Creo Medical Regulatory News (CREO)

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Creo Medical Group plc

("Creo" or the "Company")

US FDA Clearance for HS1 Haemostasis Device

Creo Medical Group plc (AIM: CREO), the medical device company focused on the emerging field of surgical endoscopy, announces that it has received 510(k) clearance from the US Food & Drug Administration ('FDA') for its HS1 Haemostasis device ('HS1'). The HS1 will be used with Creo's CROMA Advanced Energy Platform ('CROMA') and alongside the already FDA-cleared Speedboat device.

This news represents a significant milestone for the Company, being the first of a number of expected regulatory clearances which will bring a suite of devices to the flexible endoscopy markets in the EU and USA.

Creo's haemostasis technology offers exceptional levels of precision and is the only non-stick haemostasis device currently available across all electrosurgical markets. HS1 is the first incarnation of this technology in a single use device for endoscopic use and combining injection therapy. This enables the HS1 to be used to stop bleeding during treatments for peptic ulcers, dieulafoy lesions, Mallory-Weiss tears, bleeding polyp stalks, arteriovenous malformations and angiomata.

This is the second device to gain FDA regulatory clearance within Creo's wider portfolio of flexible endoscopy devices for the gastrointestinal ('GI') and pulmonary markets. CROMA has a heavily patented combination of bipolar radiofrequency ('RF') energy optimised for precise tissue dissection, with microwave energy for precision coagulation and tissue ablation. Powered by patented software controlled adaptive technology, CROMA enables intuitive, easy-to-use advanced devices such as Speedboat, HS1 and its pipeline of complementary endoscopic devices for resection, dissection, coagulation and ablation of tissue.

Creo provided an update on trading on 20 March 2020 to outline its immediate response to the COVID-19 outbreak and the inevitable impact on its Clinical Education Programme. The Company has previously announced that it expects to achieve several simultaneous device clearances with its EU regulatory bodies along with further FDA clearances in due course. It is planned that these devices will be adopted within the Clinical Education Programme that is already building on the initial launch of Speedboat. This should drive the commercial launch of Creo's suite of devices through the sales channels established in the last 12 months.

Separate to the development of its core suite of technologies, Creo is exploring opportunities to make available its small but well-qualified team of medical technology and clinical experts to assist immediately in various coordinated national initiatives to support the NHS in its management of the COVID-19 outbreak.

Craig Gulliford, Chief Executive Officer of Creo, commented:

"We are delighted to receive FDA clearance for our HS1 Haemostasis device, which is the first deployment of our unique non-stick haemostasis technology. The engineering team have worked incredibly hard for the last couple of years to get to this point with the HS1 device. They continue to work hard to close out regulatory clearances for our entire suite of advanced energy surgery products for the flexible endoscopy markets. While COVID-19 presents challenges and uncertainties for us as much as any business, we are well funded and will be ready as and when the related restrictions are eased. In the meantime, we are ready to support sector initiatives to accelerate the supply of medical equipment into the NHS."

Charles Spicer, Chairman of Creo, added:

"I would like to congratulate Craig, Chris, Rich and all the team for achieving FDA clearance for our second key device so efficiently. This follows a period of enormous effort and excellent teamwork leading into the substantial disruption of COVID-19. We have a cogent plan to manage the business during these uncertain times. The board want to thank our colleagues, our customers, and our suppliers for all their support and, of course, wish them and their families the best of health. We will support them and the wider medical technology community in any way we can."

Enquires:

About Creo Medical 

Creo Medical, founded in 2003, is a medical device company focused on the development and commercialisation of minimally invasive surgical devices, by bringing advanced energy to endoscopy. The Company's mission is to improve patient outcomes by applying microwave and RF energy to surgical endoscopy. Creo has developed CROMA, an electrosurgical Advanced Energy Platform that combines bipolar radiofrequency for precise localised cutting and microwave for controlled coagulation. This technology provides clinicians with flexible, accurate and controlled surgical solutions. 

The Company's strategy is to bring its CROMA Advanced Energy Platform powered by unique full spectrum adaptive technology to market enabling a suite of medical devices which the Company has designed, initially for the emerging field of GI therapeutic endoscopy, an area with high unmet needs. The CROMA Advanced Energy platform will be developed further for bronchoscopy and laparoscopy procedures. The Company believes its technology can impact the landscape of surgery and endoscopy by providing a safer, less-invasive and more cost-efficient option of treatment. 

For more information about Creo Medical please see our website, investors.creomedical.com