Anika Commences Full Market Rollout of the Integrity Implant System

Anika Therapeutics Inc. announced today the full U.S. market release of its Integrity Implant System. The bone/tendon fixation solution had been in limited release for the past eight months.

Comprised of a hyaluronic acid-based implant with bone and tendon fixation components and single use arthroscopic delivery instruments, the Integrity implant System is designed to protect an injured tendon and promote healing in rotator cuff repair and other tendon procedures. 

“We are proud to have Anika’s new Integrity Implant System now in full market release as we continue to build out our HA-based regenerative product portfolio,” Anika President/CEO Cheryl R. Blanchard, Ph.D., said. “The feedback we’ve received during the limited market release highlights the strong differentiation of Integrity compared to existing collagen patches, particularly with the strength and increased regenerative capacity of the implant, and the ease of use of the all-arthroscopic system. Integrity, initially designed to augment rotator cuff repairs, has been clinically used across a wide range of applications including the Achilles tendon and other foot and ankle repairs. We are now seeing strong market pull from surgeons using our Integrity system and we believe it is truly a game changer for surgeons and their patients, quicky becoming the new standard for treating rotator cuff repairs and other tendon repair applications.”   

Rotator cuff tears often fail to heal properly following surgical repair and have shown a high incidence of retearing. Bench-top testing shows that Integrity provides nearly 50% higher tensile strength, over three times greater suture retention strength, and more than three times more tear resistance when hydrated compared to the market-leading collagen implant.¹ Additionally, in a head-to-head preclinical study also comparing Integrity to the market-leading collagen implant, new collagenous tissue infiltration forming a new network of tendon tissue had occurred within the resorbing Integrity structure at 26 weeks, resulting in Integrity demonstrating greater regenerative capacity and the repaired tendon being three times greater in thickness.¹

“I have successfully completed more than 25 rotator cuff repairs using the Integrity system. The knit structure of the hyaluronic acid-based material, along with PET fiber, allows for excellent intraoperative manipulation and time-zero strength versus collagen implants I’ve used in the past,” commented Christopher E. Baker, M.D., of the Florida Orthopaedic Institute. “I am able to move and place tension on the implant in an effort to offload the underlying repair without compromising its structure. The arthroscopic instrumentation offers flexibility for a multitude of techniques, including a single or dual portal approach as well as the option to use a rigid or non-rigid cannula. My first patients are now six months post-op and are doing great! We have seen no adverse events with Integrity. I’m also very excited for the clinical case series we have initiated where we will look at imaging to help establish normal expectations for postoperative MRI findings.”

“I have relied on the Integrity Implant for all my foot and ankle tendon repair cases throughout its limited market release. The product significantly enhances both the strength and biological support at the repair site, enabling me to expedite therapy and improve range of motion more swiftly,” declared Stephan Arndt, M.D., an orthopedic foot and ankle surgeon in Jacksonville, Fla. “Early patient outcomes have been outstanding, with individuals returning to normal activities at an accelerated rate. This is truly an exciting advancement and time for tendon repairs.”

The U.S. soft tissue augmentation market is currently over $190 million, of which roughly $150 million is in rotator cuff repair and is estimated to grow nearly 7% annually² over the next five years. 

Anika Therapeutics is a global joint preservation company that creates and delivers advancements in early intervention orthopedic care. Leveraging its core expertise in hyaluronic acid and implant solutions, the company partners with clinicians to provide minimally invasive products delivered in key sites of care that restore active living for people. Anika Therapeutics’ focus is on high-opportunity spaces within orthopedics, including osteoarthritis pain management, regenerative solutions, sports medicine, and arthrosurface joint solutions. Anika’s global operations are headquartered outside of Boston, Mass.

References
¹ Data on File
² 2023 SmartTRAK