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Creo Medical Group PLC on Wednesday said the EU launch of its SpeedBoat UltraSlim device has been accelerated by around 18 months ahead of schedule. The Chepstow, Wales-based medical device company focused on surgical endoscopy said it now expects to launch Speedboat UltraSlim in Europe in early 2024, rather than mid-2025, after being advised on a regulatory pathway facilitating the earlier launch. Creo Medical said the SpeedBoat UltraSlim is the second brand in its Speedboat family of devices alongside Speedboat Inject and offers a number of different features. This primarily includes the reduced size in comparison with the Speedboat Inject, Creo Medical said, making the device compatible with all endoscopes with a 2.8 millimetre working channel or larger. Creo Medical said this accounts for the ‘vast majority of [gastrointestinal] endoscopic procedures, and significantly increasing the opportunity for more clinicians and patients to benefit from Creo’s game-changing technology.’ Chief Executive Officer Craig Gulliford 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 [US Food & Drug Administration] 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.’ Shares in Creo Medical were up 1.2% to 33.90 pence each in London on Wednesday afternoon. Copyright 2023 Alliance News Ltd. All Rights Reserved.
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