Creo Medical accelerating EU launch of Speedboat UltraSlim

25th Oct 2023 13:44

(Sharecast News) - Creo Medical Group announced the acceleration of its EU launch of the 'Speedboat UltraSlim' device by around 18 months on Wednesday.

The AIM-traded firm said the expedited timeline followed guidance from its notified body regarding the regulatory pathway.

It said Speedboat UltraSlim, a member of its Speedboat family of devices, was set to debut in early 2024 thanks to the newfound regulatory pathway.

The development would allow for an early adopter launch programme, which was initially slated for mid-2025.

Creo said the distinguishing feature of the UltraSlim is its compact size, in contrast to the Speedboat Inject.

That rendered the device compatible with all endoscopes boasting a 2.8mm working channel or larger, encompassing the majority of GI endoscopic procedures, extending the reach of its technology to a broader spectrum of clinicians and patients.

"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," said chief executive officer Craig Gulliford.

"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."

That, Gulliford said, had 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."

At 1253 BST, shares in Creo Medical Group were up 0.75% at 33.75p.

Reporting by Josh White for Sharecast.com.