Creo Medical wins expanded CE mark for Speedboat RS2 electrosurgical device

Creo Medical

Creo Medical said today it won expanded CE mark approval for its Speedboat RS2 electrosurgical device, now cleared for the use of microwave energy as well as radiofrequency.

The U.K.-based company said that in a 30-patient clinical study, the Speedboat RS2 successfully demonstrated safety and efficacy in applying microwave energy to coagulate bleeds in the colon. Creo Medical touted the device as the 1st to use microwave energy combined with radiofrequency.

“Our vision is to enable physicians to move the point of treatment from the operating theatre under general anaesthetic to a procedure under sedation in the endoscopy suite. Since the IPO, this is the 1st in a programme of necessary regulatory milestones expected for the CROMA platform and associated range of devices in the EU, the US and, working with our partners Pentax, the Asia Pacific region. We remain on track to initiate the soft launch of the Speedboat product later this year, in line with our strategy at IPO to translate this surgery sparing technology into routine clinical practice and expect this to be followed by the introduction of a range of devices for the therapeutic endoscopy market. Surgical endoscopy, a billion dollar plus market, is an emerging field and with the CROMA platform and range of endoscopic devices, we believe that we are well positioned to become a leader in this growing market,” chief exec Craig Gulliford said in a press release.

Creo Medical is developing minimally invasive surgical devices, initially focused on gastrointestinal surgery and lung cancer, using the company’s Croma system which combines bipolar radiofrequency and microwave energy technology.

Last December, Creo Medical announced plans for a U.K. initial public offering, looking to raise $25.3 million (UK £20 million).

Creo Medical said it planned to offer shares at approximately 97¢ per share (UK £0.79), which would give the company an estimated market capitalization of approximately $77.7 million (UK £61.3 million).