Creo Medical Group PLC Speedboat(R) UltraSlim: US FDA Clearance (9482R)
November 01 2023 - 2:00AM
UK Regulatory
TIDMCREO
RNS Number : 9482R
Creo Medical Group PLC
01 November 2023
Creo Medical Group plc
("Creo", the "Group" or the "Company")
Speedboat(R) UltraSlim: US FDA Clearance
Creo Medical Group plc (AIM: CREO), the medical device company
focused on the emerging field of minimally invasive surgical
endoscopy, is pleased to announce that it has received 510(k)
clearance from the US Food & Drug Administration ("FDA") for
its Speedboat(R) UltraSlim device.
FDA clearance allows the Company to initiate the launch of
UltraSlim in the USA through its existing direct sales force and
supported by its network of key opinion leaders and clinicians.
Clearance follows recent guidance received from the Company's
notified body of an EU regulatory pathway which has accelerated the
European launch of the UltraSlim device by approximately 18
months.
Speedboat(R) UltraSlim is the second brand in Creo's
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. This results
in the device being 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
cutting-edge 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.
Craig Gulliford, Chief Executive Officer of Creo, said: "We are
delighted to receive FDA clearance for Speedboat UltraSlim, which
is testament to the hard work of our entire team. Our engineering
team have overcome many challenges to scale the Speedboat
technology down to the size of the UltraSlim, and, with the support
of our regulatory team, we have been able to obtain FDA clearance
with speed and efficiency.
"Together with the recent news of the accelerated regulatory
pathway in the EU, we look forward to patients, clinicians and
healthcare providers being able to benefit from the widespread
commercialisation of Speedboat UltraSlim in both Europe and the US
in 2024 and beyond."
Enquiries:
Creo Medical Group plc www.creomedical.com
Richard Rees (CFO) +44 (0)1291 606 005
Cavendish Capital Markets Limited +44 (0)20 7220 0500
Stephen Keys / Camilla Hume (NOMAD)
Nigel Birks / Harriet Ward (Corporate
Broking)
Michael Johnson (Sales)
Deutsche Numis (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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