About Integra LifeSciences Holdings

Integra LifeSciences Holdings Corporation operates as a global leader in regenerative tissue technologies and neurological solutions. 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. The company’s products are sold in more than 130 countries through a direct sales force as well as distributors and wholesalers. Segments The company operates through two segments: Codman Specialty Surgical (CSS) and Tissue Technologies (TT). CSS The CSS segment, which represents approximately two-thirds of the company’s total revenue, consists of market-leading technologies and instrumentation used for a wide range of specialties, such as neurosurgery, neurocritical care and otolaryngology. The company is the world leader in neurosurgery and one of the top three providers in instruments used in precision, specialty, and general surgical procedures. The Codman Specialty Surgical business consists of a broad portfolio of market-leading brands, such as Codman, DuraGen, DuraSeal, CUSA, Mayfield, Bactiseal, and Certas Plus, which are used for the management of multiple disease states, including brain tumors, traumatic brain injury, hydrocephalus and other neurological conditions. The growth in this business in the recent years has been fueled by geographic expansion and new product registrations in markets, such as China, Japan, and Europe, which it expects to continue in the near-to-long term. In 2022, the company made progress to several enhancements to its CUSA Clarity Tissue Ablation System. The extended laparoscopic tip was launched in the U.S. to enhance laparoscopic liver procedures. In addition, a single-sided bone tip received 510(k) clearance. Commercial launch is expected in the first quarter of 2023. The company continues to update its CUSA Clarity platform by incorporating new ultrasonic handpiece and integrated electrosurgical capabilities. Moreover, the company is 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. The company continues to gather clinical evidence using this same technology for early surgical intervention of ICH. In 2022, the company launched the Aurora Evacuator with Coagulation device in the U.S., designed to be used in conjunction with its Aurora Surgiscope to safely address and evacuate blood in the brain caused by hemorrhagic stroke. Rounding out the portfolio is a catalog of surgical headlamps and surgical instrumentation, as well as after-market service. With thousands of surgical instrument products, including specialty surgical instruments, the company calls on the central sterile processing unit of hospitals and acute care surgical centers. Additionally, through a strong U.S. distribution model, the company serves the needs of hundreds of medical offices. The company also expanded its product offerings in 2021 with the launch of its new intracranial pressure (ICP) monitoring system, CereLink in the U.S. and Europe and continued the global rollout in the first half of 2022. The company’s 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. TT The company’s TT segment generates about one-third of its overall revenue and focuses on three main areas: complex wound surgery, surgical reconstruction, and peripheral nerve repair. The company sources most of its handheld surgical instruments and dural sealant products through specialized third-party vendors. The Tissue Technologies segment consists of five unique regenerative technology areas - highly engineered bovine collagen, bovine dermis, porcine urinary bladder, human amniotic tissue, and resorbable synthetic mesh. This broad regenerative platform, which includes multiple leading brands, such as Integra Dermal Matrices, AmnioExcel, SurgiMend, MicroMatrix and NeuraGen, primarily addresses the needs of plastic, reconstructive and general surgeons focused on the treatment of acute wounds, such as burns, chronic wounds, including diabetic foot ulcers, and surgical tissue repair, such as hernia, tendon, peripheral nerve repair and protection. During 2022, the company completed the acquisition of Surgical Innovation Associates, Inc. (SIA), which is seeking approval by the U.S Food and Drug Administration (FDA) of the PMA application for its core technology, DuraSorb, for use in IBBR. The company has a specialized sales organization composed of directly employed sales representatives, as well as specialty distributors, organized based upon their call point. The company’s 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. The company also has a dedicated surgical reconstruction sales team focused on plastic and reconstructive surgery and hernia procedures with differentiated products. Finally, the company has a distributor network focused on biologics. Outside the U.S., the company has 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 its regenerative and wound care technologies. The company’s customers are other medical technology companies that sell to end markets primarily in spine, surgical and wound care. The company anticipates new product introductions and new clinical indications will continue to contribute to the growth of the segment. In 2022, the company launched NeuraGen 3D Nerve Guide Matrix, a resorbable implant for repair of peripheral nerve discontinuities and engineered to create an optimized environment for nerve regeneration. In the third quarter of 2021, the company filed the PMA application for a specific indication for SurgiMend in the use of post-mastectomy breast reconstruction, for which it hopes to obtain FDA approval in 2024. Strategy The company is committed to delivering high quality products that positively impact the lives of millions of patients and their families. The company focuses on four key pillars of its strategy: enabling an execution-focused culture; optimizing relevant scale; advancing innovation and agility; and leading in customer experience. 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. The company’s growth strategy includes the acquisition of businesses, assets or products lines to increase the breadth of its offerings, the reach of its product portfolios and drives relevant scale to its customers. On December 6, 2022, the company completed the acquisition of Surgical Innovation Associates, Inc. (SIA), which develops, markets and sells DuraSorb, a resorbable synthetic matrix for plastic and reconstructive surgery. The company also continued to expand its product offering of regenerative technologies from its 2021 acquisition of ACell, Inc. (ACell), an innovative regenerative medicine company specializing in the manufacturing of porcine urinary bladder extracellular matrices. The company is investing in innovative product development to drive a multi-generational pipeline for its key product franchises. The company’s product development efforts span across its key global franchises focused on potential technological innovations for significant returns on investment. In August 2022, the company completed the sale of its non-core traditional wound care (TWC) business to Gentell, LLC (Gentall). Investing in the company’s sales channels is a core part of its strategy to create specialization and greater focus on reaching new and existing customers and addressing their needs. Intellectual Property 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, 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. Seasonality Revenues during the company’s fourth quarter tend to be stronger than other quarters because many hospitals increase their purchases of its products during the fourth quarter to coincide with the end of their budget cycles in the U.S. In general, the company’s 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 (year ended December 31, 2022). Competition The company’s competitors for CSS are Medtronic, Inc., Stryker Corporation, Becton Dickinson and Company, and B. Braun Medical, Inc. The company’s competition for TT includes Smith & Nephew plc, Organogenesis Holdings Inc., MiMedx Group, Inc., Allergan PLC, Becton Dickinson and Company, and Axogen, Inc. Government Regulation and Compliance The company is 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. The FDA requires, as a condition to marketing a medical device in the U.S. that the company secures a Premarket Notification clearance pursuant to Section 510(k) of the Federal Food, Drug and Cosmetic Act (the FD&C Act), or an approved premarket approval (PMA), application (or supplemental PMA application). To perform clinical trials for significant risk devices in the U.S. on an unapproved product, the company is required to obtain an Investigational Device Exemption from the FDA. The company, 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 company is licensed or have permits for tissue banking in California, Delaware, Illinois, Maryland, New York, Oregon, and Tennessee. In Tennessee, the company is registered with the FDA Center for Biological Evaluations and Research. BioD, the company’s wholly-owned subsidiary, is a registered Tissue Bank and is involved with the recovery, storage and transportation of donated human amniotic tissue. The company is required to register with the FDA as a medical device manufacturer and any devices it manufactures and distributes pursuant to clearance or approval by the FDA are subject to pervasive and continuing regulation by the FDA and certain state agencies. These include product listing and establishment registration requirements, which help facilitate FDA inspections and other regulatory actions, and the company’s manufacturing sites are subject to periodic inspection by the FDA for compliance with the FDA's Quality System Regulations. Further, the company is required to comply with various FDA requirements and other legal requirements for labeling and promotion. Medical device regulations also are in effect in many of the countries in which the company does business outside the U.S. These laws range from comprehensive medical device approval and Quality System requirements for some or all of the company’s medical device products to simpler requests for product data or certifications. Under the European Union Medical Device Directive, medical devices must meet the Medical Device Directive standards and receive CE Mark Certification prior to marketing in the European Union (EU). Similar anti-bribery laws exist in many of the countries in which the company sells its products outside the U.S., as well as the United States Foreign Corrupt Practices Act (which addresses the activities of the U.S. companies in foreign markets). The company’s products also are subject to regulation regarding reimbursement, and the U.S. healthcare laws apply when a customer submits a claim for a product that is reimbursed under a federally funded healthcare program. As a public Company, the company is subject to the securities laws and regulations, including the Sarbanes-Oxley Act of 2002. In Europe, for example, the company is 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. History Integra LifeSciences Holdings Corporation was founded in 1989. The company was incorporated in Delaware in 1989.