Creo wins US clearance for SpydrBlade Flex surgical device
Published: 02:24 11 Jun 2025 EDT
Creo Medical Group PLC (AIM:CREO) has secured regulatory approval in the US for its latest surgical tool, SpydrBlade Flex, a move that opens the door to the world’s largest healthcare market.
"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," said CEO Craig Gulliford.
The device, cleared by the US Food and Drug Administration, is designed for use in flexible endoscopy, a less invasive surgical technique that relies on long, tube-like instruments to access internal organs through natural openings rather than incisions.
Creo says SpydrBlade Flex combines cutting and sealing functions in a single tool, a feature typically seen in laparoscopic surgery, allowing it to tackle complex procedures like fibrotic tissue dissection and tumour removal with greater precision.
The company had already launched the product in Europe in March. The US green light is expected to accelerate adoption, helped by Creo’s direct salesforce and partnerships with key clinical influencers.
In a boost for the commercial roll-out, many of the procedures targeted by SpydrBlade Flex are covered by new reimbursement codes approved last month by the American Medical Association.
These codes standardise payments for hospitals and clinics performing advanced endoscopic techniques such as submucosal dissection, a method for removing cancerous tissue from the digestive tract without open surgery.
Creo, listed on London’s AIM market, specialises in high-frequency energy systems for endoscopic procedures. Its wider product suite includes the Speedboat UltraSlim and MicroBlate Fine, which also received regulatory and commercial traction in the US and Europe.
With this latest clearance, the company is looking to strengthen its foothold in the fast-growing market for minimally invasive gastrointestinal treatments.
