CE Mark awarded to Speedboat RS2 for microwave energy
Commercial plan on track
Creo Medical Group plc (AIM: CREO) (“Creo” or “the Company”), a medical device company focused on the emerging field of surgical endoscopy, is pleased to announce that the Company’s Speedboat RS2 has received CE Mark approval for microwave energy to add to the device’s previously awarded CE Mark for radiofrequency.
In clinical studies, the Speedboat RS2 has successfully demonstrated safety and efficacy of the application of microwave energy to coagulate bleeds in the colon in 30 patients and represents the first device to use microwave energy in combination with radiofrequency. The study publication has been accepted for Digestive Disease Week® (DDW), the world's largest medical meeting of physicians, researchers and industry in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery.
Creo is developing the CROMA electrosurgery platform and the Speedboat RS2 is the first product in the instrument development pipeline. It harnesses the cut and coagulation capability of CROMA and enables the removal of large and flat pre-cancerous and cancerous lesions in the bowel which are typically referred for surgical removal in western practice; surgery which carries a 6% mortality rate at 30 days.
Craig Gulliford, Chief Executive Officer of Creo Medical, said: “Our vision is to enable physicians to move the point of treatment from the operating theatre under general anaesthetic to a procedure under sedation in the endoscopy suite. Since the IPO, this is the first in a programme of necessary regulatory milestones expected for the CROMA platform and associated range of devices in the EU, the US and, working with our partners Pentax, the Asia Pacific region.
We remain on track to initiate the soft launch of the Speedboat product later this year, in line with our strategy at IPO to translate this surgery sparing technology into routine clinical practice and expect this to be followed by the introduction of a range of devices for the therapeutic endoscopy market. Surgical endoscopy, a billion dollar plus market, is an emerging field and with the CROMA platform and range of endoscopic devices, we believe that we are well positioned to become a leader in this growing market.”
The information communicated in this announcement is inside information for the purposes of Article 7 of Market Abuse Regulation 596/2014 ("MAR").
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Ivonne Cantu / Camilla Hume (NOMAD)
Michael Johnson / Russell Kerr (Sales)
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Brett Pollard / Mo Noonan
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Notes to Editors
The Speedboat will be utilised in GI Surgery for Endoscopic Submucosal Dissection (ESD). This approach can replace open or laparoscopic surgery as well as Endoscopic Mucosal Resection (EMR). EMR removes the lesion in many pieces rather than ESD that removes the lesion en bloc which can result in faster procedures and better patient recovery. There is also data which indicates that the small tissue pieces left behind with EMR may cause regrowth or cancerous growths.
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 radiowave energy to surgical endoscopy. Creo has developed CROMA, an electrosurgical platform that combines bipolar radiofrequency for precise localised cutting and microwave for controlled coagulation. This technology provides physicians with flexible, accurate and controlled surgical solutions.
The Company’s strategy is to bring the CROMA surgical system to market through a suite of medical instruments which the Company has designed, initially for GI therapeutic endoscopy, an area with high unmet needs. The CROMA system will be developed further for bronchoscopy and laparoscopy procedures. The Company believes its technology can impact the landscape of surgery and endoscopy by providing safer, less-invasive and more cost-efficient option of treatment.
For more information about Creo medical please see our website, www.creomedical.com.