PolyNovo has elaborated on an earlier U.S. Federal Food and Drug Administration approval for its regenerative medical device for use in reconstructive and surgical wounds.
The 510(k) approval allows PolyNovo to sell its device now in the U.S. surgical wound market which is estimated at US$800 million per annum.
This means that PolyNovo has approval for management of wounds including partial and full thickness wounds, pressure, venous and diabetic ulcers, surgical wounds, trauma wounds and abrasions and second-degree burns.
The FDA determined that PolyNovo's BTM is substantially equivalent for the indications above to predicate devices in the market.
However there is more to this than at first blush. PolyNovo has a distinguishing feature with its BTM device in dermal matrixes with trials to date showing outcomes with significantly improved functional and cosmetic outcomes.
Reimbursement of the dermal matrixes in hospitals and alternate care facilities is an established process with prices established on a surface area and application basis.
This paves the way for PolyNovo to pursue and open negotiations with multi-national wound companies for the U.S. distribution rights while PolyNovo retains manufacturing of the finished product.
