Melbourne-based PolyNovo (ASX:PNV) has announced that it may commence enrolling patients in a Multicentre Randomised Controlled Trial that should lead to a CE (Conformite Europeene) Mark on successful completion.
The French regulatory authority, ANSM, and the Toulon Hospital Ethics committee have granted approval for the Biodegradable Temporising Matrix (BTM) trial protocol.
The French site (Toulon) is one of three sites participating in the 20 patient trial.
The Principal Investigator in Toulon is Dr Eric Dantzer. Further centres are awaiting their respective Ethics committee approvals and will be announced as they come on board, the company said.
Patient recruitment is expected to commence in the coming months and the trial is expected to take 2 years to complete given the time required for post treatment observation.
According to the company, the trial represents a major component in fulfilling the requirements for BTM to obtain a CE mark, and successful CE certification will enable PolyNovo to sell the BTM throughout Europe.
In countries with a mutual recognition agreement of the CE Mark, it will facilitate registration processes, which includes Australia and New Zealand.
"This trial represents a significant step towards meeting out regulatory strategies and requirements," said CEO Paul Brennan. "With a CEO Mark PolyNovo will be free to sell into a significant number of markets in Europe, and Asia-Pacific."
He continued, "Our commercial strategies are strong and we look forward to revenue generation. The results we have seen to date in 3 patients in Adelaide have been outstanding. We expect results from the 20 patient trial to confirm that the BTM results in high-quality wound healing and excellent cosmetic outcome in patients with deep burn wounds."