Embody, Inc. Announces 510(k) Clearances for TAPESTRY® RC for Rotator Cuff Repair

Redefining the future of rotator cuff repair by combining a biointegrative collagen implant with streamlined arthroscopic delivery and fully bioabsorbable fixation

NORFOLK, Va., May 31, 2022 /PRNewswire/ -- Embody, Inc., a privately-held medical device company focused on soft tissue healing, announced today that it has received 510(k) clearances from the Food and Drug Administration (FDA) for its TAPESTRY RC System for the treatment of rotator cuff disease. Uniquely designed for arthroscopic procedures, TAPESTRY RC System combines the healing benefits of the biointegrative collagen TAPESTRY implant with streamlined delivery and fully bioabsorbable anchor fixation.

In 2021, there were an estimated 670,000 rotator cuff repairs in the United States.¹ The goal of rotator cuff surgery is to repair the damaged tendon and restore mobility for patients. However, failure can occur due to inadequate healing of the soft tissue, resulting in pain, loss of function and costly reoperations.

"We believe TAPESTRY RC sets a new standard in arthroscopic rotator cuff surgery," said Jeff Conroy, Chief Executive Officer of Embody. "Building on the clinical utility of TAPESTRY, now in a streamlined, all-in-one solution for arthroscopic rotator cuff surgery."

The novel design of the TAPESTRY RC System combines an arthroscopic introducer pre-loaded with the TAPESTRY biointegrative collagen implant and the first fully bioabsorbable fixation anchors FDA cleared for use for fixation in both tendon and bone in an easy-to-use, pre-loaded anchor inserter.

"There remains an important clinical need to further improve upon the current healing rates in the treatment of rotator cuff disease," said Nicholas Sgaglione, MD, senior vice president and executive director of Northwell Health Orthopaedic Institute and Chair and Professor of orthopedics surgery at Northwell Health. "Embody's TAPESTRY RC System allows for efficient and versatile delivery in a fully bioabsorbable solution to biologic augmentation of the rotator cuff in arthroscopic procedures." 

"Historical focus has been on the mechanical repair of tendon and ligaments, not the biologic augmentation," said Dr. Wasik Ashraf, Director of Sport Medicine at St. Luke's Cornwall Hospital. "TAPESTRY has enabled me to bring the power of biostimulative collagen to improve healing of my patients, now in a quick and easy solution to address rotator cuff disease."

The company is planning to extend its current post market clinical studies in shoulder arthroplasty, foot and ankle, and gluteus medius repair to further include arthroscopic rotator cuff repair.

About Embody: Embody, the soft tissue healing company, is pioneering the next generation regenerative platform with novel collagen-based bio-fabrication techniques and products for the fast-growing sports medicine market. The global market for sports medicine products is expected to reach $11 billion by 2023. Embody's products focus on the most pressing patient needs: the repair of serious tendon and ligament injuries and are developed in close collaboration with some of the most advanced clinical thought leaders. Founded in 2014 and funded more than $22 million in DARPA & DOD funding, the company is developing unique biomaterials with an initial focus on orthopedic applications including foot & ankle, rotator cuff and knee ligament.

^1. BIOMEDGPS 2022. SmartTRAK® Soft Tissue Augmentation

SOURCE Embody, Inc.