The geko™ device receives FDA 510(k) clearance to market in the USA for prevention of venous thrombosis (DVT) and for increased blood circulation

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Firstkind Ltd, a subsidiary of Sky Medical Technology Ltd, announces FDA clearance for USA commercialization of their geko™ neuromuscular stimulator, indicated for increased local blood circulation, and for immediate post-surgical stimulation of the calf muscles to prevent venous thrombosis.

We look forward to building a strong surgical network across the USA to address areas of immediate unmet need in thromboembolism prophylaxis in all post-surgical patient groups.

The size of a wrist-watch and worn at the knee, the battery powered geko™ device delivers gentle electrical impulses to the common peroneal nerve, activating the muscle pumps of the lower leg to increase venous, arterial and microcirculatory blood flow. The mechanism of action emulates the blood flow rate normally achieved by walking - up to 60% - without the patient having to move or exert energy. Self-adhesive, the geko™ device, encased in a flexible moulded strap, fits comfortably to the leg, just behind the knee.

“This achievement is testament to the ongoing dedication of our team to deliver value through better patient outcomes.” says Bernard Ross, CEO. “With this approval, we now look forward to building a strong surgical network across the USA to address areas of immediate unmet need in thromboembolism prophylaxis in all post-surgical patient groups.”

This FDA marketing authorisation follows the recent UK National Institute of Care Excellence (NICE) guidance issued in June 2014 recommending the use of the geko™ device for VTE prevention across all patients groups throughout the National Health Service.

Please visit http://www.gekodevices.com to register your pre-launch interest in the geko™ device.

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About Firstkind & Sky Medical Technology Ltd:
Firstkind Ltd, a wholly owned subsidiary of Sky Medical Technology, is a leading UK based medical devices company that creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence. Privately held and based in High Wycombe, Firstkind manufactures and distributes industry-leading medical devices utilizing OnPulse™, Sky Medical’s proprietary neuromuscular electro-stimulation technology, cleared by the US FDA to market the geko™ device for increased blood circulation, for post-surgical stimulation of the calf muscles to prevent venous thrombosis. The clinically proven OnPulse™ technology is non-invasive and embedded within the small, portable, one-size-fits-all geko™ device.

geko™ and OnPulse™ are registered trademarks of Sky Medical Technology Limited and are covered by a family of pending patent applications. All intellectual property is held by Sky Medical Technology Ltd and covers the use of the OnPulse™ technology in a range of medical indications. To find out more about the geko™ device and the OnPulse™ technology please visit: http://www.gekodevices.com

Sky Medical Technology Limited
Hawk House
Peregrine Business Park
Gomm Road
High Wycombe
Buckinghamshire
HP13 7DL
United Kingdom

Media contact:
Sue Davenport
+44 (0)1494 572044

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Amie Irish