Speedboat® UltraSlim: US FDA Clearance

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.

Craig Gulliford, CEO of Creo Medical, said:

We are delighted to receive FDA clearance for Speedboat UltraSlim, which is testament to the hard work of our entire team. Our engineering team have overcome many challenges to scale the Speedboat technology down to the size of the UltraSlim, and, with the support of our regulatory team, we have been able to obtain FDA clearance with speed and efficiency.

Together with the recent news of the accelerated regulatory pathway in the EU, we look forward to patients, clinicians and healthcare providers being able to benefit from the widespread commercialisation of Speedboat UltraSlim in both Europe and the US in 2024 and beyond.

Posted 11/01/23

For press enquiries please contact media@creomedical.com. For all other enquiries please visit our Contact page.

Further news

19 March 2024

Welsh Labour Leader visits Creo’s facilities

Read

05 February 2024

Strategic Collaboration with Khalifa University of Science and Technology, Abu Dhabi

Read

31 January 2024

Roll-out of Speedboat® UltraSlim reaches Asia Pacific

Read

10 January 2024

First Use of Speedboat® UltraSlim in Latin America

Read

13 December 2023

First European Speedboat® UltraSlim procedure marks early commercial launch

Read

25 October 2023

Speedboat UltraSlim: EU launch accelerated by 18 months

Read

12 September 2023

Half Year Report: H1-2023

Read

19 June 2023

Speedboat Inject cleared for upper GI use in Europe

Read

01 June 2023

Speedboat™ Inject selected by NICE for assessment

Read

23 May 2023

First in-human milestone reached for MicroBlate™ Flex as part of Lung Tissue ablation clinical study

Read