Creo Medical — SpydrBlade Flex set to enter the US market

Creo Medical (AIM: CREO)

Last close As at 11/06/2025

GBP0.15

−0.70 (−4.52%)

Market capitalisation

GBP62m

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Research: Healthcare

Creo Medical — SpydrBlade Flex set to enter the US market

Creo Medical has received 510(k) FDA clearance for its latest endoscopic electrosurgical device, SpydrBlade Flex, strengthening its strategic foothold in the high-value US market. SpydrBlade Flex is a next-generation electrosurgical tool designed for flexible endoscopes, enabling both laparoscopic dissection and coagulation functionality. Following its European launch in Q324, commercial roll-out began in March 2025 in the UK, with the initial focus on gastrointestinal (GI) indications. This regulatory clearance comes shortly after the American Medical Association (AMA) approved two new reimbursement codes for upper and lower GI endoscopic submucosal dissection (ESD) procedures. We expect these codes to facilitate broader procedural adoption of Creo’s electrosurgical devices, including SpydrBlade Flex, providing top-line traction.

Jyoti Prakash

Written by

Jyoti Prakash, CFA

Director, healthcare

creo05

Healthcare

Regulatory update

11 June 2025

Price 15.50p
Market cap £62m

€1.18/£

Net cash/(debt) at 31 March 2025

£22.1m

Shares in issue

412.5m
Code CREO
Primary exchange AIM
Secondary exchange N/A
Price Performance

Business description

Creo Medical is a UK-based healthcare company focused on the development and commercialisation of minimally invasive electrosurgical devices. It has six products in the flagship CROMA platform, all of which have been CE marked and cleared by the FDA. Licensing opportunities for its Kamaptive IP (current partnerships with major robotics players Intuitive Surgical and CMR Surgical) offer further monetisation opportunities. In February 2025, Creo completed the divestment of a 51% stake in its consumables business to Chinese market leader Micro-Tech.

Analysts

Jyoti Prakash, CFA
+44 (0)20 3077 5700
Arron Aatkar, PhD
+44 (0)20 3077 5700

Creo Medical is a research client of Edison Investment Research Limited

Note: PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments. The FY23 and FY24 revenues have been restated to reflect revenues from continuing operations following the 51% stake divestment in CME in early 2025.

Year end Revenue (£m) PBT (£m) EPS (p) P/E (x) Yield (%)
12/23 4.0 (25.0) (0.07) N/A N/A
12/24 4.0 (27.7) (0.07) N/A N/A
12/25e 6.1 (14.8) (0.04) N/A N/A
12/26e 10.3 (7.8) (0.01) N/A N/A

SpydrBlade Flex is Creo’s second resection device (after Speedboat) and has been specifically designed to offer combined laparoscopic dissection and coagulation functionality through flexible endoscopes, reducing instrument exchange and procedural time and making for safer and more cost-effective procedures. The device is backed by Creo’s Kamaptive-powered CROMA platform, which combines advanced bipolar radio frequency cutting with high-frequency microwave coagulation and ablation. We expect this to be particularly meaningful in high-perfusion areas such as colon, stomach, liver and spleen, as well as procedures like ESD and peroral endoscopic myotomy.

Commercial roll-out of SpydrBlade Flex commenced in March 2025, with St Mark’s Hospital in London being the first adopter, and we expect the recent FDA clearance to support sales ramp-up in the coveted US market. Creo intends to leverage its existing US salesforce and key opinion leader network for rapid market adoption. Note that SpydrBlade Flex will also benefit from the new Current Procedural Terminology (CPT) reimbursement codes for ESD procedures announced by the AMA in May 2025, and we expect this to significantly de-risk the US roll-out. In May 2025, the AMA CPT editorial panel formally issued two Category I reimbursement codes: one for upper GI and another for lower GI ESD procedures. We expect this to enhance procedural accessibility and broaden potential patient coverage for minimally invasive GI lesion removal, which should support SpydrBlade Flex’s market uptake in the medium term. These codes are expected to take effect from 1 January 2027.

With reimbursement pathways now established, we anticipate a meaningful acceleration in US sales, not only for SpydrBlade Flex but also for Creo’s broader portfolio of electrosurgical devices (all of which are CE marked and have FDA clearance). We view this development as a key near-term catalyst for revenue growth and commercial momentum.

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