- ASX 200-listed PolyNovo Limited receives FDA green light for its BARDA supported pivotal trial IDE.
- The Company is set to commence a clinical trial at 20 sites to recruit 150 patients.
- Polynovo estimate recruitment will start early in the calendar year 2021.
ASX 200-listed healthcare player PolyNovo Limited (ASX:PNV) revealed on Friday that it had received the green light from US regulator FDA for the pivotal trial investigation device exemption (IDE).
The Australia-based medical device player is engaged in the development of innovative medical devices by utilising the patented Novosorb® technology. NovoSorb BTM is the first commercialised product by the Company.
Buoyed up by this significant announcement, the share price of PolyNovo saw an uptick of 4.642% to A$2.930 at AEST 11:34 AM. The market capitalisation of PolyNovo stood at A$1.85 billion.
PolyNovo to kick off clinical trial at 20 sites
The receiving of the FDA approval for pivotal trial IDE allows PolyNovo intends to begin patient recruitment after receiving further approval from the hospital Independent Review Boards (IRB) grant. Post the IRB approval, PolyNovo is expected to start a clinical trial at 20 sites to recruit 150 patients.
The Company mentioned that additional details of the sites and study including the finalised list of trial hospitals shall be published in due course.
Polynovo estimates recruitment to commence early in the calendar year 2021 and conclude around the end of the calendar year 2023. This clinical development is supported by a US$15 million funding from BARDA. PolyNovo has a research and development service providing agreement with BARDA that has been extended until August 2025.
Managing Director PolyNovo, Paul Brennan commented-
Source: Company announcement dated 13 November 2020
PolyNovo stated that successful completion of the pivotal trial will lead to a PMA application, leading to the use of platform of PNV for full-thickness acute burns.
Also, Pivotal trial completion may lead to BARDA acquiring a stockpile of NovoSorb BTM for disaster management.
Lately, PolyNovo also updated the market with its entry in Greece. On 2 November 2020, the Company announced the appointment of Biogenesys as its distribution partner in Greece.