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.”

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.