Creo Medical Group PLC SB UltraSlim: EU launch accelerated by 18 months (1747R)
October 25 2023 - 1:00AM
UK Regulatory
TIDMCREO
RNS Number : 1747R
Creo Medical Group PLC
25 October 2023
Creo Medical Group plc
("Creo", the "Group" or the "Company")
Speedboat UltraSlim: EU launch accelerated by 18 months
EU regulatory pathway for launch earlier than originally
planned, following guidance from notified body
Speedboat UltraSlim, benefiting from the next phase of Creo's
technology miniaturisation, is compatible with all major GI
endoscopes now expected to launch in early 2024
Creo Medical Group plc (AIM: CREO), the medical device company
focused on the emerging field of minimally invasive surgical
endoscopy announces that, following a recent submission to the
Company's notified body, Creo have been advised on a regulatory
pathway facilitating the launch of their Speedboat(R) UltraSlim
device approximately 18 months ahead of schedule.
This news will now enable the Company to initiate the launch of
UltraSlim in Europe in early 2024, with an early adopter launch
programme which would otherwise have been planned for mid-2025.
Speedboat(R) UltraSlim is the second brand in its Speedboat(R)
family of devices alongside Speedboat Inject and offers a number of
different features. The primary feature is the reduced size in
comparison with the Speedboat Inject, making the device compatible
with all endoscopes with a 2.8mm working channel or larger,
accounting for the vast majority of GI endoscopic procedures, and
significantly increasing the opportunity for more clinicians and
patients to benefit from Creo's game-changing technology.
The UltraSlim device is targeting the therapeutic treatment of
Gastrointestinal ("GI") tract lesions (including Bowel and Upper GI
cancers, and pre-cancerous lesions) and swallowing disorders.
Powered by Creo's CROMA advanced energy platform, the UltraSlim
delivers advanced bi-polar Radiofrequency ("RF") energy for
controlled cutting and high frequency microwave ("MW") energy for
controlled coagulation of tissue in the GI tract. T he UltraSlim's
injection functionality is achieved through an integrated lifting
system.
Craig Gulliford, Chief Executive Officer of Creo, said: " This
excellent news is testament both to the challenges the team have
overcome to scale the technology down to a size which is as small
as it ever needs to be, with the regulatory and clinical confidence
needed to support this pathway.
"The Regulatory landscape has been particularly challenging for
all medtech companies in the last few years here in Europe, with
changing transition deadlines and elongated and uncertain clearance
pathways. This has resulted in most companies seeking clearance now
in the US ahead of the EU. We had adopted the same approach,
planning to launch the device in the US ahead of the EU, having
filed for our FDA clearance earlier this year.
"With this news, the accelerated timeframes will now see Creo,
clinicians and patients reaping the benefits of widespread
commercialisation of Speedboat UltraSlim in both Europe and the US
in 2024."
Enquiries:
Creo Medical Group plc www.creomedical.com
Richard Rees (CFO) +44 (0)1291 606 005
Cavendish Capital Markets Limited +44 (0)20 7397 8900
Stephen Keys / Camilla Hume (NOMAD)
Michael Johnson (Sales)
Numis Securities Limited (Joint
Broker)
Freddie Barnfield / Duncan Monteith
/ Euan Brown +44 (0)20 7260 1000
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 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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