Creo Medical Regulatory News (CREO)

Creo Medical Group plc

("Creo" or the "Company")

MicroBlate Fine's first in-human use update

Life-changing FDA cleared Creo device successful in adding months to patient's life expectancy and well-being

Creo Medical Group plc (AIM: CREO), the medical device company focused on the emerging field of surgical endoscopy, provides an update on its 510(k) US Food & Drug Administration ('FDA') cleared tissue ablation device MicroBlate™ Fine.

First in-human use update

Further to the announcement dated 9 December 2020, the device was successfully used for the first in-human, minimally invasive, Endoscopic Ultrasound (EUS) guided, treatment in a patient with an unresectable pancreatic neuroendocrine tumour. The procedure was performed by Dr. Carlos Robles-Medranda at Instituto Ecuatoriano de Enferemdades Digestives ("IECED"), Ecuador and the resulting outcome was successful. With a condition that was not possible to be treated surgically using traditional methods, the patient required a less invasive treatment in order to potentially prolong the patient's life. The Company is delighted to report that, following the procedure using MicroBlate™ Fine, the patient remains well and is enjoying life. Subsequent scans of the patient's pancreas continue to confirm the treatment's durability.

Led By Dr. Carlos Robles-Medranda, IECED is the most advanced Gastroenterology and Digestive Endoscopy centre in Latin America and is endorsed by the World Endoscopy Organization (WEO) which leads the promotion of Endoscopy throughout the world. When asked about his experience with the MicroBlate™ Fine, Dr Carlos Robles-Medranda stated: "I am excited about the potential of this technology for use in EUS guided therapy; the microwave energy allows me to precisely target and ablate difficult lesions. I believe this technology will have a positive impact on my patients, and I will continue to offer this treatment option."

MicroBlate™ Fine, was the third device to gain FDA regulatory clearance within Creo's portfolio of flexible endoscopy devices for the gastrointestinal ('GI') market in November 2020, -and is designed to be used with Creo's CROMA Advanced Energy Platform, powered by Kamaptive™ full-spectrum adaptive technology. The MicroBlate™ Fine device 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 has the same dimensions as a standard biopsy needle which, when used with typical EUS navigation tools, enables improved access to and the ablation of a wide range of organs (such as pancreas, liver, kidney, lung and muscle).

Craig Gulliford, Chief Executive Officer of Creo, commented:

"We are delighted to report such a positive update on our 510(k) US Food & Drug Administration cleared tissue ablation device MicroBlate™ Fine. The device was successfully used for the first in-human minimally invasive EUS guided treatment in a patient with an unresectable pancreatic neuroendocrine tumour in December 2020. The outcome of the procedure was a success, with subsequent follow up scans not only showing no return of the tumour, but also an absence of any obvious scar tissue."

Full details of Creo's product range can be found here:

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

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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