Creo gets FDA clearance for Speedboat RS2 device

Medical device company Creo Medical Group announced on Monday that it has received 510(k) clearance from the US Food and Drug Administration for its Speedboat RS2 device and the CROMA platform.

The AIM-traded firm said the Speedboat RS2 was the first of a range of medical devices in development powered by the CROMA platform, and enabled the minimally-invasive removal of early stage cancerous and precancerous lesions in the bowel through an endoscopic procedure.

It said the FDA clearance had been received ahead of schedule, with the review process being completed in 49 calendar days from submission.

As a result, Creo would now assess the necessary steps to bring forward the implementation of its commercial plans for the US.

“The FDA Clearance of Speedboat RS2 and the CROMA system, earlier than planned, is a critical step in our commercialisation strategy,” said Creo chief executive Craig Gulliford.

“Speedboat is paving the way for our suite of GI devices, which we plan to commercialise in the EU, US and globally.

“This approval is a real testament to the hard work and dedication from the Creo team - we continue to execute against our plan and, in this case, come in well ahead of our targets.”

Gulliford said that provided the company with confidence that it has the foundations in place to execute on the suite of devices currently in development.

Creo described Speedboat RS2 as the first device developed for use with the company's generator, CROMA.

The board said it harnessed the cut-and-coagulation capability of CROMA, and enabled the removal of early stage cancerous and precancerous lesions.

The use of Speedboat RS2 reduced the risks associated with incisions which are necessary for laparoscopic procedures, Creo’s board explained, and could reduce the length of hospital stay.

Endoscopy has been a rapidly expanding practice due to the advent of colorectal cancer screening in most healthcare systems, Creo explained, adding that it had driven growth in equipment and devices to enhance the ability to screen and detect early stage and pre-cancerous lesions in the GI tract.

“Over the coming weeks, we will be looking to bring forward the development of our US capabilities whilst continuing with the promising training programme underway in Europe,” Craig Gulliford added.

“Surgical endoscopy is an emerging field and we believe that with the CROMA system, Speedboat and our suite of products, we are well positioned to become a leader in this billion-dollar plus market.”