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), 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) 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."