Creo Medical Pre-Submission 510k Confirmation

RNS Number : 5043J

Creo Medical Group PLC

29 June 2017

 

Creo Medical Group plc

("Creo" or "the Company")

FDA confirms 510(K) submission pathway for Creo's Flexible Ablation System

US regulatory approval on track for 2019

Chepstow, South Wales - 29 June 2017 - Creo Medical Group plc (AIM: CREO), a medical device company focused on the emerging field of surgical endoscopy, today announces that, following a pre-submission meeting with the U.S. Food and Drug Administration (FDA) on 15^th June 2017, it plans to make a Pre-Market Notification (via the 510(k) pathway) for its Flexible Ablation System.

Creo's Flexible Ablation System is designed to ablate soft tissue, pre-cancerous and cancerous lesions, in a range of tissues using controllable microwave energy delivered from the Company's Advanced Energy Platform, CROMA. The narrow diameter Flexible Ablation System will allow access to sites in minimally invasive procedures. This is in line with the Company's strategy to enable therapy to transfer from the operating room to an endoscopy suite, where sedation replaces general anaesthetic. The Flexible Ablation System is anticipated to have multiple future applications in pulmonary, pancreatic and gastrointestinal fields.

The FDA pre-submission meeting is the first formal step to establish with the FDA, the regulatory pathway for a new device to be cleared for sale within the U.S. market. This is important as it allows the Company to plan the development programme to generate the data required by the FDA. Following this meeting, Creo has a clear understanding of the data required to support the 510(k) submission which, subject to approval, would allow the Flexible Ablation System to have broad utility in a number of soft tissue applications, not just those within pulmonary. In addition, the Company does not expect to need to include human clinical data to support the 510(k) submission.  

Accordingly, and in line with its strategy, the Company continues to anticipate U.S. regulatory clearance for this device in 2019.

Craig Gulliford, Chief Executive Officer of Creo, commented: "We were encouraged by the high level of engagement exhibited by the FDA and, following a very productive meeting, we now have a clear pathway to regulatory clearance for this important product. Subject to achieving FDA approval, which we continue to expect in 2019, we remain on target to meet another of our commercial milestones. We continue to progress the development of our portfolio of instruments aimed at arming surgeons with a more complete range of safe and effective, minimally invasive tools."

Contacts
Creo Medical:	Cenkos:	FTI Consulting:
Roseanne Varner [phone] [e-mail]	Ivonne Cantu / Camilla Hume (NOMAD) Michael Johnson / Russell Kerr (Sales) [phone]	Brett Pollard / Mo Noonan [phone] [e-mail]

Notes to the Editors

About Creo Ablation Probe

Creo's Ablation Probe is an instrument used to remove (ablate) abnormal growths from the body such as pre-cancerous and cancerous lesions using microwave energy through the Company's CROMA advanced energy platform. 

About CROMA

Creo's advanced energy platform uniquely combines bipolar radiofrequency for precise localised cutting and microwave for controlled coagulation, providing physicians with flexible, accurate and controlled surgical solutions through a single accessory port.  This technology makes it possible to treat conditions using flexible endoscopy in the endoscopy suite as opposed to a surgical outcome carried out in the operating theatre under general anaesthetic.  The Company's strategy is to bring the CROMA platform to market through a suite of medical devices which the Company has designed, initially into the emerging field of GI therapeutic endoscopy, and later into a broader range of areas including bronchoscopy and laparoscopy.

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 devices which the Company has designed, initially for the emerging field of 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.

 

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