Creo Medical Group - US FDA clearance for MicroBlate™ Fine device
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Creo Medical Group plc
("Creo" or the "Company")
US FDA clearance for MicroBlate™ Fine device
Creo Medical Group plc (AIM: CREO), the medical device company focused on the emerging field of surgical endoscopy, announces that it has received 510(k) clearance from the US Food & Drug Administration ('FDA') for its tissue ablation device MicroBlate™ Fine.
This is the third device to gain FDA regulatory clearance within Creo's portfolio of flexible endoscopy devices for the gastrointestinal ('GI') market alongside SlypSeal™ Flex and Speedboat™ Inject. The range is designed to be used with the CROMA Advanced Energy Platform, powered by Kamaptive™ full-spectrum adaptive technology, a seamless, intuitive integration of multi-modal energy sources, optimised to adapt to the tissue effect required for different procedures such as resection, dissection, coagulation and ablation of tissue.
About MicroBlate™ Fine
Creo's MicroBlate™ tissue ablation technology 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, believed to be the smallest diameter MW ablation needle antenna in the world, has the same dimensions as a standard biopsy needle which, when used with typical ultrasound navigation tools, enables improved access to and the ablation of a wide range of organs (such as pancreas, liver, kidney, lung and muscle) during open, laparoscopic, percutaneous and endoscopic procedures.
Creo's Speedboat™ Inject, already CE marked and with FDA clearance, is being used by clinicians in the
"We are delighted to receive FDA clearance for our MicroBlate™ Fine device and we continue to work hard, despite the impact of the COVID-19 pandemic, to continue our program of regulatory clearances for our expanding suite of advanced energy surgery products for the flexible endoscopy market.
"With regulatory clearance in the
"Despite the COVID-19 pandemic, during 2020 Creo has added a significant direct sales presence in both the
Creo Medical Group plc
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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
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