Last checked at 13 Dec 2023 07:00
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. 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 |
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 |
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Walbrook PR Ltd | Tel: +44 (0)20 7933 8780 or creo@walbrookpr.com |
Paul McManus / Sam Allen / Phillip Marriage | Mob: +44 (0)7980 541 893 / +44 (0)7502 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