Startup Atreon Orthopedics said that the FDA has cleared its device designed to support the regeneration of tendon in rotator cuff injuries.
The Rotium bioresorbable wick is a synthetic scaffold that is positioned between the repaired tendon and the bone to facilitate and enhance the healing of the tendon to the bone, according to the Columbus, Ohio-based company. Atreon is a subsidiary of ParaGen Technologies, a joint venture between Nanofiber Solutions, which aids in developing the core technology, and Ikove Venture Partners, which provides operational support, market strategy and access to funding via a global network of investors.
In proprietary animal research performed at Colorado State University, results in both an acute and a chronic sheep model showed a “tremendous improvement” in the strength of the repaired tendon with the Rotium device over the tendons repaired without Rotium, the company added. Histological evaluation supported the results seen by showing the development of Sharpey’s Fibers between the tendon and the bone.
Atreon’s announcement comes after ParaGen received its first FDA clearance in 2018 for the Phoenix Wound Matrix, a product from ParaGen subsidiary RenovoDerm.
“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 Atreon CEO Ross Kayuha in a prepared statement. “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.”
ParaGen recently closed a $3 million bridge funding round. Ikove Venture Partners managed and organized the round through its network of investors. About 70% of the funds came from 10 different countries.
“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,” said Flavio Lobato, managing partner of Ikove Venture Partners and board chairman at ParaGen.
“We are thrilled for all that’s to come.”