Creo Medical Group plc (AIM: CREO), the medical device company focused on the emerging field of minimally invasive surgical endoscopy announces that it has received 510(k) clearance from the US Food & Drug Administration (“FDA”) for its Speedboat® UltraSlim device.

FDA clearance allows the Company to initiate the launch of UltraSlim in the USA through its existing direct sales force and supported by its network of key opinion leaders and clinicians. Clearance follows recent guidance received from the Company’s notified body of an EU regulatory pathway which has accelerated the European launch of the UltraSlim device by approximately 18 months.

Speedboat® UltraSlim is the second brand in Creo’s Speedboat® family of devices alongside Speedboat Inject and offers a number of different features. The primary feature is the reduced size in comparison with the Speedboat Inject. This results in the device being compatible with all endoscopes with a 2.8mm working channel or larger, accounting for 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.

The UltraSlim device is targeting the therapeutic treatment of Gastrointestinal (“GI”) tract lesions (including Bowel and Upper GI cancers, and pre-cancerous lesions) and swallowing disorders. Powered by Creo’s CROMA advanced energy platform, the 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.