PolyNovo gets CE Mark for NovoPore dressing
Calzada (ASX:CZD) subsidiary PolyNovo Biomaterials has secured CE Mark certification for topical negative pressure (TNP) foam dressing NovoPore.
The company has secured approval to market NovoPore in the US, Canada and now Europe - the majority of the addressable market for the product.
“This is an important regulatory validation for our platform technology and an important commercial building block to generate strategic alliances,” Calzada Chairman David Williams commented.
Polynovo has announced that its commercialisation strategy for NovoPore includes forming a marketing and distribution alliance with a global partner which has an established TNP therapy solution.
NovoPore is designed for use in procedures including vacuum-assisted closing of pressure sores.
While current TNP dressings are associated with complications such as infection as a result of foam fragments remaining in the wound, clinical trials suggest that NovoPore has the potential to address these issues.
Notice of the European approval comes the week after Calzada announced it is conducting a significant organisational restructuring involving hiring more clinical, regulatory, commercial, quality and manufacturing staff.
The restructuring will also involve hiring a new managing director for PolyNovo and Calzada’s corporate unit.
Calzada (ASX:CZD) shares were trading unchanged at $0.12 as of around noon on Tuesday.
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