DBC receives US FDA approval to market PulseFlowDF

RNS Number : 4709J

Port Erin Biopharma Investments Ltd

17 December 2015

 

17 December 2015

Port Erin Biopharma Investments Limited

("PEBI" or the "Company")

Diabetic Boot Company Limited receives US FDA approval to market PulseFlowDF in US

PEBI is pleased to announce that the Diabetic Boot Company Limited ("DBC"), in which it recently acquired 7,105 shares via a placement, has received a letter from the US Food and Drug Administration ("FDA") confirming that the product PulseFlowDF, being developed for the treatment of diabetic foot ulcers, can be marketed in the United States. This follows the submission by DBC of a Section 510(k) premarket notification and two rounds of questions from the FDA which DBC has responded to during 2015. DBC is now moving forward with plans to commence sales of PulseFlowDF in the United States.

Nick Hyde, the chairman of DBC noted that "receipt of approval to market a product from the FDA under section 510(k) is major milestone for any company and one that marks the start of an exciting next phase for us".

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For further information please contact:-

Denham Eke, Port Erin Biopharma Investments Limited Tel: [phone]

Roland Cornish / James Biddle, Beaumont Cornish Limited (Nomad) Tel: [phone]

 

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