30th October 2023
Creo Medical Prepare to Launch New UltraSlim Device 18 Months Ahead of Schedule
EU regulatory pathway for launch earlier than originally planned, following guidance from notified body.
Speedboat UltraSlim, benefiting from the next phase of Creo’s technology miniaturisation, is compatible with all major GI endoscopes now expected to launch in early 2024.
Creo Medical Group plc (AIM: CREO), the medical device company focused on the emerging field of minimally invasive surgical endoscopy announces that, following a recent submission to the Company’s notified body, Creo have been advised on a regulatory pathway facilitating the launch of their Speedboat® UltraSlim device approximately 18 months ahead of schedule.
This news will now enable the Company to initiate the launch of UltraSlim in Europe in early 2024, with an early adopter launch programme which would otherwise have been planned for mid-2025.
Speedboat® UltraSlim is the second brand in its 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, making the device 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 game-changing 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 bi-polar Radiofrequency (“RF”) energy for controlled cutting and high frequency microwave (“MW”) energy for controlled coagulation of tissue in the GI tract. The UltraSlim’s injection functionality is achieved through an integrated lifting system.
Craig Gulliford, Chief Executive Officer of Creo, said:
“This excellent news is testament both to the challenges the team have overcome to scale the technology down to a size which is as small as it ever needs to be, with the regulatory and clinical confidence needed to support this pathway.
“The Regulatory landscape has been particularly challenging for all medtech companies in the last few years here in Europe, with changing transition deadlines and elongated and uncertain clearance pathways. This has resulted in most companies seeking clearance now in the US ahead of the EU. We had adopted the same approach, planning to launch the device in the US ahead of the EU, having filed for our FDA clearance earlier this year.
“With this news, the accelerated timeframes will now see Creo, clinicians and patients reaping the benefits of widespread commercialisation of Speedboat UltraSlim in both Europe and the US in 2024.