US based manufacturer of therapeutic products for orthopaedic diseases and traumatic conditions, Anika has announced it received 510(k) clearance from the US Food and Drug Administration (FDA) for its Integrity Implant System.
The company announced it plans a limited market release for the hyaluronic acid (HA) based patch component in the US in Q1 2024, with international market releases to follow shortly after.
The implant system uses a flexible, knitted, HA-based scaffold and has the ability to strengthen and regenerate over first-generation collagen patches, helping patients heal by using cell infiltration, tissue remodelling, and tendon thickening.
Commenting on the milestone, Cheryl R. Blanchard, CEO Anika was enthusiastic on the value the Integrity Implant System would bring to the company. “The HA-based patch, together with the instrumentation and fixation, provide a seamless, efficient, and elegant rotator cuff repair solution,” said Blanchard. “This clearance opens significant opportunities in the shoulder and we see future expansion for this innovative technology in other anatomies.”
Timothy Codd, MD, of the University of Maryland St. Joseph Medical Center agreed with Blanchard, confirming that the clearance would create opportunities in orthopaedics. “Building on previous work with biological augmentation, the new Integrity system will be the next step forward in improving tendon healing and patient outcomes, with refined and more precise delivery,” said Codd.
“With the ability to augment and improve tendon healing along with increased structural support for early tendon repairs, Integrity should be the next big advance in improving patient outcomes in rotator cuff disease.”
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According to Anika, the US rotator cuff augmentation market is currently valued at $150 million and is growing at a compound annual growth rate (CAGR) of 7% over the next 5-years. A report from GlobalData supports the view that the orthopaedics space is growing, with data showing the orthopaedic devices market is expected to reach nearly $50 billion in 2023.
Anika and its subsidiaries are currently working on the development of 33 products that fall under the Orthopaedic Devices, Wound Care Management and Drug Delivery Devices markets. The primary focus is on orthopaedic diseases, followed by wounds and injuries, hematologic diseases, and immune system diseases.
Elsewhere in the Stem/Femur market, HEMICAP from Anika saw a drop in selling price in the UK in 2022.