(Sharecast News) – Surgical endoscopy-focussed medical devices company Creo Medical Group has received 510(k) clearance from the US Food and Drug Administration (FDA) for its ‘MicroBlate Flex’ tissue ablation device, it announced on Thursday.
The AIM-traded firm said MicroBlate Flex is the fourth device within its portfolio of flexible endoscopy devices for the gastrointestinal market to receive FDA regulatory clearance, alongside CE-marking already received across the range in 2020.
It said its first product to receive FDA clearance, ‘Speedboat Inject’, was now being used by clinicians in the UK, European Union, United States, South Africa, and the Asia-Pacific region.
It explained that Creo’s MicroBlate technology used its very-high-frequency microwave energy, allowing physicians to precisely ablate diseased tissue in multiple organ types and a number of different clinical access methods.
MicroBlate Flex was an additional soft tissue ablation device within the range, designed to ablate nodules and tumours in several soft tissue types, including the lung.
The board said it had potential to treat a number of other conditions, where a small diameter flexible device would enable access into otherwise inaccessible regions of the body.
It could be “particularly useful” to treat a range of ear, nose and throat indications, it added, including nasopharyngeal cancer and nasal polyps.
Creo’s additional ablation product, ‘MicroBlate’ Fine’ also received 510(k) clearance from the FDA in November, and the first in-man clinical use of the product was announced in December.
The company said FDA clearance “paves the way” for the roll-out of the devices in the US market, adding that with the full range of products CE-marked during 2020, it also had access to the EU and UK markets, enabling commercialisation of its gastrointestinal suite.
“We are delighted to receive FDA clearance for the MicroBlate Flex device and we remain focussed on completing our programme of regulatory clearances for the full suite of advanced energy surgery products for the flexible endoscopy market,” said chief executive officer Craig Gulliford.
“We expect to see further first clinical use of our products in various markets and we look forward to utilising our enhanced global sales and marketing capability to drive commercialisation of our range.”
At 0900 GMT, shares in Creo Medical were up 8.25% at 210p.
