REG - Creo Medical Group - Speedboat® UltraSlim: US FDA Clearance

Creo MedicalAnnouncement

01/11/2023 07:15

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RNS Number : 9482R  Creo Medical Group PLC  01 November 2023

Creo Medical Group plc

("Creo", the "Group" or the "Company")

Speedboat® 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® 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® UltraSlim is the second brand in Creo's Speedboat® 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 (http://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)                      +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 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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