REG - Creo Medical Group - Speedboat Inject upper GI clearance in Europe

Creo MedicalAnnouncement

19/06/2023 07:00

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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 (http://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 558 258 / +44 (0)7867 984 082

 / Phillip Marriage

 

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
(http://www.creomedical.com)

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