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Integra LifeSciences Receives FDA 510(k) Clearance for Use of the CUSA® Clarity Ultrasonic Surgical Aspirator System for Cardiac Surgeries

1. IART received FDA clearance for CUSA Clarity in cardiac surgeries. 2. CUSA can now assist in valve repair and other cardiac procedures. 3. This expands CUSA's application to various types of surgeries. 4. Integra will showcase CUSA Clarity at an upcoming medical conference. 5. The clearance enhances Integra's position in surgical technology market.

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Why Bullish?

FDA clearance usually indicates strong market demand and potential revenue growth. Historical examples show similar product approvals positively impacted stock prices.

How important is it?

The FDA approval for a significant product enhances IART’s growth trajectory. This development is crucial for investor confidence and market perception.

Why Long Term?

The expanded applications of CUSA could lead to sustained revenue increases. As cardiac surgeries are prevalent, this positions IART for continuous growth.

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PRINCETON, N.J., Nov. 11, 2025 (GLOBE NEWSWIRE) -- Integra LifeSciences Holdings Corporation (Nasdaq: IART), a leading global medical technology company, is pleased to announce the FDA 510(k) clearance for use of its CUSA® Clarity Ultrasonic Surgical Aspirator System for cardiac surgeries. The recent clearance for specific cardiac indications encompasses the debridement of unwanted tissue in cardiac surgeries, including valve replacement and repair. In addition to cardiac surgery, the CUSA Clarity Ultrasonic Surgical Aspirator System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g. bone) tissue is desirable, such as neurosurgery, plastic and reconstructive surgery, orthopedic surgery, thoracic surgery, laparoscopic surgery, gynecological surgery, and liver resection and transplant surgery. “The utilization of CUSA Clarity for cardiac surgery marks the next pivotal expansion of the ultrasonic surgical aspirator system’s breadth of indications,” said Mike McBreen, executive vice president and president of Integra’s Codman Specialty Surgical division. “As one of the leaders in the industry, this milestone strengthens our ability to deliver advanced surgical solutions to support restoring patients’ lives.” Integra LifeSciences will spotlight the CUSA Clarity Ultrasonic Surgical Aspirator System at the American Association for Thoracic Surgeon Mitral Valve Conclave in New York City on December 11 and 12, 2025. About Integra LifeSciencesIntegra LifeSciences (Nasdaq: IART) is a global medical technology leader dedicated to restoring lives. We are advancing transformational care through impactful innovation in neurosurgery and tissue reconstruction, specialized fields that demand exceptional expertise and precision. Our portfolio of highly differentiated, gold-standard technologies is trusted by healthcare professionals to deliver transformative care. For the latest news and information about Integra and its products, please visit www.integralife.com. Investor Relations:Chris Ward(609) 772-7736chris.ward@integralife.com Media Contact:Laurene Isip(609) 208-8121laurene.isip@integralife.com A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/2795c2cd-fb23-4998-8dd9-8147f524564c CUSA Clarity CUSA Clarity Ultrasonic Surgical Aspirator System

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