9th Oct 2020 10:49
(Alliance News) - RUA Life Sciences PLC on Friday announced further regulatory and commercial progress made by subsidiary RUA Vascular towards its Elast-Eon product launch.
RUA Life Sciences is a holding company of a group of medical device businesses focused on the exploitation of implantable biostable polymer. RUA Vascular is developing Elast-Eon sealed vascular grafts and cardiac and vascular patches.
RUA Vascular recently reached the important milestone of achieving design freeze on its vascular graft products, the company said. This allowed grafts to enter the regulatory testing phase in advance of an important submission to the US Food & Drug Administration.
The company said that the testing phase is progressing well.
RUA Life Sciences said: "The RUA grafts have now been implanted without incident and the animals have recovered well. The graft has performed perfectly during surgical implant. Initial feedback given by the surgeons and confirmed by videos of the procedures was that the graft was simple to suture with no difference to the control graft. No or little bleeding from the anastomosis (or suture line) was observed with a suggestion that the elastomeric coating on the graft has assisted suture sealing. Importantly, the graft body maintained zero porosity throughout the procedure with no "blush" to the fabric which was observed in the control grafts."
In short, the company said, the graft has performed as well as, if not better than, the market leading equivalent.
Chair Bill Brown said: "I was present and observed the implantation of our final grafts and was very impressed with their performance as surgical devices. The team has succeeded in our design objectives of eliminating animal by-products and creating a zero porosity graft without having to compromise on the implantability of the product. These recent developments, both technically and commercially, are key achievements on the path to the anticipated market launch of our grafts during 2021."
RUA Life Sciences shares were up 10% at 146.00 pence each on Friday in London.
By Greg Roxburgh; [email protected]
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