Join our daily newsletter At The Bell to receive exclusive market insights
- PolyNovo (PNV) can now sell it’s NovoSorb BTM through the UK, Ireland and the European Union
- It has received CE mark approval for the skin repair product
- The company believes the CE approval will fast track regulatory approval in a number of other countries including several in South East Asia
- PolyNovo is up 12.97 per cent on the market today, selling shares for $1.96 apiece
PolyNovo (PNV) can now sell it’s NovoSorb BTM through the UK, Ireland and the European Union.
The company has received a certificate of conformance (CE Mark) approval for the product.
NovoSorb BTM is a skin repair synthetic dressing that is used to treat serve burns and wounds where there has been a significant loss of flesh.
The company will now need to file documents within each European market. PolyNovo says that this is a routine function and will not delay sale and shipment.
Throughout the year, PolyNovo has been to conferences to discuss NovoSorb BTM with a wide range of surgeons, nurses and allied health staff from the many European countries.
Conferences included the British Burn Association meeting in Leeds, the European Burn Association meeting in Helsinki, BAPRAS plastic surgery meeting in Bournemouth and Monaco, and the Harrogate Wound conference.
PolyNovo has employed a UK and Ireland salesperson for the past year to prepare for CE approval and it is looking to recruit two more.
The company says it has strong interest from doctors in the National Health Service wanting to evaluate the product as soon as possible.
“This is a watershed moment for PolyNovo. Our global regulatory approvals have expanded significantly with this certification,” CEO Paul Brennan said.
“Our early preparedness in UK and Ireland and DACH should mean a shortened timeline to booking our first sale,” he added.
PolyNovo believes the CE approval will fast track regulatory approval in a number of other countries including several in South East Asia.
PMI is the company’s distributor for Germany, Austria and Switzerland. PolyNovo has provided training, marketing resources and clinical support for the PMI team and has visited surgeons in the region.
“We are confident we will have early sales in the UK, Ireland and in Germany through PMI,” Chairman David Williams told the market.
“We will now quickly expand our direct sales force in other parts of the EU,” he added.
In light of the recent White Islands tragedy in NZ, the company is also supplying its product to burns victims who are still undergoing treatment.
PolyNovo is up 12.97 per cent on the market today, selling shares for $1.96 apiece at 12:45 pm AEDT.
