Revenio’s trading volume today, with a rising share price, is many times higher than normal. Those in the know, know, I don’t…
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Q3 was indeed rather boring, and it seems Q4 is progressing along the same lines. Reve also keeps a lower profile than before; they didn’t even bother to attend last week’s investor fair. We’ve met Salovaara and Hilden many times at that forum, but perhaps they no longer feel it necessary to meet us profit/information-hungry “slipper-wearers” with our difficult questions. A large foreign owner, of course, happily snaps up more shares as small investors look for alternative targets, of which there were indeed many at the exhibition center.
Indeed, this M&A story has been heard for quite a long time, and the discussion may continue if/when high valuations have been the problem. Many stock markets have been rising for a couple of years now, and it’s unlikely that any significant discounts on asking prices will be coming anytime soon, rather the opposite.
This global leader in ophthalmological devices and software solutions (according to its website) is now, at least from the window of my own sauna, somewhat in hibernation. Besides, a leading company in the field should have already had that much-talked-about OCT camera. The esteemed forum guru Optis has been reminding us of this for years, but now even the man on the street is starting to encounter OCT advertising in optician store windows.
Well, I guess there’s nothing for it but to start building that OCT myself. I asked the AI for some advice:
’’Yes, it is possible to buy OCT sensors and the individual components required to build or customize an OCT system. While full commercial medical systems are typically expensive and proprietary, components are readily available for researchers, OEMs, and custom system builders.
Where to Buy OCT Components
Several specialized suppliers cater to the research and development market:
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Thorlabs, Inc.: This company is a major supplier of complete OCT systems, subsystems, and individual components (e.g., light sources, beam scanning systems, scan lens kits) for custom builds in research and industrial applications. You can explore their offerings on the Thorlabs website.
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Wasatch Photonics: They offer preconfigured, high-performance OCT spectrometers (a key sensor component) at various wavelengths and speeds, making system design easier for OEMs and researchers who don’t want to build every part from scratch.
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OZ Optics Ltd.: This company provides a variety of passive and active fiber optic components, including superluminescent diode (SLD) light sources and broadband fiber components, used specifically for building OCT systems.
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Edmund Optics: A supplier of various optical components and systems, including Lumedica OCT imaging systems.
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OEM Suppliers (e.g., JADAK, G&H, Santec): Many companies offer OEM solutions, providing customized sensors, modules, and components for integration into larger commercial products.
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These specialized suppliers offer OCT system components and configurable OCT systems for various applications:
Key Considerations
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“Build vs. Buy”: Purchasing pre-optimized modules can save significant time and effort in optical design, alignment, and software development compared to sourcing every single piece independently.
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Application Specific: Components are specialized for either spectral-domain (SD-OCT) or swept-source (SS-OCT) technology, and the required wavelength will depend on the application (e.g., 850 nm and 1060 nm are popular for medical use).
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Expertise Required: Assembling a functional OCT system from individual sensors and components typically requires significant expertise in optics, engineering, and software development.
So, in Finnish: “it’s no big deal”. Let’s see if I can solder the package together before Revenio 
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The FDA has announced this week that it is changing its practices regarding medical device approval applications. Device manufacturers can now more broadly use de-identified real-world data in their approval applications, and do not necessarily always have to conduct expensive clinical trials, at least not as extensively as now. @Juha_Kinnunen, could this have an impact on getting AI product approvals faster in the US? Why not also on the possible expansion of approvals for HOME2 or other iCare products, if such are being sought. However, Revenio, to my understanding, has a lot of this real-world data in the iCare CLINIC cloud.
Edit: As an addition, is Revenio the only one with access to a massive amount of de-identified data through HOME2 measurements, or do Reichert or others have a similar cloud? If Revenio is the only one, this could be a significant competitive advantage.
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Good morning!
Thanks for the good question @MolskisPabrai - I’ll find out what that could mean in practice and get back to you as soon as possible.
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CFO Robin Pulkkinen is leaving Revenio. I had discussions with Robin at general meetings for about 10 years. An extremely competent guy, the acquisition of Centervue together with Hilden was a great value-creating move for shareholders. A shame.
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Jouni and Robin were a powerful duo. They inspired trust when you met them. It’s difficult to find a replacement, but let’s hope for the best.
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Robin seems to be joining F-Secure
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Hi @MolskisPabrai,
I looked into this directly with Revenio, as one always has to be careful with these FDA interpretations. I received some sensible answers, which I’ve tried to put into “plain language” here without the fancier terms. Hopefully, I’ve understood the details correctly myself and haven’t oversimplified them too much. If I were to summarize, it’s a good thing, but not a silver bullet by any means.
The company mentioned that it had already used this opportunity previously when obtaining marketing authorization for the IC200 tonometer’s new feature, Quick Measure. This was possible even before this new relaxation regarding the use of “real-world” data because the data was traceable (data collected in connection with a clinical trial). In the future, Revenio could use clinical data, for example, in connection with post-market surveillance or to demonstrate the effectiveness of HOME2 in the care pathway—or something similar.
According to the company, this won’t necessarily have an impact on marketing authorizations. This is because data is primarily only collected from measurements, and the software doesn’t systematically collect data from, for example, corresponding GAT measurements or CCT. So, there needs to be a reference in the study, unless I misunderstood.
The company could likely better utilize this relaxation, for example, in connection with the RedCad marketing authorization. However, this requires that care practices and device usage be consistent, for example, in the EU (cf. USA). We could strengthen our data and potential clinical evidence with device data already accumulated in the EU and other countries.
The US vs. EU comparison won’t be easy here because, for example, disease classifications are different. Furthermore, the guidelines governing software and clinical validation remain in effect for that application. Additionally, the analysis must be reproducible and the origin of the data verifiable, even though the patient does not need to be identifiable.
Demonstrating efficacy this way specifically might still not be realistic, but this will certainly be useful in demonstrating safety and usability, usage rates, and the like. FDA reviewers apparently also get more flexibility, as the announcement stated that discretion can be used on an “application by application” basis. However, some general guidance is forthcoming, after which a clearer policy on the matter will start to form.
The company did not comment on the potential data of other companies or their lack thereof.
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I have been trying for a long time to form an understanding of the impact of the ongoing AI revolution on Revenio’s business in the long term.
My investment hypothesis is that AI will enable the identification of systemic diseases from the fundus (eye ground) significantly more broadly than before. Eye scanning will become a procedure comparable to measuring blood pressure, used to monitor general health and diagnose numerous different diseases.
Based on this hypothesis, I have drafted two scenarios for Revenio.
Optimistic scenario
Revenio’s moat in easy-to-use imaging devices deepens further as scans are needed extensively in healthcare and are performed mainly by personnel other than eye specialists. Regardless of which party has produced the AI, it is completely dependent on the high-quality data generated by Revenio.
AI used in health technology is clinically validated and strictly regulated, which keeps general-purpose AIs at bay. AI development in general is moving in a direction where Big Tech’s AI models are not the best at everything; instead, specific winners emerge for different scientific fields.
Pessimistic scenario
AI develops so far that it can extract the data it needs even from lower-quality scans or images, and expensive measurement technology is no longer required.
Big Tech AIs overtake Revenio’s algorithms and make better diagnoses from eye scans. Revenio’s own algorithms become worthless.
Conclusions
Personally, I emphasize the growth opportunities of the optimistic scenario and believe that health technology will remain strictly regulated in the future. However, I must admit that painting the pessimistic scenario felt frighteningly easy.
I would be interested to hear thoughts from those more familiar with Revenio regarding my hypothesis and scenarios. Am I exaggerating the opportunities or the risks?
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In analyzing Revenio’s growth regarding the analysis of clinical findings, I believe a key factor is how effectively Revenio can lock in its device users to use only Revenio’s algorithms and software for analysis, rather than those of a competitor.
In my opinion, the best way to lock users into this pipeline would be for Revenio to turn the software into a “one-stop shop”—where data from the diagnostic device goes directly into Revenio’s software, allowing both fundus images and perimetry results to be viewed in the same program. And why not OCT images later as well, if Revenio eventually expands into OCT devices. Just add tabs to the top bar of the software for viewing different diagnostic results. I, for one, would welcome the option of being able to do everything with a single software. No time is wasted waiting for another program to start when, for instance, you want to check the perimetry findings right after viewing an OCT.
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