PolyNovo gets US tick for NovoPore dressing
Calzada (ASX:CZD) subsidiary PolyNovo Biomaterials has secured regulatory approval in the US for its topical negative pressure (TNP) foam dressing NovoPore.
The US FDA has granted NovoPore 510(k) regulatory clearance, paving the way for the product’s launch in the market.
The FDA has previously raised concerns over other TNP dressings going through the approvals process due to complications associated with infection as a result of foam fragments remaining in the wound.
But PolyNovo completed a trial in April demonstrating that NovoPore has the potential to address these concerns. Based on such results, the company filed for approval in September last year.
“This is our first regulated product for our technology, marking a significant milestone for PolyNovo and its NovoSorb technology,” PolyNovo CEO Laurent Fossaert commented.
“This 510(k) will not only allow PolyNovo to gain access to the US market for NovoPore, but will also enhance the wider commercialisation of our technology with future partners.”
The company now plans to seek a global marketing partner to handle US distribution of NovoPore, but maintain manufacturing and supply rights. PolyNovo is also finalising an application for CE Mark approval in Europe.
TNP therapy is used to treat chronic wounds such as pressure sores. The global TNP market is estimated to be worth around US$400 million ($445 million) annually.
Calzada (ASX:CZD) shares were trading 13.04% higher at $0.13 as of around 1 pm on Thursday.
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