Creo Medical Group PLC Announces US FDA Approval of Speedboat RS2 (4701O)
21 August 2017 - 4:00PM
UK Regulatory
TIDMCREO
RNS Number : 4701O
Creo Medical Group PLC
21 August 2017
Creo Medical Group plc
("Creo" or "the Company")
Announces US FDA Approval of Speedboat RS2
Approval comes ahead of schedule; Company to implement
commercial plans
Chepstow, South Wales - 21 August 2017 - Creo Medical Group plc
(AIM: CREO), a medical device company focused on the emerging field
of surgical endoscopy, today announces that it has received 510(k)
clearance ("FDA Clearance") from the US Food and Drug
Administration ("FDA") for its Speedboat RS2 device and the CROMA
platform.
Speedboat RS2 is the first of a range of medical devices in
development, powered by the CROMA platform, and enables the
minimally invasive removal of early stage cancerous and
pre-cancerous lesions in the bowel through an endoscopic procedure.
This FDA Clearance has been received ahead of schedule, with the
FDA review process being completed in 49 calendar days from
submission. Accordingly, Creo will now assess the necessary steps
to bring forward the implementation of its commercial plans for the
US.
Speedboat RS2 is the first device developed for use with the
Company's generator, CROMA. It harnesses the cut and coagulation
capability of CROMA and enables the removal of early stage
cancerous and pre-cancerous lesions. The use of Speedboat RS2
reduces the risks associated with incisions which are necessary for
laparoscopic procedures and can reduce the length of hospital stay.
Endoscopy has been a rapidly expanding practice due to the advent
of colorectal cancer screening in most healthcare systems. This has
driven growth in equipment and devices to enhance the ability to
screen and detect early stage and pre-cancerous lesions in the GI
tract.
In the US, over 16 million colonoscopies are performed annually.
Of these, 1.1 million are likely to find a lesion requiring
treatment, half of which are surgically removed. Traditional
colorectal surgery is associated with a 6 per cent mortality rate
at 30 days. Due to Speedboat RS2's ability to coagulate bleeding
vessels when the microwave energy is activated by the surgeon, and
to cut or resect when the RF energy is activated, the risk of
puncturing tissue could be reduced, offering surgeons a minimally
invasive alternative with an enhanced safety profile.
Craig Gulliford, Chief Executive Officer of Creo, commented:
"The FDA Clearance of Speedboat RS2 and the CROMA system, earlier
than planned, is a critical step in our commercialisation strategy.
Speedboat is paving the way for our suite of GI devices, which we
plan to commercialise in the EU, US and globally.
"This approval is a real testament to the hard work and
dedication from the Creo team - we continue to execute against our
plan and, in this case, come in well ahead of our targets. This
bodes well and provides us with confidence that we have the
foundations in place to execute on the suite of devices currently
in development.
"Over the coming weeks, we will be looking to bring forward the
development of our US capabilities whilst continuing with the
promising training programme underway in Europe. Surgical endoscopy
is an emerging field and we believe that with the CROMA system,
Speedboat and our suite of products, we are well positioned to
become a leader in this billion-dollar plus market."
The information contained within this announcement is deemed by
the Company to constitute inside information as stipulated under
the Market Abuse Regulations (EU) No. 596/2014 ("MAR"). Upon the
publication of this announcement via Regulatory Information Service
("RIS"), this inside information is now considered to be in the
public domain.
Contacts
Creo Medical:
Roseanne Varner
+44 (0)129 160 6005
roseanne.varner@creomedical.com
Cenkos:
Ivonne Cantu / Camilla Hume (NOMAD)
Michael Johnson / Russell Kerr (Sales)
+44 (0)207 397 8900
FTI Consulting:
Brett Pollard / Mo Noonan / Hanna Skeppner
+44 (0)203 727 1000
creo@fticonsulting.com
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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