Creo Medical Group (CREO) , a medical device company focused on minimally invasive surgical endoscopy, said it received regulatory clearance that accelerates the launch of its Speedboat® UltraSlim device in Europe to early 2024, a year and a half ahead of the original schedule.
The UltraSlim is a compact addition to the Speedboat® family, facilitating compatibility with the majority of Gastrointestinal (GI) endoscopic procedures by fitting endoscopes with a 2.8mm working channel or larger, with this advancement broadening access to Creo's technology for clinicians and patients. The UltraSlim is designed for the therapeutic treatment of GI tract lesions, including bowel and upper GI cancers, as well as pre-cancerous lesions, and it addresses swallowing disorders.
Craig Gulliford, Chief Executive Officer of Creo, said:"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."
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This regulatory milestone marks a significant leap forward for Creo's medical device solutions. Speedboat UltraSlim removes bowel cancer lesions, preventing them from developing into anything more sinister. Bowel cancer is the fourth most common cancer in the UK, with almost 43,000 people diagnosed every year in the UK. Speedboat reduces the chances of recurrence of a lesion from 15% to 1% and potentially provides a cure for lesions containing early cancer without requiring an operation.
Creo Medical’s quick approval of the Speedboat UltraSlim, reaffirms its status as one of the leading advanced endoscopy services, helping it to move closer to its goal of prevention, early detection, and treatment of bowel cancer.
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