PolyNovo (ASX:PNV) ended 2015 by announcing US FDA approval for its Biodegradable Temporising Matrix (BTM) for use in reconstructive and surgical wounds.
The approval allows the company to sell the BTM in the US surgical wound market which is estimated at US$800m per annum.
The BTM has been approved for the management of wounds including:
- partial and full thickness wounds;
- pressure, venous and diabetic ulcers;
- chronic and vascular ulcers;
- surgical wounds - donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence;
- trauma wounds - abrasions, lacerations, second-degree burns, skin tears; and
- draining wounds.
The FDA determined that the PolyNovo BTM is substantially equivalent for the indications above to predicate devices in the market.
Despite equivalency, PolyNovo says it believes the BTM is a disruptive advancement in dermal matrixes with trials to date showing outcomes with significantly improved functional and cosmetic outcomes.
The company says it will now pursue negotiations with multi-national wound companies for the US distribution rights but will retain manufacturing of the finished product.
According to CEO, Paul Brennan, “This is a significant milestone as FDA approval means we now have access to the largest reimbursed dermal matrix market in the world. We will be negotiating a North American licence agreement with multinationals so that we can get rapid market access. We are now focused on business development and execution of our commercial plans in the US and other markets.”