PolyNovo (ASX:PNV) has announced that NovoSorb BTM has been granted a certificate of conformance (CE Mark) approval for sale throughout UK/Ireland and the European Union.
It has been approved for use in all full dermal loss procedures, including full-thickness burns, trauma, reconstructive/wide excision surgery, revision of scar, venous leg ulcers, diabetic foot ulcers, pressure injuries and any loss of dermis needing repair.
The company said it will now need to file documents with each European market. However, it noted, this is a routine administrative function that will not delay sale and shipment.
It said it has had a UK/Ireland salesperson for the past year to prepare for CE approval and is currently recruiting a further two salespeople. It has also previously announced PMI as its distributor for Germany, Austria and Switzerland.
“This is watershed moment for PolyNovo. Our global regulatory approvals have expanded significantly with this certification. Our early preparedness in UK/Ireland and DACH should mean a shortened timeline to booking our first sale. We also believe CE approval will fast track regulatory approval in a number of other countries including several in South East Asia," said CEO Paul Brennan.
PolyNovo Chairman, David Williams, said, “We are confident we will have early sales in the UK/Ireland and in Germany through PMI. We will now quickly expand our direct sales force in other parts of the EU.”