PolyNovo (ASX:PNV) Obtains Taiwanese FDA Green Light, Share Price up ~7%

  • October 28, 2020 02:47 PM AEDT
  • Team Kalkine
PolyNovo (ASX:PNV) Obtains Taiwanese FDA Green Light, Share Price up ~7%

Summary

  • Medical device player PolyNovo Limited has received a green light from Taiwan FDA for the sale of NovoSorb BTM in Taiwan.
  • The Company has also signed a contract with Taiwan-based Evermed to sell its NovoSorb BTM.
  • PolyNovo disclosed that the first sales of BTM are expected around March 2021.
Gold MTF non-AMP

ASX 200-listed healthcare player PolyNovo Limited (ASX:PNV) announced today that the Taiwan FDA had approved NovoSorb BTM for sale in Taiwan. Following the announcement, PNV share price soared 6.746% to A$2.690 on 28 October 2020 (at AEST 02:31 PM).

Let us dive deep and discuss in detail- 

PolyNovo Limited

Melbourne-based medical device player PolyNovo Limited is in the business of a dermal regeneration solution known as NovoSorb Biodegradable Temporizing Matrix (BTM). The Company uses its patented NovoSorb biodegradable polymer technology to develop innovative medical devices. The development program of PolyNovo covers hernia, breast sling, as well as orthopaedic applications.

Taiwan FDA’s Green Light for NovoSorb BTM

On 28 October 2020, PolyNovo updated the market that the Company received approval from Taiwan’s FDA for the commercialisation of NovoSorb BTM in Taiwan.

In addition to the regulatory approval, PolyNovo disclosed that it has contracted with a Taiwan based distributor Evermed to sell BTM.

The Company said that Evermed is the right partner with 20 sales staff dedicated to medical devices. PNV has well-established relations with key opinion leaders and hospitals in the East Asian nation.

To start commercialising, Evermed will have to lodge reimbursement data with the health authority to achieve billing codes for use by the hospitals. This, in general, is a 3-month process. PolyNovo stated that the first sales of BTM are expected circa March 2021.

Also, PolyNovo has plans to enter the markets of Benelux, Greece, France, Finland, Italy, Korea, Kuwait, Norway, Sweden, and UAE in the financial year 2021.

Management Commentary

Paul Brennan Managing Director PolyNovo commented-

NovoSorb® in Brief

NovoSorb® is a novel bio-resorbable polymer and can be produced in the form of fibre, film, coatings, and foam. The distinctive properties of NovoSorb® offer excellent biocompatibility, programmable bio-resorption profile as well as control over physical properties. NovoSorb® BTM is a dermal scaffold for dermis regeneration when it is lost in burns or extensive surgery.

Bottomline

The approval from Taiwan FDA for NovoSorb® BTM commercialisation in Taiwan is an exciting opportunity for PolyNovo. The Company is all set to commence its sale in Taiwan’s dermal matrix market that creates a significant opportunity for PolyNovo in trauma, burns and reconstructive surgeries space.

 


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