooling the controlled air in the clean room and support areas, water-lubricated air compressors for eliminating the presence of oil particulates, heat recovery systems for energy saving, and an energy micro-grid comprised of solar panels and energy-storage batteries.
The original facility has approximately 28,000 square feet of office space and production areas which are capable of producing over 400,000 implants a year, with state-of-the-art support systems for sustaining production, including an ice-bank system for cooling the controlled air in the clean room and support areas, water-lubricated air compressors for eliminating the presence of particulates, heat recovery systems for energy saving, and an energy micro-grid comprised of solar panels and energy-storage batteries.
The three-year risk rates of first occurrence of complications for patients (95% confidence interval) in the Mia Femtech cohort were as follows: Primary Augmentation 3-year (N=100), 95% CI Capsular contracture (Baker Grade III/IV) 0.0% Rupture, suspected or confirmed (1) 0.0% Infection 0.0% Seroma 0.0% Hematoma 0.0% Changes in Nipple Sensation 0.0% Changes in Breast Sensation 0.0% Malposition/Displacement (2) 1.0% Inferior malposition 0.0% Any reoperation 1.0% This table represents preliminary follow-up data available as of October 2024 and does not necessarily reflect final clinical results nor demonstrate the ultimate safety or effectiveness of the Mia Femtech procedure.
The three-year risk rates of first occurrence of complications for patients (95% confidence interval) in the Mia Femtech cohort were as follows: 13 Table of Contents Primary Augmentation 3-year (N=100), 95% CI Capsular contracture (Baker Grade III/IV) 0.0% Rupture, suspected or confirmed (1) 0.0% Infection 0.0% Seroma 0.0% Hematoma 0.0% Changes in Nipple Sensation 0.0% Changes in Breast Sensation 0.0% Malposition/Displacement (2) 1.0% Inferior malposition 0.0% Any reoperation 1.0% This table represents preliminary follow-up data available as of October 2025 and does not necessarily reflect final clinical results nor demonstrate the ultimate safety or effectiveness of the Mia Femtech procedure.
This Certificate and the related conformity assessment process entitles the manufacturer to affix the CE mark to the medical devices after having prepared and signed a related EC Declaration of Conformity. Breast implants intended for aesthetic purposes are specifically regulated under Annex XVI of the EU MDR.
This Certificate and the related conformity assessment process allows the manufacturer to affix the CE mark to the medical devices after having prepared and signed a related EC Declaration of Conformity. Breast implants intended for aesthetic purposes are specifically regulated under Annex XVI to the EU MDR.
We have assembled a broad portfolio of intellectual property related to our medical device and aesthetics products. We believe this intellectual property, combined with proprietary manufacturing processes and the regulatory approvals we have successfully obtained outside of the United States, provides us with a strong market position.
We have assembled a broad portfolio of intellectual property related to our medical device and aesthetics products. We believe this intellectual property, combined with proprietary manufacturing processes and the regulatory approvals we have successfully obtained outside of the United States, provide us with a strong market position.
Our proprietary shell surfaces have an average roughness of 4 microns and have more regular surface features than those of our primary competitors based on several studies using methods such as scanning electron microscopy, profilometry testing and statistical parameters comparisons.
Our proprietary shell surfaces have an average roughness of 4 microns and have more uniform surface features than those of our primary competitors based on several studies using methods such as scanning electron microscopy, profilometry testing and statistical parameters comparisons.
Coverage policies and third-party reimbursement rates may change at any time. Even if favorable coverage and reimbursement status is attained for one or more products for which we receive regulatory approval, less favorable coverage policies and reimbursement rates may be implemented in the future.
Coverage policies and third-party reimbursement rates may change at any time. Even if favorable coverage and reimbursement status are attained for one or more products for which we receive regulatory approval, less favorable coverage policies and reimbursement rates may be implemented in the future.
While our instruments are 20 Table of Contents cleared as class II devices, breast implants are currently classified as Class III devices requiring an approved PMA for commercial distribution. 510(k) Clearance Pathway Manufacturers of most Class II devices are required to submit to the FDA a premarket notification under Section 510(k) of the FDC Act requesting permission to commercially distribute the device (generally known as 510(k) clearance).
While our instruments are cleared as Class II devices, breast implants are currently classified as Class III devices requiring an approved PMA for commercial distribution. 510(k) Clearance Pathway Manufacturers of most Class II devices are required to submit to the FDA a premarket notification under Section 510(k) of the FDC Act requesting permission to commercially distribute the device (generally known as 510(k) clearance).
The Motiva Flora received CE mark in June 2020 and 510(k) clearance from the FDA in October 2023, and has been registered in 70 countries. The Motiva Flora also includes the SmoothSilk surface, which provides biocompatibility benefits described above.
The Motiva Flora received CE mark in June 2020 and 510(k) clearance from the FDA in October 2023 and has been registered in 79 countries. The Motiva Flora also includes the SmoothSilk surface, which provides biocompatibility benefits described above.
Our failure to maintain compliance with the QSR requirements could result in the shut-down of, or restrictions on, our manufacturing operations and the recall or seizure of our products, which would have a material adverse effect on our business.
Our failure to maintain compliance with the QMSR requirements could result in the shut-down of, or restrictions on, our manufacturing operations and the recall or seizure of our products, which would have a material adverse effect on our business.
To reduce the risks associated with these various laws and governmental regulations, we have implemented a compliance plan. Although compliance programs can mitigate the risk of investigation and prosecution for violations of these laws, the risks cannot be entirely eliminated.
To reduce the risks associated with these various laws and governmental regulations, we have implemented a compliance program. Although compliance programs can mitigate the risk of investigation and prosecution for violations of these laws, the risks cannot be entirely eliminated.
A PMA may include post-approval conditions intended to ensure the safety and effectiveness of the device, including, among other things, restrictions on labeling, promotion, sale and distribution, and collection of long-term follow-up data from patients in the clinical study that supported the PMA or requirements to conduct additional clinical studies post-approval.
A PMA may include post-approval conditions intended to ensure the 19 Table of Contents safety and effectiveness of the device, including, among other things, restrictions on labeling, promotion, sale and distribution, and collection of long-term follow-up data from patients in the clinical study that supported the PMA or requirements to conduct additional clinical studies post-approval.
If the FDA determines that there are deficiencies or other concerns with an IDE for which modification is required, it may permit a clinical trial to proceed under a conditional approval. In addition, the study must be approved by, and conducted under the oversight of, an IRB for each clinical site.
If the FDA determines that there are deficiencies or other concerns with an IDE for which modification is required, it may permit a clinical trial to proceed under a conditional approval. 20 Table of Contents In addition, the study must be approved by, and conducted under the oversight of, an IRB for each clinical site.
Such legislative changes in the United States include the Patient Protection and Affordable Care Act (PPACA), which intended to broaden access to health insurance, reduce or constrain the growth of healthcare spending, enhance remedies against healthcare fraud and abuse, add new transparency requirements for healthcare and 26 Table of Contents health insurance industries, and impose additional health policy reforms.
Such legislative changes in the United States include the Patient Protection and Affordable Care Act (PPACA), which intended to broaden access to health insurance, reduce or constrain the growth of healthcare spending, enhance remedies against healthcare fraud and abuse, add new transparency requirements for healthcare and health insurance industries, and impose additional health policy reforms.
If we or our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us, we may be subject to penalties, including civil, criminal and administrative penalties, damages, fines, exclusion from participation in government health care programs, additional reporting and government oversight, and the curtailment or restructuring of our operations.
If we or our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us, we may be subject to penalties, including civil, criminal and administrative penalties, damages, fines, exclusion from participation in government healthcare programs, additional reporting and government oversight, or the curtailment or restructuring of our operations.
Our manufacturing facilities, as well as those of certain of our suppliers, will be subject to periodic and for-cause inspections by the FDA to verify compliance with the QSR and other regulatory requirements.
Our manufacturing facilities, as well as those of certain of our suppliers, will be subject to periodic and for-cause inspections by the FDA to verify compliance with the QMSR and other regulatory requirements.
We believe the more moderate inflammatory response observed on SmoothSilk is responsible for improved biocompatibility and lower complication profile. In November 2022, another publication related to the SmoothSilk surface was published in the Journal of Engineering Tribology by researchers from the College of Engineering at UC, Santa Barbara.
We believe the more moderate inflammatory response observed on SmoothSilk is responsible for improved biocompatibility and lower complication profile. In November 2022, another publication related to the SmoothSilk surface was published in the Journal of Engineering Tribology by researchers from the College of Engineering at University of California, Santa Barbara.
In early 2021, we completed enrollment in our one hundred patient Mia ® Femtech case series in Costa Rica. In October 2024, we published the three-year results of the Motiva Femtech Clinical Study.
In early 2021, we completed enrollment in our one hundred patient Mia ® Femtech case series in Costa Rica. In October 2025, we published the three-year results of the Motiva Femtech Clinical Study.
In October 2023, we launched Zen, the next, now non-ferromagnetic, generation of passive RFID technology, in Motiva Ergonomix2 Diamond implants used in the Mia Femtech system and select geographies with Motiva Ergonomix2 Round Implants in the JOY program. We control all the activities of the development and manufacturing of our Qid Safety Technology RFID transponders.
In October 2023, we launched Zen, a non-ferromagnetic, next- generation passive RFID technology available in Motiva Ergonomix2 Diamond implants used in the Mia Femtech system and select geographies with Motiva Ergonomix2 Round Implants in the JOY program. We control all the activities of the development and manufacturing of our Qid Safety Technology RFID transponders.
Our latest generation of Motiva Implants utilizes our proprietary Gravity Sensitive Ergonomix design, with a round base implant that responds to gravity by shifting its maximum point of projection, offering the more “natural” projection of a shaped implant without the malposition and rotation issues frequently 8 Table of Contents associated with shaped implants.
Our latest generation of Motiva Implants utilizes our proprietary Gravity Sensitive Ergonomix design, with a round base implant that responds to gravity by shifting its maximum point of projection, offering the more “natural” projection of a shaped implant without the malposition and rotation issues frequently associated with shaped implants.
The HTA Regulation aims to boost cooperation among EU Member States in assessing health technologies and providing the basis for cooperation at EU level for joint clinical assessments in these areas. The HTA Regulation entered into force on January 11, 2022, and started to apply from January 12, 2025.
The HTA Regulation aims to boost cooperation among EU Member States in assessing health technologies and providing the basis for cooperation at EU level for joint clinical assessments in these areas. The HTA Regulation entered into force on January 11, 2022, and started to apply from January 12, 2025, with phased implementation.
Additionally, the improved adhesion of the gel to the shell structure avoids the appearance of separation spots, an aesthetic defect commonly seen in competitor products. In addition to the anticipated safety advantages, our ProgressiveGel family provides for movement characteristics that resemble natural breast tissue.
Additionally, the 8 Table of Contents improved adhesion of the gel to the shell structure avoids the appearance of separation spots, an aesthetic defect commonly seen in competitor products. In addition to the anticipated safety advantages, our ProgressiveGel family provides for movement characteristics that resemble natural breast tissue.
A Form 483 notice, if issued at the conclusion of an FDA inspection, can list conditions the FDA investigators believe may have violated QSR or other FDA requirements.
A Form 483 notice, if issued at the conclusion of an FDA inspection, can list conditions the FDA investigators believe may have violated QMSR or other FDA requirements.
We believe that the cohesive properties reduce the likelihood of silicone gel leakage in the event of a rupture in the shell. The strength of the gel is believed to contribute to a 9 Table of Contents reduced frequency of gel fracture, a condition which leads to deformed implant shape and stress on the implant’s shell.
We believe that the cohesive properties reduce the likelihood of silicone gel leakage in the event of a rupture in the shell. The strength of the gel is believed to contribute to a reduced frequency of gel fracture, a condition which leads to deformed implant shape and stress on the implant’s shell.
The FDA administers requirements covering the design, development, testing (non-clinical and clinical research), safety, effectiveness, manufacturing, labeling, packaging, promotion, advertising, distribution, recordkeeping, import/export and post-market surveillance of medical devices in order to ensure that devices distributed in the U.S. are safe and effective for their intended uses and otherwise meet the requirements of the FDC Act.
The FDA administers requirements covering the design, development, testing (non-clinical and clinical research), safety, effectiveness, manufacturing, labeling, packaging, promotion, advertising, distribution, recordkeeping, import/export and post-market surveillance of medical devices in order to ensure that devices distributed in the United States are safe and effective for their intended uses and otherwise meet the requirements of the FDC Act.
This table represents the final data from the primary cohort of the same study referenced in the above five- and six-year PMA studies conducted by our competitors. This 10-year data for Sientra, Allergan and Mentor were released in 2018, 2018, and 2015, respectively.
This table represents the final data from the primary augmentation cohort of the same study referenced in the above five- and six-year PMA studies conducted by our competitors. This 10-year data for Sientra, Allergan and Mentor was released in 2018, 2018, and 2015, respectively.
This patented manufacturing innovation is intended to highlight any imperfections in the barrier layer coverage with a distinct color. Our BluSeal indicator technology also provides the plastic surgeon with the ability to verify whether the barrier layer has coverage defects or other imperfections before implantation that might lead to post- 11 Table of Contents implantation shell rupture or gel bleed.
This patented manufacturing innovation is intended to highlight any imperfections in the barrier layer coverage with a distinct color. Our BluSeal indicator technology also provides the plastic surgeon with the ability to verify whether the barrier layer has coverage defects or other imperfections before implantation that might lead to post-implantation shell rupture or gel bleed.
In October 2024, we published the three-year results of the Motiva Femtech Clinical Study of data based on a follow-up compliance rate of 93%.
In October 2025, we published the three-year results of the Motiva Femtech Clinical Study of data based on a follow-up compliance rate of 93%.
Our owned and licensed pending applications, if granted, likely would expire between September 2033 and December 2044. In addition to pursuing patents on our products, we have taken steps to protect our intellectual property and proprietary technology by entering into confidentiality agreements and intellectual property assignment agreements with our employees, consultants, corporate partners, and, when needed, our advisors.
Our owned and licensed pending applications, if granted, likely would expire between September 2033 and October 2045. In addition to pursuing patents on our products, we have taken steps to protect our intellectual property and proprietary technology by entering into confidentiality agreements and intellectual property assignment agreements with our employees, consultants, corporate partners, and, when needed, our advisors.
Health Reform In the United States and some foreign jurisdictions, there has been significant interest in implementing cost-containment programs to limit the growth of government-paid healthcare costs, including price controls and restrictions on reimbursement.
Health Reform In the United States and some foreign jurisdictions, there has been significant interest in implementing cost-containment programs to limit the growth of government-paid healthcare costs, including price controls and 24 Table of Contents restrictions on reimbursement.
We conduct annual evaluations for most of our suppliers and engage in second source supplier initiatives to ensure the continuity of business operations, enhance quality, and reduce costs. 19 Table of Contents Competition The U.S. market for silicone breast implants is relatively concentrated, within Allergan Aesthetics, a division of AbbVie, Mentor Worldwide LLC, a division of Johnson & Johnson, and Sientra Inc., recently acquired by Tiger Aesthetics Medical.
We conduct annual evaluations for most of our suppliers and engage in second-source supplier initiatives to ensure the continuity of business operations, enhance quality, and reduce costs. 17 Table of Contents Competition The U.S. market for silicone breast implants is relatively concentrated, within Allergan Aesthetics, a division of AbbVie, Mentor Worldwide LLC, a division of Johnson & Johnson, and Sientra Inc., which was acquired by Tiger Aesthetics Medical.
Various states have also implemented regulations prohibiting certain financial interactions with health care professionals or mandating public disclosure of such financial interactions. We may incur significant costs to comply with such laws and regulations now or in the future.
Various states have also implemented regulations prohibiting certain financial interactions with healthcare professionals or mandating public disclosure of such financial interactions. We may incur significant costs to comply with such laws and regulations now or in the future.
Our catalog includes 15 variations, including three different heights, and a range of volumes from 260 to 995 cc. 12 Table of Contents Minimally Invasive Aesthetics: Preservé and Mia Femtech In February 2025, we introduced Preservé, a minimally invasive breast tissue-preserving technology designed for breast augmentation, revision augmentation, and mastopexy augmentation.
Our catalog includes 15 variations, including three different heights, and a range of volumes from 260 to 995 cc. 11 Table of Contents Minimally Invasive Aesthetics: Preservé and Mia Femtech In February 2025, we introduced Preservé in targeted markets, a minimally invasive breast tissue-preserving technology designed for breast augmentation, revision augmentation, and mastopexy augmentation.
HIPAA apply to “Covered Entities,” which are health plans, health care clearing houses, and certain health care providers which conduct certain health care transactions electronically, and to “Business Associates,” persons or entities that perform a function or provide specified services on behalf of a Covered Entity that involves the creation, use, maintenance or transmission of protected health information.
HIPAA applies to “Covered Entities,” which are health plans, healthcare clearing houses, and certain healthcare providers which conduct certain healthcare transactions electronically, and to “Business Associates,” persons or entities that perform a function or provide specified services on behalf of a Covered Entity that involves the creation, use, maintenance or transmission of protected health information.
We cannot assure you that we do not currently infringe, or that we will not in the future infringe, upon any third-party patents or other proprietary rights. 17 Table of Contents Research and Development Our goal is to continue to improve our existing products, as well as develop new products and new surgical techniques.
We cannot assure you that we do not currently infringe, or that we will not in the future infringe, upon any third-party patents or other proprietary rights. Research and Development Our goal is to continue to improve our existing products, as well as develop new products and new surgical techniques.
To demonstrate compliance with the GSPR of the EU MDR and obtain the right to affix the CE mark, we must undergo a conformity assessment procedure, which varies according to the type of medical device and its classification.
To demonstrate compliance with the GSPR of the EU MDR and obtain the right to affix the CE mark, our medical devices must undergo a conformity assessment procedure, which varies according to the type of medical device and its classification.
The QSR, which covers the methods and the facilities and controls for the design, manufacture, testing, production, processes, controls, quality assurance, labeling, packaging, distribution, installation and servicing of finished devices intended for human use. The QSR also requires, among other things, maintenance of a device master file, device history file, and complaint files.
The QMSR, which covers the methods and the facilities and controls for the design, manufacture, testing, production, processes, controls, quality assurance, labeling, packaging, distribution, installation and servicing of finished devices intended for human use. The QMSR also requires, among other things, maintenance of a medical device master file and complaint files.
Sustainability is key to our existence and future. As a global medical technology company, we seek to create positive and long-term social, environmental, and economic impact with our products, experiences, activities, and corporate efforts. Accordingly, our global sustainability commitment leads us to increase our contribution toward 28 Table of Contents long-term sustainability.
Sustainability is key to our existence and future. As a global medical technology company, we seek to create positive and long-term social, environmental, and economic impact with our products, experiences, activities, and corporate efforts. Accordingly, our global sustainability commitment leads us to increase our contribution toward long-term sustainability.
In April 2022, the Company released preliminary results of the two-year patient follow-up data for the primary augmentation cohort of its IDE clinical trial. The second module was submitted in May 2022. In June 2022, full enrollment of the IDE clinical trial was complete, and all surgeries in the primary reconstruction cohort were performed.
In April 2022, we released preliminary results of the two-year patient follow-up data for the primary augmentation cohort of our IDE clinical trial. The second module was submitted in May 2022. In June 2022, full enrollment of the IDE clinical trial was complete, and all surgeries in the primary reconstruction cohort were performed.
Prohibitions under some of these laws include: • the submission of false claims or false information to government programs; • deceptive or fraudulent conduct; • excessive or unnecessary services, services that do not meet medical necessity, or services at excessive prices; and • prohibitions in defrauding private sector health insurers.
Prohibitions under some of these laws include: • the submission of false claims or false information to government programs; • deceptive or fraudulent conduct; 22 Table of Contents • excessive or unnecessary services, services that do not meet medical necessity, or services at excessive prices; and • defrauding private sector health insurers.
If the device presents a “significant risk,” to human health, as defined by the FDA, the device sponsor must submit an IDE application to the FDA, which must be approved prior to commencing human clinical trials.
If the device presents a “significant risk” to human health, as defined by the FDA, the device sponsor must submit an IDE application to the FDA, which must be approved prior to commencing human clinical trials.
Fraud and Abuse Laws As participants in the health care industry, we are subject to anti-fraud and abuse laws in various countries. Many of these anti-fraud laws are broad in scope and impose significant penalties for violation.
Fraud and Abuse Laws As participants in the healthcare industry, we are subject to anti-fraud and abuse laws in various countries. Many of these anti-fraud laws are broad in scope and impose significant penalties for violation.
We have implemented policies, procedures, and internal controls that are designed to comply with these laws and regulations. Human Capital As of December 31, 2024, we had 1,018 employees. None of our employees are represented by a labor union or covered by collective bargaining agreements except for employees in Brazil and Argentina.
We have implemented policies, procedures, and internal controls that are designed to comply with these laws and regulations. Human Capital As of December 31, 2025, we had 1,004 employees. None of our employees are represented by a labor union or covered by collective bargaining agreements except for certain employees in Brazil and Argentina.
ProgressiveGel Family The proprietary silicone chemistries that comprise our ProgressiveGel family allow for a high degree of viscoelasticity and strength but add characteristics such as softness and high ductility that enable movement dynamics more like that of natural breast tissue.
ProgressiveGel Family The proprietary silicone chemistries that comprise our ProgressiveGel family allow for a high degree of viscoelasticity and strength while adding characteristics such as softness and high ductility that enable movement dynamics more like that of natural breast tissue.
This microtransponder provides each device with a unique electronic serial number for traceability purposes. The microtransponder contains only a unique 15-digit code that identifies the product and does not contain any patient information.
This microtransponder provides each device with a unique electronic serial number for traceability purposes. 9 Table of Contents The microtransponder contains only a unique 15-digit code that identifies the product and does not contain any patient information.
Class I devices are those for which safety and effectiveness can be assured by adherence to the FDA’s General Controls for medical devices, which include compliance with the applicable portions of the Quality System Regulation (QSR), facility registration and product listing, reporting of adverse medical events, and truthful and non-misleading labeling, advertising, and promotional materials.
Class I devices are those for which safety and effectiveness can be assured by adherence to the FDA’s General Controls for medical devices, which include compliance with the applicable portions of the Quality Management System Regulation (QMSR), facility registration and product listing, reporting 18 Table of Contents of adverse medical events, and truthful and non-misleading labeling, advertising, and promotional materials.
Additionally, the FDA will not approve the PMA until it conducts a pre-approval inspection of our manufacturing facility and determines that it is in compliance with good manufacturing practices, as set forth in the FDA’s Quality System Regulation or QSR. The PMA review and approval process generally takes from one to three years but may take longer.
Additionally, the FDA will not approve the PMA until it conducts a pre-approval inspection of our manufacturing facility and determines that it is in compliance with good manufacturing practices, as set forth in the FDA’s QMSR. The PMA review and approval process generally takes from one to three years but may take longer.
We also pay significant attention to helping our distributors maintain positive relationships with surgeons and clinics in their respective regions, and to positioning our product in the marketplace as a premium product with consequent premium pricing.
We also pay significant attention to helping our distributors maintain positive 14 Table of Contents relationships with surgeons and clinics in their respective regions, and to positioning our product in the marketplace as a premium product with consequent premium pricing.
We maintain a Quality Management System database to track and report complaints received from patients or physicians. From October 2010 through December 2024, a total of 5,901 complaints have been reported, investigated and processed, representing approximately 0.1% of the total Motiva Implants sold through December 2024.
We maintain a Quality Management System database to track and report complaints received from patients or physicians. From October 2010 through December 2025, a total of 7,400 complaints have been reported, investigated and processed, representing approximately 0.1% of the total Motiva Implants sold through December 2025.
As of December 31, 2024, we own or have rights to 33 issued, one allowed and 15 pending patents in the United States related to various aspects of our Motiva Implants (such as implant barrier layers, surface texture technology, minimally invasive implant delivery systems, minimally invasive and tissue preservation procedures and systems and our Qid Safety Technology or ZEN radio frequency identification devices).
As of December 31, 2025, we own or have rights to 36 issued, 1 allowed and 12 pending patents in the United States related to various aspects of our Motiva Implants (such as implant barrier layers, surface texture technology, minimally invasive implant delivery systems, minimally invasive and tissue preservation procedures and systems and our Qid Safety Technology or ZEN radio frequency identification devices).
We have and will continue to work with several institutions in our effort to advance implant technology, and generate additional scientific data to support the improved safety outcomes associated with our products, including: • Massachusetts Institute of Technology • Medical University of Innsbruck • Department of Bioengineering at Rice University • University of Cape Town Faculty of Health Sciences • University Hospital Ghent Department of Plastic Surgery • The Chair of Plastic Surgery at the School of Medicine and Psychology of Sapienza University of Rome We have incurred, and expect to continue to incur, significant R&D expenses.
We also have sophisticated internal prototyping and testing equipment. 15 Table of Contents We have and will continue to work with several institutions in our effort to advance implant technology and generate additional scientific data to support the improved safety outcomes associated with our products, including: • Massachusetts Institute of Technology • Medical University of Innsbruck • Department of Bioengineering at Rice University • University of Cape Town Faculty of Health Sciences • University of California, Santa Barbara • University Hospital Ghent Department of Plastic Surgery • The Chair of Plastic Surgery at the School of Medicine and Psychology of Sapienza University of Rome We have incurred, and expect to continue to incur, significant R&D expenses.
These requirements impose certain procedural and documentation requirements upon us and our third-party manufacturers related to the methods used in and the facilities and controls used for designing, manufacturing, packaging, labeling and storing medical devices. As a manufacturer, we are subject to periodic scheduled or unscheduled inspections by the FDA.
These requirements impose procedural and documentation requirements upon us and our third- 21 Table of Contents party manufacturers related to the methods used in and the facilities and controls used for designing, manufacturing, packaging, labeling and storing medical devices. As a manufacturer, we are subject to periodic inspections by the FDA.
There were no reported cases of double capsule formation or breast-implant associated anaplastic large-cell lymphoma, or BIA- ALCL, in this data set, and there were 81 cases of early seroma and 13 case of late seroma reported.
There were no reported cases of double capsule formation or primary cases of breast-implant associated anaplastic large-cell lymphoma, or BIA-ALCL, in this data set. There were 82 cases of early seroma and 28 cases of late seroma reported.
These implants are unique in the industry, adapting their shape as the body changes position. Preservé is suitable for primary augmentations of up to four cups, hybrid augmentations, and mastopexy augmentations. The initial commercial launch occurred in Brazil, with further launches anticipated in other countries throughout 2025.
These implants are unique in the industry, adapting their shape as the body changes position. Preservé is suitable for primary augmentations of up to four cups, hybrid augmentations, and mastopexy augmentations. The initial commercial launch occurred in Brazil, with further launches in other countries occurring throughout 2025, including an early experience group in the United States.
This table represents preliminary data available as of October 2024 and does not necessarily reflect final clinical results nor demonstrate the investigational device’s safety and effectiveness for the United States trial.
This table represents preliminary data available as of September 2024 and does not necessarily reflect final clinical results nor demonstrate the investigational device’s safety and effectiveness for the U.S. trial.
Our Products and Technologies The key characteristics of our primary products are described in the table below: Product Motiva Round Motiva Ergonomix Motiva Ergonomix2 Motiva Flora Tissue Expander Description Round soft silicone-gel filled breast implants Gravity sensitive round soft silicone-gel-filled breast implants Gravity sensitive soft silicone-gel-filled breast implants with improved mechanical properties Breast tissue expander, used to gradually expand a patient’s breast tissue prior to the placement of a long-term breast implant Product Catalog Available in 160 round catalogs, including four projection heights Available in 160 round catalogs, including four projection heights Available in more than 160 round catalogs, including four projection heights; Available in 60 catalogs for Diamond implants Available in 15 catalogs, with three different heights Key Features • SilkSurface/SmoothSilk shell surface • ProgressiveGel PLUS Silicone gel fill • TrueMonobloc construction • BluSeal shell barrier layer • Qid Safety Technology RFID microtransponder ▪ SilkSurface/SmoothSilk shell surface ▪ ProgressiveGel Ultima, Silicone gel fill ▪ TrueMonobloc construction ▪ BluSeal shell barrier ▪ Qid Safety Technology RFID microtransponder ▪ Ergonomy and more natural look ▪ SilkSurface/SmoothSilk shell surface • ProgressiveGel Ultima, Silicone gel fill ▪ TrueMonobloc+ construction ▪ BluSeal+ shell barrier • ZEN RFID microtransponder ▪ Motiva SuperSilicones ▪ SilkSurface/SmoothSilk shell surface ▪ Anatomical design ▪ Compatible with MRI and CT scans ▪ Injection site located with RF technology, using the Motiva Port Locator ▪ Orientation line observable on X-Ray ▪ Fixation suture tabs Sales Territories 94 countries Motiva Implants The Motiva breast implants are a Class III Medical Device indicated for breast augmentation and breast reconstruction, including revision surgeries to correct or improve the result of a previous breast implant surgery.
Although the degree of seasonality may vary by geography and product line, these patterns are characteristic of the broader breast aesthetics industry and influence both distributor purchasing behavior and direct sales volume. 6 Table of Contents Our Products and Technologies The key characteristics of our primary products are described in the table below: Product Motiva Round Motiva Ergonomix Motiva Ergonomix2 Motiva Flora Tissue Expander Description Round soft silicone-gel filled breast implants Gravity sensitive round soft silicone-gel-filled breast implants Gravity sensitive soft silicone-gel-filled breast implants with improved mechanical properties Breast tissue expander, used to gradually expand a patient’s breast tissue prior to the placement of a long-term breast implant Product Catalog Available in 160 round catalogs, including four projection heights Available in 160 round catalogs, including four projection heights Available in more than 160 round catalogs, including four projection heights; Available in 60 catalogs for Diamond implants Available in 15 catalogs, with three different heights Key Features • SilkSurface/SmoothSilk shell surface • ProgressiveGel PLUS Silicone gel fill • TrueMonobloc construction • BluSeal shell barrier layer • Qid Safety Technology RFID microtransponder ▪ SilkSurface/SmoothSilk shell surface ▪ ProgressiveGel Ultima, Silicone gel fill ▪ TrueMonobloc construction ▪ BluSeal shell barrier ▪ Qid Safety Technology RFID microtransponder ▪ Ergonomy and more natural look ▪ SilkSurface/SmoothSilk shell surface • ProgressiveGel Ultima, Silicone gel fill ▪ TrueMonobloc+ construction ▪ BluSeal+ shell barrier • ZEN RFID microtransponder ▪ Motiva SuperSilicones ▪ SilkSurface/SmoothSilk shell surface ▪ Anatomical design ▪ Compatible with MRI and CT scans ▪ Injection site located with RF technology, using the Motiva Port Locator ▪ Orientation line observable on X-Ray ▪ Fixation suture tabs Sales Territories Over 100 countries Motiva Implants The Motiva breast implants are a Class III Medical Device (based on the designations in the U.S. and the E.U.) indicated for breast augmentation and breast reconstruction, including revision surgeries to correct or improve the result of a previous breast implant surgery.
These energy efficient systems generate up to 80% of the total energy consumption of the building, which received LEED Gold Certification by the U.S.
These energy efficient systems generate up to 80% of the total energy consumption of the building, which received LEED Gold Certification by the U.S. Green Building Council in August 2017.
Our catalog includes over 1,000 product variations, with round, oval and anatomical shapes, two different surfaces, SmoothSilk and VelvetSurface, and volumes ranging from 95cc to 1060cc, resulting in a wider range of options than those offered by our major competitors.
Our catalog includes over 1,000 product variations with round, oval and anatomical 7 Table of Contents shapes and volumes ranging from 95cc to 1060cc, resulting in a wider range of options than those offered by our major competitors.
We launched Motiva Implants commercially in October 2010, and to date we have sold close to 4 million units. Motiva Implants incorporate several proprietary features that we believe contribute to their favorable safety profile, natural appearance and feel.
We launched Motiva Implants commercially in October 2010. Motiva Implants incorporate several proprietary features that we believe contribute to their favorable safety profile, natural appearance and feel.
We received 510(k) clearance for the Motiva Flora SmoothSilk Tissue Expander in October 2023 and PMA approval for our Motiva Implants from the FDA in September 2024. Beginning in October 2024, we began selling Motiva Implants for use in breast augmentation for patients in the United States.
We received 510(k) clearance for the Motiva Flora SmoothSilk Tissue Expander in October 2023 and PMA approval for our Motiva Implants from the FDA in September 2024, and we began commercial sales in the United States in October 2024.
Our products are commercially available in 94 16 Table of Contents countries through exclusive distributors, except in the United States, Brazil, Argentina and several European countries where we sell through our direct sales force. As of December 31, 2024, our sales organization included 282 employees and contractors.
Our products are commercially available in over 100 countries through exclusive distributors, except in the United States, Brazil, Argentina and several European countries where we sell through our direct sales force. As of December 31, 2025, our sales organization included 278 employees and contractors.
In September 2024, we received PMA approval from the FDA for our Motiva Implants. Beginning in October 2024, we began selling Motiva Implants for use in breast augmentation for patients in the United States.
In September 2024, we received PMA approval from the FDA for our Motiva Implants including our Post Approval Study. Beginning in October 2024 we submitted a PMA Supplement for our Post Approval Study protocol, and we began selling Motiva Implants for use in breast augmentation for patients in the United States.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeIn addition, even when HIPAA does not apply, according to the FTC, failing to take appropriate steps to keep consumers’ personal information secure may constitute unfair acts or practices in or affecting commerce in violation of Section 5(a) of the FTCA, 15 U.S.C § 45(a).
Biggest changeAlthough we are not directly subject to HIPAA, we could potentially be subject to criminal penalties if we, our affiliates, or our agents knowingly receive individually identifiable health information maintained by a HIPAA-covered entity in a manner 48 Table of Contents that is not authorized or permitted by HIPAA, and subject to other civil and/or criminal penalties if we obtain, use, or disclose information in a manner not permitted by other privacy and data security consumer protection laws In addition, even when HIPAA does not apply, according to the FTC, failing to take appropriate steps to keep consumers’ personal information secure may constitute unfair acts or practices in or affecting commerce in violation of Section 5(a) of the FTCA, 15 U.S.C § 45(a).
Risks Related to Our Business, Industry and Operations We expect to incur losses for the foreseeable future, and our ability to achieve and maintain profitability depends on the commercial success of our Motiva Implants. We have incurred losses to date and expect to continue to incur losses for the foreseeable future.
Risks Related to Our Business, Industry and Operations We have incurred losses to date, and our ability to achieve and maintain profitability depends on the commercial success of our Motiva Implants. We have incurred losses to date and expect to continue to incur losses for the foreseeable future.
If our available cash resources and anticipated cash flow from operations are insufficient to satisfy our liquidity requirements, we may seek to sell equity or convertible debt securities, enter into a credit facility or another form of third-party funding, or seek other debt financing.
If our available cash resources and anticipated cash flow from operations are insufficient to satisfy our liquidity requirements, we may seek to sell equity or convertible debt securities, enter into a credit facility or another form of third-party funding, or seek other debt financing.
This can put us at a disadvantage when promoting our products to physicians and patients, even outside the United States. In addition, the significant financial and staff resources and brand recognition that our competitors possess mean they may be able to compete with us regardless of the differentiating features of our products.
This can put us at a disadvantage when promoting our products to physicians and patients, even outside of the United States. In addition, the significant financial and staff resources and brand recognition that our competitors possess mean they may be able to compete with us regardless of the differentiating features of our products.
Negative publicity concerning our products or our competitors’ products, including due to product defects, recalls and any resulting litigation, or long-term safety impacts, could harm our reputation and reduce demand for silicone breast implants, either of which could adversely impact our financial results and/or share price.
Negative publicity concerning our products or our competitors’ products, including due to product defects or recalls and any resulting litigation, or long-term safety impacts, could harm our reputation and reduce demand for silicone breast implants, either of which could adversely impact our financial results and/or share price.
If our single-source and other suppliers were to delay or stop producing our components, or if the prices they charge us were to increase significantly, or if they elected not to sell to us at all or on commercially reasonable terms, we would need to identify and initiate relationships with alternative suppliers, if possible.
If our single-source and other suppliers were to delay or stop producing our components, if the prices they charge us were to increase significantly, or if they elected not to sell to us at all or on commercially reasonable terms, we would need to identify and initiate relationships with alternative suppliers, if possible.
In addition, the off-label use of our products may increase the risk of product liability claims. Product liability claims are expensive to defend and could divert our management’s attention, result in substantial damage awards against us, and harm our reputation.
In addition, the off-label use of our products may increase the risk of product liability claims. Product liability claims are expensive to defend and could divert our management’s attention, result in substantial damage awards against us, and harm our reputation.
Companies are required to maintain certain records of recalls, even if they are not reportable to the FDA. We may initiate voluntary recalls involving Motiva Implants or other planned devices in the future that we determine do not require notification of the FDA. If the FDA disagrees with our determinations, they could require us to report those actions as recalls.
Companies are required to maintain certain records of recalls, even if they are not reportable to the FDA. We may initiate voluntary recalls involving Motiva Implants or other planned devices in the future that we determine do not require notification to the FDA. If the FDA disagrees with our determinations, they could require us to report those actions as recalls.
Among others, these provisions include the following: • while we are commencing a phased-in process to declassify our Board of Directors, our Board of Directors is divided into three classes with staggered three-year terms and will not be fully declassified until our 2026 annual meeting of shareholders, which may delay or prevent a change of our management or a change in control; • our Board of Directors has the right to elect directors to fill a vacancy created by the expansion of our Board of Directors or the resignation, death or removal of a director, which will prevent shareholders from being able to fill vacancies on our Board of Directors; • our shareholders are not able to act by written consent, and, as a result, a holder, or holders, controlling a majority of our shares are not able to take certain actions other than at annual shareholders’ meetings or special shareholders’ meetings; • our amended and restated memorandum and articles of association do not allow cumulative voting in the election of directors, which limits the ability of minority shareholders to elect director candidates; • our shareholders are required to provide advance notice and additional disclosures in order to nominate individuals for election to our Board of Directors or to propose matters that can be acted upon at a 61 Table of Contents shareholders’ meeting, which may discourage or deter a potential acquirer from conducting a solicitation of proxies to elect the acquirer’s own slate of directors or otherwise attempting to obtain control of our company; and • our Board of Directors is able to issue, without shareholder approval, preferred shares with voting or other rights or preferences that could impede the success of any attempt to acquire us.
Among others, these provisions include the following: • while we are commencing a phased-in process to declassify our Board of Directors, our Board of Directors is divided into three classes with staggered three-year terms and will not be fully declassified until our 2026 annual meeting of shareholders, which may delay or prevent a change of our management or a change in control; • our Board of Directors has the right to elect directors to fill a vacancy created by the expansion of our Board of Directors or the resignation, death or removal of a director, which will prevent shareholders from being able to fill vacancies on our Board of Directors; • our shareholders are not able to act by written consent, and, as a result, a holder, or holders, controlling a majority of our shares are not able to take certain actions other than at annual shareholders’ meetings or special shareholders’ meetings; • our amended and restated memorandum and articles of association do not allow cumulative voting in the election of directors, which limits the ability of minority shareholders to elect director candidates; 61 Table of Contents • our shareholders are required to provide advance notice and additional disclosures in order to nominate individuals for election to our Board of Directors or to propose matters that can be acted upon at a shareholders’ meeting, which may discourage or deter a potential acquirer from conducting a solicitation of proxies to elect the acquirer’s own slate of directors or otherwise attempting to obtain control of our company; and • our Board of Directors is able to issue, without shareholder approval, preferred shares with voting or other rights or preferences that could impede the success of any attempt to acquire us.
In addition, our relationship with Avantor involves other risks, including but not limited to the following: • it may not be able, or willing, to manufacture silicone raw materials with our agreed-upon specifications; • it may not be able, or willing, to manufacture our needed raw materials in compliance with regulatory requirements, or our its manufacturing facilities may not be able to maintain compliance with regulatory requirements; • it may not be able to supply sufficient quantities of each raw material quickly enough for us to respond to rapid increases in demand; • it may unintentionally convey information to our competitors that is helpful in understanding our proprietary compositions and other trade secrets of our manufacturing processes; • we may be subject to price fluctuations if we fail to meet certain minimum order requirements, or if our existing contract expires or is renegotiated; • it may lose access to critical services and components, resulting in interruption in manufacture or shipment of medical-grade silicone; • its facilities may be affected by earthquakes, wildfires, mud slides or other natural disasters, which could delay or impede production of our raw materials; • we may be required to obtain regulatory approvals related to any change in our supply chain; • Avantor may wish to discontinue supply of products to us due to its existing relationships with our competitors; • Avantor may stop supply and claim ownership of intellectual property on materials associated with future products; • Avantor or its parent entity may encounter financial or other hardships unrelated to our demand for products, which could negatively impact their ability to fulfill our orders and support our regulatory approvals; and 42 Table of Contents • disputes may arise over the terms of the Master Supply Agreement, by and between the Company and Avantor, dated May 13, 2022.
In addition, our relationship with Avantor involves other risks, including but not limited to the following: • it may not be able, or willing, to manufacture silicone raw materials with our agreed-upon specifications; • it may not be able, or willing, to manufacture our needed raw materials in compliance with regulatory requirements, or its manufacturing facilities may not be able to maintain compliance with regulatory requirements; • it may not be able to supply sufficient quantities of each raw material quickly enough for us to respond to rapid increases in demand; 41 Table of Contents • it may unintentionally convey information to our competitors that is helpful in understanding our proprietary compositions and other trade secrets of our manufacturing processes; • we may be subject to price fluctuations if we fail to meet certain minimum order requirements, or if our existing contract expires or is renegotiated; • it may lose access to critical services and components, resulting in interruption in manufacture or shipment of medical-grade silicone; • its facilities may be affected by earthquakes, wildfires, mud slides or other natural disasters, which could delay or impede production of our raw materials; • we may be required to obtain regulatory approvals related to any change in our supply chain; • Avantor may wish to discontinue supply of products to us due to its existing relationships with our competitors; • Avantor may stop supply and claim ownership of intellectual property on materials associated with future products; • Avantor or its parent entity may encounter financial or other hardships unrelated to our demand for products, which could negatively impact their ability to fulfill our orders and support our regulatory approvals; and • disputes may arise over the terms of the Master Supply Agreement, by and between the Company and Avantor, dated May 13, 2022.
In this update, the FDA updated the table on the agency’s BIA-ALCL webpage to include a total of 733 unique cases and 36 patient deaths globally as of January 5, 2020, which reflect an increase of 160 new cases and 3 deaths since the early-July 2019 update. 36 Table of Contents In September 2020, the FDA released finalized guidance on breast implant labeling recommendations, including the addition of a boxed warning, a patient decision checklist, material and device descriptions, implant rupture screening recommendations and a patient device card.
In this update, the FDA updated the table on the agency’s BIA-ALCL webpage to include a total of 733 unique cases and 36 patient deaths globally as of January 5, 2020, which reflect an increase of 160 new cases and 3 deaths since the early-July 2019 update. 35 Table of Contents In September 2020, the FDA released finalized guidance on breast implant labeling recommendations, including the addition of a boxed warning, a patient decision checklist, material and device descriptions, implant rupture screening recommendations and a patient device card.
The new Trump Administration has taken several executive actions, including the issuance of a number of Executive Orders, that could impose significant burdens on, or otherwise materially delay, the FDA’s ability to engage in routine regulatory and oversight activities, such as implementing statutes through rulemaking, issuance of guidance, and review and approval of applications.
The Trump Administration has taken several executive actions, including the issuance of a number of Executive Orders, that could impose significant burdens on, or otherwise materially delay, the FDA’s ability to engage in routine regulatory and oversight activities, such as implementing statutes through rulemaking, issuance of guidance, and review and approval of applications.
(recently acquired by Tiger Aesthetics Medical), Mentor Worldwide LLC (a division of Johnson & Johnson) and Allergan plc ( acquired by AbbVie Inc.) have conducted large prospective clinical studies that started in the United States in 2002, 2000 and 1998, respectively, and they use this data extensively to promote their products.
(acquired by Tiger Aesthetics Medical), Mentor Worldwide LLC (a division of Johnson & Johnson) and Allergan plc (acquired by AbbVie Inc.) have conducted large prospective clinical studies that started in the United States in 2002, 2000 and 1998, respectively, and they use this data extensively to promote their products.
The market price for our shares may be influenced by many factors, including the following: • our ability to successfully commercialize, and realize revenues from sales of, Motiva Implants; • the success of competitive products or technologies; • results of clinical studies of Motiva Implants or planned products or those of our competitors; • regulatory or legal developments in the United States and other countries, especially changes in laws or regulations applicable to our products; • introductions and announcements of new products by us, our commercialization partners, or our competitors, and the timing of these introductions or announcements; 58 Table of Contents • actions taken by regulatory agencies with respect to our products, clinical studies, manufacturing processes or sales and marketing terms; • variations in our financial results or those of companies that are perceived to be similar to us; • the success of our efforts to acquire or in-license additional products or planned products; • developments concerning our collaborations, including but not limited to those with our sources of manufacturing supply and our commercialization partners; • developments concerning our ability to bring our manufacturing processes to scale in a cost-effective manner; • announcements by us or our competitors of significant acquisitions, strategic partnerships, joint ventures or capital commitments; • developments or disputes concerning patents or other proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our products; • our ability or inability to raise additional capital and the terms on which we raise it; • the recruitment or departure of key personnel; • changes in the structure of health care payment systems; • negative shifts in the economy affecting the number of aesthetic breast procedures; • market conditions in the pharmaceutical and biotechnology sectors; • actual or anticipated changes in earnings estimates or changes in securities analyst recommendations regarding our common shares, other comparable companies or our industry generally; • trading volume of our common shares; • sales of our common shares by us or our shareholders; • short selling activities; • the impact of pandemics, epidemics or other public health crises; • general economic, industry and market conditions; and • the other risks described in this “Risk Factors” section.
The market price for our shares may be influenced by many factors, including the following: • our ability to successfully commercialize, and realize revenues from sales of, Motiva Implants; • the success of competitive products or technologies; • results of clinical studies of Motiva Implants or planned products or those of our competitors; • regulatory or legal developments in the United States and other countries, especially changes in laws or regulations applicable to our products; • introductions and announcements of new products by us, our commercialization partners, or our competitors, and the timing of these introductions or announcements; • actions taken by regulatory agencies with respect to our products, clinical studies, manufacturing processes or sales and marketing terms; • variations in our financial results or those of companies that are perceived to be similar to us; • the success of our efforts to acquire or in-license additional products or planned products; • developments concerning our collaborations, including but not limited to those with our sources of manufacturing supply and our commercialization partners; • developments concerning our ability to bring our manufacturing processes to scale in a cost-effective manner; • announcements by us or our competitors of significant acquisitions, strategic partnerships, joint ventures or capital commitments; • developments or disputes concerning patents or other proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our products; • our ability or inability to raise additional capital and the terms on which we raise it; • the recruitment or departure of key personnel; • changes in the structure of healthcare payment systems; • negative shifts in the economy affecting the number of aesthetic breast procedures; • market conditions in the pharmaceutical and biotechnology sectors; • actual or anticipated changes in earnings estimates or changes in securities analyst recommendations regarding our common shares, other comparable companies or our industry generally; • trading volume of our common shares; 59 Table of Contents • sales of our common shares by us or our shareholders; • short selling activities; • the impact of pandemics, epidemics or other public health crises; • general economic, industry and market conditions; and • the other risks described in this “Risk Factors” section.
Also, the failure to comply with applicable legal and regulatory obligations could result in the disruption of our shipping, marketing and sales activities. In addition, several of the countries in which we sell our products or conduct our operations are, to some degree, subject to political, economic or social instability.
Also, the failure to comply with applicable legal and regulatory obligations could result in the disruption of our shipping, marketing and sales activities. In addition, several of the countries in which we sell our products or conduct our operations are, to some degree, subject to political, economic, social or environmental instability.
Elective aesthetic procedures, including breast augmentation, are typically not covered by insurance and are less of a priority than other items for those patients that have lost their jobs, are furloughed, have reduced work hours or have to allocate their cash to other priorities.
Elective aesthetic procedures, including breast augmentation, are typically not covered by insurance and are less of a priority than other items for patients that have lost their jobs, are furloughed, have reduced work hours or have to allocate their cash to other priorities.
We have established a direct sales force for our business in Brazil and United States, and we have implemented a direct sales strategy in several European countries. We have hired and will need to retain and motivate a significant number of sales and marketing personnel in order to support our anticipated growth in these countries.
We have established a direct sales force for our business in Brazil and the United States, and we have implemented a direct sales strategy in several European countries. We have hired and will need to retain and motivate a significant number of sales and marketing personnel in order to support our anticipated growth in these countries.
As has occurred in the past, if this supplier were to increase prices for this raw material over time or experience interruptions in its ability to supply us with this raw material, our business, financial condition and results of operations could be adversely affected.” In addition, the suppliers of certain packaging components and the surgical tools that we sell with Motiva Implants, including the cannulas, retractors, and insertion sleeves, are all purchased by us from single-source suppliers.
As has occurred in the past, if this supplier were to increase prices for this raw material or experience interruptions in its ability to supply us with this raw material, our business, financial condition and results of operations could be adversely affected.” In addition, the suppliers of certain packaging components and the surgical tools that we sell with Motiva Implants, including the cannulas, retractors, and insertion sleeves, are all purchased by us from single-source suppliers.
Some of these risks include: • failure to complete sterilization on time or in compliance with the required regulatory standards; • transportation and import and export risk, particularly given the global nature of our supply and distribution chains; 43 Table of Contents • delays in analytical results or failure of analytical techniques that we depend on for quality control and release of products; • natural or other disasters, labor disputes, financial distress, lack of raw material supply, issues with facilities and equipment or other forms of disruption to business operations affecting our manufacturer or its suppliers; • latent defects that may become apparent after products have been released and that may result in a recall of such products; • contamination of our raw materials or manufactured products; and • inclusion of vendors of raw materials not in compliance with ISO-13485 requirements.
Some of these risks include: • failure to complete sterilization on time or in compliance with the required regulatory standards; • transportation and import and export risk, particularly given the global nature of our supply and distribution chains; • delays in analytical results or failure of analytical techniques that we depend on for quality control and release of products; • natural or other disasters, labor disputes, financial distress, lack of raw material supply, issues with facilities and equipment or other forms of disruption to business operations affecting our manufacturer or its suppliers; • latent defects that may become apparent after products have been released and that may result in a recall of such products; • contamination of our raw materials or manufactured products; and • inclusion of vendors of raw materials not in compliance with ISO-13485 requirements.
The FDA or other regulators could delay, limit, or deny clearance or approval of a device for many reasons, including: • our inability to demonstrate to the satisfaction of the FDA or the applicable regulatory entity or notified body that our devices and any accessories are substantially equivalent to a legally marketed predicate device or safe or effective for their proposed intended uses; • disagreement of the FDA with the design or implementation of any clinical trials or the interpretation of data from preclinical studies or clinical trials; • serious and unexpected adverse device effects experienced by participants in our clinical trials; • insufficiency of the data from preclinical studies or clinical trials to support clearance or approval; • our inability to demonstrate that the clinical and other benefits of the device outweigh the risks; • failure of our manufacturing process or facilities to meet applicable requirements; and • the potential for approval policies or regulations of the FDA or applicable foreign regulatory bodies to change significantly in a manner rendering our clinical data or regulatory filings insufficient for clearance or approval.
The FDA or other regulators could delay, limit, or deny clearance or approval of a device for many reasons, including: • our inability to demonstrate to the satisfaction of the FDA or the applicable regulatory entity or notified body that our devices and any accessories are substantially equivalent to a legally marketed predicate device or safe or effective for their proposed intended uses; • disagreement of the FDA with the design or implementation of any clinical trials or the interpretation of data from preclinical studies or clinical trials; • serious and unexpected adverse device effects experienced by participants in our clinical trials; • insufficiency of the data from preclinical studies or clinical trials to support clearance or approval; • our inability to demonstrate that the clinical and other benefits of the device outweigh the risks; • failure of our manufacturing process or facilities to meet applicable requirements; and 53 Table of Contents • the potential for approval policies or regulations of the FDA or applicable foreign regulatory bodies to change significantly in a manner rendering our clinical data or regulatory filings insufficient for clearance or approval.
If we are not successful in our efforts to continue recruiting, retaining, and motivating such personnel, we may not be able to increase our revenues, or we may increase our expenses in greater measure than our revenues, negatively impacting our operating results. 34 Table of Contents We may be subject to substantial warranty or product liability claims or other litigation in the ordinary course of business that may adversely affect our business, financial condition and operating results.
If we are not successful in our efforts to continue recruiting, retaining, and motivating such personnel, we may not be able to increase our revenues, or we may increase our expenses in greater measure than our revenues, negatively impacting our operating results. 33 Table of Contents We may be subject to substantial warranty or product liability claims or other litigation in the ordinary course of business that may adversely affect our business, financial condition and operating results.
For example, HIPAA imposes limitations on the use and disclosure of an individual’s protected health information by certain health care providers, health care clearinghouses, and health insurance plans, collectively referred to as covered entities, and their business associates, persons or entities that perform a function or provide specified services on behalf of a Covered Entity that involve the creation, use, maintenance or transmission of protected health information.
For example, HIPAA imposes limitations on the use and disclosure of an individual’s protected health information by certain healthcare providers, healthcare clearinghouses, and health insurance plans, collectively referred to as Covered Entities, and their business associates, persons or entities that perform a function or provide specified services on behalf of a Covered Entity that involve the creation, use, maintenance or transmission of protected health information.
Our results of operations have been in the past, and could be in the future, adversely affected by general conditions in the global economy and in the global financial markets, such as slower growth or recession, adverse impacts on currency exchange rates, continued inflation or decreases in consumer spending or confidence, as well as changing political conditions.
Our results of operations have been in the past, and could be in the future, adversely affected by general conditions in the global economy and in the global financial markets, such as trade wars, slower growth or recession, adverse impacts on currency exchange rates, continued inflation or decreases in consumer spending or confidence, as well as changing political conditions.
Historically, our sales model has been to sell primarily through distributors rather than through our own sales force, with the notable exception of Brazil and several European countries where we are selling directly, but, in the future, we may utilize a hybrid sales model that includes both distributors and a direct sales effort.
Historically, our sales model has been to sell primarily through distributors rather than through our own sales force, with the notable exception of Brazil, the United States and several European countries where we are selling directly, but, in the future, we may utilize a hybrid sales model that includes both distributors and a direct sales effort.
We cannot predict the impact that ongoing health care reform will have on our business, and there is uncertainty as to what healthcare programs and regulations may be implemented or changed at the federal and/or state level in the United States, and as to the effect of any future legislation or regulation.
We cannot predict the impact that ongoing healthcare reform will have on our business, and there is uncertainty as to what healthcare programs and regulations may be implemented or changed at the federal and/or state level in the United States, and as to the effect of any future legislation or regulation.
It regulates the processing of personal data and places certain obligations on the processing of such personal data including ensuring the lawfulness of processing personal data (including obtaining valid consent of the individuals to whom the personal data relates, where applicable), the processing details disclosed to the individuals, the adequacy, relevance and necessity of the personal data collected, the retention of personal data collected, the sharing of personal data with third parties, the transfer of personal data out of the European Economic Area/UK to third countries including the US, contracting requirements (such as with clinical trial sites and vendors), the use of personal data in accordance with individual rights, the security of personal data and security breach/incident notifications.
It regulates the processing of personal data and places certain obligations on the processing of such personal data including ensuring the lawfulness of processing personal data (including obtaining valid consent of the individuals to whom the personal data relates, where applicable), the processing details disclosed to the individuals, the adequacy, relevance and necessity of the personal data collected, the retention of personal data collected, the sharing of personal data with third parties, the transfer of personal data out of the European Economic Area/UK to third countries including the United States, contracting requirements (such as with clinical trial sites and vendors), the use of personal data in accordance with individual rights, the security of personal data and security breach/incident notifications.
As has occurred in the past, if this supplier were to increase prices for this raw material over time or experience interruptions in its ability to supply us with this raw material, our business, financial condition and results of operations could be adversely affected.
As has occurred in the past, if this supplier were to increase prices for this raw material or experience interruptions in its ability to supply us with this raw material, our business, financial condition and results of operations could be adversely affected.
The August 2017 update described BIA-ALCL as “rare” and stated “we have strengthened our understanding of this condition and concur with the World Health Organization designation of BIA-ALCL as a rare T-cell lymphoma that can develop following breast implants.
The August 2017 update described BIA-ALCL as “rare” and stated “we have strengthened our understanding of this condition and concur with the World Health Organization designation of BIA-ALCL as a rare T-cell lymphoma that can develop following breast implants”.
If we raise additional funds through collaborations, strategic collaborations or partnership, or marketing, distribution or licensing arrangements with third parties, we may be required to do so at an earlier stage than would otherwise be ideal and/or may have to limit valuable rights to our intellectual property, technologies, products, or future revenue streams, or grant licenses or other rights on terms that are not favorable to us.
If we raise additional funds through collaborations or partnerships, or marketing, distribution or licensing arrangements with third parties, we may be required to do so at an earlier stage than would otherwise be ideal and/or may have to limit valuable rights to our intellectual property, technologies, products, or future revenue streams, or grant licenses or other rights on terms that are not favorable to us.
In addition, activity of this type could result in an increase in the number or size of product liability claims, which would adversely affect our business, financial results, and/or the price of our shares. 35 Table of Contents News coverage in recent years has called into question the long-term safety of breast implants and reports of breast implant-associated anaplastic large cell lymphoma linked to our competitors’ products which have led to regulatory actions regarding macrotextured devices in several countries and the worldwide recall of one of our competitor’s macrotextured implants and tissue expanders.
In addition, activity of this type could result in an increase in the number or size of product liability claims, which would adversely affect our business, financial results, and/or the price of our shares. 34 Table of Contents News coverage in recent years has called into question the long-term safety of breast implants, including through reports of breast implant-associated anaplastic large cell lymphoma linked to our competitors’ products which have led to regulatory actions regarding macrotextured devices in several countries and the worldwide recall of one of our competitor’s macrotextured implants and tissue expanders.
A non-U.S. corporation will be classified as a passive foreign investment company, or PFIC, for U.S. federal income tax purposes, in any taxable year in which either (1) at least 75% of its gross income is passive income; or (2) at least 50% of the average quarterly value of its total gross assets is attributable to assets that produce 57 Table of Contents “passive income” or are held for the production of passive income.
A non-U.S. corporation will be classified as a passive foreign investment company, or PFIC, for U.S. federal income tax purposes, in any taxable year in which either (1) at least 75% of its gross income is passive income; or (2) at least 50% of the average quarterly value of its total gross assets is attributable to assets that produce “passive income” or are held for the production of passive income.
Commercial success of Motiva Implants in the United States or elsewhere depends on our ability to accurately forecast customer demand and manufacture sufficient quantities of product in the implant sizes that patients and physicians request, and to manage inventory effectively and the failure to do so could have a material adverse effect on our business, financial condition, results of operations and growth prospects.
Commercial success of Motiva Implants in the United States or elsewhere depends on our ability to accurately forecast customer demand, manufacture sufficient quantities of product in the implant sizes that patients and physicians request, and manage inventory effectively, and the failure to do so could 29 Table of Contents have a material adverse effect on our business, financial condition, results of operations and growth prospects.
Any failure to comply with applicable legal and regulatory obligations could impact us in a variety of ways that include, but are not limited to, significant criminal, civil and administrative penalties, including imprisonment of individuals, fines and penalties, denial of export or import privileges, seizure of shipments, restrictions on certain business activities and exclusion or debarment from government contracting.
Any failure to comply with applicable legal and regulatory obligations could impact us in a variety of ways that include, but are not limited to, significant criminal, civil and administrative penalties, including imprisonment of individuals, fines and penalties, denial of export or import privileges, seizure of shipments, restrictions on certain business activities 38 Table of Contents and exclusion or debarment from government contracting.
In addition, changes in either the patent laws or interpretation of the patent laws in the United States and other countries may diminish the value of the patents we rely on or narrow the scope of our patent protection. The laws of other countries may not protect our rights to the same extent as the laws of the U.S.
In addition, changes in either the patent laws or interpretation of the patent laws in the United States and other countries may diminish the value of the patents we rely on or narrow the scope of our patent protection. The laws of other countries may not protect our rights to the same extent as the laws of the United States.
Our products, marketing, sales and development activities and manufacturing processes are subject to extensive and rigorous regulation by various regulatory agencies and governing bodies. Under the US Food, Drug and Cosmetic Act (FDC Act), medical devices must receive FDA clearance or approval or an exemption from such clearance or approval before they can be commercially marketed in the U.S.
Our products, marketing, sales and development activities and manufacturing processes are subject to extensive and rigorous regulation by various regulatory agencies and governing bodies. Under the U.S. Food, Drug and Cosmetic Act (FDC Act), medical devices must receive FDA clearance or approval or an exemption from such clearance or approval before they can be commercially marketed in the United States.
It is also possible that other federal, state, or foreign enforcement authorities might take action if they consider our promotional or training materials to constitute promotion of an off-label use, which could result in significant fines or penalties under other 51 Table of Contents statutory authorities, such as laws prohibiting false claims for reimbursement.
It is also possible that other federal, state, or foreign enforcement authorities might take action if they consider our promotional or training materials to constitute promotion of an off-label use, which could result in significant fines or penalties under other statutory authorities, such as laws prohibiting false claims for reimbursement.
Although we try to ensure that our employees, advisors and consultants do not use the proprietary information or know-how of others in their work for us, we may be subject to claims that 46 Table of Contents we, or these employees, have used or disclosed intellectual property, including trade secrets or other proprietary information, of any such employee’s former employer.
Although we try to ensure that our employees, advisors and consultants do not use the proprietary information or know-how of others in their work for us, we may be subject to claims that we, or these employees, have used or disclosed intellectual property, including trade secrets or other proprietary information, of any such employee’s former employer.
We cannot provide any assurances that we will assist investors in determining whether we or any of our non-U.S. subsidiaries is treated as a controlled foreign corporation or whether any investor is treated as a U.S. shareholder with respect to any such controlled foreign corporation or furnish to any U.S. shareholders information that may be necessary to comply with the aforementioned reporting and tax paying obligations.
We cannot provide any assurances that we will assist investors in determining whether we or any of our non-U.S. subsidiaries is treated as a controlled foreign corporation or whether any investor is treated as a U.S. shareholder with respect to any such controlled foreign corporation or furnish to any U.S. shareholders information that may be necessary to comply with the 58 Table of Contents aforementioned reporting and tax paying obligations.
Furthermore, any additional fundraising efforts may divert our management from their day-to-day activities, which may adversely affect our ability to develop and commercialize our products. Our business depends on maintaining our brand and ongoing customer demand for our products and services, and a significant reduction in sentiment or demand could affect our results of operations.
Furthermore, any additional 31 Table of Contents fundraising efforts may divert our management from their day-to-day activities, which may adversely affect our ability to develop and commercialize our products. Our business depends on maintaining our brand and ongoing customer demand for our products and services, and a significant reduction in sentiment or demand could affect our results of operations.
Such litigation or proceedings could substantially increase our operating losses and reduce the resources available for development activities or any future sales, marketing or distribution activities. Uncertainties resulting from the initiation and continuation of intellectual property litigation or other proceedings could have an adverse effect on our ability to compete in the marketplace.
Such litigation or proceedings could substantially increase our operating losses and reduce the resources available for development activities or any 46 Table of Contents future sales, marketing or distribution activities. Uncertainties resulting from the initiation and continuation of intellectual property litigation or other proceedings could have an adverse effect on our ability to compete in the marketplace.
For example, on March 10, 2023, Silicon Valley Bank was closed by the California Department of Financial Protection and Innovation, which appointed the Federal Deposit Insurance Corporation, or FDIC, as receiver. Similarly, on March 12, 2023, Signature Bank Corp. and Silvergate Capital Corp. were each swept into receivership.
For example, on March 10, 2023, 37 Table of Contents Silicon Valley Bank was closed by the California Department of Financial Protection and Innovation, which appointed the Federal Deposit Insurance Corporation, or FDIC, as receiver. Similarly, on March 12, 2023, Signature Bank Corp. and Silvergate Capital Corp. were each swept into receivership.
Further, we rely on third-party service providers and technologies to operate critical business systems to process sensitive information in a variety of contexts, including, without limitation, cloud- 47 Table of Contents based infrastructure, enterprise cloud solutions, encryption and authentication technology, employee email, and other similar functions.
Further, we rely on third-party service providers and technologies to operate critical business systems to process sensitive information in a variety of contexts, including, without limitation, cloud-based infrastructure, enterprise cloud solutions, encryption and authentication technology, employee email, and other similar functions.
Efforts to ensure that our business arrangements with these third parties will comply with applicable health care laws and regulations will involve substantial costs. It is possible that governmental authorities will conclude that our business practices may not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other health care laws and regulations.
Efforts to ensure that our business arrangements with these third parties will comply with applicable healthcare laws and regulations will involve substantial costs. It is possible that governmental authorities will conclude that our business practices may not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations.
If we are not successful in integrating these businesses, as well as identifying and controlling risks associated with the past operations of these businesses, we may incur significant costs, receive penalties or other sanctions from various regulatory agencies and/or incur significant diversions of management time and attention.
If we are not successful in 36 Table of Contents integrating these businesses, as well as identifying and controlling risks associated with the past operations of these businesses, we may incur significant costs, receive penalties or other sanctions from various regulatory agencies and/or incur significant diversions of management time and attention.
Based on the project composition of our income and valuation of our assets, we do not believe we were a PFIC in 2024 and 2023, and we do not expect to become one in the future.
Based on the project composition of our income and valuation of our assets, we do not believe we were a PFIC in 2025 and 2024, and we do not expect to become one in the future.
We do not produce the types of rough textured implants that have been involved in these reports. To date, no cases of BIA-ALCL or SCC have been reported in patients with Motiva Implants. Furthermore, there have been no reported cases of BIA-ALCL in patients with smooth implants with no history of previously having a textured device.
We do not produce the types of rough textured implants that have been involved in these reports. To date, no cases of BIA-ALCL or SCC have been reported in patients who have only had Motiva Implants. Furthermore, there have been no reported cases of BIA-ALCL in patients with smooth implants with no history of previously having a textured device.
Therefore, changes in the value of the U.S. dollar in relation to the British pound, the euro, Costa Rican colones and the Brazilian real will affect our revenue, cost of goods, and operating expenses as well as the value of balance sheet items originally denominated in other currencies.
Therefore, changes in the value of the U.S. dollar in relation to the British pound, the euro, the Brazilian real and, to a lesser degree, the Costa Rican colones will affect our revenue, cost of goods, and operating expenses as well as the value of balance sheet items originally denominated in other currencies.
Our products were marketed solely in countries outside of the United States from October 2010 until 510(k) clearance for the Motiva Flora SmoothSilk Tissue Expander in October 2023 and FDA approval of our Motiva Implants in September 2024, and as such, we have a limited operating history in the United States upon which to evaluate our business and forecast our future net sales and operating results.
We marketed our products solely in countries outside of the United States from October 2010 until 510(k) clearance for the Motiva Flora SmoothSilk Tissue Expander in October 2023 and FDA approval of our Motiva 27 Table of Contents Implants in September 2024, and as such, we have a limited operating history in the United States upon which to evaluate our business and forecast our future net sales and operating results.
The manufacture of these products in compliance with ISO standards and the FDA’s regulations requires significant expertise and capital investment, including the development of advanced manufacturing techniques and process controls.
The manufacture of these products in compliance with ISO standards and the FDA’s regulations require significant expertise and capital investment, including the development of advanced manufacturing techniques and process controls.
Our relationship with customers, patients and third party payors will be subject to applicable anti-kickback, fraud and abuse, and other health care laws and regulations, which could expose us to criminal sanctions, civil penalties, damages, reputational harm and diminished profits and future earnings.
Our relationship with customers, patients and third party payors will be subject to applicable anti-kickback, fraud and abuse, and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, damages, reputational harm and diminished profits and future earnings.
There can be no assurance that our deposits in excess of the FDIC or other comparable insurance limits will be backstopped by the U.S. or any applicable foreign government in the future or that any bank or financial institution with which we do business will be able to obtain needed liquidity from other banks, government institutions or by acquisition in the event of a future failure or liquidity crisis.
There can be no assurance that our deposits in excess of the FDIC or other comparable insurance limits will be backstopped by the United States or any applicable foreign government in the future or that any bank or financial institution with which we do business will be able to obtain needed liquidity from other banks, government institutions or by acquisition in the event of a future failure or liquidity crisis.
The FDA noted that, while the agency believes the occurrences of SCC or various lymphomas in the capsule around the breast implant to be rare, health care providers and people who have or are considering breast implants should be aware that cases have been reported to the FDA and in the literature.
The FDA noted that, while the agency believes the occurrences of SCC or various lymphomas in the capsule around the breast implant to be rare, healthcare providers and people who have or are considering breast implants should be aware that cases have been reported to the FDA and in the literature.
Our headquarters are located in Costa Rica, and all of our main manufacturing activities are conducted in the ISO-13485 and GMP compliant manufacturing facilities in Costa Rica through Establishment Labs, S.A. The 40 Table of Contents newest facility in Costa Rica was completed in June 2024 and commenced manufacturing in the second half of fiscal 2024.
Our manufacturing headquarters are located in Costa Rica, and all of our main manufacturing activities are conducted in ISO-13485 and GMP compliant manufacturing facilities in Costa Rica through Establishment Labs, S.A. The newest facility in Costa Rica was completed in June 2024 and commenced manufacturing in the second half of fiscal 2024.
These consequences could be the result of current conduct or even conduct that occurred a number of years ago. We also could incur significant costs merely if we become the subject of an investigation or legal proceeding alleging a violation of these laws and regulations.
These 54 Table of Contents consequences could be the result of current conduct or even conduct that occurred a number of years ago. We also could incur significant costs merely if we become the subject of an investigation or legal proceeding alleging a violation of these laws and regulations.
In addition, our future effective tax rates could be favorably or unfavorably affected by changes in tax rates, changes in the valuation of our deferred tax assets or liabilities, the effectiveness of our tax planning strategies, or changes in tax laws or their interpretation. Such changes could have an adverse impact on our financial condition.
In addition, our future effective tax rates could be favorably or unfavorably affected by changes in tax rates, changes 57 Table of Contents in the valuation of our deferred tax assets or liabilities, the effectiveness of our tax planning strategies, or changes in tax laws or their interpretation. Such changes could have an adverse impact on our financial condition.
To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership may be diluted, and the terms of these securities may include liquidation or other preferences that 32 Table of Contents adversely affect your rights as a shareholder.
To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership may be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a shareholder.
In addition, although our contract terms require our distributors to comply with all applicable laws regarding the sale of our products, including anti-competition, anti-money laundering, and sanctions laws, we may not be able to ensure proper compliance.
In addition, although our contract terms require our distributors to comply with all applicable laws regarding the sale of our products, including anti-competition, anti-money laundering, and sanctions laws, we may not be able to 43 Table of Contents ensure proper compliance.
In October 2021, the FDA took several additional actions to strengthen breast implant risk communication, including restricting the sale and distribution of breast implants to only health care providers and facilities that provide information to patients using the patient decision checklist.
In October 2021, the FDA took several additional actions to strengthen breast implant risk communication, including restricting the sale and distribution of breast implants to only healthcare providers and facilities that provide information to patients using the patient decision checklist.
Further, regulatory authorities must inspect these manufacturing facilities and determine that they are in compliance with FDA good manufacturing practice requirements as set forth in the Quality System Regulation, or QSR, before the products can be approved.
Further, regulatory authorities must inspect these manufacturing facilities and determine that they are in compliance with FDA good manufacturing practice requirements as set forth in the Quality Management System Regulation, or QMSR, before the products can be approved.
There likely will continue to be legislative and regulatory proposals at the federal and state levels directed at containing or lowering the cost of health care. We cannot predict the initiatives that may be adopted in the future or their full impact.
There likely will continue to be legislative and regulatory proposals at the federal and state levels directed at containing or lowering the cost of healthcare. We cannot predict the initiatives that may be adopted in the future or their full impact.
If these third parties do not successfully carry out their contractual duties, meet expected deadlines or conduct our clinical studies in accordance with regulatory 41 Table of Contents requirements or our stated protocols, we will not be able to obtain, or may be delayed in obtaining, regulatory approvals for our planned products and will not be able to, or may be delayed in our efforts to, successfully commercialize our planned products.
If these third parties do not successfully carry out their contractual duties, meet expected deadlines or conduct our clinical studies in accordance with regulatory requirements or our stated protocols, we will not be able to obtain, or may be delayed in obtaining, regulatory approvals for our planned products and will not be able to, or may be delayed in our efforts to, successfully commercialize our planned products.
Evolving and changing definitions of personal data and personal information, within the European Union, the United States, and elsewhere, may limit or inhibit our ability to operate or expand our business, including limiting strategic partnerships that may involve the sharing of data.
Evolving and changing definitions of personal data 49 Table of Contents and personal information, within the European Union, the United States, and elsewhere, may limit or inhibit our ability to operate or expand our business, including limiting strategic partnerships that may involve the sharing of data.
These facilities are subject to continual review and periodic inspections by the FDA and other regulatory authorities for compliance with the QSR and associated regulations.
These facilities are subject to continual review and periodic inspections by the FDA and other regulatory authorities for compliance with the QMSR and associated regulations.
Federal and state lawmakers regularly propose and, at times, enact legislation that could result in significant changes to the health care system, some of which are intended to contain or reduce the costs of medical products and services.
Federal and state lawmakers regularly propose and, at times, enact legislation that could result in significant changes to the healthcare system, some of which are intended to contain or reduce the costs of medical products and services.
As part of our effort to educate and train plastic surgeons through our medical educational platform, we completed 239 and 192 medical training sessions worldwide during 2024 and 2023, respectively. If we are unable to offer, or if we experience a delay in offering, medical training sessions, we may experience reduced or slower than expected adoption of our products.
As part of our effort to educate and train plastic surgeons through our medical educational platform, we completed 607 and 239 medical training sessions worldwide during 2025 and 2024, respectively. If we are unable to offer, or if we experience a delay in offering, medical training sessions, we may experience reduced or slower than expected adoption of our products.
Increased competition may result 38 Table of Contents in price reductions, reduced margins and our inability to gain or hold market share, which could have an adverse effect on our financial condition and results of operations.
Increased competition may result in price reductions, reduced margins and our inability to gain or hold market share, which could have an adverse effect on our financial condition and results of operations.
The determination of our worldwide provision for income taxes and other tax liabilities requires significant judgment and, in the ordinary course of business, there are many transactions and calculations where the ultimate tax determination is complex 56 Table of Contents and uncertain.
The determination of our worldwide provision for income taxes and other tax liabilities requires significant judgment and, in the ordinary course of business, there are many transactions and calculations where the ultimate tax determination is complex and uncertain.
Sales of our Motiva Implants accounted for approximately 96% and 95% of our revenues for each of the years ended December 31, 2024 and 2023, respectively, and we expect our revenues to continue to be driven primarily by sales of these products. We also continue to incur significant research and development and general and administrative expenses related to our operations.
Sales of our Motiva Implants accounted for approximately 99% and 96% of our revenues for each of the years ended December 31, 2025 and 2024, respectively, and we expect our revenues to continue to be driven primarily by sales of these products. We also continue to incur significant research and development and general and administrative expenses related to our operations.
In addition, we rely on collaborators, consultants and advisors, including scientific and clinical advisors, to assist us in formulating our research and development and commercialization strategy. Our collaborators, consultants 37 Table of Contents and advisors are generally employed by employers other than us and may have commitments under agreements with other entities that may limit their availability to us.
In addition, we rely on collaborators, consultants and advisors, including scientific and clinical advisors, to assist us in formulating our research and development and commercialization strategy. Our collaborators, consultants and advisors are generally employed by employers other than us and may have commitments under agreements with other entities that may limit their availability to us.
If a prolonged government shutdown occurs, or if other events, including uncertainty regarding the FDA’s funding, operations or policy goals, prevent the FDA or other regulatory authorities from conducting their regular inspections, reviews or other regulatory activities in a timely manner, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business.
A prolonged government shutdown occurs, or other events, including uncertainty regarding the FDA’s funding, operations or policy goals, that prevents the FDA or other regulatory authorities from conducting their regular inspections, reviews or other regulatory activities in a timely manner could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business.
Our Qid Safety Technology microtransponder embedded in certain Motiva Implants contains metal and causes an artifact that can affect breast cancer screening using MRI, and this artifact is not present in other imaging modalities such as 30 Table of Contents breast ultrasound and film or digital mammography.
Our Qid Safety Technology microtransponder embedded in certain Motiva Implants contains metal and causes an artifact that can affect breast cancer screening using MRI, and this artifact is not present in other imaging modalities such as breast ultrasound and film or digital mammography.
If physicians and/or patients do not perceive our products to be competitive in 31 Table of Contents features and safety when compared to other products in the market, or if demand for our Motiva Implants or for breast implants in general decreases, we may fail to achieve sales levels that provide for future profitability.
If physicians and/or patients do not perceive our products to be competitive in features and safety when compared to other products in the market, or if demand for our Motiva Implants or for breast implants in general decreases, we may fail to achieve sales levels that provide for future profitability.
In October 2023, the EU Council announced that three jurisdictions have been removed from the list of non-cooperative tax jurisdiction, one of which was Costa Rica. This follows the reforms made to Costa Rica’s Income Tax Law, amending aspects of the foreign-source income exemption regime.
Shortly after this, in October 2023, the EU Council announced that three jurisdictions had been removed from the list of non-cooperative tax jurisdiction, one of which was Costa Rica. This follows the reforms made to Costa Rica’s Income Tax Law, amending aspects of the foreign-source income exemption regime.
Future clinical studies or clinical experience may indicate that breast implants expose potentially genetically predisposed patients to greater risks of BIA-ALCL, which may reduce demand for silicone implants generally, expose us to product liability claims, as well as to class actions and other lawsuits. These impacts may occur in the absence of any specific linkage with our products.
Future clinical studies or clinical experience may indicate that breast implants expose potentially genetically predisposed patients to greater risks of BIA-ALCL, which may reduce demand for silicone implants generally and expose us to product liability claims, as well as to class actions and other lawsuits. These impacts may occur even without any specific linkage with our products.
Given the amount of time required for the development, testing and regulatory review of new planned products, patents protecting such products might expire before or shortly after such products are commercialized.
Given the amount of time required for the development, testing and regulatory review of 45 Table of Contents new planned products, patents protecting such products might expire before or shortly after such products are commercialized.
The discovery of serious safety issues with our products, or a recall of our products either voluntarily or at the direction of the FDA or another governmental authority, could have a negative impact on us.
The discovery of 52 Table of Contents serious safety issues with our products, or a recall of our products either voluntarily or at the direction of the FDA or another governmental authority, could have a negative impact on us.
Further, in our operations as a public company, future federal government shutdowns, delays in annual appropriations or budget freezes could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.
Further, in our operations as a public company, future federal government shutdowns, delays in annual 28 Table of Contents appropriations or budget freezes could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.
These third parties may compete with us in recruiting and retaining qualified technical and management personnel, establishing clinical study sites and patient registrations for clinical studies, as well as in acquiring technologies complementary to, or necessary for, our programs.
These third parties may compete with us in recruiting and 32 Table of Contents retaining qualified technical and management personnel, establishing clinical study sites and patient registrations for clinical studies, as well as in acquiring technologies complementary to, or necessary for, our programs.
The full extent to which any pandemic, epidemic, or public health crisis may, directly or indirectly, impact our business, results of operations and financial condition, including our sales, expenses, supply chain integrity, manufacturing capability, research and development activities, and employee-related compensation, is highly uncertain and will depend on future developments that are also highly uncertain and cannot be predicted with reasonable accuracy at this time, including, without limitation: • the contagiousness or virulence of the virus, disease or other condition giving rise to the pandemic, epidemic or public health crisis; • the scope and length of any governmental or other restrictions implemented to reduce the spread of virus, disease or other condition giving rise to the pandemic, epidemic or public health crisis or other actions required or recommended to contain or treat infected individuals; • the deferral of procedures using our products or other adverse impact on patients’ willingness to undergo procedures in which our products could be used during or following any pandemic, epidemic or other public health crisis; • volatility in the global capital markets, impacting access to and cost of capital; • disruptions in the manufacture and distribution of our products and in our supply chain; • delays in clinical trials; 44 Table of Contents • disruptions or restrictions on the ability of many of our employees, and of third parties on which we rely, to work effectively, including “stay-at-home” orders and similar government actions; • temporary closures of our facilities and of the facilities of our customers and suppliers; and • other direct and indirect economic impacts, both domestically and abroad, of a pandemic, epidemic, or public health crisis as a result of any or all of the foregoing, including actions taken by local, state, national and international governmental agencies, whether such impact affects customers, suppliers, or markets generally.
The full extent to which any pandemic, epidemic, or public health crisis may, directly or indirectly, impact our business, results of operations and financial condition, including our sales, expenses, supply chain integrity, manufacturing capability, research and development activities, and employee-related compensation, is highly uncertain and will depend on future developments that are also highly uncertain and cannot be predicted with reasonable accuracy at this time, including, without limitation: • the contagiousness or virulence of the virus, disease or other condition giving rise to the pandemic, epidemic or public health crisis; • the scope and length of any governmental or other restrictions implemented to reduce the spread of virus, disease or other condition giving rise to the pandemic, epidemic or public health crisis or other actions required or recommended to contain or treat infected individuals; • the deferral of procedures using our products or other adverse impact on patients’ willingness to undergo procedures in which our products could be used during or following any pandemic, epidemic or other public health crisis; • volatility in the global capital markets, impacting access to and cost of capital; • disruptions in the manufacture and distribution of our products and in our supply chain; • delays in clinical trials; • disruptions or restrictions on the ability of many of our employees, and of third parties on which we rely, to work effectively, including “stay-at-home” orders and similar government actions; • temporary closures of our facilities and of the facilities of our customers and suppliers; and • other direct and indirect economic impacts, both domestically and abroad, of a pandemic, epidemic, or public health crisis as a result of any or all of the foregoing, including actions taken by local, state, national and international governmental agencies, whether such impact affects customers, suppliers, or markets generally. 44 Table of Contents Risks Related to Intellectual Property and Data Security If we are unable to protect the confidentiality of our trade secrets, the value of our technology could be materially adversely affected, harming our business and competitive position.
Moreover, as a result of the broad scale release and availability of Artificial Intelligence (AI) technologies such as generative AI, there is a global trend towards more regulation (e.g., the EU AI Act and AI laws passed in U.S. states) to ensure the ethical use, privacy, and security of AI and the data that it processes.
Moreover, as a result of the broad scale release and availability of AI technologies such as generative AI, there is a global trend towards more regulation (e.g., the EU AI Act and AI laws passed in the United States to ensure the ethical use, privacy, and security of AI and the data that it processes.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeOur cybersecurity program is designed to identify, assess, and mitigate risks from cybersecurity threats, and includes the following elements: • a risk assessment process to identify and assess cybersecurity risks; • a risk mitigation strategy to address cybersecurity risks; • an incident response plan to identify, respond to, mitigate and remediate cybersecurity incidents; • an awareness and training program to educate employees about cybersecurity risks; • a procedure to procure information technology services, including cloud computing and data storage, from third-party providers with sufficient cybersecurity provisions, and to monitor their cybersecurity process on an ongoing basis; and • periodic testing and evaluation by external parties we engage to assess the effectiveness of the cybersecurity intrusion protections and make recommendations to improve the security of our information systems.
Biggest changeOur cybersecurity program is designed to identify, assess, manage and mitigate risks from cybersecurity threats, and includes the following elements: • a risk assessment process to identify and assess cybersecurity risks; • a risk mitigation strategy to address cybersecurity risks; • an incident response plan to identify, respond to, mitigate and remediate cybersecurity incidents; • an awareness and training program to educate employees about cybersecurity risks; • a procedure to procure information technology services, including cloud computing and data storage, from third-party providers with sufficient cybersecurity provisions, and to monitor their cybersecurity process on an ongoing basis; and • periodic testing and evaluation by external parties we engage to assess the effectiveness of the cybersecurity intrusion protections and make recommendations to improve the security of our information systems.
Our IT management has obtained relevant experience in various sectors such as technology firms, financial institutions, and consulting firms and have actively engaged in continuous learning and professional development initiatives to stay updated on evolving cybersecurity threats and trends. This includes participating in industry conferences, workshops, training programs, and becoming members of professional cybersecurity organizations.
Our IT management has obtained relevant experience in various sectors such as technology firms, financial institutions, and consulting firms and has actively engaged in continuous learning and professional development initiatives to stay updated on evolving cybersecurity threats and trends. This includes participating in industry conferences, workshops, training programs, and becoming members of professional cybersecurity organizations.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeDividends We have not paid any cash dividends on our common shares since inception and do not anticipate paying cash dividends in the foreseeable future. Purchases of Equity Securities by the Issuer or Affiliated Purchasers There were no repurchases of shares of common shares made during the three months ended December 31, 2024.
Biggest changeDividends We have not paid any cash dividends on our common shares since inception and do not anticipate paying cash dividends in the foreseeable future. Purchases of Equity Securities by the Issuer or Affiliated Purchasers There were no repurchases of our common shares made during the three months ended December 31, 2025.
This graph assumes an investment of $100 at the close of trading on December 31, 2019 in each of our common stock, the NASDAQ Health Care Index and the NASDAQ Composite Index and assumes the reinvestment of dividends, if any. The comparisons shown in the graph below are based upon historical data.
This graph assumes an investment of $100 at the close of trading on December 31, 2020 in each of our common stock, the NASDAQ Health Care Index and the NASDAQ Composite Index and assumes the reinvestment of dividends, if any. The comparisons shown in the graph below are based upon historical data.
Stock Performance Graph The graph set forth below compares the cumulative total shareholder return on our common stock from December 31, 2019 through 2024, with the cumulative total return of (a) the NASDAQ Health Care Index and (b) the NASDAQ Composite Index, over the same period.
Stock Performance Graph The graph set forth below compares the cumulative total shareholder return on our common stock from December 31, 2020 through 2025, with the cumulative total return of (a) the NASDAQ Health Care Index and (b) the NASDAQ Composite Index, over the same period.
Holders There were 21 shareholders of record of our common shares as of February 27, 2025. Certain shares are held in “street” name and, accordingly, the number of beneficial owners of such shares is not known or included in the foregoing number. Sales of Unregistered Securities None.
Holders There were 12 shareholders of record of our common shares as of February 26, 2026. Certain shares are held in “street” name and, accordingly, the number of beneficial owners of such shares is not known or included in the foregoing number. Sales of Unregistered Securities None.

Item 7. Management's Discussion & Analysis

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

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Biggest changeThe following table sets forth the primary sources and uses of cash for each of the years presented below: Year Ended December 31, 2024 2023 (in thousands) Net cash provided by (used in): Operating activities $ (58,516) $ (88,513) Investing activities (15,611) (24,547) Financing activities 125,895 86,227 Effect of exchange rate changes on cash (1,456) 513 Net (decrease) increase in cash $ 50,312 $ (26,320) Net Cash Used in Operating Activities Net cash used in operating activities of $58.5 million for the year ended December 31, 2024 was primarily comprised of a net loss of $84.6 million, changes in operating assets and liabilities of $15.5 million, a $2.2 million change in provision for deferred income taxes and $0.6 million of interest capitalized for construction in progress, partially offset by $14.4 million of share-based compensation expense, $6.8 million of non-cash depreciation and amortization expense, $6.4 million of non-cash interest expense due to accretion of debt discounts, $6.0 million of non-cash loss on contract termination, $5.3 million of unrealized foreign currency loss, a $1.8 million change in provision for inventory obsolescence, a $1.7 million change in allowance for doubtful accounts, $1.0 million of stock compensation in lieu of cash fees and $0.7 million of non-cash amortization expense of right-to-use assets.
Biggest changeThe following table sets forth the primary sources and uses of cash for each of the years presented below: Year Ended December 31, 2025 2024 (in thousands) Net cash provided by (used in): Operating activities $ (50,890) $ (58,516) Investing activities (7,028) (15,611) Financing activities 40,434 125,895 Effect of exchange rate changes on cash 2,709 (1,456) Net (decrease) increase in cash $ (14,775) $ 50,312 Net Cash Used in Operating Activities Net cash used in operating activities of $50.9 million for the year ended December 31, 2025 was primarily comprised of a net loss of $51.1 million, changes in operating assets and liabilities of $13.2 million, $10.0 million of unrealized foreign currency gain, and a $9.1 million change in provision for deferred income taxes, partially offset by $11.4 million of share-based compensation expense, $9.6 million of non-cash depreciation and amortization expense, a $3.4 million change in allowance for credit losses, $3.4 million of non-cash interest expense due to accretion of debt discounts, a $2.6 million change in provision for inventory obsolescence, $0.9 million of non-cash amortization expense of right-to-use assets, $0.5 million of non-cash loss on contract termination, $0.4 million of stock compensation in lieu of cash fees and a $0.2 million loss from disposal of property and equipment.
R&D costs primarily include personnel costs, materials, clinical expenses, regulatory expenses, product development, consulting services, and outside research activities, all of which are directly related to research and development activities. We estimate IDE clinical trial expenses based on the services performed, pursuant to contracts with research institutions and clinical research organizations that conduct and manage clinical trials on its behalf.
R&D costs primarily include personnel costs, materials, clinical expenses, regulatory expenses, product development, consulting services, and outside research activities, all of which are directly related to R&D activities. We estimate IDE clinical trial expenses based on the services performed, pursuant to contracts with research institutions and clinical research organizations that conduct and manage clinical trials on its behalf.
We recognize revenue related to the sales of products at the time of shipment, except for a portion of our direct sales revenue that is generated from the sale of consigned inventory maintained at physician, hospital, and clinic locations. For consignment sales, revenue is recognized at the time we are notified by the consignee that the product has been implanted.
We recognize revenue related to the sales of products at the time of shipment, except for a portion of our sales revenue that is generated from the sale of consigned inventory maintained at physician, hospital, and clinic locations. For consignment sales, revenue is recognized at the time we are notified by the consignee that the product has been implanted.
We will continue to evaluate the warranty reserve policies for adequacy considering claims history. Deferred revenue primarily consists of payments received in advance of meeting revenue recognition criteria. We have received payments from distributors to provide distribution exclusivity within a geographic area and recognizes deferred revenue on a ratable basis over the term of such contractual distribution relationship.
We will continue to evaluate the warranty reserve policies for adequacy considering claims history. Deferred revenue primarily consists of payments received in advance of meeting revenue recognition criteria. We have received payments from distributors to provide distribution exclusivity within a geographic area and recognize deferred revenue on a ratable basis over the term of such contractual distribution relationship.
If we are unable to raise additional capital when desired, or on terms acceptable to us, our business, results of operations, and financial condition would be adversely affected. 71 Table of Contents Cash Flows The discussion related to our cash flows for 2023 is incorporated by reference to Part II, Item 7.
If we are unable to raise additional capital when desired, or on terms acceptable to us, our business, results of operations, and financial condition would be adversely affected. 71 Table of Contents Cash Flows The discussion related to our cash flows for 2024 is incorporated by reference to Part II, Item 7.
If an asset is considered impaired, the asset is written down to fair value, which is determined based either on discounted cash flows or appraised value, depending on the nature of the asset. There were no impairment charges, or changes in estimated useful lives recorded d uring the years ended December 31, 2024 and 2023.
If an asset is considered impaired, the asset is written down to fair value, which is determined based either on discounted cash flows or appraised value, depending on the nature of the asset. There were no impairment charges, or changes in estimated useful lives recorded d uring the years ended December 31, 2025 and 2024.
We regularly reviews inventory quantities considering actual losses, projected future demand, and remaining shelf life to record a provision for excess and slow-moving inventory. Provision for inventory obsolescence of $4.2 million and $3.9 million has been recorded as of December 31, 2024 and 2023 , respectively.
We regularly reviews inventory quantities considering actual losses, projected future demand, and remaining shelf life to record a provision for excess and slow-moving inventory. Provision for inventory obsolescence of $3.9 million and $4.2 million has been recorded as of December 31, 2025 and 2024 , respectively.
We believe that the critical accounting policies discussed below are essential to understanding our historical and future performance, as these policies relate to the more significant areas involving management’s estimates and judgments. Revenue Recognition We recognize revenue related to sales of products to distributors or directly to customers in markets where it has regulatory approval, net of discounts and allowances.
We believe that the critical accounting policies discussed below are essential to understanding our historical and future performance, as these policies relate to the more significant areas involving management’s estimates and judgments. 73 Table of Contents Revenue Recognition We recognize revenue related to sales of products to distributors or directly to customers in markets where it has regulatory approval, net of discounts and allowances.
Additionally, we have received payments from customers in direct markets prior to surgical implantation and recognizes deferred revenue at the time we are notified by the customer that the product has been implanted.
Additionally, we have received payments from customers in direct markets prior to surgical implantation and recognize deferred revenue at the time we are notified by the customer that the product has been implanted.
Accounts Receivable and Allowance for Credit Losses Accounts receivable is stated at invoice value less estimated allowances for returns and credit losses. We continually monitor customer payments and maintains an allowance for estimated losses resulting from customers’ inability to make required payments.
Accounts Receivable and Allowance for Credit Losses Accounts receivable is stated at invoice value less estimated allowances for returns and credit losses. We continually monitor customer payments and maintain an allowance for estimated losses resulting from customers’ inability to make required payments.
Our long-term liquidity needs consist primarily of operating expenses, including expected increases in SG&A and R&D expenses related to our IDE clinical trial, regulatory compliance and product development and funds necessary to pay for the interest and principal payment on our Term Loans (as defined below).
Our long-term liquidity needs consist primarily of operating expenses, including expected increases in SG&A and R&D expenses related to our clinical trials, regulatory compliance and product development and funds necessary to pay for the interest and principal payment on our Term Loans (as defined below).
The Company recognizes revenue in accordance with 73 Table of Contents Accounting Standards Codification, or ASC, 606, Revenue from Contracts with Customers . ASC 606 requires the Company to recognize revenue to depict the transfer of goods or services to a customer at an amount that reflects the consideration it expects to receive in exchange for those goods or services.
The Company recognizes revenue in accordance with Accounting Standards Codification, or ASC, 606, Revenue from Contracts with Customers . ASC 606 requires the Company to recognize revenue to depict the transfer of goods or services to a customer at an amount that reflects the consideration it expects to receive in exchange for those goods or services.
Net Cash Provided by Financing Activities Net cash provided by financing activities of $125.9 million for the year ended December 31, 2024 primarily consisted of $99.5 million of proceeds received for the issuance of common shares, net of underwriters’ discount and issuance costs, from our public offering in April 2023, $24.5 million of borrowings under the Tranche C Term Loan of the Credit Agreement and $2.5 million in proceeds received for stock option exercises, partially offset by $0.5 million paid to satisfy tax withholding obligations upon the vesting of restricted stock. 72 Table of Contents Net cash provided by financing activities of $86.2 million for the year ended December 31, 2023 primarily consisted of $84.5 million of proceeds received for the issuance of common shares, net of underwriters’ discount and issuance costs, from our public offering in April 2023 and $2.2 million in proceeds received for stock option exercises, partially offset by $0.5 million paid to satisfy tax withholding obligations upon the vesting of restricted stock.
Net cash provided by financing activities of $125.9 million for the year ended December 31, 2024 primarily consisted of $99.5 million of proceeds received for the issuance of common shares, net of underwriters’ discount and issuance costs, from our public offering in April 2023, $24.5 million of borrowings under the Tranche C Term Loan of the Credit Agreement and $2.5 million in proceeds received for stock option exercises, partially offset by $0.5 million paid to satisfy tax withholding obligations upon the vesting of restricted stock.
In evaluating our ability to collect outstanding receivable balances, we consider various factors including the age of the balance, the creditworthiness of the customer, which is assessed based on ongoing credit evaluations and payment history, and the customer’s current financial condition.
In evaluating our ability to collect outstanding receivable balances, we 74 Table of Contents consider various factors including the age of the balance, the creditworthiness of the customer, which is assessed based on ongoing credit evaluations and payment history, and the customer’s current financial condition.
Net Cash Used in Investing Activities Net cash used in investing activities of $15.6 million for the year ended December 31, 2024 primarily consisted of $7.0 million in purchases of intangibles, $6.1 million in purchases of property and equipment related to the new manufacturing facility and $2.4 million of cash paid for capital expenditures on construction in progress related to our new manufacturing facility in the Coyol Free Zone in Costa Rica Net cash used in investing activities of $24.5 million for the year ended December 31, 2023 primarily consisted of $15.3 million of cash paid for capital expenditures on construction in progress related to our new manufacturing facility in the Coyol Free Zone in Costa Rica, $7.9 million in purchases of property and equipment related to the new manufacturing facility and $1.3 million in purchases of intangibles.
Net cash used in investing activities of $15.6 million for the year ended December 31, 2024 primarily consisted of $7.0 million in purchases of intangibles, $6.1 million in purchases of property and equipment related to the new manufacturing facility and $2.4 million of cash paid for capital expenditures on construction in progress related to our new manufacturing facility in the Coyol Free Zone in Costa Rica.
As of December 31, 2024 and 2023, an allowance of $0.4 million and $0.3 million was recorded for product returns, respectively. Taxes collected from customers for remittance to governmental authorities are excluded from net sales. A portion of the our revenue is generated from the sale of consigned inventory maintained at physician, hospital, and clinic locations.
As of December 31, 2025 and 2024, an allowance of $1.9 million and $0.4 million was recorded for product returns, respectively. Taxes collected from customers for remittance to governmental authorities are excluded from net sales. A portion of the our revenue is generated from the sale of consigned inventory maintained at physician, hospital, and clinic locations.
In cases where there are circumstances that may impair a specific customer’s ability to meet its financial obligations, an allowance is recorded against amounts due, which reduces the net recognized receivable 74 Table of Contents to the amount reasonably believed to be collectible.
In cases where there are circumstances that may impair a specific customer’s ability to meet its financial obligations, an allowance is recorded against amounts due, which reduces the net recognized receivable to the amount reasonably believed to be collectible.
The decrease in R&D expense was primarily due to a $6.0 million decrease in personnel cost and a $1.0 million decrease in expenditures related to our IDE clinical trial in the United States, partially offset by a $0.2 million increase in regulatory affairs costs.
The increase in R&D expense was primarily due to a $1.6 million increase in personnel cost and a $0.2 million increase in regulatory affairs costs, partially offset by a $0.8 million decrease in stock compensation costs and a $0.5 million decrease in expenditures related to our IDE clinical trial in the United States.
We allow for the return of product from direct customers in certain regions in limited instances within fifteen days after the original sale and records estimated sales returns as a reduction of sales in the same period revenue is recognized.
We allow for the return of product from direct customers in certain regions in limited instances within 15 to 60 days after the original sale and records estimated sales returns as a reduction of sales in the same period revenue is recognized.
However, we expect our SG&A expenses to decrease as a percentage of our revenue over the long term, although our SG&A expenses may fluctuate from period to period due to the timing of expenses related to our sales and marketing campaigns, as well as expansion into new markets and geographies.
We expect our SG&A expenses to decrease as a percentage of our revenue; however, our SG&A expenses may fluctuate from period to period due to the timing of expenses related to our sales and marketing campaigns, as well as expansion into new markets and geographies.
The decrease was primarily due to $6.0 million in contract termination costs incurred in the fourth quarter of fiscal 2024 and to the foreign currency fluctuations of the Brazilian real and the euro as compared to the U.S. dollar, resulting in a foreign currency transaction loss of $8.8 million, for the year ended December 31, 2024, compared to a gain of $1.8 million for the year ended December 31, 2023.
The increase was primarily due to $6.0 million in contract termination costs incurred in the fourth quarter of fiscal 2024 and to the foreign currency fluctuations of the Brazilian real and the euro as compared to the U.S. dollar, resulting in a foreign currency transaction gain of $6.4 million, for the year ended December 31, 2025, compared to a loss of $8.8 million for the year ended December 31, 2024.
Sales of our Motiva breast implants accounted for over 96% of our revenues for the year ended December 31, 2024, and we expect our revenues to continue to be driven primarily by sales of these products.
Sales of our Motiva breast implants accounted for over 99% of our revenues for the year ended December 31, 2025, and we expect our revenues to continue to be driven primarily by sales of these products.
Recent Accounting Pronouncements Please refer to Note 2 “Summary of Significant Accounting Policies” in the notes to the consolidated financial statements included in this Form 10-K for information on recent accounting pronouncements and the expected impact on our unaudited consolidated financial statements.
See Note 10 “Share-Based Compensation” for additional information. Recent Accounting Pronouncements Please refer to Note 2 “Summary of Significant Accounting Policies” in the notes to the consolidated financial statements included in this Form 10-K for information on recent accounting pronouncements and the expected impact on our unaudited consolidated financial statements.
Critical Accounting Policies, Significant Judgments and Use of Estimates This discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with the generally accepted accounting principles in the United States of America, or GAAP.
See Note 6 “Debt” for additional information. Critical Accounting Policies, Significant Judgments and Use of Estimates This discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with the generally accepted accounting principles in the United States of America, or GAAP.
Management’s Discussion and Analysis of Financial Condition and Results of Operations in our Annual Report on Form 10-K for the year ended December 31, 2023, which was filed with the SEC on March 4, 2024.
Management’s Discussion and Analysis of Financial Condition and Results of Operations in our Annual Report on Form 10-K for the year ended December 31, 2024, which was filed with the SEC on February 28, 2025.
See below under “Indebtedness” and Note 6 “Debt” for additional details. (2) Contractual obligations related to the minimum lease payments and interest on our operating leases. See Note 7 “Leases” for additional details. (3) Contractual obligations related to our current contracts for software solutions and support. (4) Contractual obligations related to a short-term loan for our business insurance premiums.
See below under “Indebtedness” and Note 6 “Debt” for additional details. (2) Contractual obligations related to the minimum lease payments and interest on our operating leases. See Note 7 “Leases” for additional details. (3) Contractual obligations related to our current contracts for software solutions and support.
The Term Loans will mature on the 5-year anniversary of the Closing Date and accrue interest at a rate equal to 9% per annum for the first two tranches and 10% for the third and fourth tranches.
In September 2025, $25 million was advanced under the fourth tranche. The Term Loans will mature on the 5-year anniversary of the Closing Date and accrue interest at a rate equal to 9% per annum for the first two tranches and 10% for the third and fourth tranches.
We calculate gross margin as revenue less cost of revenue for a given period divided by revenue. Our gross margin may fluctuate from period to period depending, in part, on the efficiency and utilization of our manufacturing facilities, fluctuations of foreign currency exchange rates, targeted pricing programs and sales volume based on geography, customer and product type.
Our gross margin may fluctuate from period to period depending, in part, on the efficiency and utilization of our manufacturing facilities, fluctuations of foreign currency exchange rates, targeted pricing programs and sales volume based on geography, customer and product type.
Management's Discussion and Analysis of Financial Condition and Results of Operations in our Annual Report on Form 10-K for the year ended December 31, 2023, which was filed with the SEC on March 4, 2024. 70 Table of Contents Liquidity and Capital Resources As of December 31, 2024, we had an accumulated deficit of $444.7 million.
Management’s Discussion and Analysis of Financial Condition and Results of Operations in our Annual Report on Form 10-K for the year ended December 31, 2024, which was filed with the SEC on February 28, 2025. Liquidity and Capital Resources As of December 31, 2025, we had an accumulated deficit of $495.8 million.
For the year ended December 31, 2024, foreign currency transaction loss amounted to $8.8 million as compared to a foreign currency transaction gain of $1.8 million for the year ended December 31, 2023. Share-Based Compensation We measures and recognizes compensation expense for all share-based awards in accordance with the provisions of ASC 718, Stock Compensation .
For the year ended December 31, 2025, foreign currency transaction gain amounted to $6.4 million as compared to a foreign currency transaction loss of $8.8 million for the year ended December 31, 2024. 75 Table of Contents Share-Based Compensation We measure and recognize compensation expense for all share-based awards in accordance with the provisions of ASC 718, Stock Compensation .
Other Income (Expense), Net Other income (expense), net, decreased $15.6 million to an expense of $13.8 million for the year ended December 31, 2024, compared to an income of $1.8 million for the year ended December 31, 2023.
Other Income (Expense), Net Other income (expense), net, decreased $20.0 million to an income of $6.2 million for the year ended December 31, 2025, compared to an expense of $13.8 million for the year ended December 31, 2024.
Financial Highlights Our revenue for the years ended December 31, 2024 and 2023 was $166.0 million and $165.2 million, respectively, an increase of $0.8 million, or 0.5%. Net losses were $84.6 million for the year ended December 31, 2024 as compared to $78.5 million for the year ended December 31, 2023.
Financial Highlights Our revenue for the years ended December 31, 2025 and 2024 was $211.1 million and $166.0 million, respectively, an increase of $45.1 million, or 27.2%. Net losses were $51.1 million for the year ended December 31, 2025 as compared to $84.6 million for the year ended December 31, 2024.
Interest Expense Interest expense increased $5.4 million, or 35.1%, to $20.8 million for the year ended December 31, 2024, as compared to $15.4 million for the year ended December 31, 2023. The increase was primarily due to an increase in debt principal.
Interest Expense Interest expense increased $4.4 million, or 21.6%, to $25.3 million for the year ended December 31, 2025, as compared to $20.8 million for the year ended December 31, 2024. The increase was primarily due to an increase in debt principal.
Net cash used in operating activities of $88.5 million for the year ended December 31, 2023 was primarily comprised of a net loss of $78.5 million, changes in operating assets and liabilities of $34.1 million, $4.2 million of unrealized foreign currency gain and $3.6 million of interest capitalized for construction in progress, partially offset by $14.4 million of share-based compensation expense, $13.3 million of non-cash interest expense due to accretion of debt discounts, $4.2 million of non-cash depreciation and amortization expense, a $1.4 million change in provision for inventory obsolescence, a $1.2 million change in allowance for doubtful accounts and $0.7 million of non-cash amortization expense of right-to-use assets.
Net cash used in operating activities of $58.5 million for the year ended December 31, 2024 was primarily comprised of a net loss of $84.6 million, changes in operating assets and liabilities of $15.5 million, a $2.2 million change in provision for deferred income taxes and $0.6 million of interest capitalized for construction in progress, partially offset by $14.4 million of share-based compensation expense, $6.8 million of non-cash depreciation and amortization expense, $6.4 million of non-cash interest expense due to accretion of debt discounts, $6.0 million of non-cash loss on contract termination, $5.3 million of unrealized foreign currency loss, a $1.8 million change in provision for inventory obsolescence, a $1.7 million change in allowance for credit losses, $1.0 million of stock compensation in lieu of cash fees and $0.7 million of non-cash amortization expense of right-to-use assets.
As of December 31, 2024, $221.4 million was outstanding under the Credit Agreement representing the initial principal of $150 million for the Tranche A Term Loan, $25 million for the Tranche B Term Loan, $25 million for the Tranche C Term Loan and $17.6 million of interest accrued into the principal balance. See Note 6 “Debt” for additional information.
As of December 31, 2025, $246.4 million was outstanding under the Credit Agreement representing the initial principal of $150 million for the Tranche A Term Loan, $25 million for the Tranche B Term Loan, $25 million for the Tranche C Term Loan, $25 million for the Tranche D Term Loan and $21.4 million of interest accrued into the principal balance.
We also incur significant expenses for supplies, development prototypes, design and testing, clinical study costs and product regulatory and consulting expenses. We expect our R&D expenses to remain elevated for the foreseeable future as we continue to advance our products under development, as well as initiate and prepare for additional clinical studies.
We expect our R&D expenses to remain elevated for the foreseeable future as we continue to advance our products under development, as well as initiate and prepare for additional clinical studies.
As of December 31, 2024 and 2023, we had cash of $90.3 million and $40.0 million, respectively.
As of December 31, 2025 and 2024, we had cash of $75.6 million and $90.3 million, respectively.
Other Expense, Net Other expense, net primarily consists of foreign currency gains/losses and interest income. As of December 31, 2024, it also included $6.0 million of contract termination costs related to cancellation of certain contracts in the fourth quarter of fiscal 2024. See Note 2 “Summary of Significant Accounting Policies” for additional information.
As of December 31, 2024, it also included $6.0 million of contract termination costs related to cancellation of certain contracts in the fourth quarter of fiscal 2024. See Note 2 “Summary of Significant Accounting Policies” for additional information. Income Tax Benefit Income tax benefit primarily reflects income taxes incurred in the foreign jurisdictions in which we operate.
Comparison of the Year Ended December 31, 2023 and 2022 The discussion related to our results of operations and changes in financial condition for 2023 compared to 2022 is incorporated by reference to Part II, Item 7.
Interest income amounted to $0.4 million or the year ended December 31, 2025, as compared to $1.5 million for the year ended December 31, 2024. 70 Table of Contents Comparison of the Year Ended December 31, 2024 and 2023 The discussion related to our results of operations and changes in financial condition for 2024 compared to 2023 is incorporated by reference to Part II, Item 7.
Interest Expense Interest expense consists primarily of cash and non-cash interest related to outstanding debt and amortization of debt discounts. As of December 31, 2024, we had $221.4 million in outstanding principal under our term loan, including interest accrued into the principal balance. See Note 6 “Debt” for additional information.
As of December 31, 2025, we had $246.4 million in outstanding principal under our term loan, including interest accrued into the principal balance. See Note 6 “Debt” for additional information. Other Expense, Net Other expense, net primarily consists of foreign currency gains/losses and interest income.
Consolidated Results of Operations The following table sets forth our results of operations for the years presented, in dollars: Year Ended December 31, 2024 2023 (in thousands) Revenue $ 166,025 $ 165,151 Cost of revenue 56,500 58,174 Gross profit 109,525 106,977 Operating expenses: Sales, general and administrative 139,806 145,575 Research and development 19,706 26,428 Total operating expenses 159,512 172,003 Loss from operations (49,987) (65,026) Interest expense (20,829) (15,393) Other income (expense), net (13,812) 1,836 Loss before income taxes (84,628) (78,583) Benefit for income taxes 32 81 Net loss $ (84,596) $ (78,502) Comparison of the Year Ended December 31, 2024 and 2023 Year Ended December 31, 2024 2023 (in thousands) Revenue $ 166,025 $ 165,151 Cost of revenue 56,500 58,174 Gross profit $ 109,525 $ 106,977 Gross margin 66.0 % 64.8 % Revenue Revenue increased $0.8 million, or 0.5%, to $166.0 million for the year ended December 31, 2024, as compared to $165.2 million for the year ended December 31, 2023.
Consolidated Results of Operations The following table sets forth our results of operations for the years presented, in dollars: Year Ended December 31, 2025 2024 (in thousands) Revenue $ 211,076 $ 166,025 Cost of revenue 64,768 56,500 Gross profit 146,308 109,525 Operating expenses: Sales, general and administrative 165,069 139,806 Research and development 20,247 19,706 Total operating expenses 185,316 159,512 Loss from operations (39,008) (49,987) Interest expense (25,256) (20,829) Other income (expense), net 6,242 (13,812) Loss before income taxes (58,022) (84,628) Benefit for income taxes 6,958 32 Net loss $ (51,064) $ (84,596) Comparison of the Year Ended December 31, 2025 and 2024 Year Ended December 31, 2025 2024 (in thousands) Revenue $ 211,076 $ 166,025 Cost of revenue 64,768 56,500 Gross profit $ 146,308 $ 109,525 Gross margin 69.3 % 66.0 % Revenue Revenue increased $45.1 million, or 27.2%, to $211.1 million for the year ended December 31, 2025, as compared to $166.0 million for the year ended December 31, 2024.
Therefore, we expect an uptick in overall operating expenses in fiscal 2025 relative to fiscal 2024. 68 Table of Contents For additional information on the various risks and other uncertain macroeconomic conditions on our business, financial condition and results of operations, please see Part I, Item 1A. “Risk Factors” of this report.
For additional information on the various risks and other uncertain macroeconomic conditions on our business, financial condition and results of operations, please see Part I, Item 1A. “Risk Factors” of this report.
Cost of Revenue and Gross Margin Cost of revenue decreased $1.7 million, or 2.9%, to $56.5 million for the year ended December 31, 2024, compared to $58.2 million for the year ended December 31, 2023.
Cost of Revenue and Gross Margin Cost of revenue increased $8.3 million, or 14.7%, to $64.8 million for the year ended December 31, 2025, compared to $56.5 million for the year ended December 31, 2024.
Research and Development Expense R&D expense decreased $6.7 million, or 25.4%, to $19.7 million for the year ended December 31, 2024, compared to $26.4 million for the year ended December 31, 2023.
Research and Development Expense R&D expense increased $0.5 million, or 2.5%, to $20.2 million for the year ended December 31, 2025, compared to $19.7 million for the year ended December 31, 2024.
We expect our SG&A expenses to remain significant in absolute dollars as our business grows and we continue to invest in our sales, marketing, medical education, training and general administration resources to build our corporate infrastructure.
SG&A expenses also includes costs attributable to freight, marketing, sales support, travel, legal services, financial audit fees, insurance costs, and consulting services. We expect our SG&A expenses to remain significant in absolute dollars as our business grows and we continue to invest in our sales, marketing, medical education, training and general administration resources.
The calculation of share-based compensation expense requires us to make assumptions and judgments about the variables used in the Black-Scholes model, including the expected term, expected volatility of the underlying common shares, risk-free interest rate and dividends. See Note 10 “Share-Based Compensation” for additional information.
The fair value of options to purchase shares granted to employees is estimated on the grant date using the Black-Scholes option valuation model. The calculation of share-based compensation expense requires us to make assumptions and judgments about the variables used in the Black-Scholes model, including the expected term, expected volatility of the underlying common shares, risk-free interest rate and dividends.
We record uncertain tax positions based on a two-step process whereby (1) a determination is made as to whether it is more likely than not that the tax positions will be sustained based on the technical merits of the position and (2) for those tax positions that meet the more-likely-than-not recognition threshold we recognize the largest amount of tax benefit that is greater than 50% likely to be realized upon ultimate settlement with the related tax authority.
We recognize uncertain tax positions using a two‑step approach: (1) a tax position is recognized only if it is more likely than not to be sustained based on its technical merits, and (2) the amount recognized is the largest amount of benefit that is more than 50% likely to be realized upon settlement.
The increase was primarily due to a 43% revenue increase in the Asia Pacific region and higher revenue in North America after FDA approval of Motiva Implants in September 2024, partially offset by a 28% revenue decrease in Latin America compared to the same period in fiscal 2023. Revenue from our EMEA market remained relatively stable.
The increase was primarily due to significantly higher sales in North America after FDA approval of Motiva Implants in September 2024, a 16.4% increase in revenue in the EMEA market and a 14.1% increase in revenue in Latin America partially offset by a 28.6% decrease in Asia-Pacific, due primarily to the timing of distributor purchases and sales.
Operating Expenses Year Ended December 31, 2024 2023 (in thousands) Operating expenses: Sales, general and administrative $ 139,806 $ 145,575 Research and development 19,706 26,428 Total operating expenses $ 159,512 $ 172,003 Sales, General and Administrative Expense SG&A expense decreased $5.8 million, or 4.0%, to $139.8 million for the year ended December 31, 2024, compared to $145.6 million for the year ended December 31, 2023.
Operating Expenses Year Ended December 31, 2025 2024 (in thousands) Operating expenses: Sales, general and administrative $ 165,069 $ 139,806 Research and development 20,247 19,706 Total operating expenses $ 185,316 $ 159,512 Sales, General and Administrative Expense SG&A expense increased $25.3 million, or 18.1%, to $165.1 million for the year ended December 31, 2025, compared to $139.8 million for the year ended December 31, 2024.
The decrease was primarily due to a $6.2 million decrease in in consulting fees, a $4.1 million decrease in sales and marketing expenses and a $3.6 million decrease in freight costs, partially offset by a $2.1 million increase in depreciation and amortization costs, a $1.5 million increase in personnel and related costs, a $1.3 million increase in insurance expenses, and a $1.1 million increase in software implementation costs.
The increase was primarily due to a $7.1 million increase in personnel and related costs, a $5.1 million increase in shipping & handling associated with higher sales, a $4.7 million increase in commissions, a $4.4 million increase in expense related to the fair value remeasurement of contingent consideration related the business acquisition of Motiva Benelux BV, a $2.3 million increase in depreciation and amortization expenses, a $1.5 million increase in bad debt expense, a $0.8 million increase in consulting fees, a $0.4 million increase in software implementation costs, and a $0.4 million increase in insurance expenses, partially offset by a $2.2 million decrease in sales and marketing expenses.
The decrease in cost of revenue is primarily due to improved manufacturing efficiencies achieved at the new facility and the closure of the smallest manufacturing location. 69 Table of Contents Gross margin increased to 66.0% for the year ended December 31, 2024, compared to 64.8% for the year ended December 31, 2023 driven by a lower cost of revenue, as noted above, along with the favorable margin impact from sales within the United States due to higher selling prices.
The increase in cost of revenue is in line with the increase in revenue. 69 Table of Contents Gross margin increased to 69.3% for the year ended December 31, 2025, compared to 66.0% for the year ended December 31, 2024, primarily due to the favorable impact from sales within the United States due to higher selling prices in that region.
Cost of revenue is primarily the cost of silicone but also includes other raw materials, packaging, components, quality assurance, labor costs, as well as manufacturing and overhead expenses. Cost of revenue also includes depreciation expense for production equipment and amortization of certain intangible assets.
Cost of Revenue and Gross Margin Our implants are manufactured at our two facilities in Costa Rica. Cost of revenue is primarily the cost of silicone but also includes other raw materials, packaging, components, quality assurance, labor costs, as well as manufacturing and overhead expenses.
We have developed other complementary products and services, which are aimed at further enhancing patient outcomes. 65 Table of Contents We have devoted a majority of our resources since inception to developing our Motiva Implants, which we began selling in October 2010.
We believe these proprietary technologies that differentiate our Motiva Implants result in improved safety and aesthetic outcomes and thus drive our revenue growth. 65 Table of Contents We have devoted a majority of our resources since inception to developing our Motiva Implants, which we began selling in October 2010.
As of December 31, 2024, approximately $32.2 million has been spent on the trial to date. We also have other products under development for which we may be required to conduct clinical trials in future periods in order to receive regulatory approval to market these products.
We also have other products under development for which we may be required to conduct clinical trials in future periods in order to receive regulatory approval to market these products. Interest Expense Interest expense consists primarily of cash and non-cash interest related to outstanding debt and amortization of debt discounts.
Material Cash Requirements The following table provides a summary of our material cash requirements from known contractual and other obligations, including commitments for capital expenditures, as of December 31, 2024: 2025 2026 2027 2028 2029 Thereafter Total (in thousands) Debt obligations - principal (1) $ — $ — $ 221,367 $ — $ — $ — $ 221,367 Debt obligations - Interest payments (1) 20,453 20,453 6,500 — — — 47,406 Future minimum lease payments (2) 2,024 1,923 1,653 836 432 99 6,967 License and software commitments (3) 1,853 1,479 1,031 601 — — 4,964 Short-term borrowing (4) 1,722 — — — — — 1,722 Total material cash requirements $ 26,052 $ 23,855 $ 230,551 $ 1,437 $ 432 $ 99 $ 282,426 (1) Contractual obligations related to the Credit Agreement.
Material Cash Requirements The following table provides a summary of our material cash requirements from known contractual and other obligations, including commitments for capital expenditures, as of December 31, 2025: 2026 2027 2028 2029 2030 Thereafter Total (in thousands) Debt obligations - principal (1) $ — $ 246,367 $ — $ — $ — $ — $ 246,367 Debt obligations - interest payments (1) 22,988 7,306 — — — — 30,294 Future minimum lease payments (2) 2,097 1,807 948 459 86 37 5,434 License and software commitments (3) 1,998 1,216 674 — — — 3,888 Short-term borrowing (4) 13,141 — — — — — 13,141 Total material cash requirements $ 40,224 $ 256,696 $ 1,622 $ 459 $ 86 $ 37 $ 299,124 (1) Contractual obligations related to the Credit Agreement.
We were able to achieve higher selling prices in the United States which had a positive impact on gross margins the fourth quarter of 2024. • Outlook: Demand for our products is dependent on the relative strength of the global and regional medical device markets, which are sensitive to general macroeconomic conditions.
By December 31, 2025, we had successfully secured over 1,500 accounts across the United States, and Motiva Implants generated $45.6 million in sales within the United States for the year ended December 31, 2025. • Outlook: Demand for our products is dependent on the relative strength of the global and regional medical device and aesthetic markets, which are sensitive to general macroeconomic conditions.
Income Tax Expense Income tax expense consists primarily of income taxes in foreign jurisdictions in which we conduct business. Due to its history of losses, Motiva USA LLC, our U.S. subsidiary, maintains a full valuation allowance for deferred tax assets including net operating loss carry-forwards, R&D tax credits, capitalized R&D and other book versus tax differences.
In 2025, Motiva USA LLC, our U.S. subsidiary, released its valuation allowance on deferred tax assets, including net operating loss carryforwards, research and development tax credits, capitalized research and development costs, and other book‑to‑tax differences.
We received an approval of an IDE from the FDA in March 2018 to initiate a clinical trial and enrolled the first patient in April 2018. The IDE clinical trial is expected to cost between $30.0 million and $40.0 million over the duration of the clinical trial period of ten years.
We also incur significant expenses for supplies, development prototypes, design and testing, clinical study costs and product regulatory and consulting expenses. We received an approval of an IDE from the FDA in March 2018 to initiate a clinical trial and enrolled the first patient in April 2018.
Our post-market surveillance data (which was not generated in connection with a United States Food and Drug Administration, or FDA, pre-market approval, or PMA, study collected at defined follow-ups, but was patient or practitioner reported) and published third-party registries and data indicate that Motiva Implants have low rates of adverse events (including rupture, capsular contracture, and safety related reoperations) that we believe compare favorably with those of our competitors.
Our 5-year results from our Motiva U.S. IDE study as well as our patient and practitioner reported post-market surveillance data indicate that Motiva Implants have low rates of adverse events (including rupture, capsular contracture, and implant-related reoperations) that compare favorably with those of our competitors.
Income Taxes We record income taxes using the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in our consolidated financial statements or income tax returns.
Income Taxes We account for income taxes using the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences of differences between the financial reporting and tax bases of assets and liabilities, and for operating loss and tax credit carryforwards.
The current global macroeconomic environment remains complex, with elevated inflation and interest rates driving reductions in discretionary spending in the markets we operate. While several regions are showing strong performance, the demand remains inconsistent, with Latin America, especially Brazil, underperforming. We expect significant demand for our products as we further develop the U.S. market.
The current global macroeconomic environment remains complex, with escalating trade tensions, uncertainty regarding tariffs, volatility in the capital markets, fluctuating exchange rates, declining consumer sentiment and elevated inflation and interest rates driving reductions in discretionary spending in the markets we operate. While several regions are currently showing good performance, as explained above, the outlook remains dynamic.
Our policy is to recognize interest and penalties accrued on any unrecognized tax benefits as a component of income tax expense. Significant judgment is required in the identification of uncertain tax positions and in the estimation of penalties and interest on uncertain tax positions. There were no material uncertain tax positions as of December 31, 2024 and 2023.
Interest and penalties related to uncertain tax positions are recorded in income tax expense. There were no material uncertain tax positions as of December 31, 2025 and 2024 . Effective January 1, 2025, we adopted ASU 2023‑09, Improvements to Income Tax Disclosures, on a prospective basis.
Net proceeds to us from the offering, after deducting offering expenses, were approximately $49.7 million. See Note 8 “Shareholders’ Equity” for additional information. Components of Results of Operations Revenue We commenced sales of our Motiva Implants in October 2010 and these products have historically accounted for the majority of our revenues.
The borrowings are short‑term in nature and mature within ten months of issuance. 66 Table of Contents Components of Results of Operations Revenue We commenced sales of our Motiva Implants in October 2010, and these products have historically accounted for the majority of our revenues.
The initial commercial launch took place in Brazil, with additional launches planned in other countries throughout 2025. In January 2025, we announced the retirement of Juan José Chacón-Quirós as CEO, effective March 1, 2025. Peter Caldini, our current President, will serve as Interim CEO effective the same day. Following his departure as Chief Executive Officer, Mr.
On May 7, 2025, we announced the appointment of Peter Caldini as Chief Executive Officer following the retirement of Juan José Chacón-Quirós as CEO, effective March 1, 2025. Mr. Caldini served as Interim CEO from March 1, 2025 until May 7, 2025. Mr. Chacón-Quirós continued as a member of the Board and as an advisor with the Company.
Business Update Regarding Macroeconomic Conditions • 2024 Results: Demand in fiscal 2024 improved in our Asian markets while Latin America, Brazil in particular, continues to suffer from weaker underlying demand for aesthetic and reconstructive plastic surgery compared to fiscal 2023.
Business Update Regarding Macroeconomic Conditions • 2025 Results: As compared to the prior year, demand in fiscal 2025 improved in our EMEA markets, especially direct markets. As compared to fiscal 2024, we also saw an increase in demand in Latin America as demand in Brazil continues to stabilize and strong growth in Argentina continues.
Benefit for Income Taxes Benefit for income taxes for the year ended December 31, 2024 of $32.0 thousand stayed comparable to the tax benefit of $81.0 thousand for the year ended December 31, 2023.
Benefit for Income Taxes Income tax benefit increased to $7.0 million for the year ended December 31, 2025 as compared to a tax benefit of $32.0 thousand for the year ended December 31, 2024. The increase in the tax benefit was primarily due to the release of the valuation allowance for one of our U.S. subsidiaries.
In 2023, we completed an underwritten public offering of common shares, resulting in net proceeds to us after deducting underwriting discounts and offering expenses of approximately $84.6 million. See Note 8 “Shareholders’ Equity” for additional information. Our short-term liquidity requirements consist primarily of operating expenses and interest payments on the Credit Agreement.
The fourth tranche, or the Tranche D Term Loan, of $25 million was advanced in September 2025. See Note 6 “Debt” for additional information regarding the Credit Agreement. Our short-term liquidity requirements consist primarily of operating expenses and interest payments on the Credit Agreement and other short-term borrowings described above.
As of December 31, 2024, we had an accumulated deficit of $444.7 million. Our cash balance as of December 31, 2024 was $90.3 million. Recent Developments Regulatory and Operational Updates In February 2025, we launched Preservé, a minimally invasive breast tissue-preserving technology for breast augmentation, revision augmentation and mastopexy augmentation.
As of December 31, 2025, we had an accumulated deficit of $495.8 million. Our cash balance as of December 31, 2025 was $75.6 million. Recent Developments Regulatory and Operational Updates On October 14, 2025, we announced the publication of “The 3-Year Results of a 100-Patient Prospective Study of Safety and Effectiveness of Mia Femtech” in the Aesthetic Surgery Journal .
Removed
We believe the proprietary technologies that differentiate our Motiva Implants enable improved safety and aesthetic outcomes and drive our revenue growth.
Added
The study showed a very low rate of complications, with no reports of capsular contracture (Baker Grade III/IV), implant rupture, nipple or breast sensitivity loss, incision-related complications, infection, seroma, rippling, hematoma, or BIA-ALCL; the reoperation rate at 3 years was 1%.
Removed
Chacón-Quirós will continue as a member of the Board and as an advisor with the Company. In October 2024, we completed and announced the results of the three-year 100-patient clinical study for Mia Femtech, our patented technology that can increase breast shape by 1 to 2 cups in a 15-minute procedure without the need for general anesthesia.
Added
Patient and surgeon satisfaction was high, with patients reporting an 87% increase in breast satisfaction at 3 years and 90% of surgeons “very satisfied” with their overall experience and none “dissatisfied”. See “Our Clinical Data—Mia Femtech Clinical Study” below for additional information.
Removed
The single-center, Institutional Review Board approved study began in December 2020 and involved the participation of fifteen board-certified plastic surgeons in multiple geographies. We currently offer Mia Femtech in multiple countries across the world with plastic surgeons fully certified to provide the Mia experience. In September 2024, we received PMA approval from the FDA for our Motiva Implants.
Added
On March 6, 2025, we partnered with GRAMMY winner Meghan Trainor, generating over 9 billion media impressions and supporting our U.S. market launch. In February 2025, we launched Preservé, a minimally invasive breast tissue-preserving technology for breast augmentation, revision augmentation and mastopexy augmentation.
Removed
Beginning in October 2024, we began selling Motiva Implants for use in breast augmentation for patients in the United States.
Added
The initial commercial launch took place in Brazil, with further launches in other countries occurring throughout 2025, including an early experience group in the United States. Launches in additional countries, including a full launch in the United States, are expected in 2026.
Removed
In June 2024, we finalized the construction of our manufacturing and corporate offices in the Coyol Free Zone, or CFZ, in Costa Rica, which includes approximately 100,000 square feet of facility space intended to increase our manufacturing capacity by approximately 730,000 units per year. The facility has obtained necessary regulatory approvals to commence manufacturing.
Added
Financing Activities We signed an Inventory Funding Agreement, or Funding Agreement, on May 23, 2025, with RTW Master Fund, LTD., RTW Innovation Master Fund, LTD., and RTW Biotech Opportunities Operating LTD, collectively referred to as the Funding Providers, and RTW Investments, LP, as the funding representative, to finance purchases of silicone raw material to support the manufacture of Motiva Implants in an aggregate amount not to exceed $10 million in a funding period.
Removed
We incurred approximately $56.0 million in costs for this phase of the project over the time frame of 2020 to 2024. Additional phases of the project may be executed, at our option, to further expand manufacturing capacity at the new facility.
Added
Under the Funding Agreement, the Funding Providers will finance, upon request, eligible invoices at a 12% annual interest rate for an initial four-month term, or a later date if agreed by the Funding Providers in writing in their sole discretion.

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Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

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Biggest changeITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK Interest Rate Risk We had cash of $90.3 million and $40.0 million as of December 31, 2024 and 2023, respectively. We manage our cash portfolio for operating and working capital purposes.
Biggest changeITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK Interest Rate Risk We had cash of $75.6 million and $90.3 million as of December 31, 2025 and 2024, respectively. We manage our cash portfolio for operating and working capital purposes.
For the year ended December 31, 2024, foreign currency transaction loss amounted to $8.8 million primarily related to the remeasurement of transactions denominated in the U.S. dollar into the Brazilian real and the euro as part of the financial reporting consolidation process under GAAP. We have not engaged in any foreign currency hedging activities.
For the year ended December 31, 2025, foreign currency transaction gain amounted to $6.4 million primarily related to the remeasurement of transactions denominated in the U.S. dollar into the Brazilian real and the euro as part of the financial reporting consolidation process under GAAP. We have not engaged in any foreign currency hedging activities.
During the year ended December 31, 2024, the effect of an immediate 10% adverse change in foreign exchange rates on foreign-denominated accounts as of December 31, 2024 would have had an impact of approximately 2.4% on revenues and would have impacted our net loss by a commensurate amount.
During the year ended December 31, 2025, the effect of an immediate 10% adverse change in foreign exchange rates on foreign-denominated accounts as of December 31, 2025 would have had an impact of approximately 1.8% on revenues and would have impacted our net loss by a commensurate amount.

Other ESTA 10-K year-over-year comparisons