INTEGRA LIFESCIENCES HOLDINGS CORP
For the period ended Sep 30, 2026. Filed Oct 23, 2026.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2026 · Filed Oct 23, 2026
IART$13.42-5.0%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-06-30; filed 2026-07-29.
0000917520-26-000058
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-09-30; filed 2026-10-23.
0000917520-26-000077
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 159 previous paragraphs and 160 current paragraphs.
88 unchanged; 64 reworded; 7 added; 6 removed; 1 previous and 1 current paragraphs rearranged.
Tables are not compared: 11 previous and 11 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (7)
Current report
We continue to advance development of next-generation hydrocephalus and external ventricular drainage (“EVD”) products that combine anti-occlusive and antimicrobial technologies in a single platform. By addressing two of the most significant causes of device complications, occlusion and infection, these innovations have the potential to improve reliability and continuity of care for patients requiring cerebrospinal fluid management. We believe this combination represents the first integrated anti-occlusive and antimicrobial platform of its kind in hydrocephalus and EVD management.
Current report
We continue to advance PMA applications towards approvals for SurgiMend® and DuraSorb® in two stage implant-based breast reconstruction, representing important opportunities to expand our reconstructive surgery portfolio. We are targeting potential FDA approval for SurgiMend in 2027. For DuraSorb, we have completed enrollment, treatment and one-year patient follow-up in our U.S. breast reconstruction study and continue to progress the PMA application, with potential approval anticipated later in 2027.
Current report
On July 17, 2026, widespread flash flooding affected the Cincinnati, Ohio area, which caused damage to our Cincinnati facility, equipment, inventory, and other assets and has resulted in operational disruption to the site. The facility manufactures and supports several products within our Specialty Surgery portfolio. The operational disruption of the Cincinnati site, partially mitigated by our efforts to fulfill some customers’ orders with inventory on-hand and leverage alternate capabilities across our supply chain, reduced revenues by approximately $7 million for the three months ended September 30, 2026.
Current report
During the three months ended September 30, 2026, we incurred costs associated with the restoration of the facility of approximately $22.2 million, primarily due to the write off of unsalvageable inventory and fixed assets as well as the cost of external service providers used for our clean-up efforts.
Current report
We maintain insurance coverage for damage to our facilities and inventory, as well as business interruption insurance to mitigate the adverse impact of lost revenues and remediation costs arising from the disruption of its operations. We are in the process of reviewing these coverages with our insurance carrier. The recoveries under our property damage and business interruption claims are anticipated to mitigate a substantial portion of the financial impact associated with this event and subsequent disruption of the facility’s operations until it returns to full manufacturing capacity, which is expected to occur during the second quarter of 2027. During the three months ended September 30, 2026, we received an initial payment from our insurance carrier of $10.0 million, net of our deductible, and recognized a receivable of $11.4 million for claims on costs incurred to date that have been approved by our insurance carrier. Any reimbursement of costs incurred has been recorded as a reduction of those expenses. These amounts also include a contingent gain of $4.9 million recorded to other income reflecting the fair value of fixed assets damaged in the flooding over their net book values. We have not recognized any recoveries for lost revenues, which would be presented as other income, and are actively engaged with our insurance carrier to determine amounts recoverable.
Current report
Interest income for the three months ended September 30, 2026 was $5.0 million, consistent with the same period in the prior year.
Current report
Interest income for the nine months ended September 30, 2026 decreased by $0.7 million as compared to the same period in the prior year.
Removed paragraphs (6)
Previous report
We continue to advance the CerebroFlo® external ventricular drainage (“EVD”), a catheter with Endexo® technology. The Endexo polymer in polyurethane is a permanent additive which has shown to be effective in reducing platelet adhesion in-vitro, reducing thrombus accumulation in-vitro and in vivo, and reducing the clinical incidence of thrombus formation. In vitro evaluations and in vivo animal evaluations do not necessarily predict the clinical performance of the SureFlo EVD Catheter with respect to thrombus formation. The incidence of thrombus formation on polyurethane containing Endexo polymer in other medical devices and/or tissues systems does not necessarily predict the clinical performance of the SureFlo EVD Catheter for the intended use of CSF external drainage and monitoring. The CerebroFlo EVD catheter has demonstrated an average of 99% less thrombus accumulation onto its surface, in vitro, compared to a market leading EVD catheter. Our work to combine our Bactiseal antimicrobial technology with the Endexo anti-occlusive technology continues to progress for both a silicone-based hydrocephalus and EVD product.
Previous report
We also continue to advance the Aurora® Surgiscope, which is the only tubular retractor system designed for cranial surgery with an integrated access channel, camera and lighting. The 15mm x 60mm and 15mm x 80mm Aurora Surgiscope System version received 510(k) clearance from the FDA in 2025.
Previous report
In the third quarter of 2021, we filed a PMA application for a specific indication for SurgiMend® in the use of post-mastectomy breast reconstruction and in July 2024 received approvable pending GMP status from FDA, which approved and closed out the clinical portion of this PMA application. We expect PMA approval for SurgiMend in 2027. We are also pursuing a PMA for DuraSorb for use in implant-based breast reconstruction. We completed enrollment for the DuraSorb U.S. investigational device exemption clinical study for two-stage breast reconstruction in June 2023, completed treatment in 2024, completed patient 1-year follow up in 2025, and we continue to advance the PMA application. We expect PMA approval for DuraSorb later in 2027.
Previous report
On July 17, 2026, our manufacturing facility in Cincinnati, Ohio sustained flood damage as a result of severe weather conditions. The flooding caused damage to portions of the facility, equipment, inventory and other assets and resulted in operational disruptions at the site. We responded immediately to the event and implemented our business continuity plans to support ongoing customer service and operational continuity. We are continuing to assess the full extent of the damage and finalize remediation and recovery plans. Based on our current assessment, including available inventory at our distribution centers and our insurance coverage, we do not currently expect the event to have a material adverse effect on our operations or financial condition. However, our evaluation of the full financial impact of the event remains ongoing, including the ultimate costs of remediation and restoration, the amount of any potential asset impairments, and the timing and extent of insurance recoveries. We maintain insurance coverage for property damage and business interruption losses and are actively working with our insurance carriers to assess available coverage and potential recoveries. While we believe the event may result in insurance recoveries, the amount and timing of any such recoveries cannot be assured. For additional information regarding the flood damage to the Cincinnati facility, see Note 17. Subsequent Events.
Previous report
Interest income for the three months ended June 30, 2026 decreased by $0.4 million as compared to the same period in the prior year.
Previous report
Interest income for the six months ended June 30, 2026 decreased by $0.8 million as compared to the same period in the prior year.
Reworded paragraphs (64)
Previous wording
We have made statements in this Quarterly Report that constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934 (the “Exchange Act”). All statements other than statements of historical fact contained in this Quarterly Report, including, but not limited to, statements regarding our future business, operational and financial performance and the Company’s expectations and plans with respect to market opportunity, business and operational performance, strategic initiatives, capabilities, resources, manufacturing capabilities, product development, product availability and regulatory approvals, including our plans, production capability, and anticipated operational timelines for the Company’s manufacturing facility in Braintree, Massachusetts (“the Braintree facility”), our expectations regarding the Compliance Master Plan (“the CMP”) implementation, engagement and efficacy, our restructuring and cost-saving initiatives, our intellectual property rights, litigation and tax matters, governmental proceedings and investigations, mergers and acquisitions, divestitures, market acceptance of our products and services, accounting estimates, financing activities, ongoing contractual obligations and compliance with restrictive and financial covenants of our outstanding indebtedness, working capital adequacy, value of our investments, our effective tax rate, estimates regarding the impact of tariffs adopted or implemented by the U.S. or other countries on our business, tariff refunds, anticipated impact of the flooding event at our Cincinnati, Ohio manufacturing facility, financial condition and results of operations, our expected returns to shareholders, and our sales efforts, are forward-looking statements. In some cases, these forward-looking statements may be identified by forward-looking words such as “believe,” “may,” “might,” “could,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “seek,” “plan,” “expect,” “should,” “would” or the negative version of these words or other similar words and expressions in this Quarterly Report.
Current wording
We have made statements in this Quarterly Report that constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934 (the “Exchange Act”). All statements other than statements of historical fact contained in this Quarterly Report, including, but not limited to, statements regarding our future business, operational and financial performance and the Company’s expectations and plans with respect to market opportunity, business and operational performance, strategic initiatives, capabilities, resources, manufacturing capabilities, product development, product availability and regulatory approvals, including our plans, production capability, and anticipated operational timelines for the Company’s manufacturing facility in Braintree, Massachusetts (“the Braintree facility”), our expectations regarding the Compliance Master Plan (“the CMP”) implementation, engagement and efficacy, our restructuring and cost-saving initiatives, our intellectual property rights, litigation and tax matters, governmental proceedings and investigations, mergers and acquisitions, divestitures, market acceptance of our products and services, accounting estimates, financing activities, ongoing contractual obligations and compliance with restrictive and financial covenants of our outstanding indebtedness, working capital adequacy, value of our investments, our effective tax rate, estimates regarding the impact of tariffs adopted or implemented by the U.S. or other countries on our business, tariff refunds, the impact of the flooding event at our Cincinnati, Ohio manufacturing facility and our efforts to restore operations, financial condition and results of operations, our expected returns to shareholders, and our sales efforts, are forward-looking statements. In some cases, these forward-looking statements may be identified by forward-looking words such as “believe,” “may,” “might,” “could,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “seek,” “plan,” “expect,” “should,” “would” or the negative version of these words or other similar words and expressions in this Quarterly Report.
Previous wording
These forward-looking statements are subject to a number of risks, uncertainties and assumptions about the Company and other matters that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. We believe these risks include but are not limited to those described under the headings “Risk Factors” and “Special Note Regarding Forward-Looking Statements” in our Annual Report on Form 10-K for the year ended December 31, 2025 and in this Quarterly Report, as such factors may be updated from time to time in our periodic filings with the Securities and Exchange Commission (the “SEC”), which are accessible on the SEC’s website at https://www.sec.gov. Such risks and uncertainties include, but are not limited, to the following: increased geopolitical tension, instability and other macroeconomic factors, including trade barriers and related restrictions (including tariffs and related countermeasures), armed conflict and acts of terrorism, supply chain disruptions, and interest rate and foreign currency rate fluctuations on the Company’s suppliers, vendors and customers and on the Company’s business and financial condition, results of operations and cash flows; the Company's ability to execute its financial, strategic and operating plans effectively; the Company’s ability to remediate quality systems violations; difficulties in implementing the CMP; difficulties or delays in obtaining and maintaining required regulatory approvals, including the costs thereof; potential difficulties, delays and disruptions in manufacturing, distribution or sale of products; the Company's ongoing assessment of the flooding event at its Cincinnati, Ohio manufacturing facility, related financial impacts, recovery efforts, potential asset impairments, unforeseen costs and insurance recoveries; the failure of the Company’s suppliers, vendors, and other third parties to meet contractual, regulatory and other obligations; the anticipated development of markets the Company sells its products into and the success of the Company’s products in these markets; the Company’s ability to predict accurately the demand for its products and products under development; increasing industry competition; the coverage and reimbursement decisions of third-party payors; trends toward health care cost containment; difficulties in controlling expenses, including costs to procure and manufacture the Company’s products; the ability of the Company to successfully manage leadership and organizational changes and the impact of changes in management or staff levels; the impact of goodwill and intangible asset impairment charges if future operating results of acquired businesses are significantly less than the results anticipated at the time of the acquisitions; the geographic distribution of where the Company generates its taxable income; changes to applicable laws, regul…
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Current wording
These forward-looking statements are subject to a number of risks, uncertainties and assumptions about the Company and other matters that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. We believe these risks include, but are not limited to, those described under the headings “Risk Factors” and “Special Note Regarding Forward-Looking Statements” in our Annual Report on Form 10-K for the year ended December 31, 2025 and in this Quarterly Report, as such factors may be updated from time to time in our periodic filings with the Securities and Exchange Commission (the “SEC”), which are accessible on the SEC’s website at https://www.sec.gov. Such risks and uncertainties include, but are not limited, to the following: increased geopolitical tension, instability and other macroeconomic factors, including trade barriers and related restrictions (including tariffs and related countermeasures), armed conflict and acts of terrorism, supply chain disruptions, and interest rate and foreign currency rate fluctuations on the Company’s suppliers, vendors and customers and on the Company’s business and financial condition, results of operations and cash flows; the Company’s ability to execute its financial, strategic and operating plans effectively; the Company’s ability to remediate quality systems violations; difficulties in implementing the CMP; difficulties or delays in obtaining and maintaining required regulatory approvals, including the costs thereof; potential difficulties, delays and disruptions in manufacturing, distribution or sale of products; difficulties or delays, including unexpected costs and the availability of insurance coverage and recoveries, related to the Company’s Cincinnati facility recovery efforts; the failure of the Company’s suppliers, vendors, and other third parties to meet contractual, regulatory and other obligations; the anticipated development of markets the Company sells its products into and the success of the Company’s products in these markets; the Company’s ability to predict accurately the demand for its products and products under development; increasing industry competition; the coverage and reimbursement decisions of third-party payors; trends toward health care cost containment; difficulties in controlling expenses, including costs to procure and manufacture the Company’s products; the ability of the Company to successfully manage leadership and organizational changes and the impact of changes in management or staff levels; the impact of goodwill and intangible asset impairment charges if future operating results of acquired businesses are significantly less than the results anticipated at the time of the acquisitions; the geographic distribution of where the Company generates its taxable income; changes to applicable laws, regulations and enforcement guidance, including ta…
Excerpt shortened here; the source contains the full paragraph.
Previous wording
We manufacture and sell medical technologies and products in two reportable business segments: Specialty Surgery (formerly, Codman Specialty Surgical) and Tissue Reconstruction (formerly, Tissue Technologies). The Specialty Surgery segment, which represents approximately 70% of our total revenue, consists of market-leading technologies and instrumentation used for a wide range of specialties, such as neurosurgery, neurocritical care, and otolaryngology, commonly referred to as ear, nose, and throat (“ENT”). We are the world leader in neurosurgery and one of the top three providers in the U.S. in instruments used in precision, specialty, and general surgical procedures. Our Tissue Reconstruction segment generates about 30% of our overall revenue and focuses on wound reconstruction and private label.
Current wording
We manufacture and sell medical technologies and products in two reportable business segments: Specialty Surgery (formerly, Codman Specialty Surgical) and Tissue Reconstruction (formerly, Tissue Technologies). The Specialty Surgery segment, which represents approximately 70% of our total revenue, consists of market-leading technologies and instrumentation used for a wide range of specialties, such as neurosurgery, neurocritical care, and otolaryngology, commonly referred to as ear, nose, and throat (“ENT”). We are the world leader in neurosurgery and one of the top three providers in the U.S. in instruments used in precision, specialty, and general surgical procedures. Our Tissue Reconstruction segment generates about 30% of our overall revenue and focuses on soft tissue reinforcement, wound reconstruction and corporate partnerships.
Previous wording
We were the first company to receive an FDA claim for regeneration of dermal tissue and are a world leader in regenerative technology. We have developed numerous product lines from this technology for applications ranging from burn and deep tissue wounds to the repair of dura mater in the brain, as well as nerves and tendons. We have expanded our base regenerative technology business to include neurosurgical products, ENT, surgical instruments and wound reconstruction solutions through global acquisitions and product development to meet the evolving needs of our customers and enhance patient care.
Current wording
We were the first company to receive FDA approval for regeneration of dermal tissue and are a world leader in regenerative technology. We have developed numerous product lines from this technology for applications ranging from burn and deep tissue wounds to the repair of dura mater in the brain, as well as nerves and tendons. We have expanded our base regenerative technology business to include neurosurgical products, ENT, surgical instruments and wound reconstruction solutions through global acquisitions and product development to meet the evolving needs of our customers and enhance patient care.
Previous wording
Neurosurgery: In neurosurgery, we are a global leader in neuro-access, neuro-surgical and neuro-monitoring technologies. Our product portfolio represents a continuum of care from pre-operative, to the neurosurgery operating room, to the neuro-critical care unit and post care for both adult and pediatric patients suffering from brain tumors, brain injury, cerebrospinal fluid pressure complications and other neurological conditions. This portfolio features leading brands such as Codman®, Duraseal®, CUSA®, Mayfield® and Duragen®.
Current wording
Neurosurgery: In neurosurgery, we are a global leader in neuro-access, neuro-surgical and neuro-monitoring technologies. Our product portfolio represents a continuum of care from pre-operative, to the neurosurgery operating room, to the neuro-critical care unit and post-care for both adult and pediatric patients suffering from brain tumors, brain injury, cerebrospinal fluid pressure complications and other neurological conditions. This portfolio features leading brands such as Codman®, DuraSeal®, CUSA®, Mayfield®, Aurora® and DuraGen®.
Previous wording
Surgical Instruments: Our specialty instrumentation portfolio includes a catalog of surgical headlamps, surgical instruments, as well as after-market service. With thousands of surgical instrument products, comprised of a comprehensive portfolio of reusable and disposable instruments, including forceps, retractors, scissors, and curettes, tailored for neurosurgery and spine surgery including specialty surgical instruments, we call on the central sterile processing unit of hospitals and acute care surgical centers. Additionally, through a strong U.S. distribution model, we can serve the needs of medical offices.
Current wording
Surgical Instruments: Our specialty instrumentation portfolio includes a catalog of surgical headlamps, surgical instruments, as well as after-market service. With a comprehensive portfolio of thousands of surgical instrument products tailored for neurosurgery and spine surgery, including reusable and disposable instruments such as forceps, retractors, scissors, and curettes, we call on the central sterile processing unit of hospitals and acute care surgical centers. Additionally, through a strong U.S. distribution model, we can serve the needs of medical offices.
Previous wording
Our Tissue Reconstruction segment develops and markets a broad portfolio of tissue products and technologies primarily focused on wound reconstruction and care and private label. This segment serves a diverse range of specialties, including plastic and reconstructive surgery, general surgery, and wound management.
Current wording
Our Tissue Reconstruction segment develops and markets a broad portfolio of tissue products and technologies primarily focused on soft tissue reinforcement, wound reconstruction and care and corporate partnerships. This segment serves a diverse range of specialties, including plastic and reconstructive surgery, general surgery, and wound management.
Previous wording
Wound Reconstruction Solutions: We currently utilize five unique technology platforms consisting of highly engineered bovine collagen (derived from bovine sources for structural support), bovine dermis (acellular dermal tissue for natural integration), porcine urinary bladder (extracellular matrix for cellular repopulation), human amniotic tissue (allografts as a wound cover), and resorbable synthetic mesh (biodegradable materials for temporary reinforcement). These technologies address clinical needs in treating acute wounds such as burns, chronic wounds including diabetic foot ulcers, and surgical tissue repair applications such as hernia reinforcement, tendon protection, and peripheral nerve repair. The goal is to support the body’s wound healing process by providing scaffolds that create a wound environment that facilitates cellular invasion and revascularization. These products are often used in hospital settings, wound care clinics, or outpatient procedures.
Current wording
Wound Reconstruction Solutions: We currently utilize three unique technology platforms consisting of highly engineered bovine collagen (derived from bovine sources for structural support), porcine urinary bladder (extracellular matrix for cellular repopulation), and human amniotic tissue (allografts as a wound cover). These technologies address clinical needs in acute wounds such as burns, chronic wounds including diabetic foot ulcers, tendon protection, and peripheral nerve repair. The goal is to support the body’s wound healing process by providing scaffolds that create a wound environment that facilitates cellular invasion and revascularization. These products are often used in hospital settings, wound care clinics, or outpatient procedures.
Previous wording
We offer a continuum of advanced solutions for plastic and reconstructive surgery, complex hernias, and general surgery, including devices for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue membranes. These products provide structural support and promote tissue integration to address areas of tissue weakness. They are bioresorbable or acellular to minimize long-term foreign body reactions and reduce complications like adhesions or infections.
Current wording
Soft Tissue Solutions: We utilize bovine dermis (acellular dermal tissue for natural integration) and resorbable synthetic mesh (biodegradable materials for temporary reinforcement) across our soft tissue solutions portfolio. These technologies include devices for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue membranes and offer a continuum of advanced solutions in plastic and reconstructive surgery and general surgery, including hernia repair. These products provide structural support and promote tissue integration to address areas of tissue weakness. They are bioresorbable or acellular to minimize long-term foreign body reactions and reduce complications like adhesions or infections.
Previous wording
Private Label: We offer extensive expertise in collagen biomaterials for other medical technology companies that sell to end markets primarily in spine, surgical and wound care. We manufacture a broad set of our tissue and wound care technologies that are available for private label distribution by our customers, produce raw materials that can be integrated into our customers’ production processes, and have the expertise to design, develop and manufacture products to meet the specific needs of our customers.
Current wording
Corporate Partnerships: We offer extensive expertise in collagen biomaterials for other medical technology companies that sell to end markets primarily in spine, surgical and wound care. In the third quarter of 2026, we renamed our Private Label business to Corporate Partnerships. We manufacture a broad set of our tissue and wound care technologies that are available for private label distribution by our customers, produce raw materials that can be integrated into our customers’ production processes, and have the expertise to design, develop and manufacture products to meet the specific needs of our customers.
Previous wording
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. Our research and development activities focus on identifying unmet surgical needs and addressing those needs with innovative solutions and products. Investment in research and development is critical to driving our future growth. Our research and development efforts are focused on the further development and improvement of our existing products, the design and development of new innovative medical technologies, and regulatory compliance across all our business segments. We apply our core competency in tissue reconstruction 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.
Current wording
An important part of Integra’s growth strategy is introducing new products to strengthen and expand our portfolio with clinical evidence to support regulatory approval and strong reimbursement of our product portfolio around the world, including new indications for existing technologies. Our research and development activities focus on identifying unmet needs and addressing those needs with innovative solutions and products. Investment in research and development is critical to driving our future growth. We apply our core competency in tissue reconstruction to innovate products for neurosurgical, wound applications, tissue reinforcement, plastic surgery, and reconstructive surgery and we have extensive R&D development programs for our core platforms of electromechanical technologies.
Previous wording
Additionally, we conduct projects and clinical studies to generate effectiveness and health economic evidence. The Company has continued its investments in clinical education as a key value driver to leverage its global footprint, enhanced digital content, and strengthened its clinical network. As part of this objective, the Company remains committed to participation in clinical research demonstrating the effectiveness of its products prior to market introduction, and in supporting the clinical education and technical training.
Current wording
Additionally, we conduct clinical studies to generate effectiveness and health economic evidence. The Company has continued its investments in clinical education as a key value driver to leverage its global footprint, enhanced digital content, and strengthened its clinical network. As part of this objective, the Company remains committed to participation in clinical research demonstrating the effectiveness of its products prior to market introduction, and in supporting the clinical education and technical training.
Previous wording
Neurosurgery, Surgical Instruments, and ENT Solutions. The Specialty Surgery neurosurgical business consists of a broad portfolio of market-leading brands, which are used for the management of multiple disease states, including brain tumors, traumatic brain injury, hydrocephalus and other neurological conditions. The growth in this business in recent years has been fueled by geographic expansion and new product registrations in markets, such as China, Japan, and Europe, which we expect to continue in the near-to-long term. We have several active programs focused on life cycle management and innovation for capital and disposable products in our portfolio. Our product development efforts are focused on core clinical applications in cerebrospinal fluid (“CSF”) management, neuro-critical care monitoring, minimally invasive instruments and electrosurgery and ultrasonic medical technologies, as well as our ambition to transform the standard of care in neurosurgery with product advancements in minimally invasive surgery (“MIS”) and the surgical management of intracerebral hemorrhage (“ICH”).
Current wording
Neurosurgery, Surgical Instruments, and ENT Solutions. The Specialty Surgery neurosurgical business consists of a broad portfolio of market-leading brands, which are used for the management of multiple disease states, including brain tumors, traumatic brain injury, hydrocephalus and other neurological conditions. The growth in this business in recent years has been fueled by geographic expansion and new product registrations in markets, such as China, Japan, and Europe, which we expect to continue in the near-to-long term. We have several active programs focused on innovation for capital and disposable products in our portfolio. Our new product development efforts are focused on core clinical applications in cerebrospinal fluid (“CSF”) management, neuro-critical care monitoring, minimally invasive instruments and electrosurgery and ultrasonic medical technologies, as well as our ambition to transform the standard of care in neurosurgery with product advancements in minimally invasive surgery (“MIS”) and the surgical management of intracerebral hemorrhage (“ICH”).
Previous wording
In July 2025, we announced the inaugural enrollment of the first patient in the AERA Pediatric Registry, a prospective, multi-center observational registry evaluating the real-world use of the AERA Eustachian Tube Balloon Dilation System in children. This marks the focused effort to measure the ongoing clinical performance of AERA in pediatric patients with obstructive Eustachian tube dysfunction. The registry is designed to capture both safety and efficacy outcomes for up to 300 pediatric patients who undergo Eustachian tube balloon dilation using AERA.
Current wording
In July 2025, we announced the enrollment of the first patient in the AERA Pediatric Registry, a prospective, multi-center observational registry evaluating the real-world use of the AERA Eustachian Tube Balloon Dilation System in children with obstructive Eustachian tube dysfunction. The registry is designed to capture safety and effectiveness outcomes for up to 300 pediatric patients and represents an important investment in clinical evidence generation to support the broader adoption of innovative ENT therapies. By expanding the body of evidence for pediatric patients, we aim to help improve treatment options for a population with significant unmet clinical needs while further strengthening our leadership position in Eustachian tube dilation.
Previous wording
In September 2025, the Mayfield® Ghost Base Unit Post launched in the U.S., which is designed to help provide clear visualization of anatomical structure and to support surgical accuracy and patient positioning. Throughout the first half of 2026, we introduced the Mayfield Ghost Base Unit Post to markets in Europe, Asia, Australia, and New Zealand.
Current wording
In September 2025, we launched the Mayfield® Ghost Base Unit Post in the U.S. and expanded its availability to Europe, Asia, Australia and New Zealand during the first half of 2026. The system is designed to enhance visualization, support surgical accuracy and optimize patient positioning.
Previous wording
In November 2025, we received 510(k) clearance for the use of the CUSA Clarity system for cardiac surgeries, used for the debridement of unwanted tissue in cardiac surgeries, including valve replacement and repair.
Current wording
In November 2025, we received FDA 510(k) clearance for the use of the CUSA Clarity® system in cardiac surgery, including valve repair and replacement procedures, expanding the clinical applications of the platform into a new surgical specialty.
Previous wording
Tissue Products and Technologies. Our tissue technology development program applies our expertise in bioengineering to a range of biomaterials including natural materials such as purified collagen, intact human or animal tissues, honey as well as resorbable synthetic polymers with our DuraSorb and DuraSeal product lines. These unique product designs are used for neurosurgical and reconstructive surgical applications, as well as dermal regeneration. Our tissue technology platform includes our legacy Integra® Dermal Regeneration Template (“IDRT”) products and complementary technologies that we have acquired. Our collagen manufacturing capability, combined with our history of innovation, provides us with strong platform technologies for multiple indications.
Current wording
Tissue Products and Technologies. Our tissue technology development program applies our expertise in bioengineering to a range of biomaterials including natural materials such as purified collagen, processed human or animal tissues, honey as well as resorbable synthetic polymers with our DuraSorb and DuraSeal product lines. These unique product designs are used for neurosurgical, plastic and reconstructive, and general surgery applications, as well as for wound management and dermal regeneration. Our reconstruction platform includes our legacy Integra® Dermal Regeneration Template (“IDRT”) products and complementary technologies that we have acquired. Our collagen manufacturing capability, combined with our history of innovation, provides us with strong platform technologies for multiple indications.
Previous wording
EUROPEAN UNION MEDICAL DEVICE (“EU MDR”) REGULATION UPDATES
Current wording
EUROPEAN UNION MEDICAL DEVICE REGULATION (“EU MDR”) UPDATES
Previous wording
We continue to work towards certifying our products under the EU MDR. In recent years, we received EU MDR certification in our Specialty Surgery segment for Hakim Programmable Valves, Certas Plus with and without Bactiseal catheters, Surgical Patties and Strips, DuraSeal Dural and Xact, CUSA Clarity, DuraGen Suturable, Cranial Drills and Perforators, as well as IDRT, BioPatch, MicroMatrix, and Cytal in our Tissue Reconstruction segment. We do not currently anticipate any significant disruption to our commercial activities in Europe related to EU MDR.
Current wording
We continue to work towards certifying our products under the EU MDR. In recent years, we received EU MDR certification in our Specialty Surgery segment for Hakim Programmer and VPV System, Certas Plus valves (with and without Bactiseal catheters), CHPV & Accessories, Surgical Patties and Strips, DuraSeal Dural, DuraSeal Xact Sealant System, DuraSeal Extended Tip Applicator, CUSA Clarity (Tubing Sets, Tips, CEM Nosecones, Console, Handpieces), Codman Bactiseal EVP Catheters, Codman Shunts with Bactiseal, DuraGen Dural/Suturable Graft Matrix, DuraGen Plus Graft Matrix, Cranial Drills and Perforators, as well as IDRT, BioPatch, MicroMatrix, and Cytal in our Tissue Reconstruction segment. We do not currently anticipate any significant disruption to our commercial activities in Europe related to EU MDR.
Previous wording
On March 7, 2019, TEI Biosciences, Inc. (“TEI”), one of our wholly owned subsidiaries, received a Warning Letter (the “2019 Warning Letter”), dated March 6, 2019, from the FDA. The 2019 Warning Letter was related to quality systems issues at TEI’s manufacturing facility located in Boston, Massachusetts (the “Boston facility”). The Boston facility manufactured extracellular bovine matrix products in our Tissue Reconstruction segment that were sold both in wound reconstruction and care and surgical reconstruction franchises, and in private label channels. The 2019 Warning Letter resulted from an inspection held at the Boston facility in October and November 2018 and did not identify any new observations that were not already provided in the Form 483 that followed the inspection. We submitted our initial response to the 2019 Warning Letter on March 28, 2019 and provide regular progress reports to the FDA as to our corrective actions. On October 28, 2021, the FDA initiated an inspection of the Boston facility and at the conclusion of the inspection, issued an FDA Form 483 on November 12, 2021. On March 1, 2023, the FDA commenced an inspection of the Boston facility and issued an FDA Form 483 at the conclusion of this inspection (the “2023 Form 483”). In May 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 (the “Boston recall”). On July 19, 2023, TEI received a Warning Letter, dated July 17, 2023, from the FDA related to quality system issues at the Boston facility (the “2023 Warning Letter”). The 2023 Warning Letter did not identify any new observations that had not already been provided in the 2023 Form 483. The Company has submitted periodic responses to the FDA for both the 2023 Form 483 and the 2023 Warning Letter. We are committed to resolving the matters identified in the warning letters and Form 483s and are continuing significant efforts to remediate the observations.
Current wording
On March 7, 2019, TEI Biosciences, Inc. (“TEI”), one of our wholly owned subsidiaries, received a Warning Letter (the “2019 Warning Letter”), dated March 6, 2019, from the FDA. The 2019 Warning Letter was related to quality systems issues at TEI’s manufacturing facility located in Boston, Massachusetts (the “Boston facility”). The Boston facility manufactured extracellular bovine matrix products in our Tissue Reconstruction segment that were sold both in wound and surgical reconstruction franchises, and in private label channels. The 2019 Warning Letter resulted from an inspection held at the Boston facility in October and November 2018 and did not identify any new observations that were not already provided in the Form 483 that followed the inspection. We submitted our initial response to the 2019 Warning Letter on March 28, 2019 and provide regular progress reports to the FDA as to our corrective actions. On October 28, 2021, the FDA initiated an inspection of the Boston facility and at the conclusion of the inspection, issued an FDA Form 483 on November 12, 2021. On March 1, 2023, the FDA commenced an inspection of the Boston facility and issued an FDA Form 483 at the conclusion of this inspection (the “2023 Form 483”). In May 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 (the “Boston recall”). On July 19, 2023, TEI received a Warning Letter, dated July 17, 2023, from the FDA related to quality system issues at the Boston facility (the “2023 Warning Letter”). The 2023 Warning Letter did not identify any new observations that had not already been provided in the 2023 Form 483. The Company has submitted periodic responses to the FDA for both the 2023 Form 483 and the 2023 Warning Letter. We are committed to resolving the matters identified in the warning letters and Form 483s and are continuing significant efforts to remediate the observations.
Previous wording
Although the warning letters do not restrict the Company’s ability to seek FDA 510(k) clearance of products, PMAs for Class III devices to which the quality system regulation violations are reasonably related will not be approved until the violations have been addressed. Following its assessment of the results of a third-party audit of the Boston facility, the Company announced in the second quarter of 2024 that it no longer planned to restart the manufacture of PriMatrix and SurgiMend at its Boston facility. The restart of the manufacturing of SurgiMend 510k product will occur at the Company’s new tissue manufacturing facility in Braintree, Massachusetts (the “Braintree transition”). In addition, the Company entered into a new third-party agreement, which facilitated the relaunch of PriMatrix, as well as Durepair Dural Regeneration Matrix in 2025, ahead of previously disclosed timelines. The Braintree facility became operational in June 2026 and is currently ramping up production to support the planned SurgiMend relaunch in the fourth quarter of 2026.
Current wording
Although the warning letters do not restrict the Company’s ability to seek FDA 510(k) clearance of products, PMAs for Class III devices to which the quality system regulation violations are reasonably related will not be approved until the violations have been addressed. Following its assessment of the results of a third-party audit of the Boston facility, the Company announced in the second quarter of 2024 that it no longer planned to restart the manufacture of PriMatrix and SurgiMend at its Boston facility. The restart of the manufacturing of SurgiMend 510k product has commenced at the Company’s new tissue manufacturing facility in Braintree, Massachusetts (the “Braintree transition”). In addition, the Company entered into a new third-party agreement, which facilitated the relaunch of PriMatrix, as well as Durepair Dural Regeneration Matrix in 2025, ahead of previously disclosed timelines. The Braintree facility became operational in June 2026 and is currently ramping up production to support the planned SurgiMend relaunch in the fourth quarter of 2026.
Previous wording
In the fourth quarter of 2025, we approved a restructuring initiative to improve the Company’s operational performance by strengthening the stability and resilience of our supply chain, strengthening global commercial capabilities and advancing our prioritization and execution discipline. We expect to incur aggregate restructuring costs associated with this initiative of approximately $12.3 million related to severance and other employee costs. The costs will be incurred as specific actions required as part of the initiative are identified and approved and are expected to continue through the end of 2026. The amounts and timing of estimated restructuring costs are subject to change until finalized; actual amounts and timing may vary materially based on various factors. During 2025, we incurred $8.5 million of restructuring costs related to this initiative. In the six months ended June 30, 2026, we incurred an additional $3.8 million in restructuring related expenses, consistent with the previously announced plans. In addition, we incurred costs related to executive restructuring activities during the six months ended June 30, 2026, which were separate from the previously announced plans.
Current wording
In the fourth quarter of 2025, we approved a restructuring initiative to improve the Company’s operational performance by strengthening the stability and resilience of our supply chain, strengthening global commercial capabilities and advancing our prioritization and execution discipline. We have incurred aggregate restructuring costs associated with this initiative of approximately $12.3 million related to severance and other employee costs. The costs will be incurred as specific actions required as part of the initiative are identified and approved and are expected to continue through the end of 2026. The amounts and timing of estimated restructuring costs are subject to change until finalized; actual amounts and timing may vary materially based on various factors. During 2025, we incurred $8.5 million of restructuring costs related to this initiative. In the nine months ended September 30, 2026, we incurred an additional $3.8 million in restructuring related expenses, consistent with the previously announced plans. In addition, we incurred costs related to executive restructuring activities during the nine months ended September 30, 2026, which were separate from the previously announced plans.
Previous wording
For thethree and sixmonths ended June 30, 2026, net income (loss) was $4.5 million and $(0.1) million, or $0.06 and $(0.00) per diluted share, as compared to net losses of $(484.1) million and $(509.4) million, or $(6.31) and $(6.65) per diluted share, for thethree and six months ended June 30, 2025. The improvement in net income (loss) for the three and six months ended June 30, 2026 was primarily attributable to the goodwill impairment charge recognized in the prior year.
Current wording
For thethree and nine months ended September 30, 2026, net income was $14.9 million and $14.7 million, or $0.19 and $0.19 per diluted share, as compared to net losses of $(5.4) million and $(514.8) million, or $(0.07) and $(6.72) per diluted share, for thethree and nine months ended September 30, 2025. The improvement in net income for the three and nine months ended September 30, 2026 was primarily attributable to the goodwill impairment charge recognized in the prior year, as well as other operational challenges that adversely affected results in the prior-year periods.
Previous wording
For the three months ended June 30, 2026, total revenues increased by $3.2 million to $418.8 million from $415.6 million for the same period in 2025, representing low-single digit growth compared to the same period in the prior year.
Current wording
For the three months ended September 30, 2026, total revenues increased by $9.1 million to $411.2 million from $402.1 million for the same period in 2025, representing low-single digit growth compared to the same period in the prior year.
Previous wording
In the Specialty Surgery segment, revenues were $309.3 million which represents an increase of $5.3 million, or 2% as compared to the prior-year period. Excluding the impact of foreign currency of $0.4 million, the increase in revenue is primarily driven by Neurosurgery and Surgical Instruments, offset by decreases in our ENT Solutions business.
Current wording
In the Specialty Surgery segment, revenues were $304.1 million, which represents an increase of $11.5 million, or 4% as compared to the prior-year period. Excluding the impact of foreign currency of $0.8 million, the increase in revenue is primarily driven by Neurosurgery and Surgical Instruments, offset by decreases in our ENT Solutions business. Growth across the Neurosurgery business was partially offset by the impact of the flooding event at our Cincinnati manufacturing facility, which reduced revenues by approximately $7 million.
Previous wording
In the Tissue Reconstruction segment, revenues were $109.5 million which represents a decrease of $2.2 million, or 2% as compared to the prior-year period. The decline was attributable to lower sales of MicroMatrix and Integra Skin, partially offset by growth in PriMatrix and DuraSorb. The decrease in Integra Skin sales was primarily due to the clearance of backorders in the prior-year period.
Current wording
In the Tissue Reconstruction segment, revenues were $107.1 million which represents a decrease of $2.4 million, or 2% as compared to the prior-year period. The decline was attributable to lower sales of MicroMatrix and Integra Skin, partially offset by growth in PriMatrix and DuraSorb. The decrease in Integra Skin sales was primarily due to the clearance of backorders in the prior-year period.
Previous wording
Gross margin was $219.7 million for the three months ended June 30, 2026, an increase of $10.4 million from $209.3 million for the same period in 2025. Gross margin as a percentage of revenues was 52.5% for the three months ended June 30, 2026 and 50.4% for the same period in 2025. The increase in gross margin is primarily attributable to a reduction in costs associated with the Braintree remediation, lower costs related to quality and operational issues, and improved manufacturing performance compared to the same period in the prior year.
Current wording
Gross margin was $209.9 million for the three months ended September 30, 2026, an increase of $2.9 million from $207.0 million for the same period in 2025. Gross margin as a percentage of revenues was 51.0% for the three months ended September 30, 2026 and 51.5% for the same period in 2025.
Previous wording
Total operating expenses, which consist of research and development, selling, general and administrative, and amortization expenses, decreased by $521.5 million, or 72.2%, to $200.5 million in the three months ended June 30, 2026, compared to $722.0 million in the same period in 2025, mainly driven by the goodwill impairment charge in the second quarter of the prior year.
Current wording
Total operating expenses, which consist of research and development, selling, general and administrative, and amortization expenses, decreased by $4.3 million, or 2.2%, to $191.0 million in the three months ended September 30, 2026, compared to $195.2 million in the same period in 2025.
Previous wording
Research and development expenses for the three months ended June 30, 2026 decreased by $2.7 million as compared to the same period in the prior year, primarily attributable to reduced spending in EU MDR.
Current wording
Research and development expenses for the three months ended September 30, 2026 decreased by $0.6 million as compared to the same period in the prior year, primarily attributable to reduced spending in EU MDR.
Previous wording
Selling, general and administrative costs for the three months ended June 30, 2026 decreased by $7.5 million as compared to the same period in the prior year, primarily due a reduction in Acclarent integration costs and reduced spending in EU MDR.
Current wording
Selling, general and administrative costs for the three months ended September 30, 2026 decreased by $3.7 million as compared to the same period in the prior year, primarily due to reduced spending on EU MDR and cost saving initiatives across the organization in the current year.
Previous wording
Other income (expense), net for the three months ended June 30, 2026 changed by $6.1 million as compared to the same period in the prior year, primarily driven by higher income on our cross currency swap contracts. For additional information regarding our cross-currency swap arrangements, see Note 6. Derivative Instruments.
Current wording
Other income (expense), net for the three months ended September 30, 2026 changed by $15.6 million as compared to the same period in the prior year, primarily due to higher income on our cross-currency swap contracts, a gain contingency related to insurance recoveries associated with the flooding event at our Cincinnati manufacturing facility, and a gain recognized in connection with the Fortis litigation matter. For additional information regarding our cross-currency swap arrangements, see Note 6. Derivative Instruments.
Previous wording
The Company’s effective income tax rates for the three months ended June 30, 2026 and 2025 were 5.5% and 8.8%, respectively.
Current wording
The Company’s effective income tax rates for the three months ended September 30, 2026 and 2025 were 5.2% and 20.8%, respectively.
Previous wording
The 2026 effective tax rate was primarily impacted by tax benefits associated with returns filed in certain foreign jurisdictions, as well as the jurisdictional mix of income, including its impact on the Company’s net Controlled Foreign Corporation tested income (“NCTI”) inclusion, formerly referred to as Global Intangible Low Taxed Income (“GILTI”). The 2025 effective tax rate was primarily impacted by a partially non-deductible goodwill impairment charge, NCTI, and additional taxes related to global minimum tax requirements in certain foreign jurisdictions, partially offset by tax benefits from operating losses in certain jurisdictions.
Current wording
The 2026 effective tax rate was primarily driven by the jurisdictional mix of income, partially offset by tax expense associated with returns filed in certain jurisdictions.
Previous wording
Additionally, changes in tax laws or regulations in the jurisdictions in which the Company operates could impact its effective tax rate. Governments in the U.S. and abroad continue to focus on tax reform and revenue-raising legislation. On July 4, 2025, the One Big Beautiful Bill Act (“OBBBA”), was enacted in the U.S. The OBBBA includes several tax law changes, including extensions of certain 2017 Tax Cuts and Jobs Act provisions, immediate expensing of certain research and development costs, and changes to interest expense deduction limitations.
Current wording
Additionally, changes in tax laws or regulations in the jurisdictions in which the Company operates could impact its effective tax rate. Governments in the U.S. and abroad continue to focus on tax reform and revenue-raising legislation. On July 4, 2025, the One Big Beautiful Bill Act (“OBBBA”), was enacted in the U.S. The OBBBA includes several tax law changes, including permanent extensions of certain 2017 Tax Cuts and Jobs Act provisions, immediate expensing of certain research and development costs, and changes to interest expense deduction limitations.
Previous wording
Six Months Ended June 30, 2026 as Compared to Six Months Ended June 30, 2025
Current wording
Nine Months Ended September 30, 2026 as Compared to Nine Months Ended September 30, 2025
Previous wording
For the six months ended June 30, 2026, total revenues increased by $12.4 million to $810.7 million from $798.3 million for the same period in 2025, representing low-single digit growth compared to the same period in the prior year.
Current wording
For the nine months ended September 30, 2026, total revenues increased by $21.5 million to $1,221.9 million from $1,200.3 million for the same period in 2025, representing low-single digit growth compared to the same period in the prior year.
Previous wording
In the Specialty Surgery segment, revenues were $592.4 million, an increase of $7.8 million, or 1% from the prior year period. Excluding the impact of foreign currency of $4.5 million, the increase in revenue is primarily driven by Neurosurgery, offset by decreases in our Surgical Instrument and ENT Solutions business.
Current wording
In the Specialty Surgery segment, revenues were $896.5 million, an increase of $19.3 million, or 2% from the prior year period. Excluding the impact of foreign currency of $4.1 million, the increase in revenue is primarily driven by Neurosurgery and Surgical Instruments, offset by decreases in our ENT Solutions business. Growth across the Neurosurgery business was partially offset by decreases in DuraGen revenues and by the impact of the flooding event at our Cincinnati manufacturing facility, which reduced revenues by approximately $7 million.
Previous wording
In the Tissue Reconstruction segment, revenues were $218.3 million, an increase of $4.6 million, or 2% from the prior year period. This is primarily attributable to growth in Primatrix and Durasorb, offset by the impact of quality and operational issues associated with Medihoney.
Current wording
In the Tissue Reconstruction segment, revenues were $325.3 million, an increase of $2.2 million, or 1% from the prior year period. This is primarily attributable to growth in Primatrix and DuraSorb, offset by decreases in Cytal and MicroMatrix.
Previous wording
Gross margin was $436.7 million for the six months ended June 30, 2026, an increase of $33.0 million from $403.8 million for the same period in 2025. Gross margin as a percentage of total revenue increased to 53.9% for the six months ended June 30, 2026 from 50.6% in the same period in 2025. The increase in gross margin is primarily attributable to a reduction in costs associated with the Braintree remediation, lower costs related to quality and operational issues, and improved manufacturing performance compared to the same period in the prior year.
Current wording
Gross margin was $646.6 million for the nine months ended September 30, 2026, an increase of $35.8 million from $610.8 million for the same period in 2025. Gross margin as a percentage of total revenue increased to 52.9% for the nine months ended September 30, 2026 from 50.9% in the same period in 2025. The increase in gross margin is primarily attributable to higher revenues and a reduction in costs associated with the Braintree remediation.
Previous wording
Total operating expenses, which consist of selling, general and administrative expenses, research and development expenses, and amortization expenses, decreased by $526.0 million, or 56.4% to $406.0 million in the six months ended June 30, 2026, compared to $931.9 million in the same period in 2025, primarily driven by goodwill impairment recorded in the second quarter of the prior year.
Current wording
Total operating expenses, which consist of selling, general and administrative expenses, research and development expenses, and amortization expenses, decreased by $530.2 million, or 47.0% to $596.9 million in the nine months ended September 30, 2026, compared to $1,127.2 million in the same period in 2025, primarily driven by goodwill impairment recorded in the second quarter of the prior year.
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Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
Interest expense for the three months ended September 30, 2026 increased by $0.2 million as compared to the same period in the prior year.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
Interest expense for the six months ended June 30, 2026 increased by $5.6 million as compared to the same period in the prior year primarily due to higher interest rates on the borrowings under the revolving credit facility component of the Senior Credit Facility as compared to the interest rates on the 2025 Notes, which was repaid in August 2025.