Business
Milestone at RUA Vascular & Trading Update
Milestone at RUA Vascular & Trading Update.
About this update from Rua Life Sciences Plc
[{"type":"text","content":"\n \n \n \n RNS Number : 1198R\n RUA Life Sciences PLC\n 03 November 2021\n \n \n \n \n \n \n \n \n RUA Life Sciences plc\n \n \n (\"RUA\", the \"Company\" or the \"Group\")\n \n \n \n \n \n Significant Milestone at RUA Vascular \n \n \n and \n \n \n Trading Update\n \n \n \n \n \n RUA Life Sciences plc (AIM: RUA.L), the holding company of a group of medical device businesses focused on the exploitation of the world's leading long-term implantable biostable polymer (Elast-Eon\n ™), is pleased\n to \n announce the submission by RUA Vascular to the US Food and Drug Administration (\"FDA\") of its Premarket Notification (510k) for a range of polymerically sealed vascular grafts. In addition, it is \n providing the following update on each of the Group companies for the six months ended 30 September 2021 (the \"Period\"):\n \n \n RUA Vascular\n - the business commercialising large bore vascular grafts, cardiac and vascular patches - is delighted to announce the submission to the FDA of its Premarket Notification (510k) for a range of polymerically sealed vascular grafts. This follows an introduction of\n \n the RUA graft at the recent annual meeting of the European Association for Cardio-Thoracic Surgery (EACTS) held in Barcelona. The unmet need for non-biogenic devices was discussed broadly at the meeting and interest in implanting the RUA grafts was expressed by both US and European surgeons confirming to the Board the Company's\n \n plans for launch strategy and distribution channels. Interest from potential industry partners continues and a further two non-disclosure agreements have been entered into to allow incorporating RUA grafts into currently marketed devices. The Company's R&D team now has a major task of validating production equipment in advance of the commercial launch of grafts during the first quarter of 2022.\n \n \n The delays to patch production equipment have been resolved and prototype production is now underway. The regulatory pathway for patches is very similar to grafts and, based on current design parameters, will utilise much of the data currently submitted to the FDA for grafts. Th\n e \n Company has been advised that it would be better to run two applications relying on the same data in series rather than in parallel to avoid c...