Creo Medical Group PLC Trading update (3595B)
January 30 2020 - 1:01AM
UK Regulatory
TIDMCREO
RNS Number : 3595B
Creo Medical Group PLC
30 January 2020
Creo Medical Group plc
("Creo" or the "Company")
Trading update
Creo Medical Group plc (AIM: CREO), a medical device company
focused on the emerging field of surgical endoscopy, announces that
trading for the year ended 31 December 2019 has been in-line with
expectations and the Company continues to make progress in the
commercialisation of the CROMA Advanced Energy Platform ("CROMA")
and a suite of patented electrosurgical devices.
During 2019, the Company generated its initial revenues from its
Speedboat device, the first in a range of gastrointestinal ('GI')
devices to be cleared for use with the CROMA. The Speedboat device
uniquely delivers bipolar radiofrequency energy for precise tissue
dissection along with microwave energy for highly controlled
coagulation and tissue ablation.
Progress in gaining regulatory approvals for a further four
devices optimised around the core tissue effects of dissection,
resection, haemostasis and ablation is well advanced. Technical
files are now complete and, with revised arrangements with the
Company's Notified Body, all four products will be CE marked in
Europe simultaneously on receipt of the Company's new EC
certificate, which is expected in the near term. In addition,
alongside the FDA clearances received so far for CROMA and the
Speedboat device, we remain on track to gain clearance with the
suite of products in the USA.
Having launched the devices to the market at the United European
Gastroenterology Week Congress in October, plans are now in place
to introduce these devices into clinical practice during the first
half of the year as the Company gears up to commercialise the
product range with multiple devices.
The roll out of the Clinical Education Programme continues at
pace with clinical education centres now established in multiple
sites in the US, Spain, South Africa, India, and the UK. Initial
key opinion leaders who have come through the Company's programme
are now training other GI endoscopists. This infrastructure,
established over the last 18 months, is a significant building
block in commercialising the GI suite of products.
The Company expects to see significant growth during 2020 in
commercial orders for its Speedboat device. It is in the final
stages of agreeing a third-party manufacturing contract to
facilitate larger scale production. The Company has already
validated the first batches of products from the third-party
manufacturer and is confident of the high quality and consistency
of production. This next phase is in line with the Company's
strategy to manufacture early production in-house as processes are
optimised ahead of outsourcing capacity. This enables in-house
capacity to be focussed around early production of newly launched
devices which is already underway.
Craig Gulliford, Chief Executive Officer of Creo, commented:
"Following the completion of our suite of products and the
development of our distribution network over the last 12 months,
the whole team is gearing up for clinical activity with multiple
devices. This is based around both existing and new customers and
users. The new devices include, what we believe to be, the only
triple mode bipolar surgical scissors, the smallest microwave
ablation device, and the only non-stick haemostasis device.
"Having delivered initial revenues last year, the next few
months mark a significant step up for the business. With much
appreciated shareholder support, we now have a unique opportunity
with game changing devices to develop the business. We are excited
to be bringing these capabilities to both endoscopists and surgical
users in many disciplines over the next few years. These
achievements are testament to the hard work, passion and dedication
of the extended Creo team."
Creo Medical Group plc investors.creomedical.com
Richard Rees (CFO) +44 (0)1291 606 005
Cenkos Securities +44 (0)20 7397 8900
Stephen Keys / Cameron MacRitchie
(NOMAD)
Michael Johnson / Russell Kerr (Sales)
Walbrook PR Ltd Tel: +44 (0)20 7933 8780 or creo@walbrookpr.com
Paul McManus / Lianne Cawthorne Mob: +44 (0)7980 541 893 / +44 (0)7515
909 238
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 CROMA, an electrosurgical Advanced Energy Platform that
combines bipolar radiofrequency for precise localised cutting and
microwave for controlled coagulation. This technology provides
clinicians with flexible, accurate and controlled surgical
solutions.
The Company's strategy is to bring its CROMA Advanced Energy
Platform powered by unique full spectrum adaptive technology to
market enabling 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 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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END
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