The Polynovo Ltd (ASX: PNV) share price is soaring higher today. This comes after the company announced an approval of a pivotal trial investigation device exemption (IDE).
During mid-morning trade, shares in the medical device company reached an intra-day high of $2.98. However, the Polynovo share price has since slightly retreated to $2.97, up 6.07% at the time of writing.
Let's take a look at what Polynovo updated the market with.
Image source: Getty Images
FDA approval for clinical trial
Polynovo advised that the United States Food and Drug Administration (FDA) has approved the pivotal trial IDE for NovoSorb BTM. The authorisation allows Polynovo to begin patient recruitment, once various hospital Independent Review Boards grant approval.
Polynovo will seek to utilise 20 sites and enlist 150 patients for the clinical study of NovoSorb BTM. All locations are currently in advanced contractual negotiations, and the company will provide further details when available.
Recruitment is anticipated to start in early 2021 and conclude around the end of 2023. Polynovo advised the program was supported by the Biomedical Advanced Research and Development Authority (BARDA) funding of $150 million.
What did management say?
Polynovo managing director Paul Brennan said this was a "significant milestone" for PolyNovo:
We are excited to begin this trial as it will build significant clinical data and further demonstrate the ability of NovoSorb BTM to enhance clinical outcomes and improve patients' lives.
Recent developments
Earlier this month, Polynovo also announced that it had entered the Greek market for NovoSorb BTM. The company revealed it had appointed Biogenesys as the distributor in the Mediterranean country.
With more than 20 years of experience, Biogenesys specialises in the area of bone and tissue allograft. It has an established network servicing hospitals and surgeons in Greece.
Speaking on the new entry to market, Mr Brennan added:
Greece is the first of the Mediterranean markets to join the PolyNovo family. With Melbourne having such a close connection to Greece we are pleased that our life-changing NovoSorb BTM is now available to the wider Greek family. Biogenesys brings significant local knowledge and connections to facilitate penetration of this market.
