RCS - Creo Medical Group - First European Speedboat® UltraSlim procedure

Creo MedicalAnnouncement

13/12/2023 07:15

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RNS Number : 5519W  Creo Medical Group PLC  13 December 2023

Creo Medical Group plc

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

 

First European Speedboat® UltraSlim procedure marks early commercial launch

 

Creo Medical Group plc (AIM: CREO), the medical device company focused on the
emerging field of surgical endoscopy, announces the initiation of its
commercial launch of Speedboat® UltraSlim, following the completion of the
design transfer to manufacturing last week. The first procedure using the
device was completed in the UK.

 

This first use of Speedboat® UltraSlim was for a lower Gastrointestinal
("GI") tract procedure, and comes shortly after the Company announced the UK
and EU regulatory pathway had been accelerated by approximately 18 months
(https://otp.tools.investis.com/clients/uk/creo_medical1/rns/regulatory-story.aspx?cid=2071&newsid=1727900)
. The Company expects the first European upper GI cases to follow soon, as
well as first upper and lower GI cases in the USA, following the 510(k)
clearance being received from the US Food & Drug Administration in
November 2023.

 

Speedboat® UltraSlim is the third device in Creo's Speedboat® family of
products. The device is the culmination of a long programme of work to
miniaturise the technology to a scale which covers all the foreseeable market
applications, resulting in blanket compatibility with all commercial
endoscopes accessing the vast majority of GI endoscopic procedures and
significantly increasing the opportunity for more clinicians and patients to
benefit from Creo's cutting-edge technology.

 

Speedboat® UltraSlim is targeting the therapeutic treatment of disease in the
GI tract including cancer of the Bowel, Stomach and Oesophagus as well as
surgical procedures to deal with abnormalities resulting in swallowing
disorders and in some cases gastric reflux. Powered by Creo's CROMA advanced
energy platform, Speedboat® UltraSlim delivers advanced bipolar
radiofrequency ("RF") energy for controlled cutting and high frequency
microwave ("MW") energy for controlled coagulation of tissue in the GI tract.

 

Craig Gulliford, Chief Executive Officer of Creo Medical, said: "This is yet
another landmark moment for Creo Medical. We know what a difference this even
smaller device will make in terms of broadening access to advanced energy in
endoscopy for a wider pool of clinicians. Speedboat UltraSlim is compatible
with all major endoscopes, meaning clinicians can bring advanced energy to
their practices, allowing more patients to be treated endoscopically, which
avoids surgery and the associated secondary costs and risks. We will continue
the early market release to a designated early adopter programme over the
coming weeks before the full market launch in early 2024, with significant
demand for this product already indicated from existing and potential
Speedboat users."

 

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 7220 0500
 Stephen Keys / Camilla Hume (NOMAD)
 Michael Johnson (Sales)

 Deutsche Numis (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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