Rua Life Sci. Regulatory News (RUA)

16 August 2022

RUA Life Sciences plc

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

AGM Statement and Trading Update

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-EonTM), is holding its Annual General Meeting ("AGM") at 11.00am today.

At the AGM, the Chairman, Bill Brown, will make the following statement regarding current trading:

"There are four key parts to the RUA Life Sciences business: Biomaterials and Contract Manufacturing, being the two mature cash generative businesses; together with the new product development divisions of RUA Vascular (vascular grafts) and RUA Structural Heart (heart valves). All four business units are performing well and key achievements are summarised below:

Biomaterials

The business responsible for exploiting the Group's Elast-Eon polymer IP is currently performing ahead of budget with revenues for the four month period to the end of July amounting to £144k, an increase of 73% on the corresponding period last year. In addition, the Intellectual Property portfolio has further developed, with new patents recently being granted in Europe and China.

Contract Manufacturing

Contract Manufacturing comprises the part of the RUA Medical Devices subsidiary's activities focussed on third party supply of medical device components and finished devices. Again, this business area is exceeding expectations with revenue for the four month period to end of July being ahead of budget at £540k compared to £374k achieved in the same period last year. This growth has been driven by a combination of both price increases and an uplift in volumes of devices. Business development activities have continued despite the pandemic disruption and it is very pleasing to be able to announce that a new component manufacturing agreement has just been signed with a global medical device manufacturer. Once manufacturing is fully set up and volumes build, we anticipate this contract to becoming a material contributor to the performance of the Contract Manufacturing business.

Vascular Graft

As previously announced, the regulatory team at RUA have been actively engaging with the FDA in seeking consensus on the full scope of the anticipated additional testing required for a small clinical study. A meeting with the FDA was held earlier this month and we are pleased to update that the meeting was positive and we believe we are close to reaching agreement with the FDA on a clinical trial design that is practical for RUA to pursue.

RUA submitted a detailed trial protocol to the FDA and on review the FDA have asked for a number of relatively minor changes to be made with further statistical analysis to support trial design sample size.

The further information will be provided to the FDA and their review will be via a faster interactive process rather than a further pre-submission supplement. We would anticipate being able to inform shareholders of the full details of the clinical trial around the end of September.

Heart Valves

The team responsible for developing a new generation heart valve has made strong progress over the last few months in accelerating the concept of a composite leaflet material building upon the IP developed in the graft project.

The new material has the potential to be the ideal valve leaflet material. Mechanical property test results demonstrate being not only better than raw polymer by an order of magnitude, but also much stronger than the current material from which biological valves are made whilst being around 75% thinner. Coupling these mechanical properties with the biostability and non-calcific nature of Elast-Eon creates a very promising opportunity. Good progress has also been made on manufacturing these composite valves to allow testing of 'closer to clinical standard' product to commence.

Group Achievements

A vital part of being a medical device manufacturer is to maintain certification of our Quality Management System ("QMS"). The RUA Medical Device business was previously certified as a third-party supplier. In early August, the business underwent a full audit from our Notified Body. The objective was not only to maintain the ISO 13485 accreditation for RUA Medical but to seek extension of scope under the newly developed RUA Life Sciences QMS for the "design, development, manufacture and sale of sealed vascular prostheses and heart valves". It is a matter of pride to the business that the audit identified zero findings and a recommendation has been made to expand the scope. This is an essential step before we launch into clinical trials later this fiscal year and eventually start to sell our own devices. The audit result is the culmination of many months of hard work by individuals and teams throughout the business - almost every element of our Quality Management System has been updated in the last few months. The auditors were highly complimentary of our processes, procedures, documentation, and the professionalism of our team. 

Overall, the progress made in developing products has been matched by trading activities and although we are not currently anticipating the 50% year on year revenue growth to continue for the rest of the year, it is a good indicator of the building and development of the business."

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: