RCS - Creo Medical Group - U.S. FDA clearance for SpydrBlade™ Flex

Creo MedicalAnnouncement

11/06/2025 07:00

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RNS Number : 2865M  Creo Medical Group PLC  11 June 2025

Creo Medical Group plc

("Creo" or the "Company")

 

U.S. FDA clearance for SpydrBlade™ Flex

 

Creo Medical Group plc (AIM: CREO), the medical device company focused on the
emerging field of minimally invasive surgical endoscopy for pre-cancer and
cancer patients, announces that it has received U.S. Food & Drug
Administration ("FDA") clearance for its SpydrBlade™ Flex device, a unique
multi-modal endoscopic device designed for precision and adaptability in
therapeutic endoscopy procedures. SpydrBlade™ Flex is the latest product in
Creo's Gastro-Intestinal (GI) suite of advanced energy products to receive
clearance from the FDA.

 

SpydrBlade™ Flex delivers laparoscopic cut and seal functionality through an
endoscopic device, making it an extremely versatile dissection tool in
flexible endoscopy. Following the commercial launch of the product in Europe
(announced on 20 March 2025
(https://www.londonstockexchange.com/news-article/CREO/uk-eu-commercial-launch-of-spydrblade-tm-flex/16949440)
), the list of established clinical use-cases is growing and already includes
Z-POEMs, pedunculated polyps, general dissections and difficult-to-treat
fibrotic cases, demonstrating the versatility of the product. Simple to use,
SpydrBlade™ Flex is designed for rapid clinical adoption.

 

FDA clearance allows Creo to initiate the launch of SpydrBlade™ Flex in the
U.S. market. The existing direct sales force, alongside its established
network of key opinion leaders and clinicians, allows for rapid adoption of
SpydrBlade™ Flex in the critical US market.

 

Many of the use-cases for SpydrBlade™ Flex fall under existing reimbursement
codes and indications covered by the recent decision by the American Medical
Association (announced on 28 May 2025
(https://www.londonstockexchange.com/news-article/CREO/us-reimbursement-milestone-for-speedboat-procedure/17056584)
) to establish reimbursement codes for endoscopic submucosal dissection. This
provides a clear reimbursement framework for current and future U.S.
healthcare providers which will encourage the adoption of next-generation
products such as Creo's SpydrBlade™ Flex along with the rest of Creo's
advanced energy GI product range; Speedboat® UltraSlim, and Speedboat® Notch
and MicroBlate® Fine.

 

 

 

 

 

 

 

 

 

 

 

 

Images: SpydrBlade™ Flex

 

Commenting, Craig Gulliford, Chief Executive Officer, said: "This is an
important commercial milestone for Creo as we have now received FDA clearance
for our full suite of advanced energy GI products for resection, dissection
and ablation. This product has tested us with some of our most difficult
design challenges, the novelty of which and the associated IP (Intellectual
Property), alongside our range of GI products, significantly differentiates
Creo in the market. This is a very proud moment for the whole Creo team who
have worked so hard to reach this milestone.

 

"One of our founding advisory key opinion leaders, Professor Robert Hawes MD,
once described SpydrBlade™ Flex as 'incredible, the harmonic scalpel at the
end of a flexible scope!'. This is high praise from one of the founding
fathers of therapeutic endoscopy and a great comparison highlighting our
mission to put advanced surgical OR capability into flexible endoscopy.

 

"With the foundations of an established route to market through our existing
sales channels, established and defined future reimbursement (CPT codes), we
are excited by the potential adoption of SpydrBlade™ Flex and look forward
to patients, clinicians and healthcare providers being able to benefit from
the widespread commercialisation of SpydrBlade™ Flex in the USA."

 

For further information please contact:

 

 Creo Medical Group plc                                                        www.creomedical.com
                                                                               (https://protect.checkpoint.com/v2/___http:/www.creomedical.com/___.YzJ1OmludHVpdGl2ZTpjOm86NWJlYzBmMzJjY2MyZTBiZWFkNmJkZmVmNzdhM2MwMTI6NjoyYWU4OjczNzQyNWUwODBjYTEwNzAxYWMzNWEyZDQ3YzI1ZmEwYWMzYTc4M2Q2M2NjYzEyNTQwZWM3ODc4NTk3NTE4YTQ6cDpUOk4)
 Richard Craven, Company Secretary                                             Via Walbrook PR

 Deutsche Numis (Nominated Adviser, sole Broker and Financial Adviser)         +44 (0)20 7260 1000

 Freddie Barnfield / Duncan Monteith / Sher Shah

 Walbrook PR Ltd                      Tel: +44 (0)20 7933 8780 or creo@walbrookpr.com (mailto:creo@walbrookpr.com)
 Paul McManus / Alice Woodings        Mob: +44 (0)7980 541 893 / +44 (0)7407 804 654

 

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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