What changed in this filing

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Item 1. Business

2023-02-22 compared with 2022-02-24 · 180 added, 103 removed, 271 unchanged (51% of the section changed)

The terms “we,” “our,” “us,” “Company” and “Integra” refer to Integra LifeSciences Holdings Corporation, a Delaware corporation, and its subsidiaries, unless the context suggests otherwise.

The Company, headquartered in Princeton, New Jersey, is a world leader in medical technology.

The Company was founded in 1989 with the acquisition of an engineered collagen technology platform used to repair and regenerate tissue.

Since then, Integra has 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.

The terms “we,” “our,” “us,” “Company,” "Integra LifeSciences," and “Integra” refer to Integra LifeSciences Holdings Corporation, a Delaware corporation, and its subsidiaries, unless the context suggests otherwise.

Integra LifeSciences is a global leader in regenerative tissue technologies and neurological solutions dedicated to limiting uncertainty for clinicians so they can focus on providing the best patient care.

Founded in 1989 with the acquisition of an engineered collagen technology platform used to repair and regenerate tissue, Integra LifeSciences Holdings Corporation common stock trades on the Nasdaq Global Select Market (“Nasdaq”) under the symbol “IART.” Integra has 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.

The Company has expanded its base regenerative technology business to include surgical instruments, neurosurgical products and advanced wound care through global acquisitions and product development to meet the evolving needs of its customers and enhance patient care.

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Codman Specialty Surgical ("CSS") and Tissue Technologies ("TT").

The CSS segment, which represents 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 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.

We are the world leader in neurosurgery and one of the top three providers in instruments used in precision, specialty, and general surgical procedures.

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

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

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

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

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Strategic Acquisitions .

An important part of the Company's strategy is pursuing strategic transactions and licensing agreements that increase relevant scale in the clinical areas in which Integra competes.

During 2021, the Company acquired ACell Inc.

An important part of the our strategy is pursuing strategic transactions and licensing agreements that increase relevant scale in the clinical areas in which Integra competes.

Our growth strategy includes the acquisition of businesses, assets or products lines to increase the breadth of our offerings, the reach of our product portfolios and drive relevant scale to our customers.

On December 6, 2022, the Company completed the acquisition of Surgical Innovation Associates, Inc.

("SIA"), which develops, markets and sells DuraSorb®, a resorbable synthetic matrix for plastic and reconstructive surgery.

This acquisition will advance Integra’s global strategy in breast reconstruction, expanding plans to access the U.S.

market where SIA is pursuing pre-market approval for use in implant-based breast reconstruction ("IBBR").

We also continued to expand our product offering of regenerative technologies from our 2021 acquisition of ACell, Inc.

("ACell"), an innovative regenerative medicine company specializing in the manufacturing of porcine urinary bladder extracellular matrices .

This acquisition not only expanded the Company’s product offering of regenerative technologies, but it also supported the Company’s long-term growth and profitability strategy as this product line has a financial profile similar to Integra’s other regenerative tissue products.

All critical components of ACell have been integrated into the Company’s TT segment.

See Note 4, Acquisitions and Divestitures , to the Notes to Consolidated Financial Statements (Part II, Item 8 of this Form 10-K) for additional details.

In 2021, we continued to advance the development of pioneering neurosurgical technologies from our 2019 acquisitions, Arkis Biosciences, Inc.

and Rebound Therapeutics Corporation.

Portfolio Optimization and New Product Introductions.

See Note 4, Acquisitions and Divestitures , to the Notes to Consolidated Financial Statements (Part IV, Item 15 of this Annual Report on Form 10-K) for additional details.

New Product Introductions and Portfolio Optimization.

We are investing in innovative product development to drive a multi-generational pipeline for our key product franchises.

Our product development efforts span across our key global franchises focused on potential for significant returns on investment.

Our product development efforts span across our key global franchises focused on potential technological innovations for significant returns on investment.

In addition to new product development, we are funding studies to gather clinical evidence to support launches, ensure market access and improve reimbursement for existing products.

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As such, we may opportunistically divest businesses or discontinue products where we see limited runway for future value creation in line with our aspirations due in part to changes in the market, business fundamentals or the regulatory environment.

In August 2022, we completed the sale of our non-core traditional wound care ("TWC") business to Gentell, LLC ("Gentall") for $28.8 million, which consists of $27.8 million in cash plus $1.0 million in contingent consideration which may be received upon the achievement of certain revenue-based performance milestones.

In January 2021, we completed the sale of our Extremity Orthopedics business to Smith & Nephew USD Limited ("Smith & Nephew"), a subsidiary of Smith & Nephew plc, for approximately $240 million in cash.

This transaction enables us to increase

our investments in our core neurosurgery and tissue technologies businesses and fund pipeline opportunities to expand our addressable markets to strengthen our existing leadership positions in these segments and drive future growth.

See Note 4, Acquisitions and Divestitures , to the Notes to Consolidated Financial Statements (Part II, Item 8 of this Form 10-K) for details.

Our portfolio optimization actions over the past two years have allowed us to increase our focus on Integra’s core portfolio of market-leading products in neurosurgery, surgical instrumentation and regenerative tissue and moves us closer to achieving our long-term organic growth and profitability targets.

See Note 4, Acquisitions and Divestitures, to the Notes to Consolidated Financial Statements (Part IV, Item 15 of this Annual Report on Form 10-K) for additional details.

Commercial Channel Investments .

Investing in our sales channels is a core part of our strategy to create specialization and greater focus on reaching new and existing customers and addressing their needs.

To support our commercial efforts in Tissue Technologies, we expanded our two-tier specialist model to increase our presence in focused segments by creating a virtual selling organization to help serve the evolving needs of our customers.

To support our commercial efforts in Tissue Technologies, we utilize a two-tier specialist model to increase our presence in focused segments to help serve the evolving needs of our customers.

In addition, we continue to build upon our leadership brands across our product franchises in both CSS and TT to engage customers through enterprise-wide contracts with leading hospitals, integrated delivery networks and global purchasing organizations in the United States.

Internationally, we have increased our commercial resources significantly in key emerging markets and are making investments to support our sales organization and maximize our commercial opportunities.

These investments in our international sales channel position us well for expansion and long-term growth.

Domestically, we have also increased our TT sales force in the United States to support the expanded regenerative tissue product portfolio that includes ACell products.

These investments in our international and domestic sales channel position us well for expansion and long-term growth.

Customer Experience .

We aspire to be ranked as a best-in-class provider and are committed to strengthen our relationships with all customers.

We aspire to be ranked as a best-in-class provider and are committed to strengthening our relationships with all customers.

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

Additionally, we launched digital tools and programs, resources and virtual product training to drive continued customer familiarity with our growing portfolio of medical technologies globally.

In 2022, we outsourced certain transactional back-office finance and customer service activities to enhance customer quality, build scale for future growth, and capture cost efficiencies.

We also launched digital tools and programs, resources and virtual product training to drive continued customer familiarity with our growing portfolio of medical technologies globally.

BUSINESS SEGMENTS

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

Management's Discussion and Analysis of Financial Condition and Results of Operations", Note 16, Segment and Geographic Information to the Notes to Consolidated Financial Statements (Part II, Item 8 of this Form 10-K).

Management's Discussion and Analysis of Financial Condition and Results of Operations" and Note 16, Segment and Geographic Information to the Notes to Consolidated Financial Statements (Part IV, Item 15 of this Annual Report on Form 10-K).

Codman Specialty Surgical

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

The Codman Specialty Surgical business consists of a broad portfolio of market-leading brands, such as Codman ® , DuraGen ® , DuraSeal ® , CUSA ® , 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 growth in this business in the 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.

We also expanded our product offerings in 2021 with the launch of our new intracranial pressure ("ICP") monitoring system, CereLink™ in the U.S.

It provides clinicians with advanced continuous ICP monitoring that until now, has not been available when treating patients with traumatic brain injuries

In 2022, we made progress to 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.

Commercial launch is expected in the first quarter of 2023.

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

Moreover, we are expanding into minimally invasive surgery ("MIS") and the surgical management of intracerebral hemorrhages ("ICH"), with the 2021 clinical launch of Aurora ® Surgiscope ® , a proprietary surgical solution with integrated visualization and capabilities designed specifically for use in deep-seated brain lesions.

We started gathering clinical evidence using this same technology for early surgical intervention for the treatment of ICH.

We continue to gather clinical evidence using this same technology for early surgical intervention of ICH.

We believe this technology offers the promise of transforming the standard of care in neurosurgery.

In 2022, we launched the Aurora ® Evacuator with Coagulation device in the U.S., designed to be used in conjunction with our Aurora Surgiscope to safely address and evacuate blood in the brain caused by hemorrhagic stroke.

Rounding out the portfolio is a catalog of surgical headlamps and surgical instrumentation, as well as after-market service.

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

We also expanded our product offerings in 2021 with the launch of our new intracranial pressure ("ICP") monitoring system, CereLink ® in the U.S.

and Europe and continued the global rollout in the first half of 2022.

See additional discussion regarding certain matters with CereLink under "Item 1A.

Risk Factors" under the heading Risks Related to our Regulatory Environment

and under "Item 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations - General - FDA Matters" of this Annual Report on Form 10-K.

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.

Tissue Technologies

Following the sale of the Extremity Orthopedics business in the first quarter of 2021, we rebranded the Orthopedics and Tissue Technologies segment as Tissue Technologies.

See Note 4, Acquisitions and Divestitures , to the Notes to Consolidated Financial Statements (Part II, Item 8 of this Form 10-K) for details.

The Tissue Technologies segment consists of four unique regenerative technology areas - highly engineered bovine collagen, bovine dermis, porcine urinary bladder, and human amniotic tissue.

chronic wounds, including diabetic foot ulcers, and surgical tissue repair, such as hernia, tendon, peripheral nerve repair and protection.

The Tissue Technologies segment 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 Matrices, AmnioExcel ® , SurgiMend ® , MicroMatrix ® 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.

During 2022, we completed the acquisition of Surgical Innovation Associates, Inc.

("SIA"), which is seeking approval by the U.S Food and Drug Administration ("FDA") of the PMA application for its core technology, DuraSorb, for use in IBBR.

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

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We anticipate new product introductions and new clinical indications will continue to contribute to the growth of the segment.

In the third quarter of 2021, we filed the premarket approval application for a specific indication for SurgiMend in the use of post-mastectomy breast reconstruction, for which we hope to obtain FDA approval in 2023.

Our competitors for CSS are Medtronic, Inc., Stryker Corporation, Becton Dickinson and Company and Aesculap, a division of B.

In 2022, we launched NeuraGen ® 3D Nerve Guide Matrix, a resorbable implant for repair of peripheral nerve discontinuities and engineered to create an optimized environment for nerve regeneration.

In the third quarter of 2021, we filed the PMA application for a specific indication for SurgiMend in the use of post-mastectomy breast reconstruction, for which we hope to obtain FDA approval in 2024.

Our competitors for CSS are Medtronic, Inc., Stryker Corporation, Becton Dickinson and Company, and B.

Braun Medical, Inc.

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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 competition in TT includes Smith & Nephew plc, Organogenesis Holdings Inc., MiMedx Group, Inc., LifeCell Corporation, a subsidiary of Allergan PLC, C.R.

Bard, a subsidiary of Becton Dickinson and Company, and Axogen, Inc.

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

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

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Regenerative Technologies .

Integra was the first Company to receive a United States Food and Drug Administration ("FDA") claim for regeneration of dermal tissue and is a world leader in regenerative technology.

Integra was the first company to receive a FDA claim for regeneration of dermal tissue and is a world leader in regenerative technology.

Because regenerative technology products represent a fast-growing, high-margin opportunity for us, we allocate a large portion of our research and development budget to these projects.

Our regenerative technology development program applies our expertise in bioengineering to a range of biomaterials including natural collagen and human tissues as well as synthetics such as polymers.

These unique product designs are used for neurosurgical and orthopedic 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, provides us with strong platform technologies for multiple indications.

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 2020, we announced positive clinical and economic data on Integra ® Bilayer Wound Matrix ("IBWM") in complex lower extremity reconstruction based on two retrospective studies recently published in Plastic and Reconstructive Surgery, the official journal of the American Society of Plastic Surgeons.

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The results of this study, which was published in the Journal of Wound Care, demonstrated that PriMatrix plus standard of care ("SOC") consisting of sharp debridement, infection elimination, use of dressings and offloading was significantly more likely to achieve complete wound closure compared with SOC alone, with a median number of one application of the product.

Integra is currently pursuing pre-market approval for implant-based breast reconstruction with our Surgimend product.

In 2022, we acquired SIA, which is also pursuing a pre-market approval for IBBR.

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

We completed design control activities in 2022 for a Q1 2023 launch of Cytal and MicroMatrix in Europe and a pilot launch of the Cardion Pericardial Patch to gain clinical experience for finding a private label partner for that product.

Electromechanical Technologies and Instrumentation .

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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 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 MIS and ICH.

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 MIS and ICH.

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

The Company benefitted from our product launches from prior years, including our new electrosurgery generator and irrigator system, an innovative customer-centric toolkit for our Certas TM Plus Programmable Valve along with additional shunt configurations.

In Japan, we are experiencing strong growth as a result of the successful launch of DuraGen in mid-2019, which is the first and only collagen xenograft approved for use as a dural substitute in the country.

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

Also, we continue to update our CUSA Clarity platform by incorporating new ultrasonic handpiece, surgical tips and integrated electrosurgical capabilities.

In 2022, we made progress to 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) approval.

Commercial launch is expected in the first quarter of 2023.

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

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

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

In June 2022, we launched the Neutus ® EVD system, our first external ventricular drain (“EVD") in China.

The Neutus EVD system is manufactured in China by Shanghai Haoju Medical Technology Co., Ltd.

under an exclusive distribution arrangement.

The device is used in the management of cerebrospinal fluid and is highly complementary to our Bactiseal ® catheter and advanced intercranial pressure monitoring products.

In the third quarter of 2021, we launched our CereLink ICP Monitor System in the U.S.

CereLink provides enhanced accuracy, usability and advanced data presentation that provides clinicians with uncompromised, advanced continuous ICP monitoring that until now, has not been available when treating patients with traumatic brain injuries.

and Europe and continued the global rollout in the first half of 2022.

On August 18, 2022, the Company, after consultation with the FDA and other regulatory authorities outside of the United States, initiated an immediate voluntary global product removal of all CereLink ® intracranial pressure monitors.

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.

In 2022, we continued to advance the early-stage technology platforms we acquired in 2019.

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

Through the acquisition of Arkis Biosciences, Inc.

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

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.

In 2019, we also acquired Rebound Therapeutics, a Company that specialized in single-use medical device, known as Aurora Surgiscope, which is the only tubular retractor system designed for cranial surgery with an integrated access channel, camera and lighting.

Our work to combine our bactiseal antimicrobial technology with the Endexo anti-occlusive technology obtained through our 2019 acquisition of Arkis continues to progress for both a silicone-based hydrocephalus and EVD project.

In 2019, we also acquired Rebound Therapeutics Corporation ("Rebound Therapeutics"), a company that specialized in single-use medical device, known as Aurora Surgiscope, which is the only tubular retractor system designed for cranial surgery with an integrated access channel, camera and lighting.

In the third quarter of 2021, we conducted a limited clinical launch of the Aurora Surgiscope for use in minimally invasive neurosurgery as well as initiated a registry called MIRROR to collect data on early surgical intervention using this same technology platform for the treatment of ICH.

In 2022, we launched the Aurora ®

Evacuator with Coagulation device in the U.S., designed to be used in conjunction with our Aurora Surgiscope to safely address and evacuate blood in the brain caused by hemorrhagic stroke.

In general, raw materials essential to our businesses are readily available from multiple sources.

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These agreements also provide that all confidential information developed or made known to the individual during the course of their relationship with us must be kept confidential, except in specified circumstances.

AccuDrain ® , AmnioExcel ® , Aquasonic ® , Auragen ® , Aurora ® Surgiscope ® , Bactiseal ® , BioDFence ® , BioDOptix ® , Brainet ® , Budde ® , Buzz™, CereLink™, CerebroFlo ® EVD Catheter with Endexo ® Technology, Codman ® , Codman Accu-Flo ® , Codman Bicol ® , Codman ® Certas ® Plus, Codman ® Hakim ® Programmable valve, Codman Holter ® , Codman ICP Express ® , Codman Microsensor ® , Codman VersaTru ® , Codman VPV ® , Contour-Flex ® , Cranioplastic ®, CRW ®, CRW Precision™, Ctherm™, CUSA ® , Cytal ® , DirectLink ® , DuraGen ® , DuraSeal ® , Gentrix ® , HeliCote ® , HeliPlug ® , HeliTape ®, HeliMend ® , Helistat ® , Helitene ® , Hermetic™, Hy-Tape ® , Integra ® , IntegraLink ®, Isocool ® , Jarit ® , Lead-Lok™, Licox ® , LimiTorr™, Luxtec ®,

Mayfield ® , MatriStem UBM™, MediHone y® , MicroFrance ® , MicroMatrix ®, Miltex ® , Mischler™, MoniTorr ICP™, Natus ® , NeuraGen ® , NeuraWrap™, Nicolet ® , Omnigraft ® , Omni-Tract ® , OSV II ® , Padgett ® , PriMatrix ® , Pureflow™, Q-Snor™, Redmond™, Revize™, Ruggles ® , Signacreme ® , SurgiMend ® , TCC-EZ ® , TenoGlide ® , TissueMend ® , Ultra VS™, VersaTru ® , Xtrasorb ®, zRIP™, and the Integra logo are some of the material trademarks of Integra LifeSciences Corporation and its subsidiaries.

AccuDrain ® , AmnioExcel ® , Aquasonic ® , Auragen ® , Aurora ® Surgiscope ® , Bactiseal ® , BioDFence ® , BioDOptix ® , Brainet ® , Budde ® , Buzz™, CereLink ® , CerebroFlo ® EVD Catheter with Endexo ® Technology, Codman ® , Codman Accu-Flo ® , Codman Bicol ® , Codman ® Certas ® Plus, Codman ® Hakim ® Programmable valve, Codman Holter ® , Codman ICP Express ® , Codman Microsensor ® , Codman VersaTru ® , Codman VPV ® , Contour-Flex ® , Cranioplastic ®, CRW ®, CRW Precision™, Ctherm™, CUSA ® , Cytal ® , DirectLink ® , DuraGen ® , DuraSeal ® , DuraSorb ®, Gentrix ® , HeliCote ® , HeliPlug ® , HeliTape ®, HeliMend ® , Helistat ® , Helitene ® , Hermetic™, Hy-Tape ® , Integra ® , IntegraLink ®, Isocool ® , Jarit ® , Lead-Lok™, Licox ® , LimiTorr™, Luxtec ®, Mayfield ® , MatriStem UBM™, MediHone y® , MicroFrance ® , MicroMatrix ®, Miltex ® , Mischler™, MoniTorr ICP™, Natus ® , NeuraGen ® , NeuraWrap™, Nicolet ® , Omnigraft ® , Omni-Tract ® , OSV II ® , Padgett ® , PriMatrix ® , Pureflow™, Q-Snor™, Redmond™, Revize™, Ruggles ® , Signacreme ® , SurgiMend ® , TCC-EZ ® , TenoGlide ® , TissueMend ® , Ultra VS™, VersaTru ® , Xtrasorb ®, zRIP™, and the Integra logo are some of the material trademarks of Integra LifeSciences Corporation and its subsidiaries.

MAYFIELD ® is a registered trademark of SM USA, Inc., and is used by Integra under license.

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The main exceptions to this pattern occur because of material acquisitions as well as impacts of the COVID-19 pandemic.

Impact of COVID-19 Pandemic on our business

During the COVID-19 pandemic, the Company's focus remained on supporting patients, providing customers with life-saving products, and protecting the well-being of our employees.

The rapid and evolving spread of the virus and subsequent variants have resulted in unprecedented challenges to the global healthcare industry.

In response to the pandemic, we acted swiftly by implementing protocols to ensure continuity of our manufacturing and distribution sites around the world and to provide for the safety of our employees.

The COVID-19 pandemic continues to have widespread and unpredictable impacts and the Company has continued to manage risks in this uncertain environment.

We remain confident that the underlying markets in which the Company competes remain attractive.

We also remain focused on managing the business for the long-term.

The Company's adaptability and resiliency in the face of this unprecedented crisis is made possible in part by prior investments in technology infrastructure and operations, as well as our talented and committed global workforce.

Capital markets and worldwide economies have also been significantly impacted by the COVID-19 pandemic, and it is possible that the pandemic could cause a local and/or global economic recession.

Any such economic recession could have a material adverse effect on the Company's long-term business as hospitals curtail and reduce capital as well as overall spending.

The COVID-19 pandemic and local actions, such as “shelter-in-place” orders and restrictions on travel and access to our customers or temporary closures of our facilities or the facilities of our suppliers and their contract manufacturers, disruption and/or higher costs to the Company’s supply chain, staffing shortages in hospitals and labor constraints in our facilities, could further impact our sales, margins and our ability to ship our products and supply our customers.

Any of these events could negatively impact the number of surgical and medical intervention procedures performed and have a material adverse effect on our business, financial condition, results of operations, or cash flows.

Information pertaining to risk factors as it relates to the COVID-19 pandemic can be found in Item 1A.

Risk Factors of this Annual Report on Form 10-K.

GOVERNMENT REGULATION AND COMPLIANCE

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United States Food and Drug Administration

Our products are subject to extensive regulation particularly as to safety, efficacy and adherence to FDA Quality System Regulation, and related manufacturing standards.

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.

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.

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

The FDA requires, as a condition to marketing a medical device in the U.S., that we secure a Premarket Notification clearance pursuant to Section 510(k) of the Federal Food, Drug and Cosmetic Act (the "FD&C Act"), or an approved premarket approval ("PMA"), application (or supplemental PMA application).

Obtaining these approvals and clearances can take up to several years and may involve preclinical studies and clinical trials.

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Human Cells, Tissues and Cellular and Tissue-Based Products

Integra, through the acquisition of Derma Sciences and BioD LLC ("BioD"), is involved with the recovery, processing, storage, transportation and distribution of donated amniotic tissue.

Integra, through its wholly-owned subsidiary BioD LLC ("BioD"), is involved with the recovery, processing, storage, transportation and distribution of donated amniotic tissue.

The FDA has specific regulations governing HCT/Ps.

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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.

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

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

On June 22, 2015, the FDA issued an Untitled Letter (the "Untitled Letter") alleging that BioD's morselized amniotic membrane tissue-based products do not meet the criteria for regulation as HCT/Ps solely under Section 361 and that, as a result, BioD would need a biologics license to lawfully market those morselized products.

Since the issuance of the Untitled Letter, BioD and the Company have made known to the FDA their disagreement with the FDA’s assertion that certain products are more than minimally manipulated.

Since the issuance of the Untitled Letter, BioD and the Company has made known to the FDA their disagreement with the FDA’s assertion that certain products are more than minimally manipulated.

The FDA has not changed its position that certain of the BioD acquired products are not eligible for marketing solely under Section 361.

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As of December 31, 2022, the Company has not received any further notice of enforcement action from the FDA regarding its morselized amniotic membrane tissue-based products.

Revenues from the now discontinued BioD morselized amniotic membrane-based products for the year ended December 31, 2021 were less than 1.0% of consolidated revenues.

Medical Device Regulations

We also are required to register with the FDA as a medical device manufacturer.

As such, our manufacturing sites are subject to periodic inspection by the FDA for compliance with the FDA's Quality System Regulations.

Unless an exemption applies, the FDA requires that a manufacturer introducing a new medical device or a new indication for use of an existing medical device obtain either a Section 510(k) premarket notification clearance or a PMA, 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 one of three classes (Class I, II or III) based on the degree of risk the FDA determines to be associated with a device and the level of regulatory control deemed necessary to ensure the device’s safety and effectiveness.

The process of obtaining a Section 510(k) clearance generally requires the submission of performance data and often clinical data, which in some cases can be extensive, to demonstrate that the device is “substantially equivalent” to a device that was on the market before 1976 or to a device that has been found by the FDA to be “substantially equivalent” to such a pre-1976 device, a predecessor device is referred to as “predicate device.” As a result, FDA clearance requirements may extend the development process for a considerable length of time.

In addition, in some cases, 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 or those that are used to support or sustain human life, 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.

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 PMA approval and 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 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 devic e manufacturer and any devices we manufacture and distribute pursuant to clearance or approval by the FDA are subject to pervasive and continuing regulation by the FDA and certain state agencies.

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 System Regulations.

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.

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

In the European Economic Area ("EEA"), which is comprised of the 27 member states of the European Union plus Norway, Iceland and Liechtenstein, medical devices need to comply with specific requirements.

These requirements were previously known as "Essential Requirements" under the former EU Medical Devices Directive (Council Directive 93/42/EEC, or MDD) and are now defined "General Safety and Performance Requirements (GSPR)" under the new EU Medical Devices Regulation (Regulation (EU) 2017/745, or "EU MDR").

Although the requirements set forth in the EU MDR are generally consistent with those laid out in the MDD (with a few exceptions), the EU MDR is intended, among other things, to establish a uniform, transparent, predictable and sustainable regulatory framework across the EEA for medical devices and ensure a high level of safety and health while supporting innovation.

These laws range from comprehensive medical device approval and Quality System requirements for some or all of our medical device products to simpler requests for product data or certifications.

Under the European Union Medical Device Directive, medical devices must meet the Medical Device Directive standards and receive CE Mark Certification prior to marketing in the European Union ("EU").

In addition, the EU enacted the EU Medical Device Regulation, which imposes stricter requirements on the marketing and sales of medical devices including but not limited to quality systems, labeling and clinical data.

Under the European Union Medical Device Directive, medical devices must meet the Medical Device Directive standards and receive

CE Mark Certification prior to marketing in the EEA.

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 as these regulations come into force.

See “Item 1A.

Risk Factors - We are subject to stringent domestic and foreig n medical device regulations and oversight and any adverse action may adversely affect our ability to compete in the marketplace and our financial condition and business operations” of this Annual Report on Form 10-K.

CE Mark Certification requires a comprehensive quality system program, technical documentation, clinical evaluation and data on the product which are then reviewed, by a Notified Body.

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See “Item 1A.

Risk Factors - Certain of our products contain materials derived from animal sources and may become subject to additional regulation ” of this Annual Report on Form 10-K.

Risk Factors – Risks Related to our Regulatory Environment " of this Annual Report on Form 10-K.

Postmarket Requirements.

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These risks are managed to minimize or eliminate associated business impacts.

In the event of this type of accident, we could be held liable for damages and face a liability that could exceed our resources.

In the event of this type of accident, we could be held liable for damages

and face a liability that could exceed our resources.

We could be subject to a regulatory shutdown of a facility that could prevent the distribution and sale of products manufactured there for a significant period of time, and we could suffer a casualty loss that could require a shutdown of the facility in order to repair it, any of which could have a material, adverse effect on our business.

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federal and state, and industry levels.

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.

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.

For example, in the U.S.

we are obligated to comply with the requirements of the Health Insurance and Portability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (collectively, “HIPPA”).

Under HIPAA, the Department of Health and Human Services has issued regulations, including the HIPAA Privacy, Security and Breach Notification Rules, to protect the privacy and security of protected health information used or disclosed by covered entities including health care providers and their business associates, as well as covered subcontractors.

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.

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As of December 31, 2022, we had approximately 3,722 regular full and part time employees and 874 contingent, subcontracted, and outsourced partners.

65% of our employees are located in the United States, 23% in Europe, Middle East and Africa, 4% in Latin America and Canada and 8% in Asia Pacific which includes Australia and New Zealand.

70% of our employees are located in the United States, 21% in Europe, 2% in Latin America and Canada and 7% in Asia Pacific which includes Australia and New Zealand.

Diversity and Inclusion

A diverse workforce and an inclusive culture and work environment is a business priority and a key to our long-term success.

Our commitment to diversity and inclusion ("D&I") starts at the top with our Board of Directors and CEO.

Our commitment to diversity and inclusion starts at the top with our Board of Directors and CEO.

At all levels of the Company, we focus on attracting, retaining, and developing our diverse talent.

Leadership Commitment and Accountability

Executive leadership team members set the D&I goals for the company and advancing diversity and inclusion initiatives to build stronger teams remains a company-wide goal.

Executive leadership set diversity and inclusion goals for the Company on an annual basis.

Advancing diversity and inclusion initiatives to build stronger teams has been a company-wide goal and the direct engagement of executive leadership in advancing diversity and inclusion initiatives helps to promote awareness throughout the Company.

Leadership Councils, Employee Resource Groups and External Partnerships

We are accountable to our D&I commitment through our leadership councils, employee resource groups, and external partnerships.

• Our Women’s Leadership Council, since its establishment in 2017, is an action and results-oriented advisory group comprised of fifteen of our senior women leaders across Integra.

The specific charter of the Council is to work together to identify ways to continue to attract and retain female talent, advance the development of our women into leadership roles, increase the cultural awareness of the value of inclusion and diversity in our company, and create specific development forums for our high performing women at Integra.

We are accountable to our diversity commitment through our leadership councils, employee resource groups, and external partnerships.

• The Women’s Leadership Council, established in 2017 and chaired by our President & Chief Executive Officer, Jan De Witte, is a results-oriented advisory group comprised of ten of our senior women leaders across Integra.

specific charter of the Council is to work together to identify ways to continue to attract and retain female talent, advance the development of our women into leadership roles, increase the cultural awareness of the value of inclusion and diversity in our Company, and create specific development forums for our high performing women at Integra.

• Employee Resources Groups encourage a culture of awareness and inclusion, assist in the attraction and retention of diverse talent, and help colleagues develop leadership skills.

Members of the Executive Leadership Team serve as sponsors for each of Integra’s employee resource groups.

Integra has five Employee Resources Groups:

Integra currently has six Employee Resources Groups:

◦ Women of Integra Networks (WIN) with 20+ chapters globally

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◦ Veteran Employee Resource Group

◦ Indian American Professional Network

◦ Asian American and Pacific Islander Employee Resource Group

• We reinforce our commitment to diversity by partnering with other organizations focused on driving inclusion in the workplace including the CEO Action for Diversity & Inclusion, the largest CEO-driven business commitment to advance D&I in the workplace and Healthcare Businesswomen’s Association, an association dedicated to further the advancement and impact of women in the business of healthcare.

◦ Indian American Network

◦ Asian American and Pacific Islander Network

◦ Integra PRIDE (LGBTQ+ Employee Resource Group)

• We reinforce our commitment to diversity by partnering with other organizations focused on driving inclusion in the workplace including the CEO Action for Diversity & Inclusion, the largest CEO-driven business commitment to advance diversity and inclusion in the work place and Healthcare Businesswomen’s Association, an association dedicated to further the advancement and impact of women in the business of healthcare.

Promoting an inclusive culture through learning opportunities

To help drive our culture of inclusion, our colleagues participate in programs focused on how to manage bias and value differences.

• Members of our executive leadership, senior management team, and larger scope leaders participate in a half-day microinequities training.

To help drive our culture of inclusion, our colleagues participate in programs focused on how to manage bias, value differences, and develop inclusive leadership skills.

• Members of our executive leadership, senior management team, and larger scope leaders participated in a ½ day Microinequities training.

The content includes understanding unconscious bias and microinequities, how to identify microinequities in day-to-day decisions and actions as leaders, and ways to mitigate microinequities on an individual and organizational level.

• Upon joining Integra, colleagues globally participate in two programs to promote inclusion:

a course that creates awareness of unconscious biases in the workplaces and tools to build-bias breaking skills and a course that examines what practicing inclusion in the workplace looks like.

• In 2020, we launched two foundational programs to promote diversity and inclusion:

Introduction to Managing Unconscious Bias, a course that creates awareness of unconscious biases in the workplaces and tools to build-bias breaking skills and Practicing Inclusion which examines what practicing inclusion in the workplace looks like.

These trainings are now mandatory for all new Integra hires.

• We regularly provide educational content and resources to aid our colleagues as they build cultural competency and inclusive leadership skills

Gender Diversity

We believe that our company is stronger and will deliver strong operating results, when we build diverse teams and leverage broad perspectives to meet the needs of our shareholders, customers, colleagues, and communities we serve.

T he breakout of our colleagues by gender as of December 31, 2021:

The breakout of our colleagues by gender:

48% of Integra’s overall population is female, 52% male.

We continue to strive to ensure our diversity in our leadership roles is representative of our overall population.

We continue to strive to ensure our diversity in our leadership ranks is representative of our overall population.

Through mentorship, sponsorship, recruitment efforts, and development programs we look to continue to grow our population of females in leadership roles at Integra.

Currently, 38% of our executive leaders and 43% of senior leaders (non-executive vice presidents) are female.

In partnership with Leadership Edge, a company founded by women leaders and dedicated to growing and mentoring women, Integra sponsors the Excel Women’s Leadership Program.

In partnership with Leadership Edge, a company founded by women leaders and dedicated to growing and mentoring women.

Integra sponsors the Excel Women’s Leadership Program.

The program is designed to accelerate the development and advancement of high potential, mid-career female leaders into senior leadership roles.

The program has assisted in further building our pipeline of women leaders with 60% of the program’s graduates being promoted into roles with increased responsibility.

Compensation and Benefits

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

Our annual and long-term incentive packages are linked directly to business and individual performance, with a balance of short- and long-term financial and strategic objectives.

We have an employee stock purchase plan.

Eligibility for non-salary benefits such as salary continuance, life insurance, health insurance, and similar benefits, follows local regulations and practices.

Integra is a pay-for-performance company committed to fair pay.

All compensation decisions are made without regard to personal characteristics such as, but not limited to, gender, race, color, national or ethnic origin, age, disability, sexual orientation, gender identity or expression, genetic information, religion, or veteran status.

As part of our commitment to compensation equity, Integra regularly conducts a pay equity analysis, reviewing how our organization compensates employees against external and internal data in conjunction with the role and scope of each position and making adjustments if necessary.

Talent Development and Retention

We have comprehensive and effective human capital development programs in place because we believe that the personal success of our employees is critical to the overall success of our business.

To build a diverse and talented organization, we have invested in honing our recruiting and hiring processes to attract top talent and engage new hires from the very beginning of their experience at Integra.

We offer a variety of opportunities for our employees to learn and grow.

Continued learning and development is a critical component of employee job satisfaction, retention, and career advancement—and ultimately, a driver of business success.

We encourage and promote experiential, collaborative, and formal learning programs.

Employees are also encouraged to discuss with their managers the skills, training, and experience needed to grow and develop.

In addition to several skills-based trainings

available (technical, sales, leadership ability) to all employees, managers may recommend external job-specific development programs to employees.

These programs are paid for directly by Integra.

Employee Health and Safety:

Integra LifeSciences is committed to providing a safe environment for all employees and visitors.

Integra is 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.

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We have developed an Incident Procedure Policy and General Safety Rules that guide our colleagues to improve our workplace environment, improve safety, and reduce risk and costs.

As we navigate the COVID-19 pandemic and its variants, we have placed a high priority on employee health, providing resources to support our workforce through this challenging time.

To help limit exposure to the coronavirus, we acted to ensure employees in business-critical functions who cannot work from home are protected, including those in research and development, quality, manufacturing, distribution, and sales.

Personal protective equipment, increased sanitation and social distancing guidance are provided to protect our employees.

Throughout the COVID-19 pandemic, we have placed a high priority on employee health, providing resources to support our workforce.

At the outset of the pandemic, we sought to protect the health and safety of our employees unable to work remotely, including those in research and development, quality, manufacturing, distribution and sales roles.

Such measures included the institution of robust hygiene practices, distribution of personal protective equipment, and the adoption of increased sanitation and social distancing protocols.

We continue to actively monitor the COVID-19 pandemic and its variants and respond based on guidance from U.S.

and global health organizations, relevant governmental guidance, and evolving practices.

Employee Engagement & Wellbeing

We regularly seek employee feedback and sentiment about our workplace through global engagement surveys conducted on a bi-annual basis.

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

Each function or division appoints survey administrators who work with their respective teams to understand the feedback and establish action items.

We believe this process enables us to monitor employee engagement and create a continuously improving, satisfying work environment for our employees.

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.

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.

FINANCIAL INFORMATION ABOUT GEOGRAPHIC AREAS

Financial information about our geographical areas is set forth in our financial statements Note 16, Segment and Geographic Information , to the Notes to Consolidated Financial Statements (Part II, Item 8 of this Form 10-K).

AVAILABLE INFORMATION

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These forward-looking statements are subject to a number of risks, uncertainties and assumptions about us including, among other things:

• the COVID-19 pandemic;

• general economic and business conditions, both nationally and in our international markets;

• the on-going and possible future effects of the COVID-19 pandemic and associated economic disruptions, including supply chain constraints and inflation, on our business, financial condition, results of operations and cash flows;

• general economic and business conditions, both nationally and in our international markets, including the effect of the continuing worldwide macroeconomic uncertainty ;

• our expectations and estimates concerning future financial performance, financing plans and the impact of competition;

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• existing and future regulations affecting our business, and enforcement of those regulations;

• our failure to comply with the substantial regulation related to quality standards applicable to our manufacturing and quality processes could have an adverse effect on our business, financial condition, or results of operations;

• our ability to obtain additional debt and equity financing to fund capital expenditures, working capital requirements and acquisitions;

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• our ability to remediate all matters identified in FDA observations and warning letters that we received or may receive;

• other risk factors described in the section entitled "Risk Factors" in this report.

• other risk factors described in Item 1A.

"Risk Factors" in this Annual Report on Form 10-K.

Forward-looking statements can be identified by forward-looking words such as “believe,” “may,” “could,” “might,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “seek,” “plan,” “expect,” “should,” “would” and similar expressions in this report.

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In light of these risks and uncertainties, the forward-looking events and circumstances discussed in this report may not occur and actual results could differ materially from those anticipated or implied in the forward-looking statements.

UNRESOLVED STAFF COMMENTS

As of the filing of this Annual Report on Form 10-K, we had no unresolved comments from the staff of the Securities and Exchange Commission that were received not less than 180 days before the end of our 2021 fiscal year.

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