Creo gets CE mark for five new devices

Medical devices company Creo Medical Group announced the simultaneous CE-marking of five new devices on Monday, which form the ‘Creo GI’ gastrointestinal suite of advanced energy devices across four technology platforms.

The AIM-traded firm said the CE-marking of the full range of products provided EU and UK clearance ahead of commercial launch.

It said it expected to introduce the devices into clinical practice, and prepare for commercialisation, in the second half of the year.

The board said the range was designed to be used with the ‘CROMA’ Advanced Energy Platform’ (CROMA), powered by its ‘Kamaptive’ full-spectrum adaptive technology, which it described as an integration of multi-modal energy sources, optimised to adapt to the tissue effect required for different procedures.

It said the “heavily-patented” devices were individually optimised to utilise bipolar radiofrequency (RF) and high-frequency microwave (MW) energy for the core tissue effects of dissection, resection, haemostasis and ablation, and form the basis of four individual device platforms.

Creo had been expecting the milestone, and was launching the branding and brand hierarchy for the “powerful technology platforms” to coincide with the clearance of multiple devices alongside CROMA and Kamaptive technology.

The board explained that the individual device technology platforms each had multiple potential market applications in the company’s roadmap, including open surgical applications, several laparoscopic surgical and ablation markets, as well as its initial core focus in the therapeutic flexible endoscopy markets.

Creo said the newly CE-marked products were ‘Speedboat Slim’. ‘SpydrBlade Flex’, ‘ MicroBlate Fine’, ‘MicroBlate Flex’, and ‘SlypSeal Flex’.

Its first product, ‘Speedboat Inject’, was already CE-marked, FDA-cleared, and was being used by clinicians in the UK, European Union, United States, Africa and the Asia-Pacific region.

SlypSeal Flex, meanwhile, received US FDA 510k clearance in March.

“Since their first demonstration at the UEG Week Congress in October, the Creo team have been gearing up for first clinical use in various markets,” said chief executive officer Craig Gulliford of the suite of products.

“Procedures utilising our products have, for the right reasons, been delayed during the coronavirus pandemic as routine diagnostics have been stopped to free up resources.

“However, we are now poised with a wider range of devices than originally planned, that will allow the company to re-emerge from lock-down stronger and more confident in our medium and long-term prospects.”

Gulliford said bringing any medical device to market was “very challenging”, especially if they were “truly novel” medical devices.

“So, bringing five individual and game-changing devices to market at the same time is a phenomenal achievement for the entire Creo team and completes phase one of our big ambition which underpinned our initial public offering, and was supported by such a great group of investors.

“More importantly, this heralds the next phase of the business development as we take advanced laparoscopic surgical technology to the flexible endoscopy community worldwide.

“The whole company is gearing up for enabling doctors across Europe, India and beyond to treat patients with these new device families for the first time over the coming months.”

Gulliford noted the firm already had multiple devices in the market, within the MicroBlate and Speedboat device technology platforms.

He said the continuing development programme Creo was running would be generating “many devices” within each of those platforms in the coming months and years, enabling it to evolve as a business into a number of clinical areas.

“Our heavily patented Speedboat, SpydrBlade, SlypSeal and MicroBlate technology, powered by the CROMA platform, provide a tremendous foundation from which we can build the business.”

At 1559 BST, shares in Creo Medical Group were down 0.88% at 198.74p.