RCS - Creo Medical Group - First use of Speedboat® UltraSlim in the USA

Creo MedicalAnnouncement

15/12/2023 07:00

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RNS Number : 9096W  Creo Medical Group PLC  15 December 2023

Creo Medical Group plc

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

 

First use of Speedboat® UltraSlim in the USA

 

Creo Medical Group plc (AIM: CREO), the medical device company focused on the
emerging field of surgical endoscopy, announces that its latest device,
Speedboat® UltraSlim, has now been successfully used in the USA.

 

The limited market release of the Speedboat® UltraSlim in the USA has
resulted in the device being successfully used in multiple clinical
applications. The first was a Speedboat Submucosal Dissection (SSD) in the
colon for a precancerous lesion, followed by a precancerous resection in the
oesophagus. Additional successful indications were Upper Oesophageal Peroral
Endoscopic Myotomy and Zenkers Diverticulum, treating swallowing disorders and
gastroparesis. These procedures come shortly after the Company announced that
it had obtained 510(k) clearance from the US Food & Drug Administration
for Speedboat® UltraSlim in November 2023 and follows the first UK case
earlier this week.

 

Speedboat® UltraSlim is the third device in Creo's Speedboat® family of
products, and 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. This latest generation Speedboat
has broad application in the GI tract due to a smaller configuration, ensuring
compatibility with a wide range of colonoscopes and gastroscopes.

 

Powered by Creo's CROMA advanced energy platform, Speedboat® UltraSlim
delivers fluid as well as advanced bipolar radiofrequency ("RF") energy for
controlled cutting and high frequency microwave ("MW") energy for controlled
coagulation of tissue in the GI tract. The device is the culmination of a long
programme of work to further miniaturise Creo's technology, and is compatible
with the working channel of all commercially available endoscopes accessing
the vast majority of GI endoscopic procedures.

 

Craig Gulliford, Chief Executive Officer of Creo Medical, said: "Following the
completion of the design transfer to manufacturing last week, the whole team
has worked tirelessly to get Speedboat UltraSlim into the hands of clinicians.
Having first use in the UK and the USA in a single week, not only validates
the utility of our cutting edge technology, but succinctly illustrates the
cohesion across our team and joint intention to deliver on our objectives.

 

"Knowing the potential that having a device that is compatible with all major
endoscopes brings, we are energised to get the device into the hands of
clinicans to allow them to treat their patients, for more indications and
improve lives. With significant demand for this product already indicated from
existing and potential Speedboat users, we will continue our early market
release ahead of the full market launch in early 2024.

 

"Continued innovation of the Speedboat platform with smaller multi-modal
devices supports the continued evolution of minimally invasive procedures that
deliver better clinical and economic outcomes for the healthcare community and
their patients."

 

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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