culivate(MD) Capital Funds Announces Portfolio Company Embody, Inc.'s FDA 510(k) Clearance for TAPESTRY® RC Rotator Cuff Repair System

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They are redefining the future of rotator cuff repair by combining a biointegrative collagen implant with streamlined arthroscopic delivery and fully bioabsorbable anchor fixation.

Metadata
Provider: 
PR NewswirePR Newswire
Retrieved on: 
Monday, June 6, 2022
Information
Tags: 
Sports medicine, MBA, Foot, DOD, United, Failure, Pain, Investment, Multimedia, Sale, FDA, Patient, Capital, Ankle, MD, Industry, DARPA, Pharmaceutical industry, Antibiotics, Hospital, Risk management, Embodiment
Geotags: 
MICHIGAN, VA
Organisation: 
GENESIS INNOVATION GROUP
Summary
Key Points: 
  • They are redefining the future of rotator cuff repair by combining a biointegrative collagen implant with streamlined arthroscopic delivery and fully bioabsorbable anchor fixation.
  • In 2021, there were an estimated 670,000 rotator cuff repairs in the United States.1The goal of rotator cuff surgery is to repair the damaged tendon and restore mobility for patients.
  • "We believe TAPESTRYRC 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."


culivate(MD) Capital Funds Announces Portfolio Company Embody, Inc.'s FDA 510(k) Clearance for TAPESTRY® RC Rotator Cuff Repair System

GRAND RAPIDS, Mich., June 6, 2022 /PRNewswire/ -- Genesis Innovation Group's cultivate(MD) Capital Funds LP, funds that are focused on investments into early-stage healthcare companies with innovative technologies, announced today that one of their portfolio companies, Norfolk, VA based Embody, Inc. has received FDA 510(k) clearance for their Tapestry® RC System for Rotator Cuff Repair. 

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.

Embody is a privately-held medical device company developing novel collagen-based technologies for sports medicine and soft tissue repair. They are redefining the future of rotator cuff repair by combining a biointegrative collagen implant with streamlined arthroscopic 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.

Genesis Innovation Group's Executive Director, R. Sean Churchill, MD, MBA said, "Genesis Innovation Group and the cultivate(MD) venture capital fund have been proud to work alongside Jeff Conroy and his team at Embody since 2019 to develop what we believe to be an industry best deployment and fixation system with the TAPESTRY® RC System. We are excited about what this 510(k) Clearance represents for the future of Embody." 

Embody 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.

About cultivate(MD) Capital Funds

As a medical device venture capital fund, cultivate(MD) is dedicated to bringing emerging health care innovations to market, with a special focus on medical device and orthopedic technologies. cultivate(MD) is focused on investing in early stage healthcare companies with innovative technologies that have demonstrated evidence of effectiveness.  For more information, visit:  https://genesisinnovationgroup.com/

This press release does not constitute an offer to sell or solicitation of an offer to buy any securities in any offering of securities.  There will not be any sale of any securities in any state or jurisdiction in which such offering, sale or solicitation would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Forwarding-Looking Statements

Certain statements in this press release constitute forward-looking statements. When used in this press release, the words "will," "anticipate," and similar expressions or the negatives thereof are generally intended to identify forward-looking statements. Such forward-looking statements, including the intended actions and performance objectives of the fund, its general partner, cultivate(MD), or any cultivate(MD) portfolio company referenced herein, involve known and unknown risks, uncertainties, and other important factors that could cause the actual results, performance, or achievements of the general partner, or any cultivate(MD) fund or portfolio company to differ materially from any future results, performance, or achievements expressed or implied by such forward-looking statements. No representation or warranty is made as to future performance or such forward-looking statements. All forward-looking statements in this press release speak only as of the date hereof.  The fund, its general partner, and cultivate(MD) expressly disclaim any obligation or undertaking to disseminate any updates or revisions to any forward-looking statement contained herein to reflect any change in its expectation with regard thereto or any change in events, conditions, or circumstances on which any such statement is based. 

1.BIOMEDGPS 2022. SmartTRAK® Soft Tissue Augmentation

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SOURCE Genesis Innovation Group

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