What changed in this filing

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Item 1. Business

2022-02-24 compared with 2021-02-23 · 164 added, 162 removed, 210 unchanged (61% of the section changed)

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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 Company has expanded its base regenerative technology business to include surgical instruments, neurosurgical devices, advanced wound care products, and orthopedic hardware through a combination of several global acquisitions and development of products internally to further meet the needs of its customers and impact patient care.

We manufacture and sell our products in two reportable business segments:

Codman Specialty Surgical and Orthopedics and Tissue Technologies.

Our Codman Specialty Surgical products are comprised of specialty surgical implants and instrumentation for a broad range of specialties.

This segment includes products and solutions for dural access and repair, instruments, advanced energy, cerebral spinal fluid ("CSF") management and neuro monitoring including market-leading product portfolios used in neurosurgery operating suites and critical care units.

Codman Specialty Surgical products are sold through a combination of directly employed sales representatives, distributors and wholesalers, depending on the customer call point.

Our Orthopedics and Tissue Technologies product portfolio consists of differentiated regenerative technology products for soft tissue repair and tissue regeneration products and surgical reconstruction.

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

Orthopedics and Tissue Technologies products are sold through directly employed sales representatives and distributors focused on their respective surgical specialties, and by strategic partners.

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

This transaction enables us to increase our investments in our business which will strengthen our existing leadership positions in both areas, fund pipeline opportunities to drive future growth and expand our addressable markets.

See Note 18, Subsequent Events , for details.

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

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

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.

Integra products are sold in more than 130 countries through a direct sales force as well as distributors and wholesalers.

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 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.

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, Indiana, Maryland, Massachusetts, New Jersey, Ohio, Puerto Rico, Tennessee, Utah, Canada, China, France, Germany, Ireland 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.

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We focus on four key pillars of our strategy:

1) building an execution-focused culture, 2) optimizing relevant scale, 3) improving agility and innovation, and 4) leading in customer experience.

We believe that by sharpening our focus on these areas through improved planning and communication, optimization of our infrastructure, and strategically aligned tuck-in acquisitions, we can build scale, increase competitiveness and achieve our long-term goals.

1) enabling an execution-focused culture, 2) optimizing relevant scale, 3) advancing innovation and agility, and 4) leading in customer experience.

We believe that by sharpening our focus on these areas through improved planning and communication, optimization of our infrastructure, and strategically aligned acquisitions, we can build scale, increase competitiveness and achieve our long-term goals.

To this end, the executive leadership team has established the following key priorities aligned to the following areas of focus:

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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.

In December 2020, Integra entered into a merger agreement to acquire ACell, Inc., an innovative regenerative medicine company.

This acquisition, which closed on January 20, 2021, expands our product offering of regenerative technology and is complementary to Integra’s existing tissue technologies portfolio.

The acquisition also supports our long-term growth and profitability strategy with a financial profile similar to Integra’s tissue products.

In 2020, we continued to invest in our two recent acquisitions from 2019, Arkis Biosciences, Inc.

and Rebound Therapeutics Corporation, both of which are developing innovative technologies for neurosurgery.

During 2021, the Company acquired 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.

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 and are focused on the potential for significant returns on investment.

In February 2020, we launched the AmnioExcel® Plus Placental Allograft Membrane, the next generation wound care offering to support soft tissue repair.

Throughout 2020, we continued to reap the benefits of many of our 10 new product launches from 2019.

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.

We continue to identify ways of optimizing our portfolio including identifying low-growth, low-margin products and product franchises for discontinuation.

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

See Note 3, Assets and Liabilities Held for Sale , for details.

Our product development efforts span across our key global franchises focused on potential 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.

In addition to acquisitions and organic reinvestment, we continually look to optimize our portfolio towards higher growth and higher margin businesses.

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 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.

Commercial Channel Investments .

With acquisitions, new product introductions and a broad portfolio of products, 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.

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

We now have a strong international sales channel that delivers our current portfolio as well as positions us for future expansion.

In addition, we continue to build upon our leadership brands across our product franchises, enabling us to engage customers through enterprise-wide contracts.

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.

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.

Customer Experience .

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

We strive to consistently deliver outstanding customer service and continue to invest in technologies, systems and processes to improve the way our customers do business with us.

Additionally, we utilize professional education programs to drive customer familiarity with our growing portfolio of medical technologies globally.

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.

BUSINESS SEGMENTS

Integra currently manufactures and sells our products and technologies in the following two global reportable business segments:

Codman Specialty Surgical and Orthopedics and Tissue Technologies.

Codman Specialty Surgical and Tissue Technologies.

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 17, Segment and Geographic Information and Note 18, Subsequent Events to our consolidated financial statements.

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).

Codman Specialty Surgical

Our Codman Specialty Surgical business offers global, neurosurgery market-leading technologies, brands and instrumentation.

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, intracranial pressure ("ICP") monitoring, hydrocephalus management, and cranial stabilization systems, while providing a rich research and development pipeline for growth.

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

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 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

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

Rounding out the portfolio is a catalog of surgical headlamps and surgical instrumentation, 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.

Additionally, through a strong U.S.

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

distribution model, we serve the needs of hundreds 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.

Orthopedics and Tissue Technologies

Orthopedics and Tissue Technologies products serves some of the fastest growing markets in the medical technology industry.

The broad range of regenerative tissue technologies primarily address 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 made significant investments with our channel expansion in the U.S.

and created dedicated sales channels to have more focus and specialization within our call points to drive sustainable growth.

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.

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.

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 on physicians who treat chronic wounds in the outpatient wound care clinic setting.

Our wound reconstruction sales representatives call on surgeons doing procedures in limb salvage, trauma, wound reconstruction and burns, 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 channels in our international markets to sell certain product lines.

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 orthopedics, spine, surgical and wound care.

Our competitors for Codman Specialty Surgical are Medtronic, Inc., Stryker Corporation, Becton Dickinson and Company and Aesculap division of B.

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

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.

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 technology, and our procurement and manufacturing operations to maintain our competitive position.

Our competition in Orthopedics and Tissue Technologies includes the DePuy/Synthes business of Johnson & Johnson, Stryker Corporation, Smith & Nephew plc, MiMedx Group, Inc., LifeCell Corporation, a subsidiary of Allergan PLC, and Zimmer Biomet Holdings, Inc.

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.

We compete with many 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.

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

We apply our core competency in regenerative technology to products for neurosurgical, orthopedic and wound applications, plastic surgery, and reconstructive surgery and we have extensive programs for our core platforms of orthopedic hardware and electromechanical technologies.

We apply our core competency in regenerative technology to innovate products for neurosurgical, wound applications, plastic surgery, and reconstructive surgery and we have extensive R&D development programs for our core platforms of electromechanical technologies.

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

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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 over the last few years.

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.

We also continued to benefit from our 2019 product launches, such as DuraGen® in Japan which is the first and only non-autologous collagen xenograft approved for use as a dural substitute in Japan.

In early 2020, we launched AmnioExcel® Plus Placental Allograft Membrane, a human placental tissue product for treatment of wounds.

Additionally, the Company 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.

As surgeons looks for ways to efficiently and effectively repair and close wounds during these challenging times, IBWM helps address the efficiency needed in operating rooms by reducing both the operating time and costs to hospitals and patients.

Orthopedic Reconstruction .

We developed fixation and small joint reconstruction implants and instruments for upper and lower extremities to both provide next generation solutions and expand our product portfolio.

This portfolio focuses on joint replacement products.

Integra has a strong shoulder portfolio, which includes a total shoulder system and a reverse shoulder.

We continue to work on advanced shoulder products and are developing next generation anatomical designs, bone preserving products and techniques, and a pyrocarbon shoulder hemiarthroplasty product to add to that portfolio.

We have a strong differentiated asset that resides in our patented pyrocarbon products, and we continue to invest to bring new products to market with this technology, which has shown significantly less wear on bone than traditional metals.

We also continued to benefit from the 2019 U.S.

product launches, such as the Panta® II TTC Arthrodesis Nail System.

The Panta II system is our new fusion nail used in ankle fixation.

We also launched a small post baseplate in our reverse shoulder system that accommodates smaller patients.

In addition, we initiated the limited market release of enhancements to our Salto Talaris® Total Ankle System.

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.

As surgeons look for ways to efficiently and effectively repair and close wounds, IBWM helps address the efficiency needed in operating rooms by reducing both the operating time and costs to hospitals and patients.

In 2021, we completed one of the largest diabetic foot ulcers ("DFU"), randomized controlled trials of the PriMatrix ® Dermal Repair Scaffold for the management of DFU.

This multi-center study enrolled more than 225 patients with chronic DFU's over the course of 12-week treatments and 4-week follow-up phases.

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.

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 cerebral spinal fluid ("CSF") management, neuro-critical care ("NCC") monitoring, minimally invasive instruments and electrosurgery and ultrasonic medical technologies.

In the Codman Specialty Surgical segment, our focus is also on the new electrosurgery generator and irrigator system, an innovative customer-centric toolkit for our Certas™ Plus Programmable Valve along with additional shunt configurations.

Our lighting franchise is among the most

dynamic in the industry.

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 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.

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

This enables us to add new instruments with minimal expense and invest in ongoing development, such as our next generation of LED technology with our DUO LED Surgical Headlight System™.

We develop core clinical applications in our electromechanical technologies portfolio.

In 2020, we updated our CUSA Clarity platform to incorporate a new ultrasonic handpiece, surgical tips and integrated electrosurgical capabilities.

In addition, the CUSA® Clarity Ultrasonic Surgical Aspirator System was cleared to treat malignant and benign tumors, but not limited to meningiomas and gliomas.

It is the first and only ultrasonic tissue ablation system with this specific indication.

The FDA clearance is based on a wealth of peer-reviewed clinical publications and 40 years of surgical cases involving resection of brain and spinal tumors.

Throughout the year, we continued to advance the early-stage technology platforms we acquired in 2019.

Through the Arkis Biosciences acquisition, 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.

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.

In 2021, 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.

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.

We also acquired a company, Rebound Therapeutics, developers of a single-use medical device known as the AURORA Surgiscope® System ("Aurora") that enables minimally invasive access with enhanced lighting and visualization to the neurosurgery suite.

Importantly, these new platforms provide us with the opportunity to expand into new, faster growth therapeutic areas, such as intracerebral hemorrhage and minimally invasive neurosurgery.

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.

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

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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.

Certain of our products, including but not limited to our dermal regeneration products, duraplasty products, wound care products, bone void fillers, nerve and tendon repair products, contain material derived from bovine tissue.

Certain of our products, including but not limited to our dermal regeneration products, duraplasty products, wound care products, and nerve and tendon repair products, contain material derived from bovine tissue.

We take great care to provide 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 either from the deep flexor tendon of cattle less than 24 months old from New Zealand, a country that has never had a reported case of bovine spongiform encephalopathy (“BSE”) (otherwise known as mad cow disease), or from the U.S.

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 from New Zealand, a country that has never had a reported case of bovine spongiform encephalopathy ("BSE") (otherwise known as mad cow disease), from the U.S.

or from fetal bovine dermis.

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

In an effort to protect our trade secrets, we have a policy of requiring our employees, consultants and advisors to execute proprietary information and invention assignment agreements upon commencement of employment or consulting relationships with us.

In an effort to protect our trade secrets, we have a policy requiring our employees, consultants and advisors to execute proprietary information and invention assignment agreements upon commencement of employment or consulting relationships with us.

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®, Algicell®, AmnioExcel®, AmnioMatrix®, Aquasonic®, Auragen®, Bactiseal®, BioBlock®, BioDFactor®, BioDFence®, BioDOptix®, BioDRestore™, Bioguard®, BioMotion®, Bold®, Brainet®, Budde®, Buzz™, Capture™, CereLink™, CerebroFlo® EVD Catheter with Endexo® Technology, Certas®, Codman®, Codman Accu-Flo®, Codman Bicol®, Codman Certas®, Codman Hakim®, Codman Holter®, Codman ICP Express®, Codman Microsensor®, Codman VersaTru®, Codman VPV®, Contour-Flex®, Cranioplastic®, CRW®, CRW Precision™, Cterm™, CUSA®, DigiFuse®, DirectLink®, DuraGen®, DuraSeal®, Endorelease™, First Choice®, HeliCote®, HeliPlug®, HeliTape®, HeliMend®, Helistat®, Helitene®, Hermetic™, Hy-Tape®, ICP Express®, Integra®, IntegraLink®, IPP-ON®, Isocool®, Jarit®, Katalyst™, Lead-Lok™, Licox®, LimiTorr™, Luxtec®, Mayfield®, MediHoney®, MemoFix®, MicroFrance®, Miltex®, Mischler™, MoniTorr ICP™, Movement®, Natus®, NeuraGen®, NeuraWrap™, Nicolet®, NuGrip®, Omnigraft®, Omni-Tract®, OSV II®, Padgett®, PriMatrix®, Pureflow™, PyroSphere®, Q-Snor™, Qwix®, Redmond™, Revize™, Ruggles®, SafeGuard®, Signacreme®, Spider™, Spin®, Subtalar MBA®, SurgiMend®, TCC-EZ®, TenoGlide®, Ti6®, Tibiaxys®, TissueMend®, TruArch®, Ultra VS™, Uni-CP®, Uni-Clip®, 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 ® , 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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In general, our first quarter usually has lower revenues than the preceding fourth quarter, the second and third quarters have higher revenues than the first quarter, and the fourth quarter revenues are the highest in the year.

The main exceptions to this pattern occur because of material acquisitions as well as impacts of the novel coronavirus ("COVID-19") in 2020.

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

In March 2020, the World Health Organization recognized the novel strain of coronavirus, COVID-19, as a pandemic.

This coronavirus outbreak has significantly impacted both the world and U.S.

In response to this coronavirus outbreak, the governments of many cities, counties, states and other geographic regions have taken preventative or protective actions, such as imposing restrictions on travel and business operations and are advising or requiring individuals to limit or forego their time outside of their homes which has created significant uncertainties in the U.S.

In certain geographic regions in which the Company operates, temporary closures of businesses have been ordered or suggested and numerous other businesses have temporarily closed voluntarily.

Further, individuals' ability to travel has been curtailed through mandated travel restrictions and may be further limited through additional voluntary or mandated closures of travel-related businesses.

The Company's focus during this global crisis remains 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 has resulted in an unprecedented challenge to the global healthcare industry, as medical resources are reallocated to fight COVID-19.

During 2020, we were able to sustain ongoing operations by implementing contingency plans such as enabling its manufacturing and distribution sites around the world to continue operating at levels required to meet demand and to provide for the safety of our employees.

During April of 2020, the Company implemented cost-savings measures, which included the following:

• Reduced executive management compensation through July 2020 and director compensation;

• Reduced cash compensation for all other employees through reduced commissions, reduction in hours through July 2020 and/or furloughs;

• Hiring freeze, elimination of overtime, reduction in certain employee benefit costs, cessation of third-party services and temporary contractor relationships;

• Significant reduction in capital expenditures and discretionary spending including travel, events and marketing programs.

The Company restored employee wages and other spending in the third quarter of 2020, as revenues sequentially increased approximately 43.1% as compared to the second quarter of 2020.

We also continue to implement programs and strategies to effectively manage the business during the pandemic, such as partnering with key opinion leaders to increase our customer engagement through educational webinars and to improve the clinical components of sales training.

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

We also remain focused on managing the business for the long-term, including preserving full time jobs needed to support the rebound in surgical procedure volumes.

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 by our talented and committed global workforce.

Throughout this period, we continue to prioritize and invest in critical R&D and clinical programs.

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

Risk Factors.

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.

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

We are a manufacturer and marketer of medical devices, and therefore are subject to extensive regulation by the FDA, the Center for Medicare Services of the U.S.

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 Center for Medicare Services of the U.S.

Department of Health and Human Services, other federal governmental agencies and, in some jurisdictions, by state and foreign governmental authorities.

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

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 potential product defects, the import and export of products, and other matters.

United States Food and Drug Administration

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

on an unapproved product, we are required to obtain

an Investigational Device Exemption ("IDE") from the FDA.

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

on an unapproved product, we are required to obtain an Investigational Device Exemption 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.

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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.

The FDA has specific regulations governing human cells, tissues and cellular and tissue-based products, or HCT/Ps.

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.

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

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.

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

National Organ Transplant Act

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.

Our subsidiary, BioD LLC 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 of the Public Health Services Act ("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 more recently the Company have been in discussions with the FDA to communicate their disagreement with the FDA’s assertion that certain products are more than minimally manipulated.

BioD, our wholly-owned subsidiary, 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.

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

In July 2020, the FDA issued the final guidance document related to human tissue titled, “Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products:

Minimal Manipulation and Homologous Use” (the “HCT/PFinal Guidance”).

This Guidance document supersedes the November 2017 guidance.

Minimal Manipulation and Homologous Use” (the “2020 HCT/P Final Guidance”).

The 2020 HCT/P Final Guidance document supersedes the November 2017 guidance by the same title.

The HCT/P Final Guidance maintains the FDA’s position that products such as the Company’s morselized amniotic membrane tissue-based products do not meet the criteria for regulation solely as HCT/Ps.

In addition, the FDA articulated a risk-based approach to enforcement and, while some uses for amniotic membrane tissue-based products would have as much as thirty-six months of enforcement discretion, other high risk uses could be subject to immediate enforcement action.

The revised final guidance extends the discretionary enforcement period to May 31, 2021.

The Company does not believe the uses for its amniotic membrane tissue-based products fall into the high-risk category.

As of February 23, 2021, the Company has not received any further notice of enforcement action from the FDA regarding its morselized amniotic tissue-based products.

Nonetheless, we can make no assurances that the FDA will continue to exercise its enforcement discretion with respect to the Company’s morselized amniotic membrane tissue-based products, and any potential action of the FDA could have a financial impact regarding the sales of such products.

Revenues from BioD morselized amniotic membrane-based products for the year ended December 31, 2020 were less than 1.0% of consolidated revenues.

In addition, in the November 2017 guidance, the FDA articulated a risk-based approach to enforcement and, while some uses for amniotic membrane tissue-based products would have as much as thirty-six months of enforcement discretion, other high risk uses could be subject to immediate enforcement action.

The 2020 HCT/P Final Guidance maintained this approach and extended the discretionary enforcement period to May 31, 2021.

Considering the risk of enforcement action, the Company discontinued the manufacturing of all morselized amniotic membrane tissue-based products prior to May 31, 2021.

We no longer distribute these products.

As of December 31, 2021, 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

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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 (the “EU”).

In addition, the EU enacted the EU Medical Device Regulation, which imposes stricter requirements on the marketing and sales of medical devices which includes but is 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 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.

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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Certain countries, as well as the EU, have issued regulations that govern products that contain materials derived from animal sources.

Regulatory authorities are particularly concerned with materials infected with the agent that causes bovine spongiform encephalopathy (“BSE”), otherwise known as mad cow disease.

Regulatory authorities are particularly concerned with materials infected with the agent that causes BSE.

These regulations affect our dermal regeneration products, duraplasty products, hernia repair products, biomaterial products for the spine, nerve and tendon repair products and certain other products, all of which contain material derived from bovine tissue.

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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 .”

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.

Postmarket Requirements.

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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, recalls, etc.

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

Other regulations

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healthcare laws apply when a customer submits a claim for a product that is reimbursed under a federally funded healthcare program.

These global laws require that we exercise care in

designing our sales and marketing practices, including involving interactions with healthcare professionals, and customer discount arrangements.

These global laws require that we exercise care in designing our sales and marketing practices, including interactions with healthcare professionals, and customer discount arrangements.

See “Item 1A.

Risk Factors for further details.

Risk Factors - We are exposed to a variety of risks relating to our international sales and operations ” of this Annual Report on Form 10-K for further details.

Import-export .

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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.

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.

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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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.

Europe, for example, we are subject to EU General Data Protection Regulation ("GDPR") which requires member states to impose minimum 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.

In Europe, for example, we are subject to EU General Data Protection Regulation ("GDPR") which requires member states to impose minimum 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.

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

Risk Factors - We are subject to requirements relating to information technology which could adversely affect our business.

Please refer to “Item 1A.

Risk Factors - We are subject to requirements relating to information technology which could adversely affect our business” of this Annual Report on Form 10-K for additional discussion of the risks accompanying compliance with data privacy and cybersecurity laws and regulations .

These laws and regulations impact the ways in which we use and manage personal data, protected health information, and our information technology systems.

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Workforce Demographics

As of December 31, 2020, we had approximately 3,700 full-time and part-time employees and 700 contingent, subcontracted and outsourced partners.

As of December 31, 2020, 64% of our workforce was located in the United States, 25% in Europe, 4% in Latin America and Canada and 7% in Asia Pacific which includes Australia and New Zealand.

As of December 31, 2021, we had approximately 3,800 regular full and part time employees and 900 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.

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") begins with our Board of Directors and CEO, and extends to all levels of the Company as we focus on attracting, retaining, and developing our global talent.

Our commitment to diversity and inclusion ("D&I") 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

The executive leadership team members set the D&I goals for the company and for the past three years it has been a company-wide goal to advance diversity and inclusion initiatives to build stronger teams.

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.

Leadership Councils, Employee Resource Groups and External Partnerships:

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

• Peter Arduini, President & Chief Executive Officer has chaired our Women’s Leadership Council since its inception in 2017.

The Women’s Leadership Council is an action and results-oriented advisory group comprised of fifteen of our senior women leaders.

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 high performing women.

• Our 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 resources groups.

Integra has four employee resources groups:

◦ Women of Integra Networks with 20+ chapters globally

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.

• 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:

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

◦ African American Affinity Group

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◦ Indian American Professional Network

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

◦ 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.

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 micro-inequities training.

The content includes understanding unconscious bias and subtle behaviors that devalue, discourage and impair workplace performance, identifying these in day-to-day interactions, and exploring ways to mitigate these micro-inequities on an individual and organizational level.

• In 2020, Integra colleagues globally participated 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 which examines what practicing inclusion in the workplace looks like.

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

Gender Diversity:

We believe that our company is better and delivers 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.

Integra's overall employee population is 47% female and 53% is male.

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

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:

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.

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

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The program has assisted in further building our pipeline of women leaders with 50% of the program’s graduates being promoted into roles with increased responsibility.

Employee Health and Safety:

Integra LifeSciences 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.

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.

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.

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.

FINANCIAL INFORMATION ABOUT GEOGRAPHIC AREAS

Financial information about our geographical areas is set forth in our financial statements Note 17, Segment and Geographic Information , to our consolidated financial statements.

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;

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• anticipated demand for our products, particularly capital equipment;

• our ability to produce regenerative-based products in sufficient quantities to meet sales demands;

• our ability to produce and deliver products in sufficient quantities to meet sales demands;

• our expectations concerning our ongoing restructuring, integration and manufacturing transfer and expansion activities;

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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