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GBP58m
Research: Healthcare
Creo Medical has announced that its flagship product, Speedboat Inject, has been selected for assessment by the National Institute for Health and Care Excellence (NICE), a UK-based independent expert organisation that provides national guidance on medical practices and technologies. Post selection, the device will go through a committee review of the headline data and a multi-stage evaluation process by NICE, to investigate Speedboat for endoscopic submucosal dissection of lower gastrointestinal lesions. While Creo’s Pioneer training programme and robotics deals with Intuitive Surgical and CMR Surgical hold significant potential for Speedboat’s uptake globally, the NICE guidance, if favourable, would likely support increased adoption of the device in the UK, providing further validation for the product as well as the CROMA platform.
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Creo Medical |
NICE to review Speedboat Inject |
5 June 2023 |
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Creo Medical is a research client of Edison Investment Research Limited |
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Creo Medical has announced that its flagship product, Speedboat Inject, has been selected for assessment by the National Institute for Health and Care Excellence (NICE), a UK-based independent expert organisation that provides national guidance on medical practices and technologies. Post selection, the device will go through a committee review of the headline data and a multi-stage evaluation process by NICE to investigate Speedboat for endoscopic submucosal dissection of lower gastrointestinal lesions. While Creo’s Pioneer training programme and robotics deals with Intuitive Surgical and CMR Surgical hold significant potential for Speedboat’s uptake globally, the NICE guidance, if favourable, would likely support increased adoption of the device in the UK, providing further validation for the product as well as the CROMA platform.
Regulatory update |
Year end |
Revenue (£m) |
PBT* (£m) |
EPS* |
DPS |
P/E |
Yield |
12/21 |
25.2 |
(29.7) |
(14.6) |
0.0 |
N/A |
N/A |
12/22 |
27.2 |
(31.0) |
(14.9) |
0.0 |
N/A |
N/A |
12/23e |
32.8 |
(24.3) |
(6.3) |
0.0 |
N/A |
N/A |
12/24e |
40.8 |
(14.8) |
(3.6) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.
As part of the NICE review, Speedboat Inject will be assessed under its Medical Technologies Evaluation Programme (MTEP), which evaluates new devices and diagnostics and provides guidance for adoption. Post the device’s selection, a committee will review the headline data (to be submitted by Creo), followed by a multi-phase evaluation process by NICE. The product review will investigate Speedboat’s clinical and economic evidence, which if effective, may result in medical technologies guidance.
NICE is an independent expert body that evaluates medical devices and diagnostic technologies with an aim to improve healthcare service. The MTEP programme, which is dependent on expert guidance (including clinicians, representatives of the medical device industry, commissioners, health service managers, etc) and different patient groups, evaluates a specific product/medical device/technology at a time and provides guidance on clinical as well as cost effectiveness. The guidance, if favourable, often results in improved adoption of the device or technology. NICE guidance, though not binding, is followed by the NHS, the UK’s public-funded healthcare system, for optimising its resources.
The announcement follows the recent NHS client win with Royal Oldham Hospital (UK), which has signed up for Speedboat Inject and related endotherapy products. The NICE review, if positive, could be an important driving factor in gaining Speedboat traction in the UK market. This step is also in tandem with Creo’s target to cover more than 350 hospitals in the UK for its Speedboat range of products.
We expect further expansion of the Speedboat Inject user base (with an emphasis on training enrolment) to be the strategic priority in FY23. Robotics deals with Intuitive and CMR offer an additional upside for the company, given the market credibility and reach of Intuitive’s robotic systems (da Vinci and Ion).
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Research: Healthcare
Paradigm is focused on the development of injectable pentosan polysulfate (iPPS) for the treatment of osteoarthritis (OA). While the company has several active human clinical trials, it is also assessing iPPS in a canine model due to the similarities in disease biology. Furthermore, since dogs have a shorter lifespan than humans, the full progression of the condition can be assessed over a condensed period. Management believes that this could be advantageous in evaluating the disease-modifying OA drug (DMOAD) status of iPPS, a key goal for Paradigm. The latest data show that iPPS demonstrates durable effects on pain, function and cartilage volume in the canine OA model at the three-year human equivalent time point (canine 26 weeks). These positive results add to a growing data package to support iPPS as a potential DMOAD. Paradigm intends to present this to the FDA and EMA in H2 CY23, and the outcome of these discussions could represent a significant catalyst for the company, in our view.