Creo Medical Regulatory News (CREO)

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Creo Medical Group plc

("Creo" or the "Company")

US FDA clearance for MicroBlate™ Fine device

Creo Medical Group plc (AIM: CREO), the medical device company focused on the emerging field of surgical endoscopy, announces that it has received 510(k) clearance from the US Food & Drug Administration ('FDA') for its tissue ablation device MicroBlate™ Fine.

This is the third device to gain FDA regulatory clearance within Creo's portfolio of flexible endoscopy devices for the gastrointestinal ('GI') market alongside SlypSeal™ Flex and Speedboat™ Inject. The range is designed to be used with the CROMA Advanced Energy Platform, powered by Kamaptive™ full-spectrum adaptive technology, a seamless, intuitive integration of multi-modal energy sources, optimised to adapt to the tissue effect required for different procedures such as resection, dissection, coagulation and ablation of tissue.

About MicroBlate™ Fine

Creo's MicroBlate™ tissue ablation technology utilises Creo's very high frequency microwave energy allowing physicians to precisely ablate diseased tissue in multiple organ types and many different clinical access methods. MicroBlate™ Fine, believed to be the smallest diameter MW ablation needle antenna in the world, has the same dimensions as a standard biopsy needle which, when used with typical ultrasound navigation tools, enables improved access to and the ablation of a wide range of organs (such as pancreas, liver, kidney, lung and muscle) during open, laparoscopic, percutaneous and endoscopic procedures.

Creo's Speedboat™ Inject, already CE marked and with FDA clearance, is being used by clinicians in the UK, EU, US, Africa and APAC. On the back of this progress, the balance of Creo's GI suite of products were also CE marked during 2020 providing access to the EU and UK markets enabling commercialisation of the GI suite. MicroBlate™ Fine is the first of the ablation platform with US clearance and paves the way for the roll-out of more devices into the US market. Full details of Creo's product range can be found here:

http://www.rns-pdf.londonstockexchange.com/rns/8918P_1-2020-6-14.pdf

Craig Gulliford, Chief Executive Officer of Creo, commented:

"We are delighted to receive FDA clearance for our MicroBlate™ Fine device and we continue to work hard, despite the impact of the COVID-19 pandemic, to continue our program of regulatory clearances for our expanding suite of advanced energy surgery products for the flexible endoscopy market.

"With regulatory clearance in the UK and Europe and US clearances coming through, we are gearing up for first clinical use of these products in various markets. This rapid progression of device clearances, along with the recent dramatic expansion of Creo's Global commercial sales capability, puts Creo in great shape to drive global commercialisation.

"Despite the COVID-19 pandemic, during 2020 Creo has added a significant direct sales presence in both the USA and key EU markets as well as adding to global distribution channels. This, combined with an increased range of products including through the recent acquisition of Albyn Medical, gives Creo a full service offering in the GI sector."

Enquires:

About Creo Medical 

Creo Medical, founded in 2003, is a medical device company focused on the development and commercialisation of minimally invasive surgical devices, by bringing advanced energy to endoscopy. The Company's mission is to improve patient outcomes by applying microwave and RF energy to surgical endoscopy. Creo has developed the CROMA Advanced Energy Platform powered by Kamaptive™ full-spectrum adaptive technology to optimise surgical capability and patient outcomes. Kamaptive™ is a seamless, intuitive integration of multi-modal energy sources, optimised to dynamically adapt to patient tissue during procedures such as resection, dissection, coagulation and ablation of tissue. Kamaptive™ technology provides clinicians with increased flexibility, precision and controlled surgical solutions. 

The Company's strategy is to bring its CROMA Advanced Energy Platform powered by Kamaptive™ technology to market, enabling a wide range of medical devices which the Company has designed, initially for the emerging field of GI therapeutic endoscopy, an area with high unmet needs. The CROMA Advanced Energy Platform will be developed further for bronchoscopy and laparoscopy procedures. The Company believes its technology can impact the landscape of surgery and endoscopy by providing a safer, less-invasive and more cost-efficient option of treatment. 

For more information about Creo Medical please see our website, investors.creomedical.com