Last close As at 05/08/2026
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Market capitalisation
GBP58m
Research: Healthcare
Creo Medical has received US FDA approval for its Speedboat UltraSlim device, which will enable the company to launch it in the coveted US market. Though expected, this marks a material regulatory win for Creo as UltraSlim is the company’s thinnest and most versatile device and it is now projected to be available in both Europe (via accelerated EU regulatory pathway) and the US in 2024. The UltraSlim device remains an important addition to the portfolio as it provides broader access to gastrointestinal (GI) procedures and it is a key contributor to Creo’s near- to medium-term growth. All eyes are on the upcoming 7 November capital markets day, which will likely be the next catalyst.
Written by
Creo Medical |
FDA nod for UltraSlim |
Regulatory update |
Healthcare equipment and services |
3 November 2023 |
Share price performance
Business description
Analysts
Creo Medical is a research client of Edison Investment Research Limited |
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Creo Medical has received US FDA approval for its Speedboat UltraSlim device, which will enable the company to launch it in the coveted US market. Though expected, this marks a material regulatory win for Creo as UltraSlim is the company’s thinnest and most versatile device and it is now projected to be available in both Europe (via accelerated EU regulatory pathway) and the US in 2024. The UltraSlim device remains an important addition to the portfolio as it provides broader access to gastrointestinal (GI) procedures and it is a key contributor to Creo’s near- to medium-term growth. All eyes are on the upcoming 7 November capital markets day, which will likely be the next catalyst.
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) |
(6.6) |
0.0 |
N/A |
N/A |
12/24e |
40.8 |
(14.8) |
(3.5) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.
Creo has announced that it has received 510(k) clearance from the US FDA for its Speedboat UltraSlim device. This development is as expected and follows Creo’s submission of a 510(k) FDA application for the product in February 2023. We note that Speedboat UltraSlim is the thinnest version of Speedboat Inject (Creo’s flagship product) and is designed to be compatible with all endoscopes with a 2.8mm or larger working channel, accounting for most GI endoscopic procedures. The reduced size has wider applicability, enabling the new device to target broader treatment areas across GI tract lesions (eg bowel and upper GI cancers and precancerous lesions) and swallowing disorders, including indications where narrower and more flexible devices are required.
Last week, Creo announced that its EU notified body has guided for an accelerated regulatory pathway for its Speedboat UltraSlim device, which will enable the company to launch the product in Europe in early 2024, around 18 months earlier than planned. This means the UltraSlim device will potentially be commercially available in both the US and Europe markets in 2024, which we expect will provide a boost to the Speedboat usage and resulting company sales in the region.
We reiterate that Creo’s primary focus rests on acceleration of Speedboat adoption, through a combination of growth factors such as an increased user base (including high‐volume users) and associated volume of Speedboat procedures, geographic expansion into new territories and a growing number of clinicians under its Pioneer training programme. Key upcoming catalysts include Creo’s capital markets day on 7 November, where the company plans to provide a corporate update, an overview of the commercialisation of its products and its Kamaptive partnership programmes, as well as presentations from three NHS clinicians who are users of Creo’s technology.
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Research: Metals & Mining
Cadence Minerals remains fundamentally mispriced in our view, with the market not fully recognising the value of its unlisted assets. Cadence has recently announced progress in advancing its major non-public asset, the Amapá iron ore project in Brazil. This includes a memorandum of understanding (MOU) with Chinese firm Sinoma to potentially provide both a definitive feasibility study (DFS) and fixed-price engineering, procurement and construction (EPC) contract for the mine restart. The implied value of Cadence’s non-public assets is 3.4p/share at current prices, while in our view an appropriate value for Amapá alone is 23.9p/share.