Perhaps PolyNovo may emerge as a competitor. FDA approval yesterday.28 December 2015
PolyNovo’s US FDA approval
The Board of PolyNovo Limited ('PolyNovo') is excited to announce that the US FDA has granted regulatory approval for its Biodegradable Temporising Matrix (BTM) for use in reconstructive and surgical wounds. The 510(k) approval allows PolyNovo to sell the BTM in the USA.
The corporate office of PolyNovo is closed for Christmas/New Year and the company will provide further details on January 4th.
The CEO Paul Brennan said “This is a very significant milestone for PolyNovo. FDA approval means we are now a commercial enterprise with access to the largest reimbursed dermal matrix market in the world.”