TIDMCREO
RNS Number : 1173D
Creo Medical Group PLC
19 June 2023
Creo Medical Group plc
("Creo" the "Company" or the "Group")
Speedboat Inject cleared for upper GI use in Europe
Creo Medical Group plc (AIM: CREO), the medical device company
focused on the emerging field of surgical endoscopy, announces that
Speedboat Inject is now CE marked according to the Medical Device
Regulation ("MDR") for use throughout the entire gastrointestinal
("GI") tract, having received upper GI clearance.
Until now, Speedboat Inject has been CE marked for lower GI
tract use only within European markets. Clearance for upper GI
procedures mean that the device can now be used for endoscopic
procedures through the whole of the GI tract, from the mouth down
to the stomach (upper GI tract) as well as within the lower GI
tract. Speedboat Inject is already cleared and used in the full GI
tract for the cutting and coagulation of soft tissue using
radiofrequency (RF) and microwave energy in the US, APAC and
elsewhere.
When used as indicated for the cutting and coagulation of soft
tissue, Speedboat Inject has been used to perform procedures such
as:
-- Oesophagus per-oral endoscopic myotomy ("POEM") to treat
achalasia (a swallowing disorder), where typically a heller myotomy
(surgery) would be required;
-- Gastric per-oral endoscopic myotomy ( G-POEM) to treat
delayed gastric emptying (gastroparesis);
-- Z-POEM to treat Zenkers diverticulum, where a pouch or pocket
that forms in the wall of the oesophagus, affecting the throat and
swallowing process, and is a prominent procedure for ear, nose,
throat (ENT) and foregut surgeons;
-- F-POEM, a derivative of Oesophagus POEM, to reduce reflux -
typically this has required an invasive upper GI surgical
procedure; and
-- Speedboat Submucosal Dissections ("SSD") in the stomach and
oesophagus, to endoscopically resect certain cancerous and
pre-cancerous lesions.
In FDA regions, upper GI cases account for over 40% of global
Speedboat procedures to date. Creo Medical already has a healthy
pipeline of clinicians ready to use the device for upper GI
procedures across Europe, with demonstrations, training and
procedures already planned in.
Craig Gulliford, Chief Executive Officer of Creo Medical,
commented: " We are really excited by this extension to the
clearance in Europe which opens up increases in case volume for a
significant number of our customers with usage to treat a wide
number of additional indications. This clearance opens up
possibilities not only to increase the caseloads of existing users,
but primarily to introduce Speedboat to a large base of new
users.
"Training doctors for Speedboat use in upper GI procedures has
proven to be efficient in the USA. With our Pioneer programme now
well established, and with some of the world's finest upper GI
endoscopic practitioners championing the device and providing
mentoring, we have great capacity now to transition doctors through
our Pioneer training programme and for them to become high users
with training opportunities in multiple procedures with many
different types of patients.
"I'm also delighted that this clearance has been done under the
significantly changed regulatory framework (MDR) which has been a
significant challenge for the team. This successful approval for
Speedboat Inject according to the MDR represents a significant
achievement for the Company and the team who have been working hard
to secure this, building on the success we've already achieved in
the US and APAC where Speedboat has been treating a wide range of
upper GI procedures with excellent outcomes."
Dr Zaheer Nabi, a frequent user of Speedboat Inject for upper GI
procedures at AIG Hyderabad Hospital in India said: "The advanced
bipolar energy makes cutting and tunneling during POEM procedures
very precise, providing me with improvements in efficacy and
efficiency. I've also found that the design of the device
significantly lowers the risk of perforation during such 3rd Space
Endoscopic procedures, with the microwave energy effective in
minimising bleeds and thermal damage. The slimmer device in
particular is excellent for performing upper GI procedures."
Another prominent user, Dr Jawaid from Baylor College of
Medicine Medical Center in the US, added: "Speedboat is effective
in POEMs in particular because it can speed up the tunneling
process and prevents inadvertent thermal
injury. It may also help with post-procedural pain."
Dr. Yip, from the Division of Upper GI and Metabolic Surgery at
the Faculty of Medicine, Chinese University of Hong Kong said: "The
Speedboat device is a new revolution to the field of third space
endoscopy and advanced tissue resection. With the novel bipolar and
microwave energy platform, upper GI ESD/SSD and tunnelling
procedures can be performed safely and efficiently, thus
benefitting patients worldwide by enabling easier adoption of the
technique."
Enquiries:
Creo Medical Group plc www.creomedical.com
Richard Rees (CFO) +44 (0)1291 606 005
Cenkos Securities plc +44 (0)20 7397 8900
Stephen Keys / Camilla Hume (NOMAD)
Michael Johnson / Russell Kerr (Joint
Broker)
Numis Securities Limited (Joint
Broker) +44 (0)20 7260 1000
Freddie Barnfield / Duncan Monteith
/ Euan Brown
Walbrook PR Ltd Tel: +44 (0)20 7933 8780 or creo@walbrookpr.com
Paul McManus / Sam Allen Mob: +44 (0)7980 541 893 / +44 (0)7502
/ Phillip Marriage 558 258 / +44 (0)7867 984 082
About Creo Medical
Creo Medical is a medical device company focused on the
development and commercialisation of minimally invasive
electrosurgical devices, bringing advanced energy to endoscopy.
The Company's vision is to improve patient outcomes through the
development and commercialisation of a suite of electrosurgical
medical devices, each enabled by CROMA, powered by Kamaptive. The
Group has developed the CROMA 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. CROMA currently delivers bipolar radiofrequency
("RF") energy for precise localised cutting and focused high
frequency microwave ("MW") energy for controlled coagulation and
ablation via a single accessory port. This technology, combined
with the Group's range of patented electrosurgical devices, is
designed to provide clinicians with flexible, accurate and
controlled clinical solutions. The Directors believe the Company's
technology can impact the landscape of surgery and endoscopy by
providing a safer, less-invasive and more cost-efficient option for
procedures.
For more information, please refer to the website
www.creomedical.com
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