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(Sharecast News) - Medical device company Creo Medical Group announced on Wednesday that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Speedboat UltraSlim device.
The AIM-traded firm said FDA clearance was a significant milestone, allowing it to launch the UltraSlim device in the United States.
It said the launch would occur through its existing direct sales force, supported by a network of key opinion leaders and clinicians.
Notably, the clearance came on the heels of guidance from the company's notified body regarding an accelerated European regulatory pathway, expediting the European launch of the UltraSlim device by around 18 months.
The firm said Speedboat UltraSlim is part of its Speedboat family of devices, alongside the Speedboat Inject.
Its standout feature is its reduced size compared to the Speedboat Inject, making it compatible with all endoscopes featuring a 2.8mm working channel or larger.
The expanded compatibility covered the majority of gastrointestinal (GI) endoscopic procedures, broadening the scope for clinicians and patients to benefit from Creo's advanced technology.
Creo said the UltraSlim device targeted treatments for gastrointestinal tract lesions, including bowel and upper GI cancers, precancerous lesions and swallowing disorders.
It is powered by Creo's 'CROMA' advanced energy platform, offering bi-polar radiofrequency energy for precise cutting and high-frequency microwave energy for controlled tissue coagulation within the GI tract.
"We are delighted to receive FDA clearance for Speedboat UltraSlim, which is testament to the hard work of our entire team," said chief executive officer Craig Gulliford.
"Our engineering team has 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."
At 1403 GMT, shares in Creo Medical Group were up 0.77% at 32.75p.
Reporting by Josh White for Sharecast.com.
