Creo Medical Group PLC Creo Medical Pre-Submission 510k Confirmation (5043J)
June 29 2017 - 1:01AM
UK Regulatory
TIDMCREO
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 Ivonne Cantu Brett Pollard
+44 (0)129 160 6005 / Camilla Hume / Mo Noonan
roseanne.varner@creomedical.com (NOMAD) +44 (0)203 727
Michael Johnson 1000
/ Russell Kerr creo@fticonsulting.com
(Sales)
+44 (0)207 397
8900
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.
This information is provided by RNS
The company news service from the London Stock Exchange
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