Creo Medical Group plc (AIM: CREO) has received 510(k) clearance from the US Food & Drug Administration for its HS1 Haemostasis device.
The HS1 will be used with Creo's CROMA Advanced Energy Platform ('CROMA') and alongside the already FDA-cleared Speedboat device. This is a significant milestone for the Company, and it is the first of a number of expected regulatory clearance from a suite of devices which the Company plans to bring to the flexible endoscopy markets in the EU and USA.
Creo's haemostasis technology is the only non-stick haemostasis device currently available across all electrosurgical markets. The device offers high levels of precision in a single use device for endoscopic use and combining injection therapy and can 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 Company’s second device to gain FDA regulatory clearance within Creo's wider portfolio of flexible endoscopy devices for the gastrointestinal and pulmonary markets. In addition to its core suite of technologies, Creo is currently exploring opportunities for its team of 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."
Shares in Creo have fallen from 80p at the beginning of the year to a low of 96p. Today the shares are trading up 4.5% to 117.5p
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."