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- PolyNovo (PNV) has received Taiwanese Food and Drug Administration (FDA) approval for the company’s dermal scaffolding product NovoSorb BTM
- NovoSorb BTM is designed to treat traumatic wounds by aiding the regeneration of the dermis lost during surgery or from burns
- PolyNovo has also contracted a Tawain-based distributor with established relationships with hospitals, Evermed, to sell the product in-country
- Evermed will now lodge reimbursement data with the health authority and expects to be able to begin selling NovoSorb BTM in March 2021
- Shares in the ASX 200-lister opened up 3.57 per cent, trading for $2.61
PolyNovo (PNV) has received Taiwanese Food and Drug Administration (FDA) approval for the company’s dermal scaffolding product.
The product, NovoSorb Biodegradable Temporising Matrix (BTM), uses the company’s patented bioabsorbable polymer technology for the treatment of traumatic wounds.
NovoSorb BTM is used to aid the regeneration of the dermis, the layer of skin beneath the epidermis, which is lost during surgery or from burns.
Key milestones for the product include U.S. FDA approval in 2015, Australian Register of Therapeutic Goods listing in 2018 and European CE mark approval in 2019.
PolyNovo Managing Director Paul Brennan said the approval represents an exciting development for the company.
“Taiwan has an advanced health system and has a population of circa 23 million concentrated in three regions. The dermal matrix market in Taiwan has good potential for us in reconstructive surgery, trauma and burns.”
In addition to receiving Tawainese regulatory approval, PolyNovo has contracted Evermed, a Taiwan-based distributor which has offices in the three main regions of the country, to sell the product in-country.
“Evermed is a very good partner and has 20 sales staff focused on medical devices. The company has well-established relationships with hospitals and key opinion leaders throughout Taiwan,” said Mr Brennan.
Evermed will now lodge reimbursement data with the health authority, a process which is expected to take around three months.
PolyNovo anticipated sales of NovoSorb BTM in Taiwan will commence in March 2021.
Shares in the ASX 200-lister opened up 3.57 per cent, trading for $2.61
