Creo Medical Regulatory News (CREO)

Creo Medical Group plc

("Creo" the "Company" or the "Group")

MicroBlate™ Flex clinical study in lung lesion microwave ablation

Multicentre observational study representing first in human use of the device for

soft tissue lung lesions

Creo Medical Group plc (AIM: CREO), the medical device company focused on the emerging field of surgical endoscopy, announces a multi-site clinical study (the "Study") to evaluate the safety and feasibility of MicroBlate™ Flex, Creo's bronchoscopic microwave ablation device, for the treatment of lung lesions.

MicroBlate™ Flex is a new soft tissue ablation device, designed with the aim of being able to ablate nodules and tumours in several tissue types using the highest frequency MW energy used for tumour ablation. Lung cancer is the most common cancer in men and the second most common cancer in women[1], and treatment options are currently sub optimal and typically involve chemotherapy, radiation therapy, surgery or a combination thereof. The size and flexibility of MicroBlate™ Flex offer patients the prospect of a significantly less invasive procedure when treating lung tumours than alternatives. MicroBlate™ Flex also has potential to be used to treat a number of other conditions, where a small diameter flexible device enables access into otherwise inaccessible regions of the body.

The Study is the first of a number of planned studies designed by Creo, in conjunction with Kamaptive partners, in respect of Creo's suite of ablation devices during 2023 and beyond. The Study will initially take place in the UK, and may expand to up to a total of six sites across Europe, with the potential to expand into the United States.

As principal investigator, Pallav L Shah, MD, of the Royal Brompton and Harefield NHS Foundation Trust, has commenced the process to recruit patients to undergo treatment. The patients recruited will represent the first in-human cases for Creo's MicroBlate™ Flex device and will have regular follow-up assessments for twelve months post-procedure to monitor their progress. The first case is expected to take place during Q2 2023.

Full details of the Study can be found at: https://clinicaltrials.gov/ct2/show/NCT05786625

Craig Gulliford, Chief Executive Officer of Creo, commented: "It is pleasing that the first human use of MicroBlate™ Flex, a technology designed and developed in the UK, is likely to take place in the UK as part of this Study. The Study aims to build an evidence base as a pioneering device for the treatment of lung lesions. MicroBlate™ Flex enables a less invasive, endoscopic alternative to treat lung lesions as a first-line option, as well as treatment of patients not eligible for surgery."

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About Creo Medical 

Creo Medical is a medical device company focused on the development and commercialisation of minimally invasive electrosurgical devices, bringing advanced energy to endoscopy.

The Company's vision is to improve patient outcomes through the development and commercialisation of a suite of electrosurgical medical devices, each enabled by CROMA, powered by Kamaptive. The Group has developed the CROMA 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. CROMA currently delivers bipolar radiofrequency ("RF") energy for precise localised cutting and focused high frequency microwave ("MW") energy for controlled coagulation and ablation via a single accessory port. This technology, combined with the Group's range of patented electrosurgical devices, is designed to provide clinicians with flexible, accurate and controlled clinical solutions. The Directors believe the Company's technology can impact the landscape of surgery and endoscopy by providing a safer, less-invasive and more cost-efficient option for procedures.

For more information, please refer to the website www.creomedical.com