DBC receives US FDA approval to market PulseFlowDF

RNS Number : 4727J
FastForward Innovations Limited
17 December 2015
 

17 December 2015

 

FastForward Innovations Limited

("FastForward" or the "Company")

 

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

FastForward is pleased to announce that the Diabetic Boot Company Limited ("DBC"), in which it holds a 4.9% stake, 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 visit www.kualainnovations.com or contact:

 

FastForward Innovations Limited Tel: +44 1481 810 100 Elysium Fund Management Limited

 

Beaumont Cornish Limited (Nomad) Tel: +44 (0) 207 628 3396 James Biddle / Michael Cornish

 

Peterhouse Corporate Finance Limited (Broker) Tel: +44 (0) 20 7469 0930 Guy Miller / Lucy

Williams

 

CAUTIONARY STATEMENT

The AIM Market of London Stock Exchange plc does not accept responsibility for the adequacy or accuracy of this release. No stock exchange, securities commission or other regulatory authority has approved or disapproved the information contained herein. All statements, other than statements of historical fact, in this news release are forward-looking statements that involve various risks and uncertainties, including, without limitation, statements regarding potential values, the future plans and objectives of Kuala Innovations Limited and the companies in which it invests. There can be no assurance that such statements will prove to be accurate, achievable or recognizable in the near term.

Actual results and future events could differ materially from those anticipated in such statements. These and all subsequent written and oral forward-looking statements are based on the estimates and opinions of management on the dates they are made and are expressly qualified in their entirety by this notice. Kuala Innovations Limited assumes no obligation to update forward-looking statements should circumstances or management's estimates or opinions change.

 


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