Anika Receives 510(k) Clearance for Integrity Implant System, a Regenerative Hyaluronic Acid-Based Patch System for Augmentation of Rotator Cuff Repairs

Complete Integrity Implant System is now fully cleared; targeting launch in Q1-2024

Integrity is highly differentiated by its knitted structure, resulting in higher strength and greater regenerative capacity compared to first generation bovine collagen patches¹

Integrity marks Anika’s expansion of its proprietary regenerative portfolio and entrance into the over $150 million² U.S. rotator cuff augmentation market

BEDFORD, Mass., Aug. 17, 2023 (GLOBE NEWSWIRE) -- Anika Therapeutics, Inc. (NASDAQ: ANIK), a global joint preservation company focused on early intervention orthopedics, today announced that it has received the final 510(k) clearance from the FDA for the Integrity Implant System. The system is designed to augment an injured tendon to promote healing in rotator cuff repair procedures. Clearance of the hyaluronic acid (HA) based patch component joins the prior 510(k)s received for the associated fixation devices and instrumentation. The Integrity implant is a flexible, knitted, HA-based scaffold that provides improved strength and regenerative capacity over first generation collagen patches¹, and supports regenerative healing through improved cell infiltration¹, tissue remodeling¹, and tendon thickening¹.

“The clearance of Integrity is a key milestone in the continued build-out of Anika’s proprietary HA-based regenerative portfolio and underscores our commitment to helping surgeons improve outcomes in rotator cuff repair procedures through biologic healing,” said Cheryl R. Blanchard, Ph.D., Anika’s President and CEO. “Integrity, named for its structural integrity compared with first-generation collagen patches, is a key value driver for Anika and was developed internally using our proprietary HA technology that has demonstrated differentiated regenerative performance characteristics. The HA-based patch, together with the instrumentation and fixation, provide a seamless, efficient, and elegant rotator cuff repair solution. This clearance opens significant opportunities in the shoulder and we see future expansion for this innovative technology in other anatomies. Integrity enhances the breadth and depth of our regenerative offering, adding critical mass to a growing portfolio that provides meaningful solutions to unmet needs in early intervention orthopedics that restore active living for patients around the world.”