Creo Medical Regulatory News (CREO)

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."

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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