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Item 1. Business

2026-02-26 compared with 2025-02-25 · 303 added, 248 removed, 258 unchanged (68% of the section changed)

Integra LifeSciences Holdings Corporation was founded in 1989 and is a leading global medical technology company innovating treatment pathways to advance patient outcomes and set new standards of surgical, neurologic, ear, nose, and throat (“ENT”) and regenerative care.

Our common stock trades on the Nasdaq Global Select Market (“Nasdaq”) under the symbol “IART.” We have developed numerous product lines from this technology for applications ranging from burn and deep tissue wounds to the repair of dura mater in the brain, as well as nerves and tendons.

We have expanded our base regenerative technology business to include ENT, surgical instruments, neurosurgical products and advanced wound care through global acquisitions and product development to meet the evolving needs of our customers and enhance patient care.

Integra products are sold in more than 120 countries through a direct sales force as well as distributors and wholesalers.

Integra LifeSciences Holdings Corporation is a global medical technology company dedicated to restoring lives.

We are advancing transformational care through impactful innovation and our portfolio of highly differentiated technologies is trusted by healthcare professionals to deliver transformative care.

We manufacture and sell medical technologies and products in two reportable business segments:

Codman Specialty Surgical (“CSS”) and Tissue Technologies (“TT”).

The CSS segment, which represents approximately two-thirds of our total revenue, consists of market-leading technologies and instrumentation used for a wide range of specialties, such as neurosurgery, neurocritical care and otolaryngology.

The CSS segment, which represents approximately 70% of our total revenue, consists of market-leading technologies and instrumentation used for a wide range of specialties, such as neurosurgery, neurocritical care, and otolaryngology, commonly referred to as ear, nose, and throat (“ENT”).

We are the world leader in neurosurgery and one of the top three providers in the U.S.

in instruments used in precision, specialty, and general surgical procedures.

Our TT segment generates about one-third of our overall revenue and focuses on three main areas:

complex wound surgery, surgical reconstruction, and peripheral nerve repair.

We have key manufacturing and research facilities located in California, Maryland, Massachusetts, New Jersey, Ohio, Puerto Rico, Tennessee, Utah, France, Germany, Ireland, Israel and Switzerland.

We source most of our handheld surgical instruments and dural sealant products through specialized third-party vendors.

We aspire to continue to be a worldwide leader in neurosurgery and reconstructive surgery with a portfolio of leading businesses that delivers outstanding customer experiences through innovation, execution and teamwork to positively impact the lives of millions of patients and their families.

Our strategies are focused around five pillars.

Of these five pillars, we have identified three core growth drivers:

(1) innovating for outcomes, (2) growing internationally, and (3) broadening our impact on care pathways.

Our execution of the core growth drivers is enabled by two key levers:

(4) driving operational and customer excellence and (5) cultivating a high-performance culture.

As outlined in greater detail below, we believe these five pillars will enable us to realize and advance our integrated growth strategy.

To this end, our executive leadership team has established the following key priorities aligned to the following five pillars:

Innovating for Outcomes .

An important part of Integra’s growth strategy is introducing new products to strengthen and expand our portfolio through clinical evidence to support regulatory approval and strong reimbursement of our product portfolio around the world, including new indications for existing technologies.

For example, in 2021, we filed a pre-market approval (“PMA”) application for a specific indication for Surgimend® in the use of post-mastectomy breast reconstruction.

We anticipate PMA approval following the operationalization of the Braintree facility, which is expected in the first half of 2026.

We are also pursuing a PMA for DuraSorb for use in implant-based breast reconstruction (“IBBR”).

We completed enrollment for the DuraSorb U.S.

investigational device exemption clinical study for two-stage breast reconstruction in June 2023;

and in 2024 we have continued to advance the PMA application.

Currently, we hope to secure PMA approval for DuraSorb in 2026.

In 2024 we expanded our urinary bladder matrix platform with the U.S.

launch of MicroMatrix® Flex, a dual-syringe system enabling the convenient mixing and precise delivery of MicroMatrix® paste to provide convenient access to hard-to-reach spaces and to help prepare an even wound surface in challenging wound areas.

Additionally, in 2024, we successfully re-launched our CereLink intracranial pressure (“ICP”) monitor system.

CereLink provides enhanced accuracy, usability and advanced data presentation that provides clinicians with uncompromised, advanced continuous ICP monitoring when treating patients with traumatic brain injuries.

Growing Internationally.

Over the years, we have been significantly expanding our global footprint through investments in our commercial and manufacturing organizations, the expansion and development of international markets and new product introductions.

As part of our In-China-For-China strategy, we continue to build out our assembly capabilities in our new facility in Suzhou, China.

Several new products were introduced in select international markets in 2023 and 2024, including MicroMatrix® and Certas Plus® Programmable Valve, which were launched in Europe, and CUSA Clarity laparoscopic tip,

which was launched in Australia, New Zealand, Japan, Canada, South Africa and Israel.

In addition, DuraGen® Secure, received approval in Japan, while DuraGen Plus, an absorbable and sutureless collagen onlay indicated as a dura substitute for the repair of dura mater, and Certas Plus were approved in China.

Broadening Impact on Care Pathways .

We seek ways to develop and acquire products and technologies that impact the lives of patients, starting with the journey that a patient takes from diagnosis and treatment planning to surgery and postoperative care.

We are well-established in acute care in the hospital setting and continue to leverage that strong position to grow in this segment and shape treatment pathways into preoperative care and additional sites of care.

On April 1, 2024, we successfully completed the acquisition of Acclarent, Inc.

(“Acclarent”).

Acclarent is an innovator and market leader in ENT procedures and the acquisition of Acclarent has positioned Integra as one of the leading providers of ENT products and technologies.

Furthermore, we believe that, owing to the ENT business being an anatomical adjacency to neurosurgery, the acquisition will allow Integra to deliver future innovation both within the ENT business and across our other CSS technology platforms.

Driving Operations and Customer Excellence.

We have been making investments to build more responsive and scalable processes, enhance the reliability of our quality systems and supply chain, and drive productivity initiatives to further supply and lower costs.

We continue to invest in technologies, systems and processes to enhance the customer experience.

We also continue to invest in our capacity expansion.

This includes ongoing projects of transferring our Boston manufacturing to a new location in Braintree, Massachusetts and further investing in capacity and validating manufacturing processes in our manufacturing facility in Plainsboro, New Jersey.

We are implementing a Compliance Master Plan (the “CMP”), a systematic and holistic approach to improving our quality management system across our manufacturing and supply network.

The primary objectives of the CMP are to remediate quality system gaps, harmonize the quality management system across the company, and enhance the quality culture at the company.

Cultivating a High-Performance Culture.

In seeking to sustain a culture of excellence and accountability, we focus on employee empowerment, professional development and building an environment where all employees can contribute to their fullest potential.

These efforts have been recognized through our inclusion in several best workplace lists globally in 2023 and 2024.

Additionally, we continue to advance our broader organizational sustainability initiatives and published our third annual environmental, social and governance (“ESG”) report.

For more information on our ESG strategy, goals, performance, and achievements, please visit “Our Company—ESG Report” at https://www.integralife.com/esg-report.

Information on our website is not incorporated by reference herein and is not part of this Annual Report on Form 10-K.

BUSINESS SEGMENTS

We currently manufacture and sell our medical technologies and products in the following two reportable business segments:

Codman Specialty Surgical and Tissue Technologies.

Our TT segment generates about 30% of our overall revenue and focuses on wound reconstruction and care and private label.

OUR PRODUCTS, SERVICES AND TECHNOLOGIES

We were the first company to receive an FDA claim for regeneration of dermal tissue and are a world leader in regenerative technology.

We have developed numerous product lines from this technology for applications ranging from burn and deep tissue wounds to the repair of dura mater in the brain, as well as nerves and tendons.

We have expanded our base regenerative technology business to include neurosurgical products, ENT, surgical instruments and advanced wound care through global acquisitions and product development to meet the evolving needs of our customers and enhance patient care.

Each of these categories and the key products sold therein are described in more detail below.

We include financial information regarding our reportable business segments and certain geographic information under “Item 7.

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CODMAN SPECIALTY SURGICAL

Our CSS segment consists of neurosurgery, specialty instrumentation, and ENT surgical solutions, augmented by the 2024 acquisition of Acclarent, a U.S.

leader in ENT solutions.

Acclarent pioneered the balloon sinuplasty market, and has expanded balloon dilation for Eustachian Tube, and surgical navigation and instrumentation for ENT and skull-base procedures.

Neurosurgery :

In neurosurgery, we are a global leader in neuro-access, neuro-surgical and neuro-monitoring technologies.

The product portfolio represents a continuum of care from pre-operative, to the neurosurgery operating room, to the neuro-critical care unit and post care for both adult and pediatric patients suffering from brain tumors, brain injury, cerebrospinal fluid pressure complications and other neurological conditions.

We offer leading technologies in dural repair, ultrasonic tissue ablation, ICP monitoring, hydrocephalus management, and cranial stabilization systems, while providing a rich research and development pipeline for growth.

Our product portfolio represents a continuum of care from pre-operative, to the neurosurgery operating room, to the neuro-critical care unit and post care for both adult and pediatric patients suffering from brain tumors, brain injury, cerebrospinal fluid pressure complications and other neurological conditions

We offer leading technologies in dural repair, ultrasonic tissue ablation, intracranial pressure (“ICP”) monitoring, hydrocephalus management, and cranial stabilization systems, while providing a rich research and development pipeline for growth.

Principal products include:

• CUSA® (Cavitron Ultrasonic Surgical Aspirator) Platform:

An ultrasonic surgical aspirator platform, including the CUSA Clarity, which is used in various surgical procedures, primarily for the fragmentation, emulsification, and aspiration of soft and hard tissues;

• CereLink® intercranial pressure (“ICP”) Monitor:

An advanced, digital intracranial pressure monitoring platform, designed for use in neuro-intensive care and operating room environments, which offers uncompromised advanced continuous ICP monitoring — with minimal drift, MRI conditional capability, durable, flexible ICP sensors, and advanced data presentation features;

• Codman® Neurosurgical Accessories:

A portfolio of surgical consumables for use in the protection of tissue, including brain and other tissues of the central nervous system, during surgery and disposable perforators for use in perforating the cranium;

• DuraGen® Dural Graft Matrix:

An absorbable implant for sutureless repair of dural defects after cranial or spinal surgery and which acts as an onlay dural graft which provide a highly porous scaffold for the purpose of patching large gaps in the dura and facilitating patient recovery;

• DuraSeal® Dural Sealant System:

An absorbable polyethylene glycol (“PEG”) hydrogel designed to provide a watertight seal, particularly around suture lines or at the edge of an onlay graft, for cranial and spinal surgery patients;

• Mayfield® Standard Cranial Stabilization System:

A surgical device used to stabilize the patient’s head during neurosurgical procedures;

• Bactiseal® Anti-Microbial Catheters:

Antimicrobial external ventricular drainage (“EVD”) catheters and shunts designed to allow for the draining or shunting of cerebrospinal fluid (“CSF”) while reducing the risk of surgical site infections;

• Certas® Plus Programmable Valve:

A programable shunt valve which is designed to provide constant intraventricular pressure and drainage of CSF for the management of hydrocephalus

Specialty Instrumentation :

Our specialty instrumentation portfolio includes a catalog of surgical headlamps, surgical instruments, as well as after-market service.

With thousands of surgical instrument products, including specialty surgical instruments, we call on the central sterile processing unit of hospitals and acute care surgical centers.

With thousands of surgical instrument products, comprised of a comprehensive portfolio of reusable and disposable instruments, including forceps, retractors, scissors, and curettes, tailored for neurosurgery and spine surgery including specialty surgical instruments, we call on the central sterile processing unit of hospitals and acute care surgical centers.

Additionally, through a strong U.S.

distribution model, we can serve the needs of medical offices.

Our global commercial network includes clinical specialists, a large direct global sales force and strategic partnerships and distributors that serve hospitals, integrated health networks, group purchasing organizations, clinicians, surgery centers and health care providers.

Outside the U.S., we have a combination of direct and indirect sales channels in international markets to sell certain product lines.

ENT Surgical Solutions :

The Company’s ENT portfolio comprises a broad range of products including the TruDi® Navigation System featuring navigated surgical instrumentation, the RELIEVA SPINPLUS® Balloon Sinuplasty System, the AERA® Eustachian Tube Dilation System, and the MicroFrance ENT instrumentation line.

TISSUE TECHNOLOGIES

Our TT segment focuses on three main areas:

complex wound surgery, surgical reconstruction, and peripheral nerve repair and consists of five unique regenerative technology areas - highly engineered bovine collagen, bovine dermis, porcine urinary bladder, human amniotic tissue, and resorbable synthetic mesh.

This broad regenerative platform, which includes multiple leading brands such as Integra® Dermal Regeneration Template, PriMatrix ® , AmnioExcel ® , SurgiMend ® , MicroMatrix ® , DuraSorb ® and NeuraGen ® , primarily addresses the needs of plastic, reconstructive and general surgeons focused on the treatment of acute wounds, such as burns, chronic wounds, including diabetic foot ulcers, and surgical tissue repair, such as hernia, tendon, peripheral nerve repair and protection.

We have a specialized sales organization composed of directly employed sales representatives, as well as specialty distributors, organized based upon their call point.

Our wound reconstruction sales representatives call on surgeons doing procedures in limb salvage, trauma, wound reconstruction and burns, and chronic wounds primarily in the inpatient wound care clinic setting.

We also have a dedicated surgical reconstruction sales team focused on plastic and reconstructive surgery and hernia procedures with differentiated products.

Finally, we have a distributor network focused on biologics.

Outside the U.S., we have a combination of direct and indirect sales channels in international markets to sell certain product lines.

This business segment also includes private-label sales of a broad set of our regenerative and wound care technologies.

Our customers are other medical technology companies that sell to end markets primarily in spine, surgical and wound care.

The healthcare industry is highly competitive and characterized by continual change and improvements in technology.

This is particularly the case in the market segments in which we operate.

A number of companies have developed or are expected to develop products that compete or will compete with our products.

Many of these competitors offer a broader product portfolio and have greater brand recognition than we do, which may make these competitors more attractive to hospitals, group purchasing organizations, laboratories, physicians and other potential customers.

Competitors may develop superior products or products of similar quality for sale at the same or lower prices.

Moreover, our products could be rendered obsolete by changes to industry standards or guidelines or advances in technology.

We can give no assurance that we will be able to compete suc cessfully with existing or new competitors

Our competitors for CSS include divisions within Medtronic, Inc., Stryker Corporation, Steris PLC, and B.

Braun Medical, Inc.

In addition, we compete with many smaller specialized companies and larger companies that do not otherwise focus on the offerings of Codman Specialty Surgical technologies.

We rely on the depth and breadth of our sales and marketing organization, our innovative technologies, and our procurement and manufacturing operations to maintain our competitive position.

Our competitors for TT include Smith & Nephew plc, Organogenesis Holdings Inc., MiMedx Group, Inc., Allergan PLC, Becton Dickinson and Company, and Axogen, Inc.

We compete with additional companies who partially participate in soft tissue reconstruction of complex wounds, peripheral nerve repair and surgical reconstruction.

In addition, our products also compete against medical practices that treat a condition without using a medical device or any particular product, such as medical practices that utilize autograft tissue instead of our dermal regeneration products, duraplasty products and nerve repair products.

Depending on the product line, we compete based on our products' features, strength of our sales force or distributors, sophistication of our technology and cost effectiveness of our solution.

We believe that the success of our products depends on our ability to differentiate ourselves and to demonstrate that our products deliver the clinical and operational attributes that are most important and cost-effective to customers.

These attributes include, but are not limited to, superiority in efficacy, ease of use, reliability, accuracy, quality and cost.

We believe our continued success depends in large par t upon our ability to invest in product enhancements and technologies that will help us distinguish our product portfolio from our competitors.

Our Tissue Technologies segment develops and markets a broad portfolio of regenerative tissue products and technologies primarily focused on wound reconstruction and care and private label.

This segment serves a diverse range of specialties, including plastic and reconstructive surgery, general surgery, and wound management.

We currently utilize five unique regenerative technology platforms consisting of highly engineered bovine collagen (derived from bovine sources for structural support), bovine dermis (acellular dermal tissue for natural integration), porcine urinary bladder (extracellular matrix for cellular repopulation), human amniotic tissue (allografts for anti-inflammatory and protective properties), and resorbable synthetic mesh (biodegradable materials for temporary reinforcement).

These technologies address clinical needs in treating acute wounds such as burns, chronic wounds including diabetic foot ulcers, and surgical tissue repair applications such as hernia reinforcement, tendon protection, and peripheral nerve repair.

Wound Reconstruction and Care:

We offer a broad portfolio of products and solutions addressing a full spectrum of needs when managing complex wounds including for the treatment of acute wounds (e.g., burns and trauma), chronic wounds (e.g., diabetic foot ulcers and venous ulcers), and other complex wound types.

The goal is to promote healing by providing scaffolds that encourage cellular invasion, revascularization, and tissue regeneration while managing infection, exudate, and inflammation.

These products are often used in hospital settings, wound care clinics, or outpatient procedures to accelerate closure, reduce scarring, and prevent complications like amputation in diabetic cases.

Principal products include:

• Integra Skin:

Comprised of the first FDA-approved bilayer matrix for the regeneration of dermal tissue, indicated for third-degree burns and scar contractures, which consists of a collagen and chondroitin-6-sulfate matrix with a silicone epidermal layer to protect against infection and dehydration and several other bilayer wound matrices used for a variety of wound types, providing a scaffold for cellular invasion and capillary growth, often used with negative pressure wound therapy;

• PriMatrix® Dermal Repair Scaffold:

A collagen-based dermal repair scaffold for managing a broad range of wounds, including diabetic and venous ulcers;

• MicroMatrix® Urinary Bladder Matrix (“UBM”) and Cytal® Wound Matrix:

These products use porcine urinary bladder matrix technology to support complex wound management;

• AmnioExcel® and AmnioExcel® Plus Placental Allograft Membrane:

Human tissue-based allografts in various surgical and chronic wound applications;

• MediHoney® Wound and Burn Dressings:

Medical-grade Manuka honey-based dressings used for debridement and moisture balance in burns, ulcers, and surgical wounds.

We offer a continuum of advanced solutions for plastic and reconstructive surgery, complex hernias, and general surgery, including devices for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue membranes.

These products provide structural support and promote tissue integration to address areas of tissue weakness.

They are bioresorbable or acellular to minimize long-term foreign body reactions and reduce complications like adhesions or infections.

Principal products include:

• SurgiMend® Collagen Matrix:

An implant for soft tissue reinforcement in plastic and reconstructive surgery, including hernia repair.

It is derived from bovine collagen and is designed to integrate with host tissue while minimizing complications;

• Gentrix® Surgical Matrix:

Porcine UBM matrix for hernia (including hiatal) and abdominal wall repair;

• DuraSorb® Monofilament Mesh:

A resorbable mesh used in reconstructive surgery to provide temporary support during tissue healing, particularly in hernia repair and other soft tissue applications.

Private Label :

We offer extensive expertise in collagen biomaterials for other medical technology companies that sell to end markets primarily in spine, surgical and wound care.

We manufacture a broad set of our regenerative and wound care technologies that are available for private label distribution by our customers, produce raw materials that can be integrated into our customers’ production processes, and have the expertise to design, develop and manufacture products to meet the specific needs of our customers.

We sell our medical devices and therapies through a combination of direct sales representatives and independent distributors globally.

Our global commercial network includes clinical specialists, direct sales force in key markets and strategic partnerships and distributors that serve hospitals, integrated health networks, group purchasing organizations, clinicians, surgery centers and health care providers.

Our marketing and sales strategy is focused on cost-effective delivery of high-quality products to a diverse group of customers worldwide.

To achieve this objective, our direct global sales force teams are organized around physician specialties.

This focus enables us to develop highly knowledgeable and dedicated sales representatives who are able to foster strong relationships with physicians and enhance our ability to support our customers and cross-sell complementary products.

Over the years, we have significantly expanded our global footprint by investing in our commercial and manufacturing operations, as well as introducing new products.

In the last two years, we have expanded our presence in key markets such as Southeast Asia, India, South Korea and Brazil.

As part of our In-China-For-China strategy, we continue to build out our assembly capabilities in our facility in Suzhou, China.

We did not have any customers that represented more than 10% of our consolidated revenues in 2025.

RESEARCH AND DEVELOPMENT STRATEGY

Our research and development activities focus on identifying unmet surgical needs and addressing those needs with innovative solutions and products.

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Additionally, we conduct projects and clinical studies to generate efficacy and health economic evidence.

Regenerative Technologies .

We were the first company to receive an FDA claim for regeneration of dermal tissue and are a world leader in regenerative technology.

Our regenerative technology development program applies our expertise in bioengineering to a range of biomaterials including natural materials such as purified collagen, intact human or animal tissues, honey as well as resorbable synthetic polymers with our DuraSorb and DuraSeal® product lines.

These unique product designs are used for neurosurgical and reconstructive surgical applications, as well as dermal regeneration, including the healing of

chronic and acute wounds, tendon and nerve repair.

Our regenerative technology platform includes our legacy Integra® Dermal Regeneration Template (“IDRT”) products and complementary technologies that we have acquired.

Our collagen manufacturing capability, combined with our history of innovation, including our launch of NeuraGen 3D, provides us with strong platform technologies for multiple indications.

In the third quarter of 2021, we filed a PMA application for a specific indication for Surgimend® in the use of post-mastectomy breast reconstruction and in July 2024 received approvable pending GMP status from FDA, which approved and closed out the clinical portion of this PMA application.

We anticipate PMA approval following the operationalization of the Braintree facility, which is expected in the first half of 2026.

In 2022, we acquired SIA, which has also submitted a PMA application for DuraSorb with IBBR, and in June 2023 we completed enrollment in the DuraSorb U.S.

investigational device exemption clinical study for two-stage breast reconstruction;

and in 2024 we have continued to advance the PMA application.

Currently, we hope to secure PMA approval for DuraSorb in 2026.

By offering two distinct product solutions, we believe we have the opportunity to build a leading position in the IBBR market.

Following the completion of design control activities in 2022, we launched both Cytal and MicroMatrix in Europe in 2023.

In March 2024, MicroMatrix® Flex, used in the management of wounds with hard-to-reach geometries, such as deep wounds that present with tunneling or undermining, became commercially available in the U.S.

The Company has continued its investments in clinical education as a key value driver to leverage its global footprint, enhanced digital content, and strengthened its clinical network.

As part of this objective, the Company remains committed to participation in clinical research demonstrating the efficacy of its products prior to market introduction, and in supporting the clinical education and technical training.

Neurosurgical Solutions, Surgical Instruments, and ENT Solutions.

The CSS neurosurgical business consists of a broad portfolio of market-leading brands, such as Codman®, DuraGen®, DuraSeal®, CUSA®, CereLink®, Mayfield®, Bactiseal®, and Certas® Plus, which are used for the management of multiple disease states, including brain tumors, traumatic brain injury, hydrocephalus and other neurological conditions.

The CSS neurosurgical business consists of a broad portfolio of market-leading brands, which are used for the management of multiple disease states, including brain tumors, traumatic brain injury, hydrocephalus and other neurological conditions.

The growth in this business in recent years has been fueled by geographic expansion and new product registrations in markets, such as China, Japan, and Europe, which we expect to continue in the near-to-long term.

Because our electromechanical products and instruments address significant needs in surgical procedures and limit uncertainty for surgeons, we continue to invest in registrations, clearances, and approvals for new indications and next generation improvements to our market-leading products.

We have several active programs focused on life cycle management and innovation for capital and disposable products in our portfolio.

Our product development efforts are focused on core clinical applications in cerebrospinal fluid (“CSF”) management, neuro-critical care monitoring, minimally invasive instruments and electrosurgery and ultrasonic medical technologies, as well as our ambition to transform the standard of care in neurosurgery with product advancements in minimally invasive surgery (“MIS”) and the surgical management of intracerebral hemorrhage (“ICH”).

Our lighting franchise is among the most dynamic in the industry.

We are focused on the development of core clinical applications in our electromechanical technologies portfolio.

We continue to update our CUSA® Clarity platform by incorporating new ultrasonic handpiece and integrated electrosurgical capabilities.

We have made several enhancements to our CUSA® Clarity Tissue Ablation System.

The extended laparoscopic tip was launched in the U.S.

to enhance laparoscopic liver procedures.

In addition, a single-sided bone tip received 510(k) clearance from the FDA.

Commercial launch was completed successfully in early 2023.

In August 2023, we launched a modified 23 kHz CUSA® Electrosurgery Module (“CEM”) for Clarity handpieces that can be used with additional electrosurgery generators.

We continue to work with several instrument partners to bring new surgical instrument platforms to the market.

We also continued to advance the early-stage technology platforms we acquired in 2019.

Through the acquisition of Arkis Biosciences, Inc.

(“Arkis”) we added a platform technology, CerebroFlo® external ventricular drainage (“EVD”), a catheter with Endexo® technology, a permanent additive designed to reduce the potential for catheter obstruction due to thrombus formation.

We continue to advance the CerebroFlo® external ventricular drainage (“EVD”), a catheter with Endexo® technology.

The Endexo polymer in polyurethane is a permanent additive which has shown to be effective in reducing platelet adhesion in-vitro,

reducing thrombus accumulation in-vitro and in vivo, and reducing the clinical incidence of thrombus formation.

In vitro evaluations and in vivo animal evaluations do not necessarily predict the clinical performance of the SureFlo EVD Catheter with respect to thrombus formation.

The incidence of thrombus formation on polyurethane containing Endexo polymer in other medical devices and/or tissues systems does not necessarily predict the clinical performance of the SureFlo EVD Catheter for the intended use of CSF external drainage and monitoring.

The CerebroFlo EVD catheter has demonstrated an average of 99% less thrombus accumulation onto its surface, in vitro, compared to a market leading EVD catheter.

Our work to combine our Bactiseal® antimicrobial technology with the Endexo anti-occlusive technology continues to progress for both a silicone-based hydrocephalus and EVD project.

We also continued to advance our innovation from the Rebound Therapeutics Corporation (“Rebound Therapeutics”), which was acquired in 2019.

Rebound Therapeutics specializes in a single-use medical device, known as the Aurora Surgiscope, which is the only tubular retractor system designed for cranial surgery with an integrated access channel, camera and lighting.

The 9mm Surgiscope received 510(k) clearance from the FDA in the fourth quarter of 2023.

In the first quarter of 2024, we relaunched our CereLink ICP monitoring system, after initiating an immediate voluntary global product removal of all CereLink® intracranial pressure monitors in 2022.

Cerelink p rovides enhanced accuracy, usability and advanced data presentation to clinicians treating patients with traumatic brain injuries.

In the second quarter of 2024, we acquired Acclarent, expanding our capabilities in the U.S.

Acclarent pioneered the balloon sinuplasty market and has a broad portfolio including the RELIEVA SPINPLUS® Balloon Sinuplasty System.

Acclarent also pioneered eustachian tube balloon dilation, and currently markets the AERA® Eustachian Tube Dilation System, which received 510(k) clearance for expanded pediatric indications in 2023.

Acclarent sells the TruDi® Navigation System, which includes a portfolio of navigated surgical instrumentation.

Our work to combine our Bactiseal antimicrobial technology with the Endexo anti-occlusive technology continues to progress for both a silicone-based hydrocephalus and EVD product.

We also continue to advance the Aurora® Surgiscope, which is the only tubular retractor system designed for cranial surgery with an integrated access channel, camera and lighting.

The 15mm x 60mm and 15mm x 80mm Aurora Surgiscope System version received 510(k) clearance from the FDA in 2025.

In July 2025, we announced the inaugural enrollment of the first patient in the AERA Pediatric Registry, a prospective, multi-center observational registry evaluating the real-world use of the AERA Eustachian Tube Balloon Dilation System in children.

This marks the focused effort to measure the ongoing, clinical performance of AERA in pediatric patients with obstructive Eustachian tube dysfunction.

The registry is designed to capture both safety and efficacy outcomes for up to 300 pediatric patients who undergo Eustachian tube balloon dilation using AERA.

In September 2025 the Mayfield® Ghost Base Unit Post launched in the U.S., which is designed to help provide clear visualization of anatomical structure and to support surgical accuracy and patient positioning.

Regenerative Technologies .

These unique product designs are used for neurosurgical and reconstructive surgical applications, as well as dermal regeneration.

Our regenerative technology platform includes our legacy Integra® Dermal Regeneration Template (“IDRT”) products and complementary technologies that we have acquired.

Our collagen manufacturing capability, combined with our history of innovation, provides us with strong platform technologies for multiple indications.

In the third quarter of 2021, we filed a PMA application for a specific indication for SurgiMend® in the use of post-mastectomy breast reconstruction and in July 2024 received approvable pending GMP status from FDA, which approved and closed out the clinical portion of this PMA application.

We anticipate PMA approval following the operationalization of the Braintree facility, which is expected in 2026.

We are also pursuing a PMA for DuraSorb for use in implant-based breast reconstruction (“IBBR”).

We completed enrollment for the DuraSorb U.S.

investigational device exemption clinical study for two-stage breast reconstruction in June 2023;

and we continue to advance the PMA application.

Currently, we hope to secure PMA approval for DuraSorb in 2026.

In 2024, we acquired the product rights for Durepair Dural Regeneration Matrix, a suturable dural graft which complements our portfolio of dural grafts and sealants, and subsequently launched the product for commercial sale in the U.S.

in October 2025.

Risk Factors, under the heading Risks Related to our Regulatory Environment and under Item 7.

General Management’s Discussion and Analysis of Financial Condition and Results of Operations - FDA Matters of this Annual Report on Form 10-K for further discussion.

MANUFACTURE AND AVAILABILITY OF RAW MATERIALS

We manufacture products at manufacturing facilities located in various countries throughout the world.

QUALITY SYSTEMS, SUPPLY CHAIN AND PRODUCT MANUFACTURE

We continue to invest in technologies, systems and processes to enhance the customer experience.

We also continue to invest in our capacity expansion.

In 2024, we initiated a Compliance Master Plan (the “CMP”), a systematic and holistic approach to improving our quality management system, or QMS, across our manufacturing and supply network.

The primary objectives of the CMP are to remediate quality system gaps, harmonize the quality management system across the company, and enhance the quality culture across our organization.

In executing our remediation plans, we have introduced objective metrics to assess opportunities in our QMS and supply chain which we believe has allowed for the effective allocation of resources and consistent tracking of our results.

In conjunction with our work under the CMP, we are focused on improving operational and execution excellence.

Through leadership appointments and the development of a comprehensive plan to establish a robust end-to-end supply chain, we hope to enhance our supply chain capabilities and overall product available and operational reliability and resiliency.

We have key manufacturing and research facilities located in California, Maryland, Massachusetts, New Jersey, Ohio, Puerto Rico, Tennessee, Utah, France, Germany, Ireland, Israel and Switzerland.

We source most of our handheld surgical instruments and dural sealant products through specialized third-party vendors

AVAILABILITY OF RAW MATERIALS

We purchase many of the components and raw materials used in manufacturing our products from numerous suppliers in various countries.

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We have established long-term supply contracts with many of our suppliers and our practice is to maintain sufficient inventory of components so that our production will not be significantly disrupted even if a particular component or material is not available for a period of time.

Due to the high standards and FDA requirements applicable to manufacturing our products, such as the FDA ’ s Quality System Regulation and Good Manufacturing Practices, we may not be able to quickly establish additional or replacement sources for certain components or materials.

Some of our manufacturing operations are located outside of the U.S., including in Puerto Rico, Switzerland, Ireland and France.

Those manufacturing operations are also subject to additional challenges and risks associated with international operations described under the caption “Risk Factors” set forth in Part I, Item 1A of this Annual Report on Form 10-K.

Due to the high standards applicable to manufacturing our products, such as the FDA ’ s Quality Management System Regulation (“QMSR”), which became effective on February 2, 2026, and which superseded the prior Quality System Regulation (“QSR”) and Good Manufacturing Practices, we may not be able to quickly establish additional or replacement sources for certain components or materials .

Some of our manufacturing operations are located outside of the U.S., including Switzerland, Ireland, Israel, and France.

Those man ufacturing operations are also subject to additional challenges and risks associated with international operations described under the caption “Risk Factors” set forth in Part I, Item 1A of this Annual Report on Form 10-K.

In the event we are unable to obtain sufficient quantities of raw materials or components on commercially reasonable terms or in a timely manner, our ability to manufacture our products on a timely and cost-competitive basis may be compromised, which may have a material adverse effect on our business, financial condition and results of operations.

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We take great care to provide medical products that are safe and free of agents that can cause disease.

In particular, the collagen used in the products that we manufacture is derived from the deep flexor tendon of cattle less than 24-months old or from fetal bovine dermis from New Zealand, a country that has never had a reported case of bovine spongiform encephalopathy (“BSE”) (otherwise known as mad cow disease), and from the U.S.

In particular, the collagen used in the products that we manufacture is derived from fetal bovine dermis from the U.S.

and deep flexor tendon from the U.S.

and New Zealand.

New Zealand is a country that has never had a reported case of bovine spongiform encephalopathy (“BSE”) (otherwise known as mad cow disease).

The World Health Organization classifies different types of cattle tissue for relative risk of BSE transmission.

Deep flexor tendon and fetal bovine dermis are in the lowest-risk category for BSE transmission, and therefore considered to have a negligible risk of containing the agent that causes BSE.

Fetal bovine dermis and deep flexor tendon are in the lowest-risk category for BSE transmission, and therefore considered to have a negligible risk of containing the agent that causes BSE.

INTELLECTUAL PROPERTY

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When determined appropriate, we have enforced and plan to continue to enforce and defend our patent and trademark rights.

In general, however, we do not rely solely on our patent and trademark estate to provide us with any significant competitive advantages as it relates to our existing product lines.

In general, however, we do not rely solely on our patent and trademark estate to provide us with significant competitive advantages as it relates to our existing product lines.

We also rely upon trade secrets and continuing technological innovations to develop and maintain our competitive position.

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The main exceptions to this pattern occur because of material acquisitions.

The markets in which we compete are highly competitive and are characterized by rapid change resulting from technological advances, innovations and scientific discoveries.

Our product lines face a mix of competitors ranging from large manufacturers with multiple business lines to small manufacturers offering a limited selection of products.

Many of these competitors offer a broader product portfolio and important competitive factors include product efficacy, safety and ease of use, price and demonstrated cost-effectiveness, marketing effectiveness, product labeling, customer service and R&D of new products and processes.

Major shifts in industry market share have occurred in connection with product corrective actions, physician advisories, safety alerts, results of clinical trials to support superiority claims, and publications about our products, reflecting the importance of product quality, product efficacy and quality systems in the medical device industry.

Government and private sector initiatives to limit the growth of healthcare costs, including price regulation, competitive pricing, bidding and tender mechanics, coverage and payment policies, comparative effectiveness of therapies, technology assessments and managed-care arrangements, are continuing in many countries where we do business, including the U.S.

These initiatives put increased emphasis on the delivery of more cost-effective medical devices and therapies.

Government programs, including Medicare and Medicaid, private healthcare insurance, managed-care plans, and volume-based procurement tenders in China, have attempted to control costs by limiting the amount of reimbursement they will pay for particular procedures or treatments, tying reimbursement to outcomes, shifting to population health management, and other mechanisms.

Hospitals, which purchase our technology, are also seeking to reduce costs through a variety of mechanisms, including, for example, centralized purchasing, and in some cases, limiting the number of vendors that may participate in the purchasing program.

Hospitals are also aligning interests with physicians through employment and other arrangements, such as gainsharing, where a hospital agrees with physicians to share any realized cost savings resulting from changes in practice patterns such as device standardization.

This has created an increased level of price sensitivity among customers for our products.

Our competitors for CSS include divisions within Medtronic, Inc., Stryker Corporation, Steris PLC, and B.

Braun Medical, Inc.

In addition, we compete with many smaller specialized companies and larger companies that do not otherwise focus on the offerings of Codman Specialty Surgical technologies.

We rely on the depth and breadth of our sales and marketing organization, our innovative technologies, and our procurement and manufacturing operations to maintain our competitive position.

Our competitors for TT include Smith & Nephew plc, Organogenesis Holdings Inc., MiMedx Group, Inc., Allergan PLC, Becton Dickinson and Company, and Axogen, Inc.

We compete with additional companies who partially participate in soft tissue reconstruction of complex wounds and surgical reconstruction.

Depending on the product line, we compete based on our products' features, strength of our sales force or distributors, sophistication of our technology and cost effectiveness of our solution.

In addition, our International team faces significant global and regional competition across our entire portfolio, with local competition also playing a role in countries where local suppliers may be advantaged.

These attributes include, but are not limited to, superiority in efficacy, ease of use, reliability, accuracy, quality and cost.

We believe our continued success depends in large par t upon our ability to invest in product enhancements and technologies that will help us distinguish our product portfolio from our competitors.

GOVERNMENT REGULATION AND COMPLIANCE

We are a manufacturer and marketer of medical devices and Human Tissue and Cell Based Products (“HCT/Ps”) and therefore are subject to extensive regulation by the FDA, the Centers for Medicare & Medicaid Services (“CMS”) of the U.S.

Department of Health and Human Services (“HHS”), other federal governmental agencies and, in some jurisdictions, by state and foreign governmental authorities.

These regulations govern the introduction of new medical devices and HCT/Ps, the observance of certain standards with respect to the design, manufacture, testing, labeling, promotion and sales of the products, the maintenance of certain records, the ability to track devices, the reporting of adverse affects and potential product defects, the import and export of products, and other matters.

Department of Health and Human Services (“HHS”), other federal governmental agencies and, in some jurisdictions, by state and equivalent foreign governmental authorities.

These regulations govern the development and introduction to the market of new medical devices and HCT/Ps, the observance of certain standards with respect to the design, manufacture, testing, labeling, promotion and sales of the products, the maintenance of certain records, the ability to track devices, the reporting of adverse affects and potential product defects, the import and export of products, and other matters.

FDA product approvals, as well as equivalent approvals or certifications issued by foreign authorities or bodies, may be withdrawn or suspended, or other enforcement actions may occur, if compliance with regulatory standards is not maintained or if problems occur following initial marketing.

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Medical device products are subject to rigorous FDA and other governmental agency regulations in the United States and similar regulations of foreign agencies abroad.

The FDA regulates the design, development, research, preclinical and clinical testing, introduction, manufacture, advertising, labeling, packaging, marketing, distribution, import and export, and record keeping for such products, in order to ensure that medical products distributed in the United States are safe and effective for their intended use.

The FDA regulates the design, development, research, preclinical and clinical testing, introduction, manufacture, advertising, labeling, packaging, marketing, distribution, import and export, and record keeping for such products to ensure that medical products distributed in the United States are safe and effective for their intended use.

In addition, the FDA is authorized to establish special controls to provide reasonable assurance of the safety and effectiveness of most devices.

Non-compliance with applicable requirements can result in import detentions, fines, civil and administrative penalties, injunctions, suspensions or losses of regulatory approvals, recall or seizure of products, operating restrictions, refusal of the government to approve product export applications or allow us to enter into supply contracts, and criminal prosecution.

Non-compliance with applicable requirements can result in, without limitation, warning or untitled letters, the FDA’s delay or refusal to approve pending applications, a clinical hold on a clinical investigation, import detentions, fines, civil and administrative penalties, injunctions, suspensions or losses of regulatory approvals, product recalls, withdrawals from the market, product seizures, operating restrictions, including total or partial suspension of production or distribution, refusal of the government to approve product export applications or allow us to enter into supply contracts, and criminal prosecution.

The regulatory process for obtaining product approvals and clearances can be onerous and costly.

Under the Federal Food, Drug and Cosmetic Act (the “FD&C Act”), authorization to commercially distribute a new medical device in the U.S.

is generally obtained in one of two primary ways, both of which require review by the FDA.

The first, known as pre-market notification or the 510(k) process, requires us to demonstrate that our medical device is substantially equivalent to a legally marketed medical device.

A 510(k) pre-market notification filing must contain information establishing that the device to be sold is substantially equivalent to a device commercially distributed prior to May 28, 1976 or to a device that has been determined by the FDA to be substantially equivalent.

The PMA process is the second, more rigorous process, which requires us to independently demonstrate that a medical device is safe and effective for its intended use.

This process is generally much more time-consuming and expensive than the 510(k) process.

The PMA process involves a complex and lengthy testing process and may require several years to obtain.

Medical Device Regulation

Under the Federal Food, Drug and Cosmetic Act (the “FDCA”), unless a device is exempt or marketed under an FDA enforcement discretion, premarket authorization is required to commercially distribute a new medical device in the U.S market.

A new medical device could either be a device that has not previously received marketing authorization in the U.S, or a previously authorized device that has been changed in such a way that would require a new marketing application.

Changes that could require a new marketing application for an existing device may relate to, but are not limited to, the intended use of the device, the indications for use, manufacturing, and technological characteristics or functionalities.

The type of marketing authorization is generally linked to the classification of the device.

The FDA classifies medical devices into three classes based on risk.

Regulatory control increases from Class I (lowest risk) to Class III (highest risk).

The FDA generally must clear or approve the commercial sale of new medical devices in Classes II and III, respectively.

Commercial sales of our Class II medical devices (except for Class II exempt devices) and Class III medical devices within the U.S.

must be preceded by either a pre-market notification filing pursuant to Section 510(k) of the FDCA (Class II) or the granting of a pre-market approval, or a PMA (Class III).

As the risk of the device increases, so do the FDA’s requirements to obtain market authorization.

Generally, all Class III and some Class II medical devices will require clinical testing to adequately demonstrate the safety and effectiveness of the device prior to FDA approval or clearance of the device for commercialization.

The extent to which FDA is involved in the development of clinical trial protocols depends, in part, on whether the study is a significant risk (SR) study or a nonsignificant risk (NSR) study.

Before testing begins, all clinical studies must obtain Institutional Review Board (IRB) approval and for SR medical devices, an Investigational Device Exemption (IDE) from the FDA must be obtained.

This exemption allows for clinical testing while ensuring participant safety and adherence to ethical standards.

Though the regulatory requirements for an NSR study are less burdensome than those for an SR study, all clinical trials can be time consuming and costly and may not result in our desired outcomes.

Class I devices are those for which safety and effectiveness can be reasonably assured by adherence to a set of requirements referred to as general controls, which previously required compliance with the applicable portions of FDA’s QSR, and more recently, aspects of the FDA’s QMSR.

These include facility registration and device listing, reporting of adverse events and malfunctions, which is referred to as medical device reporting, and truthful and non-misleading labeling and promotional materials.

Most Class I devices are exempt from the premarket notification requirements (i.e., 510(k)-exempt).

510(k) Clearance Process

Class II devices are those that are subject to general controls, as well as special controls, which can include performance standards, specialized labeling and post-market surveillance.

Most Class II devices are subject to the premarket notification requirements or the 510(k) process.

To obtain 510(k) clearance, we must submit a premarket notification, or 510(k), to the FDA and demonstrate that our proposed medical device is substantially equivalent to a medical device that is legally marketed for the same intended use or a device commercially distributed prior to May 28, 1976, for which the FDA has not yet called for the submission of a PMA.

The device to which the company must show substantial equivalence is known as a predicate device.

A proposed device is substantially equivalent to a predicate device if, with respect to the predicate device, it has the same intended use and has either (i) the same technological characteristics or (ii) different technological characteristics that do not raise different questions of safety and effectiveness, and the information submitted demonstrates to the FDA that the proposed device is as safe and effective as the predicate device.

If the FDA determines that our device is “not substantially equivalent” to a previously cleared device, for example, due to a finding of a lack of a predicate device, or that the proposed device has a new intended use or different technological

characteristic that raise different questions of safety or effectiveness when the proposed device is compared to the cited predicate device, the device is automatically designated as a Class III device.

As the device sponsor, we must then fulfill more rigorous PMA requirements, or we can request a risk-based classification determination for the device in accordance with the FDA’s de novo classification process.

As a result, FDA clearance requirements may extend the device development process for a considerable length of time.

If the FDA agrees that the proposed device is substantially equivalent to the predicate device proposed by the manufacturer, it will grant 510(k) clearance to commercially market the device.

De Novo Classification Process

For novel medical devices that are low to moderate risk and are not substantially equivalent to a predicate device, a manufacturer may request a risk-based classification determination for the device in accordance with de novo classification process.

This procedure allows a de novo requester whose novel device is automatically classified into Class III to request down-classification of its medical device into Class I or Class II on the basis that the device presents low or moderate risk, rather than requiring the submission and approval of a PMA.

A requestor may submit a de novo request for classification after receiving a “not substantially equivalent” determination in response to a 510(k) submission or, absent the prior submission of a 510(k), when the sponsor determines that there is no legally marketed device upon which to base a determination of substantial equivalence.

The FDA may reject the de novo request if it identifies a legally marketed predicate device that would be appropriate for a 510(k) or determines that the device is not low to moderate risk or that general controls would be inadequate, and special controls cannot be developed, to control the risks.

In the event the FDA determines that the data and information submitted demonstrate that general controls or general and special controls are adequate to provide reasonable assurance of safety and effectiveness, the FDA will grant the de novo request and a classification regulation will be established for the device type.

When the FDA grants a de novo request for classification, the device is granted marketing authorization and can further serve as a predicate device for a future 510(k) submissions of that device type.

Class III devices include devices deemed by FDA to pose the greatest risk, such as life-supporting or life-sustaining devices, or implantable devices.

With a few exceptions for certain types of devices classified into Class III that were in commercial distribution in the U.S.

before May 28, 1976, Class III devices are subject to the pre-market approval (“PMA”) process which requires us to independently demonstrate that a medical device is safe and effective for its intended use.

This process is generally much more time-consuming and expensive than the 510(k) or de novo processes.

The PMA process involves a complex and lengthy testing process and may require several years to complete.

We may need to first obtain an investigational device exemption (for significant risk devices), known as an IDE, in order to conduct extensive clinical testing of the device to obtain the necessary clinical data for submission to the FDA.

Prior to obtaining approval, the manufacturer typically undergoes a bioresearch monitoring (“BIMO”) audit of the supporting clinical trial and a manufacturing audit, which could lengthen the process and potentially raise unforeseen issues that undermine the approvability of the product.

The FDA may also require review by an advisory panel, which can further lengthen the process.

The FDA will approve a PMA only if after evaluating the supporting technical data it finds that the PMA contains sufficient, valid scientific evidence to assure that the device is safe and effective for its intended use(s).

This approval may be granted with post-approval requirements including inspection of manufacturing facilities and/or additional patient follow-up for an indefinite period of time.

The FDA also may require a post-approval clinical study as a condition of approval.

To perform clinical trials for significant risk devices in the U.S.

on an unapproved product, we are required to obtain an IDE from the FDA.

The FDA also may require a filing for approval prior to marketing products that are modifications of existing products or new indications for existing products.

Moreover, after clearance/approval is given, if the product is shown to be hazardous or defective, the FDA and foreign regulatory agencies have the power to withdraw the clearance or approval, as the case may be, or require us to change the device, its manufacturing process or its labeling, to supply additional proof of its safety and effectiveness or to recall, repair, replace or refund the cost of the medical device.

This approval may be granted with post-approval requirements including inspection of manufacturing facilities, additional patient follow-up for an indefinite period of time and/or post-approval clinical study or studies.

Exempt Devices

If a manufacturer’s device falls into a generic category of Class I or Class II devices that FDA has exempted by regulation, a premarket notification is not required before marketing the device in the U.S.

(most Class I devices, and some Class II devices, are 510(k)-exempt.) Manufacturers of such devices are required to comply with FDA’s general controls, including FDA’s establishment registration and device listing requirements.

Some 510(k)-exempt devices are also exempt from QMSR requirements, except for their respective complaint handling and recordkeeping requirements.

Device Modifications Post-clearance or Approval

Medical devices can be marketed only for the indications for which they are cleared or approved.

After a device has received 510(k) clearance for a specific intended use, any change or modification that significantly affects its safety or effectiveness, such as a significant change in the design, materials, method of manufacture or intended use, may require a new 510(k) clearance or, depending on the modification, a de novo classification request or PMA approval, as well as payment of an FDA user fee.

The determination as to whether or not a modification could significantly affect the device’s safety or effectiveness is initially left to the manufacturer using available FDA guidance;

however, the FDA may, if it disagrees with the manufacturer’s determination, review this determination to evaluate the regulatory status of the modified product at any time and may require the manufacturer to cease marketing and recall the modified device until a new 510(k) clearance or PMA approval is obtained.

The manufacturer may also be subject to significant regulatory fines or penalties for marketing a modified device without the requisite pre-marketing authorization.

Postmarket Requirements

After a device is cleared or approved for commercial distribution, numerous federal and state regulatory requirements apply.

These include product listing and establishment registration requirements, which help facilitate FDA inspections and other regulatory actions, and our manufacturing sites are subject to periodic inspection by the FDA for compliance with the FDA’s Quality Management System Regulations, which cover the procedures and documentation of the design, testing, production, control, quality assurance, labeling, packaging, sterilization, storage and shipping of medical devices;

the Medical Device Reporting regulation, which requires that manufacturers report to the FDA if their device may have caused or contributed to a death or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if the malfunction were to recur;

and the Reports of Corrections and Removals regulation, which requires manufacturers to report recalls and field corrective actions to the FDA if initiated to reduce a risk to health posed by the device or to remedy a violation of the FDCA.

Postmarket requirements are also followed globally where our products are registered and approved.

These foreign jurisdictions have similar requirements to the FDA, including product registration, reporting of adverse events or serious incidents, trend reporting and reporting of withdrawals, recalls, and other corrective measures.

In addition, labeling and promotional activities are subject to scrutiny by the FDA and, in certain circumstances, by the Federal Trade Commission.

Medical devices that are approved or cleared by the FDA may not be promoted for unapproved or uncleared uses, otherwise known as “off-label” promotion.

The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted off-label uses may be subject to significant liability, including substantial monetary penalties and criminal prosecution.

If the FDA believes that a company is not in compliance with applicable regulations, it may issue a warning letter or untitled letter, institute proceedings to detain or seize products, issue a recall or market withdrawal order, impose operating restrictions including total or partial suspension of production or distribution, enjoin future violations, assess civil penalties against the company, its officers or its employees and may recommend criminal prosecution to the U.S.

Department of Justice.

The majority of Integra manufacturing facilities participate in the Medical Device Single Audit Program and are audited annually for compliance with the Quality System for U.S.

FDA, Canada, Australia, Brazil, and Japan.

Moreover, after clearance or approval is given, if the product is shown to be hazardous or defective, the FDA and foreign regulatory agencies have the power to withdraw the clearance or approval, as the case may be, or require us to change the device, its manufacturing process or its labeling, to supply additional proof of the device’s safety and effectiveness or to recall, repair, replace or refund the cost of the medical device.

Because we currently export medical devices manufactured in the U.S.

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The FDA has specific regulations governing HCT/Ps.

An HCT/P is a

product containing, or consisting of, human cells or tissue intended for transplantation into a human patient.

An HCT/P is a product containing, or consisting of, human cells or tissue intended for transplantation into a human patient.

Examples of HCT/Ps include bone, ligament, skin and cornea.

Some HCT/Ps fall within the definition of a biological product, medical device or drug regulated under the FD&C Act.

Some HCT/Ps fall within the definition of a biological product, medical device or drug regulated under the FDCA.

These biologic, device or drug HCT/Ps must comply both with the requirements exclusively applicable to HCT/Ps and, in addition, with requirements applicable to biologics, devices or drugs, including premarket clearance or approval from the FDA.

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In Tennessee, we are registered with the FDA Center for Biological Evaluations and Research.

Procurement of certain human organs and tissue for transplantation is subject to the restrictions of the National Organ Transplant Act, which prohibits the transfer of certain human organs, including skin and related tissue for valuable consideration, but permits the reasonable payment associated with the removal, transportation, implantation, processing, preservation, quality control and storage of human tissue and skin.

consideration, but permits the reasonable payment associated with the removal, transportation, implantation, processing, preservation, quality control and storage of human tissue and skin.

BioD is a registered Tissue Bank and is involved with the recovery, storage and transportation of donated human amniotic tissue.

Medical Device Regulations

The FDA requires that a manufacturer obtain 510(k) clearance or a PMA for a variety of reasons, such as introducing a new medical device or new indication for use of an existing medical device, before introducing it into the U.S.

The type of marketing authorization is generally linked to the classification of the device.

The FDA classifies medical devices into three classes based on risk.

Regulatory control increases from Class I (lowest risk) to Class III (highest risk).

The FDA generally must clear or approve the commercial sale of new medical devices in Classes II and III.

Commercial sales of our Class II medical devices (except for Class II exempt devices) and Class III medical devices within the U.S.

must be preceded by either a pre-market notification filing pursuant to Section 510(k) of the FD&C Act (Class II) or the granting of a pre-market approval, or PMA (Class III).

The process of obtaining a Section 510(k) clearance generally requires the submission of performance data and may require clinical data, which in some cases can be extensive, to demonstrate that the device is “substantially equivalent” to another device that is currently marketed under a 510(k);

a device that is referred to as “predicate device.” As a result, FDA clearance requirements may extend the development process for a considerable length of time.

In the case of a PMA, the FDA may require additional review by an advisory panel, which can further lengthen the process.

The PMA process, which is reserved for new devices that are not substantially equivalent to any predicate device and for high-risk devices (i.e., Class III devices) that are used to support or sustain human life or which present a potential, unreasonable risk of illness or injury, may take several years and requires the submission of extensive performance and clinical information.

Medical devices can be marketed only for the indications for which they are cleared or approved.

The determination as to whether or not a modification could significantly affect the device’s safety or effectiveness is initially left to the manufacturer using available FDA guidance;

however, the FDA may review this determination to evaluate the regulatory status of the modified product at any time and may require the manufacturer to cease marketing and recall the modified device until 510(k) clearance or PMA approval is obtained.

The manufacturer may also be subject to significant regulatory fines or penalties.

We also are required to register with the FDA as a medical device manufacturer and any devices we manufacture and distribute pursuant to clearance or approval by the FDA are subject to comprehensive and continuing regulation by the FDA and certain state agencies.

These regulations require that we manufacture our products and maintain our documents in a prescribed manner with respect to design, manufacturing, testing and control activities.

Further, we are required to comply with various FDA requirements and other legal requirements for labeling and promotion.

The De Novo medical device clearance pathway is a regulatory process established by the FDA for novel medical devices that do not have a legally marketed predicate device and so do not qualify for the 510(k) clearance pathway, but are considered low to moderate risk.

The De Novo clearance pathway allows such devices to be classified as either Class I or Class II providing a marketing pathway when general

controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness.

If the FDA believes that a company is not in compliance with applicable regulations, it may issue a warning letter, institute proceedings to detain or seize products, issue a recall order, impose operating restrictions, enjoin future violations and assess civil penalties against that company, its officers or its employees and may recommend criminal prosecution to the U.S.

Department of Justice.

The majority of Integra manufacturing facilities participate in the Medical Device Single Audit Program and are audited annually for compliance with the Quality System for US FDA, Canada, Australia, Brazil, and Japan.

Postmarket Requirements .

After a device is cleared or approved for commercial distribution, numerous regulatory requirements apply.

These include the FDA Quality System Regulations which cover the procedures and documentation of the design, testing, production, control, quality assurance, labeling, packaging, sterilization, storage and shipping of medical devices;

the FDA’s general prohibition against promoting products for unapproved or ‘off-label’ uses;

and the Reports of Corrections and Removals regulation, which require manufacturers to report recalls and field corrective actions to the FDA if initiated to reduce a risk to health posed by the device or to remedy a violation of the FD&C Act.

Postmarket requirements are also followed globally where our products are registered and approved.

These foreign jurisdictions have similar requirements to the FDA which include reporting requirements such as adverse events and recalls.

International

Regulations Outside of the U.S.

Medical device regulations also are in effect in many of the countries in which we do business outside the U.S.

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The requirements set forth in the EU MDR are generally consistent with those laid out in the EU MDD, but in many topics there are additional or stricter requirements.

Although we continue to transition our certification profile to meet the new EU MDR requirements, these stricter regulations set forth in the EU MDR may pose additional challenges for Integra to continue marketing products in the EU.

See “ Item 1A.

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Once a device is on the EEA market, manufacturers must comply with certain vigilance requirements, such as reporting serious incidents and field safety corrective actions (even those occurring outside the EEA) to the relevant competent authorities.

On December 16, 2025, the European Commission published a proposal to amend the EU MDR to simplify the regulation and address various concerns, including those related to notified body capacity constraints, certification timelines, regulatory burden and device availability.

If adopted, the proposed revisions could impact, amongst others, certification timelines, recertification (the maximum period of validity of certificates, currently 5 years, is proposed to be removed), certification activities (for example, a reduced involvement of notified bodies in the conformity assessment of class IIa and IIb devices is proposed, as well

as the possibility to replace on-site audits by remote audits) and post-market surveillance requirements (the proposal provides the possibility to conduct surveillance audits only every two years, and unannounced audits only ‘for-cause’).

The scope and timing for potential adoption of this revision is still unknown.

The ultimate effect of any EU MDR amendments on our business will depend on the shape of the adopted revised legislation and corresponding application timelines.

The EU MDD, EU MDR, ISO 9000 series and ISO 13485 are recognized international quality standards that are designed to ensure that we develop and manufacture quality medical devices.

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The manner in which reimbursement is sought and obtained varies based upon the type of payor involved and the setting in which the product is furnished and utilized.

Government payors, such as Medicare, are increasingly seeking additional clinical evidence beyond the data required to obtain marketing clearance, before covering our products for their patients.

Government payors, such as Medicare and national health systems of EU countries, are increasingly seeking additional clinical evidence beyond the data required to obtain marketing clearance, before covering our products for their patients.

For example, in the EU, the Health Technology Assessment (HTA) Regulation (EU) 2021/2282 which began to apply from January 12, 2025 (subject to phased implementation), provides for the use of common HTA tools, methodologies, and procedures across the EU for certain categories of health technologies, including certain medical devices, and sets the basis for enhanced cooperation at the EU level for joint clinical assessments.

Reimbursement from Medicare, Medicaid and other third-party payors may be subject to periodic adjustments as a result of legislative, regulatory and policy changes, as well as budgetary pressures.

For instance, in the 2026 Medicare physician, hospital outpatient, and ambulatory surgical center payment system final rules, Medicare revised its payment methodology for most sheet skin substitute products to a single per square centimeter payment rate regardless of product and settings, which may significantly alter Medicare payment for such products in these settings.

Possible reductions in, or eliminations of, coverage or reimbursement by third-party payors, or denial of, or provision of uneconomical reimbursement for new products may affect our customers' revenue and ability to purchase our products.

Any changes in the healthcare regulatory, payment or enforcement landscape relative to our customers’ healthcare services have the potential to significantly affect our operations and revenue.

Implementation of legislative or regulatory reforms to reimbursement systems, including price regulation, competitive bidding and tendering, coverage and payment policies, comparative effectiveness of therapies, technology assessments and managed-care arrangements, or adverse decisions relating to our products by administrators of these systems in coverage or reimbursement, could significantly reduce reimbursement or result in the denial of coverage, which could have an impact on the acceptance of and demand for our products and the prices that our customers are willing to pay for them.

Implementation of legislative or regulatory reforms to reimbursement systems, including price regulation, reference pricing systems, competitive bidding and tendering, coverage and payment policies, comparative effectiveness of therapies, health technology assessments and managed-care arrangements, or adverse decisions relating to our products by administrators of these systems in coverage or reimbursement, could significantly reduce reimbursement or result in the denial of coverage,

which could have an impact on the acceptance of and demand for our products and the prices that our customers are willing to pay for them.

Healthcare Reform

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For example, in August 2011, the Budget Control Act of 2011, among other things, created measures for spending reductions by Congress.

A Joint Select Committee on Deficit Reduction, tasked with recommending a targeted deficit reduction of at least $1.2 trillion for the years 2012 through 2021, was unable to reach required goals, thereby triggering the legislation’s automatic reduction to several government programs.

This includes aggregate reductions of Medicare payments to providers of up to 2% per fiscal year, which went into effect in April 2013 and, due to subsequent legislative amendments, will remain in effect through 2031.

Sequestration is currently set at 2% and will increase to 2.25% for the first half of fiscal year 2030, to 3% for the second half of fiscal year 2030, and to 4% for the remainder of the sequestration period that lasts through the first six months of fiscal year 2031.

When Congress was unable to reach required deficit reduction, it triggered the legislation’s automatic reduction to several government programs.

This included aggregate reductions of Medicare payments to providers currently at 2% per fiscal year and, due to subsequent legislative amendments, will remain in effect through 2033.

On July 4, 2025, the “One Big Beautiful Bill Act,” or OBBBA, was signed into law.

The OBBBA is projected to decrease federal health care spending by approximately $1 trillion by reducing Medicaid spending and enrollment and making changes to federal Medicare spending.

The law also made changes to ACA marketplace enrollment that are projected to decrease the number of individuals with marketplace coverage.

It is unclear if these changes will impact demand for our products.

Some of the provisions of the ACA and related laws have been, and may continue to be, subject to judicial and Congressional challenges, and to modifications in their interpretation or implementation.

We plan to continue to evaluate the effect that the ACA and its possible modification may have on our business.

We plan to monitor health care legislation and the impact these changes, if enacted, may have on our business.

There has also been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products, which has resulted in several recent Congressional inquiries and proposed bills designed to, among other things, bring more transparency to product pricing and review the relationship between pricing and manufacturer programs.

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The AKS is broad and prohibits many arrangements and practices that are lawful in businesses outside of the healthcare industry.

There are a number of statutory exceptions and regulatory safe harbors that may protect certain business arrangements from prosecution if strictly complied with, however, those exceptions and safe harbors are drawn narrowly.

There are a number of statutory exceptions and regulatory safe

harbors that may protect certain business arrangements from prosecution if strictly complied with;

however, those exceptions and safe harbors are drawn narrowly.

There are also no available exceptions or safe harbors for many common business activities.

Practices that involve remuneration to those who prescribe, purchase, recommend or

arrange for the purchase, order or recommendation of medical devices, including discounts, providing items or services for free or engaging such individuals as consultants, advisors, or speakers, may be subject to scrutiny if they do not fit squarely within an available exception or safe harbor and would be subject to a facts and circumstances analysis to determine compliance with the AKS.

Practices that involve remuneration to those who prescribe, purchase, recommend or arrange for the purchase, order or recommendation of medical devices, including discounts, providing items or services for free or engaging such individuals as consultants, advisors, or speakers, may be subject to scrutiny if they do not fit squarely within an available exception or safe harbor and would be subject to a facts and circumstances analysis to determine compliance with the AKS.

A violation of the AKS can be established without proving that the person or entity had actual knowledge of the statute or specific intent to violate it.

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Actions under the False Claims Act can be brought by qui tam relators, or whistleblowers, on behalf of themselves and the government, and those relators can share in any settlement or resolution.

If an entity is determined to have violated the False Claims Act, it may be required to pay up to three times the actual damages sustained by the government, plus civil penalties for each separate false claim.

• The Health Insurance and Portability Act of 1996, and its implementing regulations (collectively, “HIPAA”), which imposes criminal and civil liability for, among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, or knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement, in connection with the delivery of, or payment for healthcare benefits, items or services by a healthcare benefit program, which includes both government and privately funded benefits programs.

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• State and foreign laws that require medical device companies to comply with the industry’s voluntary compliance guidelines and the applicable compliance guidance promulgated by the federal government or otherwise restrict payments (or require reporting transfers of value) that may be made to healthcare providers and other potential referral sources.

• The federal Physician Payments Sunshine Act, implemented as the Open Payments program, and its implementing regulations, require certain manufacturers of drugs, devices, biologics and medical supplies that are reimbursable (directly or indirectly) under Medicare, Medicaid, or the Children’s Health Insurance Program to report annually to the CMS information related to certain payments made in the preceding calendar year and other transfers of value to physicians, physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists, certified nurse-midwives and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members.

• The federal Physician Payments Sunshine Act, implemented as the Open Payments program, and its implementing regulations, requires certain manufacturers of drugs, devices, biologics and medical supplies that are reimbursable (directly or indirectly) under Medicare, Medicaid, or the Children’s Health Insurance Program to report annually to the CMS information related to certain payments or others transfers of value made in the preceding calendar year to physicians, other health care professionals, such as physician assistants and nurse practitioners, and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members.

Certain foreign countries, including the EEA, have similar requirements for the reporting of transfers of value to healthcare professionals.

Anti-bribery laws exist in many of the countries in which we sell our products outside the U.S., as well as the United States Foreign Corrupt Practices Act (the “FCPA”) which addresses the activities of U.S.

companies in foreign markets.

Violations of these laws are punishable by criminal and civil sanctions, including, but not limited to, civil and criminal penalties, up to treble damages, fines, restitution and exclusion from participation in federal and state healthcare programs, including Medicare and Medicaid.

Our products also are subject to regulation regarding reimbursement, and U.S.

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companies from directly or indirectly selling goods, technology or services to people or entities in certain countries.

In addition, these laws require that we exercise care in our business dealings with entities in and from foreign countries.

These laws also require that we exercise care in our business dealings with entities in and from foreign countries.

In addition to our need to comply with such regulations in connection with our direct activities, we also sell and provide goods, technology and services to agents, representatives and distributors who may export such items to customers and end-users.

If we, or the third parties through which we do business, are not in compliance with applicable import, export control or economic sanctions laws and regulations, we may be subject to civil or criminal enforcement action, and varying degrees of liability.

Such actions may disrupt or delay

sales of our products or services or result in restrictions on our distribution and sales of products or services that may materially impact our business.

If we, or the third parties through which we do business, are not in compliance with applicable import, export control or economic sanctions laws and regulations,

we may be subject to civil or criminal enforcement action, and varying degrees of liability.

Such actions may disrupt or delay sales of our products or services or result in restrictions on our distribution and sales of products or services that may materially impact our business.

Environmental Health and Safety .

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Our business relies on the secure electronic transmission, storage and hosting of sensitive information, including personal information, financial information, intellectual property, and other sensitive information related to our customers and workforce.

For example, in the U.S., the collection, maintenance, protection, use, transmission, disclosure and disposal of certain personal information and the security of medical devices are regulated at the U.S.

federal and state, and industry levels.

federal and state laws protect the confidentiality of certain patient health information, including patient medical records, and restrict the use and disclosure of patient health information by health care providers and other persons or entities that create, receive, maintain, or transmit health information.

In the U.S., the collection, maintenance, protection, use, transmission, disclosure and disposal of certain personal information and the security of medical devices are regulated at the U.S.

federal, state, and industry levels.

federal and state laws govern the confidentiality of certain patient health information, including patient medical records, and restrict the use and disclosure of patient health information by health care providers and other persons or entities that create, receive, maintain, or transmit health information.

For example, in the U.S., depending on the facts and circumstances, we could be subject to the requirements of HIPAA.

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HIPAA also regulates standardization of data content, codes and formats used in health care transactions and standardization of identifiers for health plans and providers.

Penalties for violations of HIPAA regulations include significant civil and criminal penalties for each violation.

In addition, the FDA has issued guidance advising manufacturers to take cybersecurity risks into account in product design for connected medical devices and systems, to assure that appropriate safeguards are in place to reduce the risk of unauthorized access or modification to medical devices that contain software and reduce the risk of introducing threats into hospital systems that are connected to such devices.

Penalties for violations of HIPAA include significant civil and criminal penalties for each violation.

In addition, the FDA has issued guidance advising manufacturers to take cybersecurity risks into account in product design for connected medical devices and systems, to assure that appropriate safeguards are in place to reduce the risk of unauthorized access or modification to medical devices that contain software and reduce the risk of introducing threats into healthcare systems that are connected to such devices.

The FDA also issued guidance on post market management of cyber security in medical devices.

Under section 5 of the Federal Trade Commission (“FTC”), the FTC expects a company’s data privacy and security measures to be reasonable and appropriate in light of the sensitivity and volume of consumer information it holds, the size and complexity of its business, and the cost of available tools to improve security and reduce vulnerabilities.

The Federal Trade Commission (“FTC”) also sets expectations for taking appropriate steps to safeguard consumers’ personal information, and providing a level of privacy or security commensurate to promises made to individuals.

Pursuant to Section 5 of the FTC Act, which governs unfair and deceptive trade practices, the FTC expects a company’s data privacy and security measures to be reasonable and appropriate in light of the sensitivity and volume of consumer information it holds, the size and complexity of its business, and the cost of available tools to improve security and reduce vulnerabilities.

Failure to meet these standards may constitute unfair or deceptive acts or practices in violation of the FTC Act.

The FTC also has the power to enforce the Health Breach Notification Rule, which imposes notification obligations on companies for breaches of certain health information contained in personal health records.

At the state level, the California Consumer Privacy Act (“CCPA”), as amended by the California Privacy Rights Act (“CPRA”), establishes certain requirements for data use and sharing transparency and provides California consumers (as defined in the law) certain rights concerning the use, disclosure, and retention of their personal data.

Such rights include rights to access and delete personal information, opt out of certain personal information sharing, and receive detailed information about how personal information is used.

Enforcement by the FTC under the FTC Act and Health Breach Notification Rule can result in civil penalties or enforcement actions.

At the state level, the California Consumer Privacy Act (“CCPA”)establishes certain requirements for processing personal data, including obligations related to transparency and the collection, use, retention, and disclosure of personal data, and provides California consumers (as defined in the law) certain rights.

Such rights include rights to access, correct, and delete personal

information, opt out of certain personal information sharing, and receive detailed information about how personal information is used.

The CCPA provides for civil penalties for violations, as well as a private right of action for data breaches—involving certain types of personal information—that is expected to increase data breach litigation.

The CCPA may increase our compliance costs and potential liability.

Numerous other states, such as Virginia, Colorado, Utah, and Connecticut, have

enacted privacy laws similar to the CCPA, and some states, like Washington and Nevada, have enacted health privacy specific laws that grant heightened rights with respect to health information.

Nearly two dozen other states have enacted privacy laws similar to the CCPA, and some states, like Washington and Nevada, have enacted health privacy specific-specific consumer laws that grant heightened rights with respect to health information.

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.

states) designed to ensure the ethical use, privacy, and security of AI and the data that it processes.

Compliance with such laws will likely be an increasing and substantial cost in the future.

Outside the U.S., we are impacted by the privacy and data security requirements at the international, national and regional level, and on an industry specific basis.

Legal requirements in these countries relating to the collection, storage, handling and transfer of personal data and, potentially, intellectual property continue to evolve with increasingly strict enforcement regimes.

In Europe, for example, we are subject to the EU General Data Protection Regulation, including as implemented in the UK (collectively, “GDPR”) which imposes restrictions on the collection, use and transfer of personal data and includes, among other things, a requirement for prompt notice of data breaches to data subjects and supervisory authorities in certain circumstances and significant fines for non-compliance, which can go up to €20 million or up to 4% of the total worldwide annual turnover of the preceding financial year, whichever is higher.

The GDPR also requires companies processing personal data of individuals residing in the EU to comply with EU privacy and data protection rules.

In particular, when we rely on third-party service providers processing personal data of subjects in the EU, we must enter into suitable agreements with these providers and receive sufficient assurances that the providers meet the requirements of the GDPR.

The obligations under the GDPR may therefore be onerous and adversely affect our business, financial condition, results of operations and prospects.

Legal requirements in these countries relating to the collection, use, retention, disclosure, and international transfer of personal data and, potentially, intellectual property continue to evolve with increasingly strict enforcement regimes.

In Europe, for example, we are subject to the EU General Data Protection Regulation (EU GDPR) and the UK General Data Protection Regulation (UK GDPR) which impose restrictions on the collection, use and transfer of personal data and includes, among other things, a requirement for prompt notice of data breaches to data subjects and supervisory authorities in certain circumstances and significant fines for non-compliance, which can go up to €20 million/ GBP 17.5 million or up to 4% of the total worldwide annual turnover of the preceding financial year, whichever is higher.

The EU and UK GDPR also confer the right for data subjects to lodge complaints with supervisory authorities, seek judicial remedies and obtain compensation for damages resulting from violations of the GDPR.

The EU and UK GDPR also requires companies processing personal data (including health data from clinical trials) of individuals residing in the EU or UK to comply with local privacy and data protection rules.

The EUK and UK GDPR governs the lawfulness of processing personal data (including obtaining valid consent of the individuals to whom the personal data relates, where applicable), the disclosure of processing details to individuals, the adequacy, relevance and necessity of the personal data collected, the retention of personal data, 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 U.S., 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.

Data protection authorities from the different European Member States and the UK may interpret the GDPR and applicable related national laws differently and impose requirements additional to those provided in the GDPR that sit alongside the GDPR, as set out under applicable local data protection law.

In addition, guidance on implementation and compliance practices may be issued, updated or otherwise revised.

Enforcement by European and UK regulators is generally active, and failure to comply with the GDPR or applicable Member State/UK local law may result in fines or other penalties.

Further, the EU or UK Government may amend or update data protection law, which may result in changes to our business operations and potentially incur commercial cost.

In particular, when we rely on third-party service providers processing personal data of subjects in the EU or UK, we must enter into suitable agreements with these providers and receive sufficient assurances that the providers meet the requirements of the EU and UK GDPR.

The obligations under the EU and UK GDPR may therefore be onerous and adversely affect our business, financial condition, results of operations and prospects.

Please refer to “ Item 1A.

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HUMAN CAPITAL

Our people are our greatest asset and we view human capital management and the strength of our employees as integral to the long-term success of our business.

We understand that we rely on our employees worldwide to propel our organization forward with great ideas, innovations and leadership.

O ur people are our greatest asset and we view human capital management and the strength of our employees as integral to the long-term success of our business.

We understand that we rely on our employees worldwide to propel our organization forward with great innovations, strong leadership and a focus on execution excellence.

These efforts have been recognized through our inclusion in several best workplace lists globally in 2025 and 2024.

We continue to advance our broader organizational sustainability initiatives, and published our annual environmental, social and governance (“ESG”) report in the third quarter of 2025.

For more information on our ESG strategy, goals, performance, and achievements, please visit “Our

Company—ESG Report” at https://www.integralife.com/esg-report.

Information on our website is not incorporated by reference herein and is not part of this Annual Report on Form 10-K.

WORKFORCE DEMOGRAPHICS

As of December 31, 2024, we had approximately 4,396 regular full and part time employees.

Approximately 70% of our employees are located in the United States, 20% in Europe, 9% in Asia Pacific which includes Australia and New Zealand and 1% in Latin America and Canada.

As of December 31, 2025, we had 4,427 regular full and part time employees.

69.6% of our employees are located in the United States, 20.6% in Europe, 4.9% in Asia Pacific, 3.6% in China and 1.3% in Latin America and Canada.

BUILDING A STRONG WORKFORCE

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At all levels of the Company, we focus on attracting, retaining, and developing talent that drives innovation and results.

Through various Employee Resource Groups (“ERGs”), leadership councils and external partnerships, we provide opportunities for colleagues to contribute to our culture, develop professionally and provide feedback to our executive team.

In fiscal year 2024, we maintained seven (7) Integra-sponsored ERGs, which are employee-led groups, provide career development, leadership opportunities and networking connections across the organization.

Compensation and Benefits

Through various Business Resource Groups (“BRGs”), leadership councils and external partnerships, we provide opportunities for colleagues to contribute to our culture, develop professionally and provide feedback to our executive team.

As of December 31, 2025 there are eight (8) Integra-sponsored BRGs, employee-led groups, which provide career development, leadership opportunities and networking connections across the organization.

COMPENSATION BENEFIT

Our compensation philosophy is designed to reinforce and align with our mission, business strategy, and financial needs.

We invest in the physical, emotional and financial well-being of our employees through our robust compensation and benefit programs.

We invest in the physical, emotional and financial well-being of our employees through our compensation and benefit programs.

We provide market-competitive compensation and benefits based on benchmarking surveys we conduct regularly for all position levels against relevant peer companies.

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We are committed to providing a safe environment for all employees and visitors.

We rely on our environmental, health and safety management systems as well as entrusting our managers to oversee and ensure health and safety at their respective sites and foster a workplace culture to achieve that end.

This commitment is supported by our environmental, health, and safety management systems, alongside entrusting managers to oversee and ensure compliance with local laws and safety standards at their respective sites to foster a safe workplace culture.

We implement our approach globally by our systems and support at regional and country levels from colleagues that implement proper safety protocols, identify and correct hazards, and remain safety conscious at all times.

Managers are expected to enforce health and safety regulations, including compliance with applicable federal, state and local laws.

Our Environmental Health and Safety (“EH&S”) organizational structure incorporates both workplace EH&S coordinators and compliance teams.

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We regularly seek employee feedback and sentiment about our workplace through global engagement pulse surveys conducted on at least an annual basis.

After each survey is complete, we share detailed results with senior management and all employees within each department.

After each survey is complete, we share detailed results with senior management and all employees

within each department.

We are incorporating employee survey results into our corporate strategies – across company, division and function levels – and have further used this employee feedback to modify corporate programs and initiatives.

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We are committed to improving the quality of life of our employees and their families.

Our health and wellbeing programs differ by country and typical benefits include comprehensive health insurance, disability coverage, workplace accommodations, parental leave and other leaves of absence based on health or life events (e.g., bereavement), employee assistance programs, fitness reimbursement, and flu shots.

Our health and wellbeing programs differ by country and typical benefits include comprehensive health insurance, disability coverage, workplace accommodations, parental leave and other leaves of absence based on health or life events, employee assistance programs, fitness reimbursement, and flu shots fully covered by the company.

We also provide on-demand health advocates to help employees navigate the health insurance system, access to digital health solutions, a weight management program, smoking cessation assistance, a substance use disorder helpline, a diabetes health program and other similar programs to drive healthy behaviors and awareness.

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Segment and Geographic Information , to the Notes to Consolidated Financial Statements (Part IV, Item 15 of this Annual Report on Form 10-K).

AVAILABLE INFORMATION

CORPORATE HISTORY AND AVAILABLE INFORMATION

Integra LifeSciences Holdings Corporation was founded in 1989.

Our common stock trades on the Nasdaq Global Select Market (“Nasdaq”) under the symbol “IART.”

We are subject to the informational requirements of the Exchange Act of 1934.

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Investors and others should note that we announce material financial information to our investors using our investor relations website (investor.integralife.com), SEC filings, press releases, public conference calls and webcasts.

We use these channels as

well as social media to communicate with the public about our Company, our services and other issues.

We use these channels as well as social media to communicate with the public about our Company, our services and other issues.

It is possible that the information we post on social media could be deemed to be material information.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business