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Futura Medical confirms regulatory timeline for breakthrough gel; excited about its commercial potential

“Following positive feedback after consultations with regulators we are confident MED3000 has a well-defined path to approval as a medical device as a clinically proven ED [erecrtile dsyfunction] therapy,” said chief executive James Barder

Futura Medical PLC -

Futura Medical PLC (LON:FUM) said it is “increasingly excited” about the commercial potential of its fast-acting gel for erectile dysfunction as discussions with potential partners continue “in earnest”.

With its annual results, Futura confirmed that the EU filing for MED3000 is likely by the end of July, with the US Food & Drug Administration submission expected by the end of the third quarter.

“Following positive feedback after consultations with regulators we are confident MED3000 has a well-defined path to approval as a medical device as a clinically proven ED [erecrtile dsyfunction] therapy,” chief executive James Barder said in the statement.

“Futura remains in consultation with the FDA regarding overall data requirements as we move towards targeted regulatory submissions for MED3000 in both the US and EU in the next six months.”

In the update, Futura said it had just over £2.5mln at the December 31 period-end, topped up in January by a fundraiser that brought in a gross £3.25mln.

This provides a “cash runway” into the second quarter of next year, thanks to significantly reduced spending of research and development, Futura said.

The medical technology group told investors it was anticipating “limited impact” from the coronavirus (COVID-19) outbreak that has forced Britain into lockdown.

Futura has developed a method of delivering a medicinal payload through the skin that can be used in harness with a host of drugs.

Its topical pain and inflammation relief product, TPR100, is the subject of “formulation dosing adjustment” as it and partner Thornton & Ross seek its regulatory sign-off. There are “ongoing commercial discussions” with several overseas distributors, the firm said.

As is common for a company carrying out significant R&D, Futura booked a loss of £8.92mln for 2019, up from £5.88mln.

Quick facts: Futura Medical PLC

Price: 15.7 GBX

AIM:FUM
Market: AIM
Market Cap: £38.56 m
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Futura Medical's James Barder says regulatory submissions for MED3000 remain...

Futura Medical PLC's (LON:FUM) James Barder tells Proactive London's Andrew Scott they've seen little impact from the coronavirus lockdown and that regulatory submissions for its erectile dysfunction treatment remain on track. The treatment is MED3000 - a fast-acting gel that will be targeted...

1 week, 6 days ago

2 min read