06/02/2017

Alesi Surgical pioneering surgical device gains United States FDA approval

Alesi Surgical Limited, the leading innovator of minimally invasive surgery technologies has successfully secured FDA (Food and Drug Administration) approval for its Ultravision™ system.

The Ultravision™ system is a world first that clears the vapour and particulate matter generated by modern surgical cutting instruments during abdominal keyhole (laparoscopic) surgery through the use of electrostatic technology. The technology dramatically and effortlessly improves visibility for surgeons that is otherwise rapidly obscured by this “plume” or “surgical smoke”.

“We are thrilled to have gained FDA approval for our Ultravision™ system that will now allow us to enter the US market. Commercially the US represents approximately fifty per cent of the global medical device market and so it is difficult to overstate the importance of this for the company,” said Dr Dominic Griffiths, Managing Director of Alesi Surgical.

Alesi Surgical becomes a member of a select group of only 26 medical device companies worldwide in the last 12 months that have successfully navigated the FDA De Novo regulatory review process.

The Ultravision™ system, which produces a small, low-energy electrostatic charge similar to the principal of static electricity, is able to greatly improve visibility for surgeons by actively getting rid of surgical ‘smoke’.

The technology also benefits the patient as it minimises the amount of cold, dry carbon dioxide gas – used to create a working space inside the abdomen – which a patient is exposed to during the keyhole procedure. It is not uncommon for abdominal keyhole procedures to require several hundred litres of this gas to clear the visual field throughout the procedure. Excessive use of carbon dioxide contributes to post-surgical pain and prolongs recovery time for the patient.

FDA approval is a significant milestone on the road to the company gaining traction in a global market worth an estimated £800m per year and forms part of the strategic growth of the business that has also seen the appointment of a UK national sales team.

Dr Griffiths said: “Gaining FDA approval for Ultravision™ allows us to continue the progress and development in the US market. This is the next step after launching our new Ultravision Trocar product in Europe which integrates the benefits of Ultravision™ into a pen-like access device, used in over seven million abdominal keyhole procedures performed annually, worldwide. The combination of these two major achievements places us in a strong position to enter 2017 with confidence.”

Alesi Surgical launched in 2009 as a spin out from the internationally recognised Welsh Institute of Minimally Invasive Surgery, part of Cardiff University.  To date, Alesi has secured £6.1m worth of venture capital funding, principally from its lead investors IP Group PLC and Finance Wales Limited.

Phil Barnes of Finance Wales said, “We are delighted with the progress Alesi is making and gaining this FDA clearance provides a cornerstone for their future success. We are pleased to support Alesi as they enter the US market and look forward to further growth of this innovative Welsh company.”