Creo Medical - Potential UltraSlim upside with swift EU pathway
Creo Medical has announced that its EU notified body has guided for an accelerated clinical pathway for its Speedboat UltraSlim device, the slimmest Speedboat Inject version that is compatible with most endoscopes. The reduced regulatory path will enable the company to launch the versatile product in Europe in early 2024, roughly 18 months earlier than planned. As the FDA application was submitted for this device in February 2023 (management expects clearance in Q423), UltraSlim is now projected to be available in both Europe and the US within the next 12 months. The UltraSlim device is an important addition to Creo’s portfolio as it provides broader access to gastrointestinal (GI) procedures with the potential to be accretive to the company’s top line in near/medium term.Creo Medical Group is a medical device company focused on the field of surgical endoscopy, a recent development in minimally invasive surgery. Co. is focused on developing and commercializing a suite of medical devices based on its CROMA electrosurgery platform.
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