Creo Medical Regulatory News (CREO)

Creo Medical Group plc

("Creo" or the "Company")

Trading update

Creo Medical Group plc (AIM: CREO), a medical device company focused on the emerging field of surgical endoscopy, announces that trading for the year ended 31 December 2019 has been in-line with expectations and the Company continues to make progress in the commercialisation of the CROMA Advanced Energy Platform ("CROMA") and a suite of patented electrosurgical devices.

During 2019, the Company generated its initial revenues from its Speedboat device, the first in a range of gastrointestinal ('GI') devices to be cleared for use with the CROMA. The Speedboat device uniquely delivers bipolar radiofrequency energy for precise tissue dissection along with microwave energy for highly controlled coagulation and tissue ablation.

Progress in gaining regulatory approvals for a further four devices optimised around the core tissue effects of dissection, resection, haemostasis and ablation is well advanced. Technical files are now complete and, with revised arrangements with the Company's Notified Body, all four products will be CE marked in Europe simultaneously on receipt of the Company's new EC certificate, which is expected in the near term. In addition, alongside the FDA clearances received so far for CROMA and the Speedboat device, we remain on track to gain clearance with the suite of products in the USA.

Having launched the devices to the market at the United European Gastroenterology Week Congress in October, plans are now in place to introduce these devices into clinical practice during the first half of the year as the Company gears up to commercialise the product range with multiple devices.

The roll out of the Clinical Education Programme continues at pace with clinical education centres now established in multiple sites in the US, Spain, South Africa, India, and the UK. Initial key opinion leaders who have come through the Company's programme are now training other GI endoscopists. This infrastructure, established over the last 18 months, is a significant building block in commercialising the GI suite of products.

The Company expects to see significant growth during 2020 in commercial orders for its Speedboat device. It is in the final stages of agreeing a third-party manufacturing contract to facilitate larger scale production. The Company has already validated the first batches of products from the third-party manufacturer and is confident of the high quality and consistency of production. This next phase is in line with the Company's strategy to manufacture early production in-house as processes are optimised ahead of outsourcing capacity. This enables in-house capacity to be focussed around early production of newly launched devices which is already underway.

Craig Gulliford, Chief Executive Officer of Creo, commented:

"Following the completion of our suite of products and the development of our distribution network over the last 12 months, the whole team is gearing up for clinical activity with multiple devices. This is based around both existing and new customers and users. The new devices include, what we believe to be, the only triple mode bipolar surgical scissors, the smallest microwave ablation device, and the only non-stick haemostasis device.

"Having delivered initial revenues last year, the next few months mark a significant step up for the business. With much appreciated shareholder support, we now have a unique opportunity with game changing devices to develop the business. We are excited to be bringing these capabilities to both endoscopists and surgical users in many disciplines over the next few years. These achievements are testament to the hard work, passion and dedication of the extended Creo team."

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 CROMA, an electrosurgical Advanced Energy Platform that combines bipolar radiofrequency for precise localised cutting and microwave for controlled coagulation. This technology provides clinicians with flexible, accurate and controlled surgical solutions. 

The Company's strategy is to bring its CROMA Advanced Energy Platform powered by unique full spectrum adaptive technology to market enabling a suite 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