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Research: Healthcare
Creo Medical has announced that its EU notified body has guided for an accelerated clinical pathway for its Speedboat UltraSlim device, the slimmest Speedboat Inject version that is compatible with most endoscopes. The reduced regulatory path will enable the company to launch the versatile product in Europe in early 2024, roughly 18 months earlier than planned. As the FDA application was submitted for this device in February 2023 (management expects clearance in Q423), UltraSlim is now projected to be available in both Europe and the US within the next 12 months. The UltraSlim device is an important addition to Creo’s portfolio as it provides broader access to gastrointestinal (GI) procedures with the potential to be accretive to the company’s top line in near/medium term.
Written by
Creo Medical |
Potential UltraSlim upside with swift EU pathway |
Regulatory update |
Healthcare equipment and services |
26 October 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 announced that its EU notified body has guided for an accelerated clinical pathway for its Speedboat UltraSlim device, the slimmest Speedboat Inject version that is compatible with most endoscopes. The reduced regulatory path will enable the company to launch the versatile product in Europe in early 2024, roughly 18 months earlier than planned. As the FDA application was submitted for this device in February 2023 (management expects clearance in Q423), UltraSlim is now projected to be available in both Europe and the US within the next 12 months. The UltraSlim device is an important addition to Creo’s portfolio as it provides broader access to gastrointestinal (GI) procedures with the potential to be accretive to the company’s top line in near/medium term.
Year end |
Revenue |
PBT* |
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.
Following the recent submission to its EU notified body, Creo Medical has been advised to undertake a faster development route for Speedboat UltraSlim (previously called Speedboat Flush). We note that Speedboat UltraSlim is the slimmest 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 the majority of 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 pre-cancerous lesions) and swallowing disorders including indications where narrower and more flexible devices are required.
This development follows Creo’s submission of a 510(k) FDA application for Speedboat UltraSlim in February 2023 and management expects US commercial launch in Q423. Now that product launch is anticipated in both key markets, namely the US and Europe, over the next 12 months, we expect some support in accelerating Speedboat usage. 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), a higher number of procedures using Speedboat, geographic expansion into new territories and a strong pipeline of clinicians under its Pioneer training programme. The recent CE mark for upper GI procedures has also expanded the addressable market opportunity.
We expect Speedboat UltraSlim to provide a similar boost to Speedboat usage as the commercial launch of Speedboat Slim in November 2022. Speedboat Slim is a slimmer version of Speedboat Inject, launched in late FY22, compatible with endoscopes with a working channel of 3.2mm or more. According to management, the product received a positive response post launch, resulting in enhanced usage of the Speedboat device and uptake of its Pioneer training programme in H123.
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