Fusion IP plc (AIM: FIP), the university IP commercialisation company that turns world class research into business, is pleased to announce that Cardiff University spin-out company, Asalus Medical Instruments ("Asalus"), has successfully completed its 'first-in-man' trial of its lead product, UltravisionTM, the company's revolutionary surgical smoke clearing system for use in laparoscopic surgery.
This is a key milestone for the company and, together with the recently announced funding, will enable the company to complete product development and apply for regulatory approval to launch the product in 2013.
The randomised, controlled comparative study was the first use of the UltravisionTM device in patients, with the dual aims of assessing safety and performance. The trial assessed the use of UltravisionTM in thirty participants undergoing scheduled laparoscopic gallbladder removal. The study was undertaken at University Hospital Llandough (Cardiff and Vale University Health Board, Wales, UK).
The results demonstrated that UltravisionTM was effective in maintaining a clear visual field throughout the laparoscopic procedure. This was achieved without the need to deflate the abdomen or release smoke produced during surgery into the operating theatre environment. In addition 77% of the procedures were completed without interruption compared to less than 1% in the control group that did not use UltravisionTM. There were no adverse events.
UltravisionTM is one product in a range of laparoscopic surgery devices being developed by Asalus. Laparoscopic surgery is a modern surgical technique in which operations in the abdomen are performed through small incisions, as compared to the larger incisions needed in traditional surgical procedures. There are several benefits to conducting laparoscopic surgery and, as a result, over 2 million laparoscopic operations per year are now performed in the USA alone.
Fusion owns a 44% undiluted shareholding in Asalus.
Dominic Griffiths, MD of Asalus, said:
"Maintaining a clear visual field during laparoscopic surgery remains a key unmet surgical need. The clinical trial results demonstrate that Ultravision is a simple yet highly effective means of achieving this. The feedback from surgeons has been extremely encouraging. Ultravision will help them undertake complex operations as safely as possible whilst at the same time reducing the long-term exposure of the theatre team to surgical smoke".
Peter Grant, Operations Director at Fusion said:
"Successful human trials are a major milestone for any company and these results will enable the company to complete product development and apply for regulatory approval of the product this year. We are delighted with their considerable progress."
Ann Casey, Investment Executive at Finance Wales said:
"Finance Wales has backed Asalus over four investment rounds and we are pleased Ultravision's clinical trials have been successful. Ultravision is an innovative product with great commercial potential and Asalus has had a clear focus on bringing it to market.."