RUA Vascular submits premarket notification to US FDA

Medical devices company RUA Life Sciences said on Wednesday that RUA Vascular has submitted a premarket notification, or ‘510k’, the US Food and Drug Administration (FDA), for a range of polymerically-sealed vascular grafts.

The AIM-traded firm said its cash position as at 30 September totalled £4.76, down from £6.29 at the end of March.

It said that cash burn included the final element of consideration payable for the acquisition of RUA Medical in April 2020, together with additional research and development costs and capital investment.

The company previously announced its intention to further strengthen its senior management team, confirming on Wednesday that the role of clinical and regulatory affairs director had now been filled, with the appointee due to start on 16 November.

Additionally, it said the process of recruiting a chief financial officer had concluded, with the successful candidate expected to start next month, and a further announcement to be made on their commencement.

“I am very happy with the developments at RUA,” said chairman Bill Brown.

“Our two revenue-generating businesses are growing.

“RUA Vascular has reached a major milestone in submitting for regulatory clearance to market and with the risk in biogenic material becoming a serious topic of conversation, our strategy of exploiting Elast-Eon in both vascular and heart valve devices is now very much of the moment.”

At 1415 GMT, shares in RUA Life Sciences were up 9.37% at 165.7p.