Le Lézard
Classified in: Health
Subject: FDA

Atreon Orthopedics Received FDA Clearance for Rotator Cuff Regeneration Product

COLUMBUS, Ohio, March 19, 2019 /PRNewswire/ -- Today, Atreon Orthopedics, a ParaGen Technologies subsidiary company that focuses on orthopedic products, announced that the U.S. Food and Drug Administration (FDA) has cleared its proprietary product, the RotiumTM Bioresorbable Wick, which supports the regeneration of healthy tendon in the healing of rotator cuff injuries. This announcement comes after ParaGen received its first FDA clearance in 2018 for the Phoenix Wound MatrixTM, a product from ParaGen subsidiary RenovoDerm.

RotiumTM is a synthetic bioresorbable scaffold that is positioned between the repaired tendon and the bone and acts to facilitate and enhance the healing of the tendon to the bone. In proprietary animal research performed at Colorado State University, results in both an acute and chronic sheep model showed a tremendous improvement in the strength of the repaired tendon with the RotiumTM Bioresorbable Wick over the tendons repaired without RotiumTM. Histological evaluation supported the results seen by showing the development of Sharpey's Fibers between the tendon and the bone. 

"To receive the second FDA clearance in a year, in two different clinical areas, tells us we are on the right track in developing our regeneration technology platform," said Ross Kayuha, CEO of Atreon Orthopedics. "We saw impressive success with this product in both acute and chronic animal trials, and are looking forward to how this can help people who are recovering from rotator cuff injuries."

Atreon Orthopedics is a subsidiary company of ParaGen Technologies. ParaGen, a joint venture between Nanofiber Solutions, which aids in developing the core technology, and Ikove Venture Partners, which provides full operational support, market strategy and access to funding via a global network of investors.

"Through Ikove's proprietary Startup Nursery, we're helping develop life-changing technologies like RotiumTM to be shared with humanity," said Flavio Lobato, managing partner of Ikove Venture Partners and board chairman at ParaGen. "The milestones and accelerated success we are seeing with our regenerative medicine products are made possible through the continued supported from our global network of investors. We are thrilled for all that's to come."

About Atreon Orthopedics
Atreon Orthopedics is based in Columbus, Ohio, whose mission is to dramatically improve healing and the speed of recovery for patients encountering sports medicine injuries by developing scaffold-based orthopedic products that accelerate and improve the quality of the repair at the site of a soft tissue injury.

About ParaGen Technologies
ParaGen Technologies is the parent of a family of companies focused on diverse clinical areas including wound care, orthopedics, peripheral vascular and hernia repair. ParaGen aims to redefine tissue engineering by addressing the problems associated with synthetic and biologic implants while incorporating their advantages. The company is utilizing synthetic nanofiber scaffolds that promote healing by mimicking the physical structures found naturally in the body. This technology is tailored to meet the needs of specific clinical verticals.

About Ikove Venture Partners
Ikove is a venture development company founded to pursue early-stage investments with emphasis on technology commercialization in the Midwest. Through its proprietary Startup Nursery, in partnership with multiple U.S. research institutions, Ikove identifies and validates developing high-impact technologies, providing capital and commercialization resources to bridge the gap between R&D and VC-funded rounds. To date, Ikove has successfully launched 10 technology companies and created over $150 million in equity value.

About Nanofiber Solutions
Nanofiber Solutions is a regenerative medicine company developing a new class of implants with unrivaled performance for the $20 billion soft tissue/organ repair/regeneration market. The platform technology is used to build off-the-shelf scaffolds that are critical in the development of life-saving and life-changing tissue-engineered implants. Nanofiber Solutions is a leader in scaffold development for tissue regeneration and we are rapidly expanding our product offerings and patent estate based on this proven scaffold technology.

All claims are supported by non-clinical animal data.

Heather Phillips                        

SOURCE Atreon Orthopedics

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