REG - Creo Medical Group - SB UltraSlim: EU launch accelerated by 18 months

Creo MedicalAnnouncement

25/10/2023 07:00

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RNS Number : 1747R  Creo Medical Group PLC  25 October 2023

Creo Medical Group plc

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

Speedboat UltraSlim: EU launch accelerated by 18 months

 

EU regulatory pathway for launch earlier than originally planned, following
guidance from notified body

 

Speedboat UltraSlim, benefiting from the next phase of Creo's technology
miniaturisation, is compatible with all major GI endoscopes now expected to
launch in early 2024

 

Creo Medical Group plc (AIM: CREO), the medical device company focused on the
emerging field of minimally invasive surgical endoscopy announces that,
following a recent submission to the Company's notified body, Creo have been
advised on a regulatory pathway facilitating the launch of their Speedboat®
UltraSlim device approximately 18 months ahead of schedule.

This news will now enable the Company to initiate the launch of UltraSlim in
Europe in early 2024, with an early adopter launch programme which would
otherwise have been planned for mid-2025.

 

Speedboat® UltraSlim is the second brand in its Speedboat® family of devices
alongside Speedboat Inject and offers a number of different features. The
primary feature is the reduced size in comparison with the Speedboat Inject,
making the device compatible with all endoscopes with a 2.8mm working channel
or larger, accounting for the vast majority of GI endoscopic procedures, and
significantly increasing the opportunity for more clinicians and patients to
benefit from Creo's game-changing technology.

 

The UltraSlim device is targeting the therapeutic treatment of
Gastrointestinal ("GI") tract lesions (including Bowel and Upper GI cancers,
and pre-cancerous lesions) and swallowing disorders. Powered by Creo's CROMA
advanced energy platform, the UltraSlim delivers advanced bi-polar
Radiofrequency ("RF") energy for controlled cutting and high frequency
microwave ("MW") energy for controlled coagulation of tissue in the GI tract.
The UltraSlim's injection functionality is achieved through an integrated
lifting system.

 

Craig Gulliford, Chief Executive Officer of Creo, said: "This excellent news
is testament both to the challenges the team have overcome to scale the
technology down to a size which is as small as it ever needs to be, with the
regulatory and clinical confidence needed to support this pathway.

 

"The Regulatory landscape has been particularly challenging for all medtech
companies in the last few years here in Europe, with changing transition
deadlines and elongated and uncertain clearance pathways. This has resulted in
most companies seeking clearance now in the US ahead of the EU. We had adopted
the same approach, planning to launch the device in the US ahead of the EU,
having filed for our FDA clearance earlier this year.

 

"With this news, the accelerated timeframes will now see Creo, clinicians and
patients reaping the benefits of widespread commercialisation of Speedboat
UltraSlim in both Europe and the US in 2024."

 

 

 

Enquiries:

 

 Creo Medical Group plc                             www.creomedical.com (http://www.creomedical.com)
 Richard Rees (CFO)                                 +44 (0)1291 606 005

 Cavendish Capital Markets Limited                  +44 (0)20 7397 8900
 Stephen Keys / Camilla Hume (NOMAD)
 Michael Johnson (Sales)

 Numis Securities Limited (Joint Broker)            +44 (0)20 7260 1000

 Freddie Barnfield / Duncan Monteith / Euan Brown

 Walbrook PR Ltd                                    Tel: +44 (0)20 7933 8780 or creo@walbrookpr.com
 Paul McManus / Sam Allen /                         Mob: +44 (0)7980 541 893 / +44 (0)7502 558 258 / +44 (0)7867 984 082

 Phillip Marriage

 

 

About Creo Medical

 

Creo is a medical device company focused on the development and
commercialisation of minimally invasive electrosurgical devices, bringing
advanced energy to endoscopy.

 

The Company's vision is to improve patient outcomes through the development
and commercialisation of a suite of electrosurgical medical devices, each
enabled by CROMA, powered by Kamaptive. The Group has developed the CROMA
powered by Kamaptive full-spectrum adaptive technology to optimise surgical
capability and patient outcomes. Kamaptive is a seamless, intuitive
integration of multi-modal energy sources, optimised to dynamically adapt to
patient tissue during procedures such as resection, dissection, coagulation
and ablation of tissue. Kamaptive technology provides clinicians with
increased flexibility, precision and controlled surgical solutions. CROMA
currently delivers bipolar radiofrequency ("RF") energy for precise localised
cutting and focused high frequency microwave ("MW") energy for controlled
coagulation and ablation via a single accessory port. This technology,
combined with the Group's range of patented electrosurgical devices, is
designed to provide clinicians with flexible, accurate and controlled clinical
solutions. The Directors believe the Company's technology can impact the
landscape of surgery and endoscopy by providing a safer, less-invasive and
more cost-efficient option for procedures.

 

 

For more information, please refer to the website www.creomedical.com
(http://www.creomedical.com)

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