−Removed: Integra LifeSciences Holdings Corporation is a leading global medical technology company innovating treatment pathways to advance patient outcomes and set new standards of surgical, neurologic and regenerative care.
−Removed: Founded in 1989 with the acquisition of an engineered collagen technology platform used to repair and regenerate tissue, our common stock trades on the Nasdaq Global Select Market (“Nasdaq”) under the symbol “IART.” We have developed numerous product lines from this technology for applications ranging from burn and deep tissue wounds to the repair of dura mater in the brain, as well as nerves and tendons.
−Removed: We have expanded our 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 our customers and enhance patient care.
+Added: Integra LifeSciences Holdings Corporation was founded in 1989 and is a leading global medical technology company innovating treatment pathways to advance patient outcomes and set new standards of surgical, neurologic, ear, nose, and throat (“ENT”) and regenerative care.
+Added: Our common stock trades on the Nasdaq Global Select Market (“Nasdaq”) under the symbol “IART.” We have developed numerous product lines from this technology for applications ranging from burn and deep tissue wounds to the repair of dura mater in the brain, as well as nerves and tendons.
+Added: We have expanded our base regenerative technology business to include ENT, surgical instruments, neurosurgical products and advanced wound care through global acquisitions and product development to meet the evolving needs of our customers and enhance patient care.
Integra products are sold in more than 120 countries through a direct sales force as well as distributors and wholesalers.
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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.
−Removed: We are the world leader in neurosurgery and one of the top three providers in instruments used in precision, specialty, and general surgical procedures.
+Added: We are the world leader in neurosurgery and one of the top three providers in the U.S.
+Added: 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.
−Removed: 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.
+Added: We have key manufacturing and research facilities located in California, Maryland, Massachusetts, New Jersey, Ohio, Puerto Rico, Tennessee, Utah, France, Germany, Ireland, Israel and Switzerland.
We source most of our handheld surgical instruments and dural sealant products through specialized third-party vendors.
We aspire to continue to be a worldwide leader in neurosurgery and reconstructive surgery with a portfolio of leading businesses that delivers outstanding customer experiences through innovation, execution and teamwork to positively impact the lives of millions of patients and their families.
−Removed: Following the completion of our strategic refresh in 2023, we refocused our strategies around five pillars.
+Added: Our strategies are focused around five pillars.
Of these five pillars, we have identified three core growth drivers:
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Innovating for Outcomes .
−Removed: An important part of Integra’s growth strategy is introducing new products to strengthen and expand our portfolio, including via acquisitions.
−Removed: For example, we entered into a stock purchase agreement to acquire Acclarent, Inc.
−Removed: (“Acclarent”) from Ethicon, Inc., a subsidiary of Johnson & Johnson in December 2023.
−Removed: Acclarent is an innovator and market leader in ear, nose and throat (“ENT”) procedures and we believe that the acquisition of Acclarent will provide Integra with the opportunity to become a leading provider of ENT products and technologies.
−Removed: Furthermore, we believe that, owing to the ENT segment being an anatomical adjacency to neurosurgery, the acquisition will allow Integra to deliver future innovation both within the ENT segment and across our other CSS technology platforms.
−Removed: Additionally, we seek clinical evidence to support regulatory approval and strong reimbursement of our product portfolio around the world, including new indications for existing technologies.
+Added: An important part of Integra’s growth strategy is introducing new products to strengthen and expand our portfolio through clinical evidence to support regulatory approval and strong reimbursement of our product portfolio around the world, including new indications for existing technologies.
For example, in 2021, we filed a pre-market approval (“PMA”) application for a specific indication for Surgimend® in the use of post-mastectomy breast reconstruction.
−Removed: In 2022, we acquired SIA, which is also pursuing a pre-market approval for DuraSorb for use in implant-based breast reconstruction (“IBBR”), and in June 2023 we completed enrollment in the DuraSorb U.S.
−Removed: IDE clinical study for two-stage breast reconstruction;
−Removed: the primary follow-up period is one year after device implantation.
−Removed: We hope to obtain FDA approvals for both products in 2025.
−Removed: We also continued to advance the development of pioneering neurosurgical technologies with the expansion of our product offerings.
−Removed: In 2023 we launched the CUSA® Clarity Tips for use in surgical procedures requiring the controlled fragmentation, emulsification and aspiration of bone as well as in laparoscopic liver surgery.
+Added: We anticipate PMA approval following the operationalization of the Braintree facility, which is expected in the first half of 2026.
+Added: We are also pursuing a PMA for DuraSorb for use in implant-based breast reconstruction (“IBBR”).
+Added: We completed enrollment for the DuraSorb U.S.
+Added: investigational device exemption clinical study for two-stage breast reconstruction in June 2023;
+Added: and in 2024 we have continued to advance the PMA application.
+Added: Currently, we hope to secure PMA approval for DuraSorb in 2026.
+Added: In 2024 we expanded our urinary bladder matrix platform with the U.S.
+Added: launch of MicroMatrix® Flex, a dual-syringe system enabling the convenient mixing and precise delivery of MicroMatrix® paste to provide convenient access to hard-to-reach spaces and to help prepare an even wound surface in challenging wound areas.
+Added: Additionally, in 2024, we successfully re-launched our CereLink intracranial pressure (“ICP”) monitor system.
+Added: CereLink provides enhanced accuracy, usability and advanced data presentation that provides clinicians with uncompromised, advanced continuous ICP monitoring when treating patients with traumatic brain injuries.
Growing Internationally.
−Removed: Over the years, we have been significantly expanding our global footprint through investments in our commercial organization, the expansion and development of international markets and new product introductions.
−Removed: As part of our In-China-For-China strategy, we continue the build out of our assembly capabilities in our new facility in Suzhou, China.
−Removed: Several new products were introduced in select international markets in 2023, including MicroMatrix® and Certas Plus® Programmable Valve which were launched in Europe, and CUSA Clarity Laparoscopic tip which was launched in Australia,
−Removed: New Zealand, Japan, Canada, South Africa and Israel.
−Removed: In addition, DuraGen Secure, received approval in Japan, while DuraGen Plus, an absorbable and sutureless collagen onlay indicated as a dura substitute for the repair of dura mater, was approved in China.
+Added: Over the years, we have been significantly expanding our global footprint through investments in our commercial and manufacturing organizations, the expansion and development of international markets and new product introductions.
+Added: As part of our In-China-For-China strategy, we continue to build out our assembly capabilities in our new facility in Suzhou, China.
+Added: Several new products were introduced in select international markets in 2023 and 2024, including MicroMatrix® and Certas Plus® Programmable Valve, which were launched in Europe, and CUSA Clarity laparoscopic tip,
+Added: which was launched in Australia, New Zealand, Japan, Canada, South Africa and Israel.
+Added: In addition, DuraGen® Secure, received approval in Japan, while DuraGen Plus, an absorbable and sutureless collagen onlay indicated as a dura substitute for the repair of dura mater, and Certas Plus were approved in China.
Broadening Impact on Care Pathways .
−Removed: We seek ways to develop products and technologies that impact the lives of patients, starting with the journey that a patient takes from diagnosis and treatment planning to surgery and postoperative care.
+Added: We seek ways to develop and acquire products and technologies that impact the lives of patients, starting with the journey that a patient takes from diagnosis and treatment planning to surgery and postoperative care.
We are well-established in acute care in the hospital setting and continue to leverage that strong position to grow in this segment and shape treatment pathways into preoperative care and additional sites of care.
+Added: On April 1, 2024, we successfully completed the acquisition of Acclarent, Inc.
+Added: (“Acclarent”).
+Added: Acclarent is an innovator and market leader in ENT procedures and the acquisition of Acclarent has positioned Integra as one of the leading providers of ENT products and technologies.
+Added: Furthermore, we believe that, owing to the ENT business being an anatomical adjacency to neurosurgery, the acquisition will allow Integra to deliver future innovation both within the ENT business and across our other CSS technology platforms.
Driving Operations and Customer Excellence.
−Removed: We have been making investments to build more responsive and scalable processes, enhance the reliability of our supply chain, and drive productivity initiatives to further supply and lower costs.
−Removed: Additionally, we continue to invest in technologies, systems and processes to enhance the customer experience.
−Removed: In 2023, we continued to invest in our capacity expansion.
−Removed: This includes ongoing projects of transferring our Boston manufacturing to a new location in Braintree, Massachusetts., validating manufacturing processes in our manufacturing facility in Plainsboro, New Jersey and increasing cleanroom capacity in our Memphis, Tennessee location.
+Added: We have been making investments to build more responsive and scalable processes, enhance the reliability of our quality systems and supply chain, and drive productivity initiatives to further supply and lower costs.
+Added: We continue to invest in technologies, systems and processes to enhance the customer experience.
+Added: We also continue to invest in our capacity expansion.
+Added: This includes ongoing projects of transferring our Boston manufacturing to a new location in Braintree, Massachusetts and further investing in capacity and validating manufacturing processes in our manufacturing facility in Plainsboro, New Jersey.
+Added: We are implementing a Compliance Master Plan (the “CMP”), a systematic and holistic approach to improving our quality management system across our manufacturing and supply network.
+Added: The primary objectives of the CMP are to remediate quality system gaps, harmonize the quality management system across the company, and enhance the quality culture at the company.
Cultivating a High-Performance Culture.
−Removed: In seeking to sustain a culture of excellence and accountability, we have focused on employee empowerment and agility and building a diverse and inclusive workplace.
−Removed: These efforts resulted in our being named in several best workplace lists globally in 2023.
−Removed: Additionally, we have been making further strides in advancing our environmental, social and governance ("ESG") agenda to drive sustainability across the organization and recently published our second annual ESG report in the third quarter of 2023.
+Added: In seeking to sustain a culture of excellence and accountability, we focus on employee empowerment, professional development and building an environment where all employees can contribute to their fullest potential.
+Added: These efforts have been recognized through our inclusion in several best workplace lists globally in 2023 and 2024.
+Added: Additionally, we continue to advance our broader organizational sustainability initiatives and published our third annual environmental, social and governance (“ESG”) report.
For more information on our ESG strategy, goals, performance, and achievements, please visit “Our Company—ESG Report” at https://www.integralife.com/esg-report.
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We include financial information regarding our reportable business segments and certain geographic information under “Item 7.
−Removed: 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).
+Added: Management’s Discussion and Analysis of Financial Condition and Results of Operations” and Note 16.
+Added: 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
−Removed: Our CSS segment offers global, neurosurgery market-leading technologies, brands and instrumentation.
+Added: Our CSS segment consists of neurosurgery, specialty instrumentation, and ENT surgical solutions, augmented by the 2024 acquisition of Acclarent, a U.S.
+Added: leader in ENT solutions.
+Added: Acclarent pioneered the balloon sinuplasty market, and has expanded balloon dilation for Eustachian Tube, and surgical navigation and instrumentation for ENT and skull-base procedures.
+Added: In neurosurgery, we are a global leader in neuro-access, neuro-surgical and neuro-monitoring technologies.
The product portfolio represents a continuum of care from pre-operative, to the neurosurgery operating room, to the neuro-critical care unit and post care for both adult and pediatric patients suffering from brain tumors, brain injury, cerebrospinal fluid pressure complications and other neurological conditions.
−Removed: 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.
−Removed: Rounding out the portfolio is a catalog of surgical headlamps, surgical instrumentation, as well as after-market service.
+Added: We offer leading technologies in dural repair, ultrasonic tissue ablation, ICP monitoring, hydrocephalus management, and cranial stabilization systems, while providing a rich research and development pipeline for growth.
+Added: Our specialty instrumentation portfolio includes a catalog of surgical headlamps, surgical instruments, as well as after-market service.
With thousands of surgical instrument products, including specialty surgical instruments, we call on the central sterile processing unit of hospitals and acute care surgical centers.
Additionally, through a strong U.S.
−Removed: distribution model, we can serve the needs of hundreds of medical offices.
+Added: distribution model, we can serve the needs of medical offices.
Our global commercial network includes clinical specialists, a large direct global sales force and strategic partnerships and distributors that serve hospitals, integrated health networks, group purchasing organizations, clinicians, surgery centers and health care providers.
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complex wound surgery, surgical reconstruction, and peripheral nerve repair and consists of five unique regenerative technology areas - highly engineered bovine collagen, bovine dermis, porcine urinary bladder, human amniotic tissue, and resorbable synthetic mesh.
−Removed: 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.
−Removed: Following our acquisition of SIA in 2022, we have also sought to expand our IBBR product offerings and in June 2023 we completed enrollment in the DuraSorb U.S.
−Removed: IDE clinical study for two-stage breast reconstruction.
+Added: This broad regenerative platform, which includes multiple leading brands such as Integra® Dermal Regeneration Template, PriMatrix ® , AmnioExcel ® , SurgiMend ® , MicroMatrix ® , DuraSorb ® and NeuraGen ® , primarily addresses the needs of plastic, reconstructive and general surgeons focused on the treatment of acute wounds, such as burns, chronic wounds, including diabetic foot ulcers, and surgical tissue repair, such as hernia, tendon, peripheral nerve repair and protection.
We have a specialized sales organization composed of directly employed sales representatives, as well as specialty distributors, organized based upon their call point.
Our wound reconstruction sales representatives call on surgeons doing procedures in limb salvage, trauma, wound reconstruction and burns, and chronic wounds primarily in the inpatient wound care clinic setting.
−Removed: also have a dedicated surgical reconstruction sales team focused on plastic and reconstructive surgery and hernia procedures with differentiated products.
+Added: 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.
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Our research and development activities focus on identifying unmet surgical needs and addressing those needs with innovative solutions and products.
−Removed: The markets in which we participate are characterized by rapid technological change, frequent product introductions and evolving customer requirements.
Investment in research and development is critical to driving our future growth.
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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.
−Removed: Additionally, we conduct products and clinical studies to generate efficacy and health economic evidence.
+Added: Additionally, we conduct projects and clinical studies to generate efficacy and health economic evidence.
Regenerative Technologies .
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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.
−Removed: 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.
+Added: These unique product designs are used for neurosurgical and reconstructive surgical applications, as well as dermal regeneration, including the healing of
+Added: 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.
−Removed: In the second quarter of 2023, after consultation with the FDA, The Company initiated a voluntary global recall of all products manufactured at the Boston facility, including Primatrix®, Surgimend®, Revize™, and TissueMend™, distributed between March 1, 2018 and May 22, 2023.
−Removed: Risk Factors, under the heading Risks Related to our Regulatory Environment and under Item 7.
−Removed: 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.
−Removed: In the third quarter of 2021, we filed a PMA application for a specific indication for Surgimend® in the use of post-mastectomy breast reconstruction.
−Removed: In 2022, we acquired SIA, which is also PMA for DuraSorb with IBBR, and in June 2023 we completed enrollment in the DuraSorb U.S.
−Removed: IDE clinical study for two-stage breast reconstruction;
−Removed: the primary follow-up period is one year after device implantation.
+Added: In the third quarter of 2021, we filed a PMA application for a specific indication for Surgimend® in the use of post-mastectomy breast reconstruction and in July 2024 received approvable pending GMP status from FDA, which approved and closed out the clinical portion of this PMA application.
+Added: We anticipate PMA approval following the operationalization of the Braintree facility, which is expected in the first half of 2026.
+Added: In 2022, we acquired SIA, which has also submitted a PMA application for DuraSorb with IBBR, and in June 2023 we completed enrollment in the DuraSorb U.S.
+Added: investigational device exemption clinical study for two-stage breast reconstruction;
+Added: and in 2024 we have continued to advance the PMA application.
+Added: Currently, we hope to secure PMA approval for DuraSorb in 2026.
By offering two distinct product solutions, we believe we have the opportunity to build a leading position in the IBBR market.
−Removed: We hope to obtain FDA approvals in 2025.
−Removed: Additionally, 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.
Following the completion of design control activities in 2022, we launched both Cytal and MicroMatrix in Europe in 2023.
−Removed: In 2023, the Company received 510(k) clearance from the FDA for MicroMatrix® Flex.
−Removed: Electromechanical Technologies and Instrumentation .
−Removed: The CSS 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.
+Added: In March 2024, MicroMatrix® Flex, used in the management of wounds with hard-to-reach geometries, such as deep wounds that present with tunneling or undermining, became commercially available in the U.S.
+Added: Neurosurgical Solutions, Surgical Instruments, and ENT Solutions.
+Added: The CSS neurosurgical business consists of a broad portfolio of market-leading brands, such as Codman®, DuraGen®, DuraSeal®, CUSA®, CereLink®, Mayfield®, Bactiseal®, and Certas® Plus, which are used for the management of multiple disease states, including brain tumors, traumatic brain injury, hydrocephalus and other neurological conditions.
The growth in this business in recent years has been fueled by geographic expansion and new product registrations in markets, such as China, Japan, and Europe, which we expect to continue in the near-to-long term.
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We continue to update our CUSA® Clarity platform by incorporating new ultrasonic handpiece and integrated electrosurgical capabilities.
−Removed: In 2022, we made progress to several enhancements to our CUSA Clarity Tissue Ablation System.
+Added: We have made several enhancements to our CUSA® Clarity Tissue Ablation System.
The extended laparoscopic tip was launched in the U.S.
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We continue to work with several instrument partners to bring new surgical instrument platforms to the market.
−Removed: Throughout 2023 we also continued to advance the early-stage technology platforms we acquired in 2019.
+Added: We also continued to advance the early-stage technology platforms we acquired in 2019.
Through the acquisition of Arkis Biosciences, Inc.
−Removed: ("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.
+Added: (“Arkis”) we added a platform technology, CerebroFlo® external ventricular drainage (“EVD”), a catheter with Endexo® technology, a permanent additive designed to reduce the potential for catheter obstruction due to thrombus formation.
The CerebroFlo EVD catheter has demonstrated an average of 99% less thrombus accumulation onto its surface, in vitro, compared to a market leading EVD catheter.
Our work to combine our Bactiseal® antimicrobial technology with the Endexo anti-occlusive technology continues to progress for both a silicone-based hydrocephalus and EVD project.
−Removed: Throughout 2023, we continued to advance our innovation from the Rebound Therapeutics Corporation ("Rebound Therapeutics"), which was acquired in 2019.
+Added: We also continued to advance our innovation from the Rebound Therapeutics Corporation (“Rebound Therapeutics”), which was acquired in 2019.
Rebound Therapeutics specializes in a single-use medical device, known as the Aurora Surgiscope, which is the only tubular retractor system designed for cranial surgery with an integrated access channel, camera and lighting.
The 9mm Surgiscope received 510(k) clearance from the FDA in the fourth quarter of 2023.
−Removed: In the third quarter of 2021, we launched our CereLink ICP Monitor System in the U.S.
−Removed: and Europe and continued the global rollout in the first half of 2022.
−Removed: 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.
−Removed: We believe that the out-of-range readings are principally caused by a combined interaction of electrical noise (originating from sources such as electrical components in the device, other devices set up near the CereLink Monitor, and the hospital power grid) and an electrical potential difference between the patient and monitor.
−Removed: We submitted a traditional 510(k) submission to the FDA on September 15, 2023 as a result of customer reports about monitors whose pressure readings were out of range.
−Removed: We have received 510(k) clearance from the FDA on February 4th, 2024.
−Removed: We plan to resume shipments of CereLink monitors in the U.S.
−Removed: in the first quarter of 2024.
−Removed: Shipments resumed in international markets with a limited release in the third quarter of 2023.
+Added: In the first quarter of 2024, we relaunched our CereLink ICP monitoring system, after initiating an immediate voluntary global product removal of all CereLink® intracranial pressure monitors in 2022.
+Added: Cerelink p rovides enhanced accuracy, usability and advanced data presentation to clinicians treating patients with traumatic brain injuries.
+Added: In the second quarter of 2024, we acquired Acclarent, expanding our capabilities in the U.S.
+Added: Acclarent pioneered the balloon sinuplasty market and has a broad portfolio including the RELIEVA SPINPLUS® Balloon Sinuplasty System.
+Added: Acclarent also pioneered eustachian tube balloon dilation, and currently markets the AERA® Eustachian Tube Dilation System, which received 510(k) clearance for expanded pediatric indications in 2023.
+Added: Acclarent sells the TruDi® Navigation System, which includes a portfolio of navigated surgical instrumentation.
Risk Factors, under the heading Risks Related to our Regulatory Environment and under Item 7.
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In the event we are unable to obtain sufficient quantities of raw materials or components on commercially reasonable terms or in a timely manner, our ability to manufacture our products on a timely and cost-competitive basis may be compromised, which may have a material adverse effect on our business, financial condition and results of operations.
−Removed: 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.
−Removed: We take great care to provide products that are safe and free of agents that can cause disease.
−Removed: 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.
−Removed: or from fetal bovine dermis.
+Added: 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 natural collagen material derived from bovine tissue.
+Added: We take great care to provide medical products that are safe and free of agents that can cause disease.
+Added: In particular, the collagen used in the products that we manufacture is derived from the deep flexor tendon of cattle less than 24-months old or from fetal bovine dermis from New Zealand, a country that has never had a reported case of bovine spongiform encephalopathy (“BSE”) (otherwise known as mad cow disease), and from the U.S.
The World Health Organization classifies different types of cattle tissue for relative risk of BSE transmission.
−Removed: Deep flexor tendon and fetal bovine skin are in the lowest-risk category for BSE transmission, and therefore considered to have a negligible risk of containing the agent that causes BSE.
+Added: Deep flexor tendon and fetal bovine dermis are in the lowest-risk category for BSE transmission, and therefore considered to have a negligible risk of containing the agent that causes BSE.
INTELLECTUAL PROPERTY
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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.
−Removed: 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™,
−Removed: 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.
+Added: Acclarent Aera®, 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™, MediHoney ® , MicroFrance ® , MicroMatrix ®, Miltex ® , Mischler™, MoniTorr ICP™, Natus ® , NeuraGen ® , NeuraWrap™, Nicolet ® , Omnigraft ® , Omni-Tract ® , OSV II ® , Padgett ® , PriMatrix ® , Pureflow™, Q-Snor™, Redmond™, Relieva Spinplus®, Revize™, Ruggles ® , Signacreme ® , SurgiMend ® , TCC-EZ ® , TenoGlide ® , TissueMend ® , TruDi ® , 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.
Revenues during our fourth quarter tend to be stronger than other quarters because many hospitals increase their purchases of our products during the fourth quarter to coincide with the end of their budget cycles in the U.S.
−Removed: 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.
+Added: 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
+Added: quarter, and the fourth quarter revenues are the highest in the year.
The main exceptions to this pattern occur because of material acquisitions.
GOVERNMENT REGULATION AND COMPLIANCE
−Removed: 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.
+Added: We are a manufacturer and marketer of medical devices and Human Tissue and Cell Based Products (“HCT/Ps”) and therefore are subject to extensive regulation by the FDA, the Centers for Medicare & Medicaid Services (“CMS”) of the U.S.
Department of Health and Human Services (“HHS”), other federal governmental agencies and, in some jurisdictions, by state and foreign governmental authorities.
−Removed: 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.
−Removed: FDA product approvals may be withdrawn or suspended if compliance with regulatory standards is not maintained or if problems occur following initial marketing.
+Added: These regulations govern the introduction of new medical devices and HCT/Ps, the observance of certain standards with respect to the design, manufacture, testing, labeling, promotion and sales of the products, the maintenance of certain records, the ability to track devices, the reporting of adverse affects and potential product defects, the import and export of products, and other matters.
+Added: FDA product approvals, as well as equivalent approvals or certifications issued by foreign authorities or bodies, may be withdrawn or suspended, or other enforcement actions may occur, if compliance with regulatory standards is not maintained or if problems occur following initial marketing.
Our business is also affected by patient and data privacy laws and government payer cost containment initiatives, as well as environmental health and safety laws and regulations.
United States Food and Drug Administration
−Removed: Our products are subject to extensive regulation particularly as to safety, efficacy and adherence to FDA Quality System Regulation, and related manufacturing standards.
+Added: Our products are subject to extensive regulation particularly as to safety, efficacy and adherence to the 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.
4 unchanged sentences
Under the Federal Food, Drug and Cosmetic Act (the “FD&C Act”), authorization to commercially distribute a new medical device in the U.S.
−Removed: is generally obtained in one of two primary ways.
+Added: is generally obtained in one of two primary ways, both of which require review by the FDA.
The first, known as pre-market notification or the 510(k) process, requires us to demonstrate that our medical device is substantially equivalent to a legally marketed medical device.
A 510(k) pre-market notification filing must contain information establishing that the device to be sold is substantially equivalent to a device commercially distributed prior to May 28, 1976 or to a device that has been determined by the FDA to be substantially equivalent.
−Removed: The second, more rigorous process, known as pre-market approval (“PMA”) requires us to independently demonstrate that a medical device is safe and effective for its intended use.
+Added: The PMA process is the second, more rigorous process, which requires us to independently demonstrate that a medical device is safe and effective for its intended use.
This process is generally much more time-consuming and expensive than the 510(k) process.
−Removed: The PMA process involves a complex and lengthy testing process that is subject to review by the FDA and may require several years to obtain.
+Added: The PMA process involves a complex and lengthy testing process and may require several years to obtain.
We may need to first obtain an investigational device exemption (for significant risk devices), known as an IDE, in order to conduct extensive clinical testing of the device to obtain the necessary clinical data for submission to the FDA.
5 unchanged sentences
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.
−Removed: 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,
−Removed: replace or refund the cost of the medical device.
+Added: 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.
Because we currently export medical devices manufactured in the U.S.
3 unchanged sentences
The FDA has specific regulations governing HCT/Ps.
−Removed: An HCT/P is a product containing, or consisting of, human cells or tissue intended for transplantation into a human patient.
−Removed: Examples of HCTPs include bone, ligament, skin and cornea.
+Added: An HCT/P is a
+Added: product containing, or consisting of, human cells or tissue intended for transplantation into a human patient.
+Added: 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.
26 unchanged sentences
The manufacturer may also be subject to significant regulatory fines or penalties.
−Removed: We also are required to register with the FDA as a medical device manufacturer and any devices we manufacture and distribute pursuant to clearance or approval by the FDA are subject to pervasive and continuing regulation by the FDA and certain state agencies.
+Added: We also are required to register with the FDA as a medical device manufacturer and any devices we manufacture and distribute pursuant to clearance or approval by the FDA are subject to comprehensive and continuing regulation by the FDA and certain state agencies.
These 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.
1 unchanged sentence
Further, we are required to comply with various FDA requirements and other legal requirements for labeling and promotion.
−Removed: FDA regulates unclassified devices via the 510(k) process and has the authority to classify these devices and/or require Special Controls, additional testing and submission of a new 510(k) as part of the classification process for unclassified devices that are currently on the market as 510(k) cleared products.
+Added: The De Novo medical device clearance pathway is a regulatory process established by the FDA for novel medical devices that do not have a legally marketed predicate device and so do not qualify for the 510(k) clearance pathway, but are considered low to moderate risk.
+Added: The De Novo clearance pathway allows such devices to be classified as either Class I or Class II providing a marketing pathway when general
+Added: controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness.
If the FDA believes that a company is not in compliance with applicable regulations, it may issue a warning letter, institute proceedings to detain or seize products, issue a recall order, impose operating restrictions, enjoin future violations and assess civil penalties against that company, its officers or its employees and may recommend criminal prosecution to the U.S.
1 unchanged sentence
The majority of Integra manufacturing facilities participate in the Medical Device Single Audit Program and are audited annually for compliance with the Quality System for US FDA, Canada, Australia, Brazil, and Japan.
+Added: Postmarket Requirements .
+Added: After a device is cleared or approved for commercial distribution, numerous regulatory requirements apply.
+Added: These include the FDA Quality System Regulations which cover the procedures and documentation of the design, testing, production, control, quality assurance, labeling, packaging, sterilization, storage and shipping of medical devices;
+Added: the FDA’s general prohibition against promoting products for unapproved or ‘off-label’ uses;
+Added: the Medical Device Reporting regulation, which requires that manufacturers report to the FDA if their device may have caused or contributed to a death or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if it were to recur;
+Added: and the Reports of Corrections and Removals regulation, which require manufacturers to report recalls and field corrective actions to the FDA if initiated to reduce a risk to health posed by the device or to remedy a violation of the FD&C Act.
+Added: Postmarket requirements are also followed globally where our products are registered and approved.
+Added: These foreign jurisdictions have similar requirements to the FDA which include reporting requirements such as adverse events and recalls.
+Added: International
Medical device regulations also are in effect in many of the countries in which we do business outside the U.S.
+Added: These regulations may vary substantially from country to country.
+Added: To market our products in most countries, we must obtain regulatory approvals or certifications and comply with extensive safety and quality regulations in those countries.
+Added: The time required to obtain approval or certification to market our products in a foreign country may be longer or shorter than that required for FDA clearance or approval, and the requirements may differ.
In the European Economic Area (“EEA”), which is comprised of the 27 member states of the European Union (the “EU”) plus Norway, Iceland and Liechtenstein, medical devices need to comply with specific requirements.
−Removed: 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").
−Removed: 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.
−Removed: 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.
−Removed: Under the MDD, medical devices must meet the MDD standards and receive CE Mark Certification prior to marketing in the EEA.
−Removed: 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.
+Added: Medical device manufacturers are required to affix the CE mark (i.e., a mandatory conformity marking for certain products sold within the EEA) to their medical devices, often after the intervention of a Notified Body and the issuing of a CE Certificate of Conformity.
+Added: Regulation 2017/745 on medical devices (the “EU MDR”) sets out the basic regulatory framework currently applicable to medical devices in the EEA.
+Added: The EU MDR became applicable on May 26, 2021, repealing the prior Council Directive 93/42/EEC (the “EU MDD”), which had been regulating medical devices in the EEA for more than 20 years.
+Added: This represented a major change in the regulatory landscape of medical devices in the EEA.
+Added: The EU MDR sets out certain transitional provisions that allow for medical devices covered by the repealed EU MDD (called “legacy devices”) to still be marketed in the EEA for a certain period of time.
+Added: Currently, manufacturers can place on the EEA market legacy devices until maximum December 31, 2027 or December 31, 2028, depending on the type of device and subject to meeting certain conditions.
+Added: The requirements set forth in the EU MDR are generally consistent with those laid out in the EU MDD, but in many topics there are additional or stricter requirements.
+Added: Although we continue to transition our certification profile to meet the new EU MDR requirements, these stricter regulations set forth in the EU MDR may pose additional challenges for Integra to continue marketing products in the EU.
See “ Item 1A.
−Removed: 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.
−Removed: 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.
−Removed: A Notified Body is an organization designated by the national governments of the EU member states to make independent judgments about whether a product complies with the requirements established by each CE marking directive.
−Removed: The MDD, MDR, ISO 9000 series and ISO 13485 are recognized international quality standards that are designed to ensure that we develop and manufacture quality medical devices.
+Added: Risk Factors - We are subject to stringent domestic and foreign 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.
+Added: In the EEA, medical devices are currently required to comply with the General Safety and Performance Requirements (or “GSPR”) in Annex I of the EU MDR (for legacy devices, this corresponds to the Essential Requirements of Annex I of the EU MDD).
+Added: Compliance with GSPR is a prerequisite to be able to affix the CE mark to medical devices, without which they cannot be commercialized in the EEA.
+Added: To demonstrate compliance with the GSPR and obtain the right to affix the CE mark, a manufacturer must undergo a conformity assessment procedure, which varies according to the type of medical device and its classification.
+Added: In the EEA medical devices are classified into four different risk classes:
+Added: Class I (which is further divided into (i) devices that are placed on the market in sterile condition, (ii) have a measuring function, (iii) are reusable surgical instruments, and (iv) all others), IIa, IIb and III.
+Added: Apart from low risk medical devices (Class I if they have no measuring function, are not sterile, and are not reusable surgical instruments), where the manufacturer can issue an EU Declaration of Conformity based on a self-assessment of the conformity of the devices with the GSPR, a conformity assessment procedure requires the intervention of a Notified Body, which is an organization accredited by the competent authority of an EEA country to conduct conformity assessments.
+Added: The Notified Body typically audits and examines the products’ technical documentation and the quality management system for the manufacture, design and final inspection of the medical devices before issuing a CE Certificate of Conformity.
+Added: After receiving the CE Certificate of Conformity from the Notified Body upon successful completion of the conformity assessment, the manufacturer can draw up an EU Declaration of Conformity which allows it to affix the CE mark to the products.
+Added: Besides its involvement in the initial conformity assessment procedure, the Notified Body is required to carry out an annual audit (surveillance audit) and is also required to randomly perform unannounced audits at least once every five years.
+Added: The quality management system and technical documentation of manufacturers will be required to be recertified periodically, as CE Certificates of Conformity issued by a Notified Body remain valid only for the period indicated in them, in no case exceeding five years.
+Added: The EU MDR also provides various requirements relating to post-market surveillance and vigilance, including the obligation for manufacturers to implement a post-market surveillance system.
+Added: Once a device is on the EEA market, manufacturers must comply with certain vigilance requirements, such as reporting serious incidents and field safety corrective actions (even those occurring outside the EEA) to the relevant competent authorities.
+Added: The EU MDD, EU MDR, ISO 9000 series and ISO 13485 are recognized international quality standards that are designed to ensure that we develop and manufacture quality medical devices.
+Added: A Notified Body audits our facilities annually to verify our compliance with the ISO 13485 Quality System standard.
Other countries are also instituting regulations regarding medical devices or interpreting and enforcing existing regulations more strictly.
Compliance with these regulations requires extensive documentation and clinical reports for our products, revisions to labeling, and other requirements such as facility inspections to comply with the registration requirements.
−Removed: A recognized Notified Body audits our facilities annually to verify our compliance with the ISO 13485 Quality System standard.
−Removed: Certain countries, as well as the EU, have issued regulations that govern products that contain materials derived from animal sources.
+Added: Certain countries, including those in the EEA, 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 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.
−Removed: Although we take great care to provide that our products are safe and free of agents that can cause disease, products that contain materials derived from animals, including our products, may become subject to additional regulation, or even be banned in certain countries, because of concern over the potential for prion transmission.
+Added: Although we take great care to ensure that our products are safe and free of agents that can cause disease, products that contain materials derived from animals, including our products, may become subject to additional regulation, or even be banned in certain countries, because of concern over the potential for prior transmission.
Significant new regulations, a ban of our products, or a movement away from bovine-derived products because of an outbreak of BSE could have a material, adverse effect on our current business or our ability to expand our business.
1 unchanged sentence
Risk Factors – Risks Related to our Regulatory Environment ” of this Annual Report on Form 10-K.
−Removed: Postmarket Requirements .
−Removed: After a device is cleared or approved for commercial distribution, numerous regulatory requirements apply.
−Removed: These include the FDA Quality System Regulations which cover the procedures and documentation of the design, testing, production, control, quality assurance, labeling, packaging, sterilization, storage and shipping of medical devices;
−Removed: the FDA's general prohibition against promoting products for unapproved or 'off-label' uses;
−Removed: the Medical Device Reporting regulation, which requires that manufacturers report to the FDA if their device may have caused or contributed to a death or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if it were to recur;
−Removed: and the Reports of Corrections and Removals regulation, which require manufacturers to report recalls and field corrective actions
−Removed: to the FDA if initiated to reduce a risk to health posed by the device or to remedy a violation of the FD&C Act.
−Removed: Postmarket requirements are also followed globally where our products are registered and approved.
−Removed: These foreign jurisdictions have similar requirements to the FDA which include reporting requirements such as adverse events and recalls.
+Added: Regarding HCT/Ps and as happens in the U.S., these products can have various regulatory qualifications (medical devices, medicinal products or blood/tissues/cells products).
+Added: The donation, collection, procurement, testing, processing, preservation, storage, import, export and distribution in the EEA of human blood, tissues and cells is currently mainly regulated by Directive 2002/98/EC (the “Blood Directive”), Directive 2004/23/EC (the “Tissues and Cells Directive”) and the implementing acts adopted by each EEA country.
+Added: This legislation also partially applies to manufactured products derived from human blood, tissues and cells.
+Added: In July 2024, Regulation (EU) 2024/1938 on standards of quality and safety for substances of human origin intended for human application (the “SoHO Regulation”) was published.
+Added: This new Regulation will apply from August7,2027 and replace the Blood Directive and the Tissues and Cells Directive, changing the regulatory framework for the use of these substances in the EEA.
Regulations Governing Reimbursement
6 unchanged sentences
The manner in which reimbursement is sought and obtained varies based upon the type of payor involved and the setting in which the product is furnished and utilized.
+Added: Government payors, such as Medicare, are increasingly seeking additional clinical evidence beyond the data required to obtain marketing clearance, before covering our products for their patients.
Reimbursement from Medicare, Medicaid and other third-party payors may be subject to periodic adjustments as a result of legislative, regulatory and policy changes, as well as budgetary pressures.
2 unchanged sentences
Implementation of legislative or regulatory reforms to reimbursement systems, including price regulation, competitive bidding and tendering, coverage and payment policies, comparative effectiveness of therapies, technology assessments and managed-care arrangements, or adverse decisions relating to our products by administrators of these systems in coverage or reimbursement, could significantly reduce reimbursement or result in the denial of coverage, which could have an impact on the acceptance of and demand for our products and the prices that our customers are willing to pay for them.
+Added: Healthcare Reform
+Added: A primary trend in the U.S.
+Added: healthcare industry and elsewhere is cost containment.
+Added: For example, the Affordable Care Act (“ACA”), went into effect in 2010, and, among other things, includes changes to the coverage and payment for products under government health care programs.
+Added: In the United States, there have been, and we expect there to continue to be, a number of legislative and regulatory initiatives, at both the federal and state government levels, to change the healthcare system in ways that, if approved, could affect our ability to sell our products profitably.
+Added: Among policy makers and payors in the United States and elsewhere, there is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs, improving quality and/or expanding access.
+Added: Current and future legislative proposals to further reform healthcare or reduce healthcare costs may limit coverage of or lower reimbursement for the procedures associated with the use of our products.
+Added: The cost containment measures that payors and providers are instituting and the effect of any healthcare reform initiative implemented in the future could impact our revenue from the sale of our products.
+Added: Other legislative changes have been proposed and adopted in the United States since the ACA was enacted.
+Added: For example, in August 2011, the Budget Control Act of 2011, among other things, created measures for spending reductions by Congress.
+Added: A Joint Select Committee on Deficit Reduction, tasked with recommending a targeted deficit reduction of at least $1.2 trillion for the years 2012 through 2021, was unable to reach required goals, thereby triggering the legislation’s automatic reduction to several government programs.
+Added: This includes aggregate reductions of Medicare payments to providers of up to 2% per fiscal year, which went into effect in April 2013 and, due to subsequent legislative amendments, will remain in effect through 2031.
+Added: Sequestration is currently set at 2% and will increase to 2.25% for the first half of fiscal year 2030, to 3% for the second half of fiscal year 2030, and to 4% for the remainder of the sequestration period that lasts through the first six months of fiscal year 2031.
+Added: Some of the provisions of the ACA and related laws have been, and may continue to be, subject to judicial and Congressional challenges, and to modifications in their interpretation or implementation.
+Added: We plan to continue to evaluate the effect that the ACA and its possible modification may have on our business.
+Added: There has also been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products, which has resulted in several recent Congressional inquiries and proposed bills designed to, among other things, bring more transparency to product pricing and review the relationship between pricing and manufacturer programs.
+Added: Individual states in the U.S.
+Added: have also become increasingly active in enacting legislation and implementing regulations designed to control product pricing.
+Added: We expect that additional foreign, federal and state healthcare reform measures will be adopted in the future, any of which could limit the amounts that federal and state governments will pay for healthcare products and services, which could result in limited coverage and reimbursement and reduced demand for our products.
+Added: There have been, and likely will continue to be, legislative and regulatory proposals at the national level in the U.S.
+Added: and other jurisdictions globally, as well as at some regional, state and/or local levels within the U.S.
+Added: or other jurisdictions, directed at broadening the availability of healthcare and containing or lowering the cost of healthcare.
+Added: Such reforms could have an adverse effect on anticipated revenues from product that we may successfully develop and for which we may obtain marketing approval and may affect our overall financial condition and ability to develop product.
Other regulations
−Removed: Anti-Bribery Laws .
−Removed: In the U.S., we are subject to laws and regulations pertaining to healthcare fraud and abuse, including anti-kickback laws and physician self-referral laws that regulate the means by which companies in the health care industry may market their products to hospitals and health care professionals and may compete by discounting the prices of their products.
−Removed: Similar anti-bribery laws exist in many of the countries in which we sell our products outside the U.S., as well as the United States Foreign Corrupt Practices Act (the “FCPA”) which addresses the activities of U.S.
+Added: Healthcare Fraud and Abuse Laws .
+Added: In the U.S., we are subject to laws and regulations pertaining to healthcare fraud and abuse, including anti-kickback laws, false claims, and other health care fraud laws that regulate, among other things, the means by which companies in the health care industry may sell and market their products to hospitals and health care professionals and regulate the arrangements and engagements with customers.
+Added: We are also subject to other federal and state laws that constrain the way we can market and sell our products, or require reporting of certain transfers of value to health care professionals.
+Added: Some of the laws and regulations we are subject to include:
+Added: federal Anti-Kickback Statute (the “AKS”), which prohibits, among other things, persons or entities from knowingly and willfully soliciting, offering, receiving or paying any remuneration, directly or indirectly, overtly or covertly, in cash or in kind, in exchange for or to induce either the referral of an individual for the furnishing or arranging for a good or service, or for the purchasing, leasing, ordering, or arranging for or recommending any good, facility, service or item for which payment may be made in whole or in part under federal healthcare programs, such as the Medicare and Medicaid programs.
+Added: The term “remuneration” expressly includes kickbacks and bribes, and also has been broadly interpreted to include anything of value, including, for example, gifts, discounts, the furnishing of supplies or equipment, credit arrangements, payments of cash, waivers of payments, ownership interests and providing anything at less than its fair market value.
+Added: The AKS is broad and prohibits many arrangements and practices that are lawful in businesses outside of the healthcare industry.
+Added: There are a number of statutory exceptions and regulatory safe harbors that may protect certain business arrangements from prosecution if strictly complied with, however, those exceptions and safe harbors are drawn narrowly.
+Added: There are also no available exceptions or safe harbors for many common business activities.
+Added: Practices that involve remuneration to those who prescribe, purchase, recommend or
+Added: arrange for the purchase, order or recommendation of medical devices, including discounts, providing items or services for free or engaging such individuals as consultants, advisors, or speakers, may be subject to scrutiny if they do not fit squarely within an available exception or safe harbor and would be subject to a facts and circumstances analysis to determine compliance with the AKS.
+Added: A violation of the AKS can be established without proving that the person or entity had actual knowledge of the statute or specific intent to violate it.
+Added: A claim that includes items or services resulting from an AKS violation constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act (the “False Claims Act”).
+Added: • The False Claims Act, which prohibits, among other things, persons, or entities from knowingly presenting or causing to be presented a false or fraudulent claim for payment of government funds or knowingly presenting or causing to be presented a false record or statement material to an obligation to pay money to the government or knowingly and improperly avoiding, decreasing, or concealing an obligation to pay money to the federal government.
+Added: Medical device manufacturers have been investigated and have reached substantial financial settlements with the federal government under the False Claims Act for a variety of alleged improper activities, including causing false claims to be submitted as a result of the marketing of their products including for unapproved and thus non-reimbursable uses and interactions with prescribers and other customers, including those that may have affected their billing or coding practices and submission of claims to the federal government.
+Added: Actions under the False Claims Act can be brought by qui tam relators, or whistleblowers, on behalf of themselves and the government, and those relators can share in any settlement or resolution.
+Added: If an entity is determined to have violated the False Claims Act, it may be required to pay up to three times the actual damages sustained by the government, plus civil penalties for each separate false claim.
+Added: • The Health Insurance and Portability Act of 1996, and its implementing regulations (collectively, “HIPAA”), which imposes criminal and civil liability for, among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, or knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement, in connection with the delivery of, or payment for healthcare benefits, items or services by a healthcare benefit program, which includes both government and privately funded benefits programs;
+Added: similar to the U.S.
+Added: federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation.
+Added: • Analogous state and foreign law equivalents of each of the above U.S.
+Added: federal laws, such as anti-kickback and false claims laws that apply to items or services reimbursed by any third-party payor, including commercial insurers.
+Added: • State and foreign laws that require medical device companies to comply with the industry’s voluntary compliance guidelines and the applicable compliance guidance promulgated by the federal government or otherwise restrict payments (or require reporting transfers of value) that may be made to healthcare providers and other potential referral sources.
+Added: • The federal Physician Payments Sunshine Act, implemented as the Open Payments program, and its implementing regulations, require certain manufacturers of drugs, devices, biologics and medical supplies that are reimbursable (directly or indirectly) under Medicare, Medicaid, or the Children’s Health Insurance Program to report annually to the CMS information related to certain payments made in the preceding calendar year and other transfers of value to physicians, physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists, certified nurse-midwives and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members.
+Added: Anti-bribery laws exist in many of the countries in which we sell our products outside the U.S., as well as the United States Foreign Corrupt Practices Act (the “FCPA”) which addresses the activities of U.S.
companies in foreign markets.
11 unchanged sentences
If we, or the third parties through which we do business, are not in compliance with applicable import, export control or economic sanctions laws and regulations, we may be subject to civil or criminal enforcement action, and varying degrees of liability.
−Removed: Such actions may disrupt or delay sales of our products or services or result in restrictions on our distribution and sales of products or services that may materially impact our business
+Added: Such actions may disrupt or delay
+Added: sales of our products or services or result in restrictions on our distribution and sales of products or services that may materially impact our business.
Environmental Health and Safety .
6 unchanged sentences
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.
−Removed: Although we continuously strive to maintain full compliance with respect to all applicable global
−Removed: environmental, health and safety laws and regulations, we could incur substantial costs to fully comply with future laws and regulations, and our operations, business or assets may be negatively affected.
+Added: Although we continuously strive to maintain full compliance with respect to all applicable global environmental, health and safety laws and regulations, we could incur substantial costs to fully comply with future laws and regulations, and our operations, business or assets may be negatively affected.
Furthermore, global environmental, health and safety compliance is an ongoing process.
7 unchanged sentences
federal and state, and industry levels.
−Removed: 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.
−Removed: For example, in the U.S.
−Removed: 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”).
−Removed: Under HIPAA, the HHS 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.
+Added: federal and state laws protect the confidentiality of certain patient health information, including patient medical records, and restrict the use and disclosure of patient health information by health care providers and other persons or entities that create, receive, maintain, or transmit health information.
+Added: For example, in the U.S., depending on the facts and circumstances, we could be subject to the requirements of HIPAA.
+Added: HIPAA imposes privacy and security obligations on covered entity health care providers, health plans, and health care clearinghouses, as well as their “business associates” – certain persons or entities that create, receive, maintain, or transmit protected health information in connection with providing a specified service or performing a function on behalf of a covered entity.
HIPAA also regulates standardization of data content, codes and formats used in health care transactions and standardization of identifiers for health plans and providers.
2 unchanged sentences
The FDA also issued guidance on post market management of cyber security in medical devices.
+Added: Under section 5 of the Federal Trade Commission (“FTC”), the FTC expects a company’s data privacy and security measures to be reasonable and appropriate in light of the sensitivity and volume of consumer information it holds, the size and complexity of its business, and the cost of available tools to improve security and reduce vulnerabilities.
+Added: Failure to meet these standards may constitute unfair or deceptive acts or practices in violation of the FTC Act.
+Added: The FTC also has the power to enforce the Health Breach Notification Rule, which imposes notification obligations on companies for breaches of certain health information contained in personal health records.
+Added: At the state level, the California Consumer Privacy Act (“CCPA”), as amended by the California Privacy Rights Act (“CPRA”), establishes certain requirements for data use and sharing transparency and provides California consumers (as defined in the law) certain rights concerning the use, disclosure, and retention of their personal data.
+Added: Such rights include rights to access and delete personal information, opt out of certain personal information sharing, and receive detailed information about how personal information is used.
+Added: The CCPA provides for civil penalties for violations, as well as a private right of action for data breaches—involving certain types of personal information—that is expected to increase data breach litigation.
+Added: The CCPA may increase our compliance costs and potential liability.
+Added: Numerous other states, such as Virginia, Colorado, Utah, and Connecticut, have
+Added: enacted privacy laws similar to the CCPA, and some states, like Washington and Nevada, have enacted health privacy specific laws that grant heightened rights with respect to health information.
+Added: Moreover, as a result of the broad scale release and availability of Artificial Intelligence (“AI”) technologies such as generative AI, there is a global trend towards more regulation (e.g., the EU AI Act and AI laws passed in U.S.
+Added: states) to ensure the ethical use, privacy, and security of AI and the data that it processes.
+Added: Compliance with such laws will likely be an increasing and substantial cost in the future.
Outside the U.S., we are impacted by the privacy and data security requirements at the international, national and regional level, and on an industry specific basis.
Legal requirements in these countries relating to the collection, storage, handling and transfer of personal data and, potentially, intellectual property continue to evolve with increasingly strict enforcement regimes.
−Removed: 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.
+Added: In Europe, for example, we are subject to the EU General Data Protection Regulation, including as implemented in the UK (collectively, “GDPR”) which imposes restrictions on the collection, use and transfer of personal data and includes, among other things, a requirement for prompt notice of data breaches to data subjects and supervisory authorities in certain circumstances and significant fines for non-compliance, which can go up to €20 million or up to 4% of the total worldwide annual turnover of the preceding financial year, whichever is higher.
The GDPR also requires companies processing personal data of individuals residing in the EU to comply with EU privacy and data protection rules.
+Added: In particular, when we rely on third-party service providers processing personal data of subjects in the EU, we must enter into suitable agreements with these providers and receive sufficient assurances that the providers meet the requirements of the GDPR.
+Added: The obligations under the GDPR may therefore be onerous and adversely affect our business, financial condition, results of operations and prospects.
Please refer to “ Item 1A.
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Workforce Demographics
−Removed: As of December 31, 2023, we had approximately 3,946 regular full and part time employees and 1383 contingent, subcontracted, and outsourced partners.
−Removed: Approximately 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.
−Removed: Diversity and Inclusion
−Removed: A diverse workforce and an inclusive culture and work environment is a business priority and a key to our long-term success.
−Removed: We believe our company is stronger when we build diverse teams and leverage broad perspectives.
−Removed: Diverse teams meet the needs of our shareholders, customers, colleagues and communities we serve.
−Removed: Our commitment to diversity and inclusion starts at the top with our Board of Directors and Chief Executive Officer.
−Removed: At all levels of the Company, we focus on attracting, retaining, and developing our diverse talent.
−Removed: We have implemented initiatives to promote awareness of our corporate commitment to diversity and inclusion and employ trainings and other educational programs to inform and educate our workforce – forming communities of advocates and allies to help advance a culture of inclusion – develop inclusive leadership skills and identify and minimize the impact of unconscious bias.
−Removed: Through our Employee Resource Groups (ERGs), leadership councils and external partnerships, we provide opportunities for colleagues to create a welcoming culture, advance diversity and inclusion in the workplace and to provide feedback to our executive team.
−Removed: In fiscal year 2023, we expanded the number of Integra-sponsored ERGs to seven (7) as we believe our ERGs, which are employee-led groups, provide career and leadership development and networking opportunities for members and strengthen ties between employees of many different backgrounds, cultures, and interests.
+Added: As of December 31, 2024, we had approximately 4,396 regular full and part time employees.
+Added: Approximately 70% of our employees are located in the United States, 20% in Europe, 9% in Asia Pacific which includes Australia and New Zealand and 1% in Latin America and Canada.
+Added: Building a Strong Workforce
+Added: A talented and engaged workforce is a business priority and a key to our long-term success.
+Added: We believe our company is stronger when we leverage broad perspectives to meet the needs of our shareholders, customers, colleagues and the communities we serve.
+Added: Our commitment to workforce development starts at the top with our Board of Directors and Chief Executive Officer.
+Added: At all levels of the Company, we focus on attracting, retaining, and developing talent that drives innovation and results.
+Added: Through various Employee Resource Groups (“ERGs”), leadership councils and external partnerships, we provide opportunities for colleagues to contribute to our culture, develop professionally and provide feedback to our executive team.
+Added: In fiscal year 2024, we maintained seven (7) Integra-sponsored ERGs, which are employee-led groups, provide career development, leadership opportunities and networking connections across the organization.
Compensation and Benefits
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Managers are expected to enforce health and safety regulations, including compliance with applicable federal, state and local laws.
−Removed: Our Environmental Health and Safety ("EH&S") organizational structure incorporates both
−Removed: workplace EH&S coordinators and compliance teams.
+Added: 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.
Employee Engagement and Wellbeing
−Removed: We regularly seek employee feedback and sentiment about our workplace through global engagement surveys conducted on at least a bi-annual basis.
+Added: We regularly seek employee feedback and sentiment about our workplace through global engagement pulse surveys conducted on at least an annual basis.
After each survey is complete, we share detailed results with senior management and all employees within each department.
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FINANCIAL INFORMATION ABOUT GEOGRAPHIC AREAS
−Removed: 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 IV, Item 15 of this Annual Report on Form 10-K).
+Added: Financial information about our geographical areas is set forth in our financial statements Note 16.
+Added: Segment and Geographic Information , to the Notes to Consolidated Financial Statements (Part IV, Item 15 of this Annual Report on Form 10-K).
AVAILABLE INFORMATION
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Investors and others should note that we announce material financial information to our investors using our investor relations website (investor.integralife.com), SEC filings, press releases, public conference calls and webcasts.
−Removed: We use these channels as well as social media to communicate with the public about our Company, our services and other issues.
+Added: We use these channels as
+Added: well as social media to communicate with the public about our Company, our services and other issues.
It is possible that the information we post on social media could be deemed to be material information.
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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.