Embody, Inc. Announces FDA 510(k) Clearance of TAPESTRY® Biointegrative Implant for Tendon and Ligament Repair
Oct 22, 2020, 08:35 ET
NORFOLK, Va., Oct. 22, 2020 /PRNewswire/ -- Embody, Inc., a privately-held medical device company developing novel collagen-based technologies for sports medicine and soft tissue repair, announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its TAPESTRY Biointegrative Implant for tendon and ligament repair. TAPESTRY is a bioengineered collagen-based implant with a proprietary micro-architecture specifically designed for tendon and ligament repair. With initial funding through the Defense Advanced Research Projects Agency (DARPA) Atoms to Products Program, Embody has pioneered additive manufacturing and advanced biofabrication techniques to assemble collagen from the molecular scale to produce bioengineered medical devices specifically designed for soft tissue repair. According to Smarttrak Biomed GPS, in 2019 over 2.4 million surgeries were performed in the U.S. to repair soft tissue injuries.
"This FDA clearance represents a major milestone in the advancement of Embody's mission to improve outcomes for patients who suffer from tendon and ligament injuries," said Jeff Conroy, CEO of Embody. "We believe TAPESTRY represents a significant advancement in collagen science and provides surgeons with a compelling solution with broad clinical utility for tendon repair procedures."
"There is clearly a clinical need to further improve upon our current healing rates in the treatment of many tendon and ligament injuries," said Kevin F. Bonner, MD, an orthopedic surgeon and Director of the Research Foundation at The Jordan-Young Institute in Virginia Beach, VA. "Embody's TAPESTRY implant represents a breakthrough in implant design that combines the benefits of collagen with the structural integrity required for demanding tendon and ligament applications from foot & ankle to complex shoulder repair procedures."
About Embody: Embody is pioneering the next generation regenerative platform for the repair of tendon and ligament injuries with novel collagen-based bio-fabrication techniques and products for the fast-growing sports medicine market. Founded in 2014 and funded with $20 million in DARPA & DOD funding, the company is developing unique biomaterials with an initial focus on orthopedic applications including Achilles, rotator cuff and knee ligament repair.
SOURCE Embody, Inc.
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