REG - RUA Life Sciences - Trading Update

Rua Life SciencesAnnouncement

14/11/2022 07:00

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RNS Number : 2130G  RUA Life Sciences PLC  14 November 2022

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-Eon(TM), the world's leading long-term implantable
polyurethane. Whether it is licensing Elast-Eon(TM), 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:

 

 RUA Medical:           End-to-end contract developer and manufacturer of medical devices and
                        implantable fabric specialist.

 RUA Biomaterials:      Licensor of Elast-Eon(TM) polymers to the medical device industry.

 RUA Vascular:          Commercialisation of open surgical vascular grafts and patches

 RUA Structural Heart:  Development of polymeric leaflet systems for heart valves.

 

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