Creo Medical Regulatory News (CREO)

Creo Medical Group plc

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

Royal Oldham SSD service going from strength to strength

40 cases completed in record time, with patients and waiting lists experiencing immediate benefits

Creo Medical Group plc (AIM: CREO), the medical device company focused on the emerging field of minimally invasive surgical endoscopy, provides an update on the implementation of its technology within The Royal Oldham Hospital ("Royal Oldham"). On 17 May, Creo announced that Royal Oldham had become the first NHS hospital to immediately implement CROMA and Speedboat™ Inject across multiple endoscopy rooms, putting in place weekly lists for multiple SSD (Speedboat Submucosal Dissection) cases.

The hospital has now treated over 40 patients using the new service, representing the fastest time for any NHS hospital to reach the landmark, with exceptional results for patients, the hospital and its staff. Multiple doctors at the hospital have already progressed through Creo's Pioneer Programme mentoring stage and are independently treating regular lists of patients presenting with complex, high-risk lesions in the colon.

Creo has a target base for the Speedboat range of products of more than 350 NHS hospitals, with each SSD procedure demonstrated to save the NHS up to £10k when compared to traditional surgery, alongside a typically far shorter hospital stay and significantly lower risk of complications. There are 23 NHS England healthcare settings that have now adopted SSD.

Dr Sal Khalid, Consultant Gastroenterologist at the Royal Oldham Hospital, said: "I'm very pleased with the outcomes the Speedboat Inject device is facilitating for our patients, allowing our advanced endoscopists to remove complex high-risk lesions and even early cancer without the patient requiring invasive surgical treatment.

"Almost all bowel cancers start as a lesion, and so having the technology now available to us to cut deeper and more safely through the layers of the bowel when removing a lesion enables us to ensure that it's completely removed and reduce the chances of patients requiring an operation.

"It's already clear that this will have a lasting effect, with the treatment reducing the chances of recurrence from 15% to 1% and potentially providing a cure for lesions containing early cancer without requiring operation.

"Indeed, only three months into the new service we are already recording a reduction in the waiting lists not only across our endoscopy suites but, perhaps most importantly, in terms of those waiting for the surgical treatment of more invasive cancers.

"The best part about the new service is being able to call a patient a few days later and tell them that they have had a curative outcome - that the lesion has been removed with the necessary margins not to have to worry about it anymore. That was rarely the case before we introduced Speedboat Inject and the advanced energy.

"The establishment of this service will help us maintain our status as one of the leading advanced endoscopy services in the country and help us move towards our goal of prevention, early detection, and treatment of bowel cancer."

Dr Khalid has now completed over 15 procedures using the Speedboat Inject device. Out of the first 10 cases, two were confirmed as cancers and three as showing features of high grade dysplasia, suggesting lesions very close to turning into a cancer. All of these lesions were successfully removed completely through an SSD procedure using Creo's advanced energy device.

What next?

· SSD will become Royal Oldham's treatment of choice for high-risk polyps suspected of containing early cancer. Hundreds of patients every year are expected to benefit from this treatment option.

· Royal Oldham plans to expand the service and increase the number of conditions it can treat using this equipment. This will involve training endoscopists to perform a wider array of procedures using CROMA and Speedboat.

· An expanded service will be supported by a dedicated multidisciplinary team involving experts from across all the relevant specialties, ensuring every patient gets the best treatment based on expert knowledge, with every decision supported by the most current medical evidence.

· Royal Oldham will also aim to offer training opportunities to help teach this advanced technique to a wider pool of doctors, including the establishment of training posts of Endoscopy Fellows who will receive dedicated training and experience of decision making and performing SSD procedures under direct supervision of Dr Sal Khalid and his team.

Craig Gulliford, CEO of Creo Medical said: "Oldham provides a phenomenal model for what's possible when a hospital immediately recognises the potential of the device and implements the right pathways and resource to maximise its impact.

"To know that there are 40 patients in and around Oldham who have already benefited from our technology and the excellent service provided by Dr Khalid and his team is incredibly gratifying, with the knock-on positive effects on waiting lists and hospital resources now well established.

"To hear plans for the further expansion of the service is also excellent news and we look forward to supporting the hospital in every way we can."

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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