Creo Medical Group PLC First use of Speedboat(R) UltraSlim in the USA
15 Diciembre 2023 - 1:00AM
RNS Non-Regulatory
TIDMCREO
Creo Medical Group PLC
15 December 2023
Creo Medical Group plc
("Creo" the "Company" or the "Group")
First use of Speedboat(R) 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(R) UltraSlim, has now been
successfully used in the USA.
The limited market release of the Speedboat(R) 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(R) UltraSlim in November
2023 and follows the first UK case earlier this week.
Speedboat(R) UltraSlim is the third device in Creo's
Speedboat(R) 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(R)
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
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)
Freddie Barnfield / Duncan Monteith
/ Euan Brown +44 (0)20 7260 1000
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
Phillip Marriage 558 258 / +44 (0)7867 984 082
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
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