Creo Medical Group PLC (AIM:CREO), a specialist in minimally invasive surgical endoscopy, has announced an accelerated European Union launch for its Speedboat UltraSlim device.
Initially planned for mid-2025, the device is now expected to debut in early 2024. This advancement comes after Creo received guidance from its notified body, an organisation responsible for certifying medical products, which has outlined a faster regulatory pathway for the device.
"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 Creo chief executive Craig Gulliford.
Speedboat UltraSlim is a significant addition to Creo's Speedboat family of devices, which includes Speedboat Inject. The UltraSlim device is notably smaller, making it compatible with most gastrointestinal (GI) endoscopes, the instruments used to examine the digestive tract.
This compatibility opens up opportunities for more clinicians and patients to benefit from Creo's innovative technology. The new product aims to treat lesions in the gastrointestinal tract, which includes conditions such as bowel and upper GI cancers, as well as pre-cancerous lesions and swallowing disorders.
It operates on Creo's CROMA advanced energy platform, utilising bi-polar Radiofrequency (RF) energy for precise cutting and high-frequency microwave (MW) energy for the controlled coagulation, or clotting, of tissue. The UltraSlim also features an integrated lifting system for injection functionality.
The accelerated launch of Speedboat UltraSlim is a significant milestone for Creo Medical Group, offering a promising new treatment option for gastrointestinal conditions much sooner than anticipated.