Port Erin Biopharma Investments Ltd DBC receives US FDA approval to market PulseFlowDF (4709J)
18 December 2015 - 3:00AM
UK Regulatory
TIDMPEBI
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".
-ends-
For further information please contact:-
Denham Eke, Port Erin Biopharma Investments Limited Tel: +44
1624 639396
Roland Cornish / James Biddle, Beaumont Cornish Limited (Nomad)
Tel: +44 (0) 207 628 3396
This information is provided by RNS
The company news service from the London Stock Exchange
END
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