Britain's Creo Receives Speedy FDA Approval for Its Endoscopic Device

By Reuters Staff

August 22, 2017

LONDON (Reuters) - Britain's Creo Medical Group said its device to remove cancerous lesions in the bowel during an endoscopy had received U.S. approval much quicker than it planned, shaking up a timetable that had been focused on a European launch.

The company, which listed late last year, said the U.S. Food and Drug Administration (FDA) had cleared its Speedboat RS2 device and its CROMA platform just 49 days after it was submitted. Creo Medical had expected the process to take about six months.

Chief Executive Craig Gulliford said FDA clearance was a critical step in commercialization of the device, which is able to cut out a lesion using bipolar radiofrequency and stop associated bleeding using microwave energy.

"(The approval) has caught us almost two quarters in advance," he told Reuters by phone on Monday.

"The next step is to roll out the training course that is under way in Europe at the moment and start rolling that into physicians in the U.S."

He said the company would look again at its plans over the next couple of weeks and bring some time scales forward.

Shares in the company were trading up 2.4% at 85.1 pence on Monday, valuing the company at 69 million pounds ($89 million).