Fidia entered the regenerative medicine segment with U.S. launch of NuDYN™ acellular amnion-derived injectable allograft. The shelf-stable, flowable allograft is the first product in the company's new orthobiologic portfolio, and complements Fidia's current hyaluronic acid-based HYALGAN® and HYMOVIS® products, which are used to treat osteoarthritis knee pain.
In the U.S., Fidia seeks to diversity into new, emerging product categories to serve patients who seek non-surgical solutions.
NuDYN does not require any reconstitution. As a true acellular amnion-derived allograft without any chorion, the product is non-immunogenic. Third-party CLIA-certified labs conduct serological and endotoxin testing that exceed FDA requirements to ensure the safety and quality of this product.
Source: Fidia Pharma USA Inc.