What changed in this filing

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Item 1. Business

2026-03-25 compared with 2025-03-21 · 111 added, 93 removed, 754 unchanged (21% of the section changed)

12 unchanged sentences

In February 2023, we launched two larger configurations of OviTex LPR, designed for ventral and incisional hernias.

In April 2024, we launched OviTex IHR Reinforced Tissue Matrix, a new OviTex configuration specifically designed to address inguinal hernia procedures performed robotically and laparoscopically.

In April 2024, we launched OviTex IHR Reinforced Tissue Matrix, a new OviTex configuration specifically designed to address inguinal hernia procedures performed robotically and laparoscopically in the U.S., followed by a launch in the European markets in June 2025.

We have also focused on evaluating and publishing clinical data on the effectiveness and safety of our OviTex products.

To date, there have been over forty published or presented works relating to these clinical findings, either by us or a third-party evaluating one or more product configurations in our OviTex portfolio.

To date, there have been over sixty-five published or presented works relating to these clinical findings, either by us or a third-party evaluating one or more product configurations in our OviTex portfolio.

In October 2022, the 24-month results of our single arm, multicenter post-market clinical study, which we refer to as our BRAVO study, were published in the Annals of Medicine and Surgery .

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OviTex PRS Long-Term Resorbable, our most recent product configuration, launched in August 2023, and was designed to enhance the OviTex PRS portfolio with specific design features including bi-directional stretch and a fully resorbable, long-term polymer for reinforcement .

In March 2025, we announced the U.S.

launch of larger sizes of OviTex PRS, which we believe may reduce the need for multiple smaller pieces and have the potential to simplify more complex plastic and reconstructive procedures.

Our OviTex PRS portfolio is supported by non-human primate data that demonstrated more rapid tissue integration and tissue remodeling compared to the market leading biologic matrix used in this indication.

In addition, there have been a growing number of published or presented works evaluating the use of OviTex PRS in plastic and reconstruction applications.

We also continue to enroll patients in our OPERA study, a retrospective-prospective trial evaluating the safety profile of OviTex PRS in previous pre-pectoral and sub-pectoral implant-based breast reconstructions.

We also continue to collect patient data in our OPERA study, a retrospective-prospective trial evaluating the safety profile of OviTex PRS in previous pre-pectoral and sub-pectoral implant-based breast reconstructions.

Based on the current sales of biologic matrices in the U.S., we estimate the annual U.S.

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We continue to evaluate and finalize the clinical study protocol and anticipate additional FDA interactions related to such to support a pre-market application to obtain approval for an indication for OviTex PRS for use in breast reconstruction.

In December 2024, we received clearance of a Special 510(k) related to two new additional large size product offerings in our OviTex PRS portfolio.

Historically, we have sought to expand our service offerings beyond our OviTex and OviTex PRS products through commercial partnerships to distribute complimentary soft tissue preservation and restoration solutions.

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Our intellectual property applies to our differentiated product construction and materials.

In addition, we believe our exclusive manufacturing and long-term supply and license agreement with Aroa (the “Aroa License”) creates a competitive advantage by allowing us to secure an exclusive supply of ovine rumen at a low cost.

In addition, we believe our exclusive manufacturing and long-term supply and license agreement with Aroa (the “Aroa License”) creates a

competitive advantage by allowing us to secure an exclusive supply of ovine rumen at a low cost.

Ovine rumen, the forestomach of a sheep, is the source of the biologic material used in both of our OviTex and OviTex PRS products.

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We have invested in our direct sales and marketing infrastructure to expand our presence and to promote awareness and adoption of our products.

As of December 31, 2024, we had 75 sales territories in the U.S.

and 13 sales territories in Europe.

We believe we can enhance the productivity of our sales force by improving customer segmentation and targeting, implementing and further refining our proprietary training programs, leveraging support from our medical education and medical affairs functions to drive physician awareness, education and clinical understanding of our products, and utilizing engagement analytics to support further product development and enhancement opportunities.

Additionally, we have contracted with three national group purchasing organizations (“GPOs”) in the United States covering our OviTex and OviTex PRS products and plan to continue to contract with additional GPOs and other integrated delivery networks (“IDNs”) to increase access to and penetration of hospital accounts for all products we commercialize.

We are currently devoting research and development resources to develop additional variations of our OviTex and OviTex PRS products, including larger versions of our current OviTex PRS product configurations, the development of OviTex configurations with longer-acting resorbable polymers and other potential product and packaging enhancements to extend the shelf life of our products.

We are currently devoting research and development resources to develop additional variations of our OviTex and OviTex PRS products, including the development of OviTex configurations with longer-acting resorbable polymers and other potential product and packaging enhancements to extend the shelf life of our products.

In addition, we also continue to explore the development of lower-cost, higher-margin resorbable polymer-based devices targeting our current indications.

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Our revenue for the years ended December 31, 2025 and 2024 was $80.3 million and $69.3 million, respectively, which represents an increase of $11.0 million, or 16% for the year ended December 31, 2025.

Our net loss for the same time periods was $37.8 million and $46.7 million, respectively, which represents a decrease of $8.8 million, or 19% for the year ended December 31, 2024 inclusive of the gain recognized of $7.6 million on the sale of NIVIS to the MiMedx Group, Inc.

Our net loss for the same time periods was $38.8 million and $37.8 million, respectively, which represents an increase of $1.0 million, or 3% for the year ended December 31, 2025.

As of December 31, 2025, we had an accumulated deficit of $397.6 million.

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Increased pain from the hernia is the most common reason that a patient who is deferring surgical hernia repair will ultimately elect repair surgery.

Following surgical hernia repair, convalescence has a significant

socioeconomic impact.

Following surgical hernia repair, convalescence has a significant socioeconomic impact.

Absence from work during this period can range from approximately five to 14 days according to one study.

Pain is the most common cause of delay in returning to work, followed by wound problems.

Long-term pain or discomfort at the hernia repair site is one of the most serious complications of hernia surgery and may, in some cases, persist for years.

Long-term pain

or discomfort at the hernia repair site is one of the most serious complications of hernia surgery and may, in some cases, persist for years.

Given the limitations of and lack of innovation in existing hernia repair products, we believe a significant market opportunity exists for our portfolio of OviTex products.

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The vast majority of hernias are treated with surgical repair.

Surgical hernia repair is performed either through open repair, which uses a single incision to open the abdomen or groin across the hernia, or minimally invasive repair, which involves laparoscopic or robotic-assisted techniques.

Surgical hernia repair is performed either through open repair, which uses a single incision to open the abdomen or groin across the hernia, or minimally invasive repair, which

involves laparoscopic or robotic-assisted techniques.

Laparoscopic surgery is a minimally invasive surgical technique performed in the abdomen or groin through small incisions.

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Resorbable synthetic mesh is polymer-based and does not include biologic material to promote tissue remodeling and healing.

Despite improvements compared to the use of permanent synthetic mesh or biologic matrices, current limitations of resorbable synthetic mesh may include:

Despite improvements

compared to the use of permanent synthetic mesh or biologic matrices, current limitations of resorbable synthetic mesh may include:

● significant foreign body inflammatory response that can result in encapsulation or contraction of the mesh until resorbed;

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This material consists of an intact, minimally-processed extracellular matrix derived from ovine rumen, which is the forestomach of a sheep.

Polymer fibers are interwoven through the layers of biologic

material in unique embroidered patterns and contribute to approximately 5% of the overall device by mass.

Polymer fibers are interwoven through the layers of biologic material in unique embroidered patterns and contribute to approximately 5% of the overall device by mass.

The interwoven polymer utilized can be either permanent, made from polypropylene, or resorbable, made from polyglycolic acid (“PGA”) or polylactic-co-glycolic acid (“PLGA”).

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● Enhanced remodeling of soft-tissue and rate of healing.

Our reinforced tissue matrices are constructed to provide increased surface area and permeability, allowing for rapid absorption of wound fluids and blood during implantation and enabling oxygen supply, cellular infiltration, migration, and repopulation for revascularization and functional tissue remodeling during healing.

revascularization and functional tissue remodeling during healing.

In our non-human primate comparative study, at 24 weeks the pattern of collagen formation in our OviTex products resembled connective tissue as opposed to the random fibers typical of scar tissue that were seen adjacent to the synthetic mesh.

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In our BRAVO study, the recurrence rate at the 24-month time point was 2.6%, and SSOs were observed in 38% of the study population.

Of the enrolled patients, 78%

were characterized as high risk for experiencing an SSO based on at least one known risk factor, which included obesity, active smoking, COPD, diabetes mellitus, coronary artery disease, or advanced age (≥75 years).

Of the enrolled patients, 78% were characterized as high risk for experiencing an SSO based on at least one known risk factor, which included obesity, active smoking, COPD, diabetes mellitus, coronary artery disease, or advanced age (≥75 years).

We believe based on a review of available literature that the BRAVO recurrence rate is among the lowest reported rate in any published study, including our biologic or resorbable synthetic mesh competitors evaluating product use in this procedural setting and with a similar cohort of high-risk patients.

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The biologic matrix is derived from ovine rumen and utilizes a patented process to create a reinforced tissue matrix that is optimized for soft-tissue reconstruction.

Our OviTex and OviTex PRS products are available in resorbable and permanent polymer versions in a variety of configurations and sizes.

Our OviTex and OviTex PRS products are available in resorbable and permanent polymer

versions in a variety of configurations and sizes.

For example, our OviTex devices are currently available in sizes ranging from 4 × 8 cm to 25 × 40 cm, and our OviTex LPR devices are designed with specific thickness, handling properties and shapes optimized for use in laparoscopic and robotic-assisted surgery.

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Our executive team has led and managed companies through significant growth and introduction and commercialization of multiple new products, including driving surgeon adoption of biologic and biosurgery technologies.

Members of our team have held leading positions with medical technology companies such as Orthovita Inc., Stryker Corporation, OraSure Technologies, Inc., LifeCell and Medtronic plc.

Members of our team have held leading positions with medical technology companies such as Orthovita Inc., Stryker Corporation, OraSure Technologies, Inc., Abiomed, LifeCell and Medtronic plc.

We believe this team is well-positioned to lead us through the commercial expansion of our products and development and launch of future products.

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We primarily sell our products through a single direct sales organization in the U.S.

As of December 31, 2024, we had 75 sales territories in the U.S.

which are supported by 133 employees in our U.S.

As of December 31, 2025, we had 150 employees in our U.S.

based commercial organization.

15 unchanged sentences

Our analysis of patients in the BRAVO study reaching 24-month follow-up was published in the Annals of Medicine and Surgery in October 2022.

We have begun our next post-market prospective study, BRAVO II, which evaluates OviTex LPR, OviTex Core Permanent and OviTex 1S Permanent in the robotic repair of ventral and inguinal hernias over 24 months.

With respect to OviTex PRS, in addition to independent, third-party publications evaluating the use of the product in various soft tissue applications, we also continue to enroll patients in our OPERA study, a retrospective-prospective trial evaluating the safety profile of OviTex PRS in previous pre-pectoral and sub-pectoral implant-based breast reconstructions.

Our post-market prospective study, BRAVO II, is ongoing and evaluates OviTex LPR, OviTex Core Permanent and OviTex 1S Permanent in the robotic repair of ventral and inguinal hernias over 24 months.

We have also initiated a post-market prospective study, ECH 2 O 2 , to evaluate OviTex 1S Resorbable and OviTex Core Resorbable in the repair of hiatal hernias over five years.

evaluating the safety profile of OviTex PRS in previous pre-pectoral and sub-pectoral implant-based breast reconstructions.

Following receipt of our investigational device exemption application in October 2024 relating to the study of the safety and effectiveness of our OviTex PRS product in implant-based breast reconstruction, we continue to evaluate and finalize the clinical study protocol to eventually support a pre-market application to obtain approval for an indication for OviTex PRS for use in breast reconstruction.

Lastly, we have initiated the collection of real-world quality improvement data on 1,100 patients across the entire OviTex and OviTex PRS portfolio of products and will be evaluating these patients over a 24 month follow-up period.

● Advance our portfolio of reinforced tissue matrices with the introduction of new product features and designs.

We plan to continue to expand our product offerings and the treatment capabilities of our products to address a broader patient base within soft-tissue reconstruction.

As we innovate and develop our

products, the new features and improved surgical techniques expand the clinical applications for soft-tissue reinforcement.

As we innovate and develop our products, the new features and improved surgical techniques expand the clinical applications for soft-tissue reinforcement.

Areas of focus include enhanced surgical handling, larger product configurations, increased permeability, and longer-acting resorbable polymers.

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Our textile engineering utilizes a computer-controlled fabrication method that is scalable, reproducible, efficient and customizable.

This embroidery process creates hundreds of micro-channels to allow the multi-directional passage of the patients’ native cells and fluids throughout the product.

This embroidery process creates hundreds of micro-channels to allow the multi-directional passage of the patients’ native cells and fluids

throughout the product.

The interwoven polymers are embroidered using a lockstitch pattern, which allows for the device to be trimmed while minimizing unraveling (when cut), and we use a patented corner-lock pattern, which creates a stable polymer fabric within the biologic material.

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OviTex Reinforced Tissue Matrix

Our OviTex Reinforced Tissue Matrix has received 510(k) clearance from the FDA, which clearance was obtained and is currently held by Aroa and is intended for use as a surgical mesh to reinforce and/or repair soft-tissue where weakness exists.

Indications for use include the repair of hernias and/or abdominal wall defects that require the use of reinforcing

or bridging material to obtain the desired surgical outcome.

Our OviTex Reinforced Tissue Matrix has received multiple 510(k) clearances from the FDA, which were obtained and are currently held by Aroa.

OviTex is intended for use as a surgical mesh to reinforce and/or repair soft-tissue where weakness exists.

Indications for use include the repair of hernias and/or abdominal wall defects that require the use of reinforcing material to obtain the desired surgical outcome.

Our OviTex products can be used in a variety of hernia repairs, including simple and complex ventral, inguinal and hiatal hernias, as well as abdominal wall reconstructions.

Our OviTex products are sterile reinforced tissue matrices derived from ovine rumen with either polypropylene or PGA.

Our OviTex products are sterile reinforced tissue matrices derived from ovine rumen with either polypropylene, PGA or PLGA.

The product is provided in a dry, hydratable form and packaged in a double pouched configuration.

The product can be stored at room temperature and only needs five minutes of rehydration for use.

To be used in surgery our OviTex product is placed in a sterile dish, rehydrated with sterile saline for five minutes, trimmed to fit the site, if needed, and then positioned to achieve maximum contact between the device and the surrounding tissue.

To be used in surgery our OviTex product is trimmed to fit the site, if needed, rehydrated with sterile saline for five minutes and then positioned to achieve maximum contact between the device and the surrounding tissue.

The device may be sutured, stapled or tacked into place.

All of our OviTex products were designed to minimize the amount of polymer material implanted in patients.

The synthetic material in our OviTex products comprise less than 5% of our final product or approximately 12% in our OviTex LPR devices or approximately 15% in our OviTex IHR devices.

The synthetic material in our OviTex products comprise approximately 5% of our final Core, 1S and 2S products and approximately 13% in our OviTex LPR devices and IHR devices.

Depending on the configuration selected, the amount of polymer is approximately 75% less than the polymer content of the most widely implanted permanent synthetic mesh, thereby reducing the patient’s foreign body inflammatory response to the polymer.

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12x18 cm to 15x25 cm* (Ellipse);

9cm to 15cm (Round)

6cm**, 9cm to 15cm (Circle)

10x17 cm (Anatomical);

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Laparoscopic or Robotic-assisted inguinal hernia repair

Resorbable (PGA) or Permanent (Polypropylene)

Permanent (Polypropylene)

Resorbable (PGA or PLGA) or Permanent (Polypropylene)

Resorbable (PLGA) or Permanent (Polypropylene)

Resorbable‑18 months

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Permanent-36 months

Resorbable‑18 months

Permanent-36 months

Resorbable‑18 months

Permanent-36 months

Configuration

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* 25 x 30 cm and 25 x 40 cm sizes currently only available with permanent (polypropylene) polymer.

** OviTex LPR 6 cm circle currently only available with resorbable (PLGA) polymer.

*** Resorbable PLGA variants of OviTex currently only available in the U.S.

+ Denotes relative level of strength.

1 unchanged sentence

OviTex PRS, has received 510(k) clearance from the FDA, which clearance was obtained by Aroa and is held by us, and is indicated for use in implantation to reinforce soft-tissue where weakness exists in patients requiring soft-tissue repair or reinforcement in plastic and reconstructive surgery.

In March 2023, we received an additional 510(k) clearance, which expands the OviTex PRS portfolio to include OviTex PRS Long-Term Resorbable.

In March 2023, we received an additional 510(k) clearance, which expands the OviTex PRS portfolio to include OviTex PRS Long-Term Resorbable and in March 2025, we announced the U.S.

launch of larger sizes of OviTex PRS.

Our OviTex PRS portfolio can be stored at room temperature and comes in the same packaging and requires the same rehydration and fixation as our OviTex products.

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Machine punched regularly spaced fenestrations, or holes and die-cut slits in the product facilitate fluid management, allow for rapid cellular infiltration and create a directional bias to the stretch.

The third option, the long-term resorbable PRS, provides bi-directional stretch and longer resorption profile utilizing PLGA.

Our OviTex PRS product is available in arced rectangle, contour and oval shapes in a range of sizes (4 × 16 cm through 20 × 25 cm) to suit surgeon preference and nature of the soft-tissue repair in plastic and

reconstructive surgery.

The third option, the long-term resorbable PRS, provides bi-directional stretch and longer resorption profile

utilizing PLGA.

Our OviTex PRS product is available in arced rectangle, contour and oval and circular shapes in a range of sizes (4.5 × 16 cm through 25 × 30 cm, 25 cm diameter circle) to suit surgeon preference and nature of the soft-tissue repair in plastic and reconstructive surgery.

The device may be trimmed to a desired shape to further accommodate individual anatomy.

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The data from our preclinical and clinical studies strengthens our ability to raise surgeon awareness and drive adoption of our products as a new category of soft-tissue reconstruction products.

We expect our clinical evidence will provide surgeons with safety and efficacy data on the appropriate use of our products and we plan to obtain further clinical evidence to support additional regulatory clearances or approvals of our reinforced tissue matrices for additional indications for use in the future.

We expect our clinical evidence will provide surgeons with safety and efficacy data on

the appropriate use of our products and we plan to obtain further clinical evidence to support additional regulatory clearances or approvals of our reinforced tissue matrices for additional indications for use in the future.

Preclinical Programs

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Surgeons continue to use our OviTex PRS reinforced tissue matrices in their surgeries and, in addition to a potential IDE study, we have also commenced our OPERA study, a retrospective-prospective trial evaluating the safety profile of OviTex PRS in previous pre-pectoral and sub-pectoral implant-based breast reconstructions.

Intellectual Property

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patents that will expire in 2029 and 2031.

We own twenty-three U.S.

issued or allowed patents which will expire between 2035 and 2041 and twelve pending U.S.

We own twenty-six U.S.

issued patents which will expire between 2035 and 2041 and ten pending U.S.

patent applications, which subject to issuance, are projected to expire between 2035 and 2045, without taking into account potential patent term extensions or adjustments.

In addition to our U.S.

intellectual property, we also own eight issued non-U.S.

patents and seven pending non-U.S.

patent applications, including six applications under the Patent Cooperation Treaty (“PCT”), which, subject to issuance, would be projected to expire between 2036 and 2044 and have exclusively licensed issued patents in Europe and Canada that will expire in 2029.

intellectual property, we also own eleven issued non-U.S.

patents and fourteen pending non-U.S.

patent applications, including seven applications under the Patent Cooperation Treaty (“PCT”), which, subject to issuance, would be projected to expire between 2036 and 2044 and have exclusively licensed issued patents in Europe and Canada that will expire in 2029.

Our patents and patent applications cover, among other things, our corner-lock embroidery pattern, the use of adhesion barriers sewn into soft-tissue and compliance associated with stretching.

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As of December 31, 2025, we had 150 employees in our U.S.

based commercial organization in 75 sales territories, which includes sales management, territory managers, marketing and administrative and field-

based support staff.

based commercial organization, which includes sales management, territory managers, marketing and administrative and field-based support staff.

We plan to hire additional territory managers and field-based support employees to support and service new accounts for soft-tissue reconstruction procedures.

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In the event of an uncured supply failure by Aroa, we have the right to, directly or through a third-party, step in and operate the Aroa Auckland facility to manufacture our products on behalf of Aroa.

The proprietary ovine rumen used in the manufacturing of our products is obtained from sheep raised for human consumption in New Zealand and is currently sourced by Aroa from two abattoirs, or slaughterhouses.

Although only two abattoirs are currently qualified, there are more than 30 additional abattoirs in New Zealand that could be used to source the ovine rumen.

The proprietary ovine rumen used in the manufacturing of our products is obtained from sheep raised for human consumption in New Zealand and is currently sourced by Aroa from a New Zealand abattoir, or slaughterhouse.

Although only one abattoir is currently qualified, there are more than 30 additional abattoirs in New Zealand that could be used to source the ovine rumen.

New Zealand cattle and sheep are considered by the USDA to be free of prion disease (progressive neurodegenerative disorders, including scrapie).

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Many of these competitors are large, well-capitalized companies with significantly greater market share and resources than we have, selling products that have been on the market prior to the commercialization of our products.

As a consequence, they are able to spend more on product development, marketing, sales and other product initiatives than we can, while also benefiting from greater brand awareness.

As a consequence, they are able to spend more on product development, marketing, sales and other product initiatives than we

can, while also benefiting from greater brand awareness.

We also compete with smaller medical device companies that have single products or a limited range of products.

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Under the FDCA, medical devices are classified into one of three classes — Class I, Class II or Class III — depending on the degree of risk associated with each medical device and the extent of control needed to provide reasonable assurances with respect to safety and effectiveness.

Class I includes devices with the lowest risk to the patient and are those for which safety and effectiveness can be reasonably assured by adherence to a set of FDA regulations, referred to as the General Controls for Medical Devices, which require compliance with the applicable portions of the Quality Systems Regulations, or QSR, facility registration and product listing, reporting of adverse events and malfunctions, and appropriate, truthful and non-misleading labeling and promotional materials.

Some Class I devices, also called Class I reserved devices, also require premarket clearance

by the FDA through the 510(k) premarket notification process described below.

Class I includes devices with the lowest risk to the patient and are those for which safety and effectiveness can be reasonably assured by adherence to a set of FDA regulations, referred to as the General Controls for Medical Devices, which require compliance with the applicable portions of the Quality Management System Regulation, or QMSR, facility registration and product listing, reporting of adverse events and malfunctions, and appropriate, truthful and non-misleading labeling and promotional materials.

Some Class I devices, also called Class I reserved devices, also require premarket clearance by the FDA through the 510(k) premarket notification process described below.

Most Class I products are exempt from the premarket notification requirements.

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If the FDA determines that the device is “not substantially equivalent” to a previously cleared device, the device is automatically designated as a Class III device.

The device sponsor must then fulfill more rigorous PMA requirements, or can request a risk-based classification determination for the device in accordance with the de novo classification procedure, which is a route to market for novel medical devices that are low to moderate risk and are not substantially equivalent to a predicate device.

The device sponsor must then fulfill more rigorous PMA requirements, or can request a risk-based classification determination for

the device in accordance with the de novo classification procedure, which is a route to market for novel medical devices that are low to moderate risk and are not substantially equivalent to a predicate device.

After a device receives 510(k) marketing clearance, any modification that could significantly affect its safety or effectiveness, or that would constitute a major change or modification in its intended use, will require a new 510(k) marketing clearance or, depending on the modification, a de novo classification or PMA approval.

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The FDA can always review these letters-to-file in an inspection.

If the FDA disagrees with a manufacturer’s determination, the FDA can

require the manufacturer to cease marketing and/or request the recall of the modified device until marketing authorization is obtained.

If the FDA disagrees with a manufacturer’s determination, the FDA can require the manufacturer to cease marketing and/or request the recall of the modified device until marketing authorization is obtained.

Also, in these circumstances, we may be subject to significant regulatory fines or penalties.

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The FDA has 180 days to review a filed PMA application, although the review of an application can occur over a significantly longer period of time, and can take up to several years.

During this review period, the FDA may request additional information or clarification of information already provided, or the FDA may issue a major deficiency letter to the applicant, requesting the applicant’s response to deficiencies communicated by the FDA.

During this review

period, the FDA may request additional information or clarification of information already provided, or the FDA may issue a major deficiency letter to the applicant, requesting the applicant’s response to deficiencies communicated by the FDA.

The FDA considers a PMA or PMA supplement to have been voluntarily withdrawn if an applicant fails to respond to an FDA request for information (e.g., a major deficiency letter) within 360 days.

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Prior to approval of a PMA, the FDA may conduct inspections of the clinical trial data and clinical trial sites, as well as inspections of the manufacturing facility and processes.

Beginning in February 2026, FDA will evaluate PMA submissions against the harmonized QMSR.

Overall, the FDA review of a PMA application generally takes between one and three years, but may take significantly longer.

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Clinical trials are almost always required to support a PMA and are sometimes required to support a 510(k) submission.

All clinical investigations of investigational devices to determine safety and effectiveness must be conducted in accordance with the FDA’s IDE regulations which govern investigational device labeling, prohibit promotion of the investigational device, and specify an array of recordkeeping, reporting and monitoring responsibilities of study sponsors and study investigators.

investigational device, and specify an array of recordkeeping, reporting and monitoring responsibilities of study sponsors and study investigators.

Some types of studies deemed to present a “non-significant risk” are deemed to have an approved IDE once certain requirements are addressed and Institutional Review Board, or IRB approval is obtained.

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Generally, clinical trials for a significant risk device may begin once the IDE application is approved by the FDA and the study protocol and informed consent are approved by an appropriate IRB.

number of subjects, it does not bind the FDA to accept the results of the trial as sufficient to prove the product’s safety and efficacy, even if the trial meets its intended success criteria.

There can be no assurance that submission of an IDE will result in the ability to commence clinical trials, and although the FDA’s approval of an IDE allows clinical testing to go forward for a specified number of subjects, it does not bind the FDA to accept the results of the trial as sufficient to prove the product’s safety and efficacy, even if the trial meets its intended success criteria.

During a study, the sponsor is required to comply with the applicable FDA requirements, including, for example, trial monitoring, selecting clinical investigators and providing them with the investigational plan, ensuring IRB review, adverse event reporting, record keeping and prohibitions on the promotion of investigational devices or on making safety or effectiveness claims for them.

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These include:

● the FDA’s Quality Systems Regulations (“QSR”), which requires manufacturers, including third party manufacturers, to follow stringent design, testing, production, control, supplier/contractor selection, complaint handling, documentation and other quality assurance procedures during all aspects of the manufacturing process;

● the FDA’s “QMSR”, which requires manufacturers, including third party manufacturers, to follow stringent design, testing, production, control, supplier/contractor selection, complaint handling, documentation and other quality assurance procedures during all aspects of the manufacturing process;

● labeling and marketing regulations which require that promotion is truthful, not misleading, fairly balanced and provides adequate directions for use and that all claims are substantiated;

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The FDA has broad post-market and regulatory enforcement powers.

Medical device manufacturers are subject to unannounced inspections by the FDA and other state, local and foreign regulatory authorities to assess compliance with the QSR and other applicable regulations, and these inspections may include the manufacturing facilities of any suppliers.

Medical device manufacturers are subject to unannounced inspections by the FDA and other state, local and foreign regulatory authorities to assess compliance with the QMSR and other applicable regulations, and these inspections may include the manufacturing facilities of any suppliers.

Failure to comply with applicable regulatory requirements can result in enforcement action by the FDA, which may include any of the following sanctions:

● warning letters, untitled letters, Form 483s, fines, injunctions, consent decrees and civil penalties;

● warning letters, untitled letters, FDA Form 483s, fines, injunctions, consent decrees and civil penalties;

● recall or seizure of products;

2 unchanged sentences

● the FDA’s refusal to issue certificates to foreign governments needed to export products for sale in other countries;

● withdrawing approvals that have already been granted;

● withdrawing approvals that have already been granted or reclassifying the devices;

● criminal prosecution.

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the UDI/device registration module) will become mandatory six months after the publication in the OJEU of the notice confirming the functionality of such module.

The Medical Device Coordination Group (MDCG) has published guidance (in November 2024) on the gradual roll-out of Eudamed.

The United Kingdom formally left the EU on January 31, 2020.

In respect of medical devices, since the end of the Brexit transitional period on January 1, 2021, medical devices must be registered with the Medicines and Healthcare products Regulatory Agency (“MHRA”) (the UK medicines and medical devices regulator) before being placed on the Great Britain market.

If a manufacturer of a device placed on the market in Great Britain is based outside of the United Kingdom, the manufacturer must appoint a UK responsible person with a registered place of business in the United Kingdom to act on the manufacturer’s behalf in respect of certain activities (e.g.

device registration).

CE marks issued by EU notified bodies to place medical devices on the market in the EU will remain valid in the United Kingdom up until, at the latest, June 30, 2028 (for CE marks issued under the EU MDD) or June 30, 2030 (for CE marks issued under the EU MDR), following which a UK Conformity Assessed (“UKCA”) mark will be required to place a device on the Great Britain market.

In November 2025, the European Commission published a notice declaring the functionality of the first four Eudamed modules, which triggers mandatory use of those modules from 28 May 2026 under the MDR transitional provisions.

In Great Britain (England, Wales and Scotland), in respect of medical devices, since the end of the Brexit transitional period on January 1, 2021, medical devices must be registered with the Medicines and Healthcare products Regulatory Agency (“MHRA”) (the UK medicines and medical devices regulator) before they are placed on the market.

If a manufacturer is based outside the United Kingdom, it must appoint a single UK Responsible Person established in the United Kingdom to act on its behalf in relation to specified obligations, including device registration.

Under current

transitional measures, certain CE-marked devices may continue to be placed on the Great Britain market for limited periods depending on the EU legislation the device complies with, including generally up to the sooner of certificate expiry or June 30, 2028 for devices compliant with the EU MDD, and up to June 30, 2030 for devices compliant with EU MDR.

After the applicable transition period, a UK Conformity Assessed (“UKCA”) mark will be required to place a device on the Great Britain market.

Manufacturers may choose to use the UKCA mark on a voluntary basis prior to such dates.

UCKA marking will, however, not be recognized in the EU.

The EU regulatory framework on medical devices continues to apply in Northern Ireland under the Windsor Framework and medical devices in Northern Ireland may either carry an EU CE mark or a UK and Northern Ireland CE mark (“CE UK(NI)”), although devices bearing the CE UK(NI) marking will not be accepted on the EU market.

The UKCA mark is not recognized for placing devices on in the EU market.

EU medical device rules continue.

For Northern Ireland, devices generally require CE marking and where a UK notified body is used for mandatory third-party conformity assessment, the device must bear the combined CE and UKNI mark (“CE UKNI”), although devices bearing CE UKNI mark are not accepted on the EU market.

Following a public consultation, the UK government is implementing changes to the medical devices legislation.

The first piece of legislation will come into force on June 16, 2025, and implements changes to the post-market surveillance requirements for medical devices in Great Britain, with the aim of facilitating greater traceability of incidents.

legislation will be put in place in 2025 and 2026 to introduce new pre-market requirements, including an international reliance procedure for approval of certain medical devices for the Great Britain market.

The first piece of legislation became law in December 2024 and took effect on June 16, 2025, implementing changes to the post-market surveillance requirements for medical devices in Great Britain, with the aim of facilitating greater traceability of incidents.

Further legislation will be put in place in 2026 to introduce new pre-market requirements, including an international reliance procedure for approval of certain medical devices for the Great Britain market.

Privacy and Security Laws

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For example, the California Consumer Privacy Act (“CCPA”) is a comprehensive privacy law that created individual privacy rights for California residents and increased the privacy and security obligations of entities handling certain personal data, including sensitive personal information.

Certain states have also passed laws regulating specific aspects of privacy.

For example, the State of Washington recently passed a law regulating health and medical information that is not subject to HIPAA.

We may be subject to other state and federal privacy laws, including laws that prohibit unfair privacy and security practices and deceptive statements about privacy and security, laws that place specific requirements on certain types of activities, such as data security and texting, and laws requiring holders of personal information to maintain safeguards and to take certain actions in response to a data breach.

Foreign data protection laws, including the General Data Protection Regulation, (“GDPR”) may also apply to health-related and other personal information belonging to individuals who reside outside of the U.S.

The GDPR went into effect in the European Union in May 2018 and introduced strict requirements for processing the personal data of data subjects residing in the European Economic Area.

Companies that must comply with the GDPR face increased compliance obligations and risk, including more robust regulatory enforcement of data protection requirements and potential fines for noncompliance of up to €20 million or 4% of the annual global revenues of the noncompliant company, whichever is greater.

Among other requirements, the GDPR regulates cross-border transfers of personal data and requires transferee countries to have protections equivalent to protections available in the EU.

Foreign data protection laws may also apply to health-related and other personal information belonging to individuals who reside outside of the U.S.

whose personal information we process.

For example, the collection, use, disclosure, transfer, or other processing of personal information regarding individuals in the European Economic Area (EEA) and the United Kingdom (UK), including personal health information, is subject to the strict requirements of the EU General Data Protection Regulation (the “EU GDPR”), the UK General Data Protection Regulation (the “UK GDPR”) (collectively referred to as the “GDPR”), as well as other national data protection legislation in force in the relevant EEA

Member States and the UK (including the UK Data Protection Act 2018 and UK (Data Use and Access) Act) 2025.

Companies that must comply with the GDPR face increased compliance obligations and risk, including more robust regulatory enforcement of data protection requirements and potential fines for noncompliance of up to €20 million (£17.5 million for the UK GDPR) or 4% of the annual global revenues of the corporate group of the noncompliant company, whichever is greater.

The GDPR also confers a private right of action on data subjects and consumer associations to lodge complaints with supervisory authorities, seek judicial remedies, and obtain compensation for damages resulting from violations of the GDPR.

Among other requirements, the GDPR regulates cross-border transfers of personal data and requires transferee countries to have protections equivalent to protections available in the EEA and UK.

In July 2023, the EU adopted the EU-U.S.

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A company may participate under the DPF by self-certifying and publicly committing to comply with the applicable DPF principles.

Further, the United Kingdom’s exit from the European Union, referred to as Brexit, has created uncertainty regarding data protection regulation in the United Kingdom.

The United Kingdom has transposed the GDPR into domestic law with a United Kingdom version of the GDPR that took effect in January 2021 (“UK GDPR”).

Currently, the GDPR and UK GDPR remain largely aligned, but the United Kingdom announced plans to reform the country’s data protection legal framework in its Data Reform Bill, which failed in the UK legislative process.

A new Data (Use and Access) Bill, or UK Bill, has been introduced into parliament.

If passed, the final version of the UK Bill may have the effect of further altering the similarities between the UK and EU data protection regime and threaten the UK adequacy decision from the EU Commission.

This may lead to divergence between the GDPR and UK GDPR.

Currently, the EU and UK data protection regimes remain largely aligned, but there is a possibility of further divergence in the future.

EU member states have introduced national laws implementing the GDPR which impose additional requirements;

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There are many potential bases for liability under the False Claims Act.

Liability arises, primarily, when an entity knowingly submits, or causes another to submit, a false claim for reimbursement to the federal government, but also may arise when an entity knowingly makes a false statement material to an obligation to pay or transmit money or property to the federal government or knowingly conceals or knowingly and improperly avoids or decreases an obligation to pay or transmit money or property to the federal government.

Liability arises, primarily, when an entity knowingly submits, or causes another to submit, a false claim for reimbursement to the federal government, but also may

arise when an entity knowingly makes a false statement material to an obligation to pay or transmit money or property to the federal government or knowingly conceals or knowingly and improperly avoids or decreases an obligation to pay or transmit money or property to the federal government.

Various states have also enacted false claims and insurance fraud laws that are analogous to the federal False Claims Act.

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The federal Physician Payments Sunshine Act (“Sunshine Act”) which was enacted as part of the Patient Protection and Affordable Care Act (“PPACA”) generally requires certain manufacturers of a drug, device, biologic or other medical supply that is covered by Medicare, Medicaid or the Children’s Health Insurance Program and applicable GPOs to report on an annual basis:

(i) certain payments and other transfers of value given to certain healthcare professionals and

teaching hospitals and (ii) any ownership or investment interest that U.S.

(i) certain payments and other transfers of value given to certain healthcare professionals and teaching hospitals and (ii) any ownership or investment interest that U.S.

physicians, or their immediate family members, have in their company.

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businesses and their representatives from offering to pay, paying, promising to pay or authorizing the payment of money or anything of value to a foreign official in order to influence any act or decision of the foreign official in his or her official capacity or to secure any other improper advantage in order to obtain or retain business.

The FCPA also obligates companies whose securities are listed in the U.S.

The FCPA also obligates companies whose securities are listed in the

to comply with accounting provisions requiring us to maintain books and records, which in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the corporation, including international subsidiaries, if any, and to devise and maintain a system of internal accounting controls sufficient to provide reasonable assurances regarding the reliability of financial reporting and the preparation of financial statements.

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Accordingly, we are committed to their health, safety and wellness.

We provide our employees and their families with access to a variety of flexible and convenient health and wellness programs, including benefits that provide protection and security so they can have peace of mind concerning events that may require time away from work or that impact their financial well-being;

We provide our employees and their families with access to a variety of flexible and convenient health and wellness programs, including benefits that provide protection and security so they can

have peace of mind concerning events that may require time away from work or that impact their financial well-being;

that support their physical and mental health by providing tools and resources to help them improve or maintain their health status and encourage engagement in healthy behaviors;

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What changed 10-K

Item 1. Business