RUA Life Sciences shares rise on vascular graft progress
By Josh White
Date: Friday 09 Oct 2020
(Sharecast News) - Medical devices company RUA Life Sciences announced on Friday that its subsidiary RUA Vascular, which is developing 'Elast-Eon' sealed vascular grafts and cardiac and vascular patches, had made further progress on both the regulatory and commercial pathways towards product launch.
The AIM-traded firm said RUA Vascular had recently reached the milestone of achieving design freeze on its vascular graft products, allowing the grafts to enter the regulatory testing phase in advance of 510k submission to the US Food and Drug Administration (FDA).
It said the 510k process, or 'premarket notification', is a much simpler regulatory path than the more stringent 'pre-market approval' process and is available to medical devices that can claim 'substantial equivalence' to legally-marketed equivalent devices that are for the same intended use, and have the same technology or different technology that does not raise new questions regarding safety or effectiveness.
The RUA Vascular graft was designed with the 510k process in mind, and the testing of the recently-frozen design is to demonstrate that substantial equivalence.
RUA said it was expecting the 510k data package to be submitted early in the second quarter of 2021.
The company said an important part of the testing phase included a long-term animal trial of both the graft and the market leading graft as a control.
It said the RUA grafts had now been implanted without incident, with the animals said to be recovering well.
The graft had performed "perfectly" during the surgical implant, with initial feedback from surgeons, confirmed by videos of the procedures, being that the graft was simple to suture with no difference to the control graft.
No or little bleeding from the anastomosis was observed, the firm explained, with a suggestion that the elastomeric coating on the graft had assisted suture sealing.
RUA said that importantly, the graft body maintained zero porosity throughout the procedure with no "blush" to the fabric, which was observed in the control grafts.
The board said that meant the RUA graft had performed at least as well as the market-leading 'substantial equivalent'.
Good progress was also reported on commercialising the product development work undertaken by its research and development team.
The route-to-market was expected to be through a combination of original equipment manufacturer agreements and distribution agreements.
RUA said it had been engaged with the medical device industry for some time around potential OEM agreements.
Those discussions were said to be developing "at pace", and had now progressed to sharing volume data and requests for quotations.
"I was present and observed the implantation of our final grafts and was very impressed with their performance as surgical devices," said RUA chairman Bill Brown.
"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."
At 1451 BST, shares in RUA Life Sciences were up 9.45% at 145.02p.
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