Rua Life Sci. Regulatory News (RUA)

14 November 2022

RUA Life Sciences plc

("RUA", the "Company" or the "Group")

Half Year Trading Update

RUA Life Sciences (AIM: RUA), 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™), today provides an unaudited trading update for the six-month period ended 30 September 2022, being the first half of the 2023 financial year ("H1 2023").

The Group is pleased to report that trading in H1 2023 has been strong with revenue ahead of the Board's expectations. 

Revenue

Sales (including royalties) for the period increased to £1,104k, representing year on year growth of 56% (H1 2022: £708k).

· Elast-Eon royalties for the period increased to £187k, representing year on year growth of 20% (H1 2022: £156k).

· Contract manufacturing revenues for the period increased to £917k, representing year on year growth of 66% (H1 2022: £552k), primarily reflecting increased sales volume in the period.

Cash

The Group continues to tightly manage its resources with cash and cash equivalents as at 30 September 2022 of £2.5m (as at 31 March 2022: £3m). In addition, during the six month period, a R&D Tax Credit claim of £328k was submitted to HMRC and it is anticipated that this sum will be received in the short term.

Loss for period

Group losses for the period reduced by 15% to £1.1m (H1 2022: £1.3m).

R&D Activities

The key regulatory and clinical programs are making progress with the focus being on progressing the FDA 510(k) pre-submission of the Group's range of Elast-Eon sealed vascular grafts. The FDA discussions to date have been constructive, with agreement on the clinical endpoints and duration of the required clinical trial. The last remaining outstanding point relates to statistical analysis, with RUA's proposal based on the preferred FDA methodology currently under consideration. We will update the market on the details of the agreed regulatory process in due course.

Bill Brown, Chairman of RUA Life Sciences, stated: "Our Biomaterials and Contract Manufacturing businesses have performed very well over the period, which has further assisted in the tight control of cash, resulting in a strong cash position at the end of the half year. The outcomes of our discussions with the FDA have been positive, if taking a little longer than we would prefer, and I hope to be able to provide more details on the scale of the required trial relatively soon."

The Group expects to announce its interim results on Monday 12th December 2022.

The information contained within this announcement is deemed by the Company to constitute inside information as stipulated under the UK version of the EU Market Abuse Regulation (2014/596) which is part of UK law by virtue of the European Union (Withdrawal) Act 2018, as amended and supplemented from time to time.

For further information contact:

RUA Life Sciences

Bill Brown, Chairman Tel: +44 (0)1294 317073

Dr Caroline Stretton, Group MD Tel: +44 (0)1294 317073

Cenkos Securities plc (Nominated Adviser and Broker)  Tel: +44 (0)20 7397 8900

Giles Balleny/Max Gould (Corporate Finance)

Michael Johnson (Sales)

About RUA Life Sciences

The RUA Life Sciences group was created in April 2020 when RUA Life Sciences Plc (formerly known as AorTech International Plc) acquired RUA Medical Devices Limited to create a fully formed medical device business. RUA Life Sciences is the holding company of the Group's four trading businesses, each exploiting the Group's patented polymer technology.

Our vision is to improve the lives of millions of patients by enabling medical devices with Elast-EonTM, the world's leading long-term implantable polyurethane. Whether it is licensing Elast-EonTM, manufacturing a device or component, or developing next generation medical devices, a RUA Life Sciences business is pursuing our vision.

Elast-Eon™'s biostability is comparable to silicone while exhibiting excellent mechanical, blood contacting and flex-fatigue properties. These polymers can be processed using conventional thermoplastic extrusion and moulding techniques. With over 8 million implants and 15 years of successful clinical use, RUA's polymers are proven in long-term life enabling applications.

The Group's four business units are: