UK-based medical devices company, Sky Medical Technology, has announced FDA 510(k) clearance for the use of its innovative medical device, geko, in the treatment of pre- and post-operative oedema (swelling) in the US.
The patented neuromuscular electrostimulation technology will now be used to improve patient care in the lead up to and after orthopaedic surgery.
This latest accreditation furthers Sky Medical Technology access to the US’ multi-billion-dollar healthcare market as the company’s ambitious international growth plans continue to gather pace.
Sky Medical Technology CEO, Bernard Ross, said: “The American healthcare market is receptive to any new innovation that can provide high-impact therapies that address unmet clinical needs, and this latest clearance reflects our strengths in this very arena. Our products and evidence-based therapies - developed in the UK and then exported globally - are helping to establish new standards of care that simplify treatments for clinicians and improve patient outcomes.
“To provide some context on the market potential”, Ross continued, “there are around 700,000 knee replacements and 300,000 hip replacements performed in the US every year, all of which could benefit from the use of geko. This is not to mention fractures and other orthopaedic surgery where oedema reduction is paramount.”
The Daresbury-headquartered firm has entered a number of new markets across the globe through direct sales or distributor partnerships, bringing the total number of countries with a direct presence to 34.
“We’re exploring a growing number of research streams for the use of our core technology and anticipate further international growth in the coming year”, said Ross.
“Central to our success overseas has been our proven model of partnering with many inspiring healthcare practitioners that actively seek out ways to transform how healthcare is delivered. The growth of our export business has been a direct result of our collaboration with early adopters in the UK to generate proven clinical and health economic data that can translate globally”, he finished.
