Alesi Surgical gains crucial FDA product clearance and targets US and Asia Pacific markets

Alesi Surgical Limited, the leading innovator of minimally invasive surgery technologies, has achieved a significant milestone, receiving United States FDA clearance for its world-first Ultravision Trocar device. This follows last year’s pivotal FDA clearance of the Ultravision technology.his development follows the announcement in June 2017 of the multi-million- pound funding from its existing investors Finance Wales and IP Group, and new investors Panakes Partners and EarlyBird Venture Capital.

Following this latest achievement, and as part of the ambitious global strategy Alesi has established a US subsidiary, Alesi Surgical Technologies Inc. It is also making key appointments of new personnel to spearhead growth in North America and the Asia Pacific Rim, whilst continuing its efforts to bring the Ultravision technology to operating theatres in the UK, Europe and Middle East.

The key appointments are Charles LeDoux, US Vice President of Commercial Development, and Michael Inouye, Country Manager for Japan and Asia Pacific.

Dr Dominic Griffiths, Managing Director of Alesi Surgical, said: “We are absolutely delighted that we have received FDA clearance for the Ultravision Trocar device. This technology will make a real difference for surgeons, operating theatre staff and patients in the laparoscopic surgical field across the world.

“With FDA and other regulatory approvals in hand, it is time for Alesi to accelerate its growth. Charles LeDoux and Michael Inouye will lead the commercial activities and provide the vital inroads that will enable key clinical staff and patients to benefit from the Ultravision technology in the USA and Japan, as is already the case in Europe and the Middle East.”

The UltravisionTM system is the world’s first use of electrostatic technology to clear the vapour and particulate matter – so called “surgical smoke” – that is generated by modern surgical cutting instruments during abdominal keyhole (laparoscopic) surgery.

By integrating its technology with a trocar, the company has expanded its range of Ultravision consumables. Trocars are the devices used to access the abdominal cavity and typically 3-5 trocars are used in each of the millions of laparoscopic procedures performed worldwide each year.

Charles LeDoux, who has developed multi-million-dollar sales operations within the US medical device sector, whilst Vice President of Sales for Conmed Corporation, said: “Having worked for some of the world’s finest and best known medical device and healthcare companies, I’ve been looking for a product that improves the outcome of a patient’s surgery, enhances the surgeons’ technique and finally satisfies the economic challenges faced by the industry. The Ultravision technology is the first product I’ve come across that genuinely meets all these three criteria without question.”

Michael Inouye, who has many years’ experience of setting up and implementing multi-million-pound medical device distribution networks in Japan and across Asia, said: “I am really excited at the prospect of delivering the pioneering Ultravision technology to this part of the world. The Japanese laparoscopic (minimally invasive surgery) sector is one of the most mature markets of its type anywhere, second only to the United States in scale.

“Japan therefore is a key area of focus but we will also be looking to target South Korea and Taiwan as they too have been practicing laparoscopic techniques for many years and have sizable domestic markets as a result.”

The revolutionary Ultravision technology produces a low-energy electrostatic charge and can greatly improve visibility for surgeons by actively eliminating surgical smoke as it is created by the cutting instrument. Improving surgeons’ visibility improves the safety of the procedure, whilst minimising healthcare professionals’ exposure to surgical smoke is increasingly important worldwide because of concerns over the health risks of long-term exposure.

The technology also benefits the patient because it minimises the amount of cold, dry carbon dioxide gas – used to create a working space inside the abdomen – that a patient is exposed to during the keyhole procedure.  Excessive use of carbon dioxide contributes to cardiovascular problems, complications in anesthesia, post-surgical pain and longer recovery time for the patient.

Surgeons across the UK have confirmed the Ultravision technology as facilitating the advancement of keyhole surgery and helping to improve patient outcomes.

For more information, contact James Barton at 2B Communications Limited on 07955 227046 or james@2bcommunications.co.uk

Notes to editors

  1. Alesi Surgical founded in 2009 as a spin-out from the Welsh Institute for Minimal Access Therapy (WIMAT), has developed and commercialised Ultrasounds, the world’s first system that eliminates laparoscopic surgical smoke without the need for gas exchange.