Hi Stefan,
We've known each other for a few years, since the Young Physician Leaders event at the World Health Summit (WHS) in Berlin. At that time, I think you were still pretty much at the beginning with your start-up. You have just received funding of 12 million euros. Congratulations! Tell us again briefly what Dopavision is all about.
Hi Sebastian,
Yes, exactly! We are developing a digital therapy for myopia for children and adolescents that can be used from a smartphone. Nearsightedness, or myopia, is, after all, a very large - and still increasing - problem worldwide, with prevalences in Asia of over 80% in young adults. Our therapeutic approach is based on light stimulation of certain photosensitive cells on the retina to modulate dopamine, which plays an important role in the regulation of eye growth. Our goal is to develop a clinically validated digital therapy for progressive myopia in children and adolescents.
Great idea. Myopia is actually increasing at an insane rate and the numbers of refractive surgery procedures like LASIK, Relex Smile and PRK are on the rise. You have a huge market at your feet! Is your approach scientifically sound?
Together with academic partners around the world, we have investigated our approach in preclinical models and initial exploratory clinical studies. In the process, we were able to confirm the functioning of MyopiaX - as we call our therapeutic approach internally - and specifically the stimulation of the relevant cells on the retina that influence dopamine levels. The results are currently being published or have already been published in part. In the coming months, we will conduct further studies to further validate and improve our approach.
That sounds exciting. Many ophthalmologists will certainly criticize the fact that light in certain spectral ranges is in itself toxic for the retina above a certain limit and can induce apoptosis in certain cells of the retina. In addition, your (smartphone-based) app also acts as an accommodative stimulus. What do you have to counter this?
Our light stimulus is emitted from commercially available smartphone screens - no additional light source - and is well below the limits set by the IEC (International Electrotechnical Commission) in terms of duration and intensity. We will of course investigate this further as part of the clinical evaluation, but see no evidence of safety risks based on current findings.
Regarding accommodation, there is evidence in the literature that virtual reality headsets do not act as a myopia-triggering stimulus in young adults despite the short viewing distance. Nevertheless, we took care to design our content to minimize the impact on the accommodative system.
There are studies that show that completely different spectral compositions of the light are emitted depending on the manufacturer of the displays. How do you want to achieve standardization here?
We want to make our treatment approach available to as many children and adolescents as possible, and this includes making the therapy available on commercially available smartphones. Basically, our light stimulus is in a spectrum that can also be generated by common smartphone screens. We are optimistic that we have found a way to validate the light stimulus on different types of devices.
Okay, that sounds promising. Let's go back to your roots. What was your path to founding a start-up like? What were the hurdles and how would you rate the startup ecosystem in Germany?
I had met Hamed, the scientific head and founder of Dopavision, in 2018 at Flying Health in Berlin, where he had been working on the topic for some time. Flying Health is an ecosystem for digital health and "next generation healthcare", from which the idea formed and we then founded Dopavision.
With Dopavision, we are a digital health startup with a very high scientific focus, almost like in biotech. In the initial phase, it is important to generate meaningful data to support the method and the therapeutic approach. With a limited budget, this is of course a challenge; however, we were able to secure funding from the BMBF (Ministry of Education and Research) even before the seed round, which supported us in this phase.
I think the digital health ecosystem in Berlin is very good, there are many impressive ideas here and you meet great creative founders. Unfortunately, it is not always easy to found startups in Germany, especially in the area of human resources, where the topics are sometimes very complex and simply not relevant for small startups or without corresponding added value for the employees. In my view, there is still a clear need for improvement here.
Do the new MDR law and the current data protection regulation represent a major hurdle for you?
Of course, it is essential that only safe and effective medical devices are approved for the market - this naturally also applies to digital therapies. Since we have developed MyopiaX® for children and adolescents, it is particularly important that privacy and data protection are safeguarded. We have implemented this with the support of experts using the relevant regulations.
With the DiGAs, Germany has taken on a pioneering role for the market entry of digital health applications, which I personally find very good. On the regulatory side, the MDR still has some regulatory gaps in the area of software where improvements can be made and which must take software processes into account. The U.S. regulation or the FDA seems to be a bit further ahead here, we have to catch up in Europe.
What about the prescribability of your app? Is it planned in the long run that we ophthalmologists can simply distribute your app on (e-)prescription?
We want to launch MyopiaX® as a CE-certified medical device. In Germany, of course, the DiGA route would then be a good way to quickly gain a foothold in healthcare. Ophthalmologists will certainly be involved in the patient treatment pathway, although this may vary from country to country - in the UK and Ireland, for example, optometrists take on many functions for children that are performed by ophthalmologists in Germany. Digital therapies offer great opportunities here to simplify and accelerate access to therapies for patients - and in our case for parents.
At the moment, people always like to talk about mistakes. What were your mistakes during the founding process and what advice would you give to young founders who want to establish a start-up in ophthalmology?
You always make a lot of mistakes - we do too - the decisive factor is always how you deal with them. This is true for me and also for the whole Dopavision team: Making mistakes is completely ok, as long as you get up again afterwards, continue and learn from the mistakes and develop further.
We are in contact with some ophthalmologists and orthoptists, whom we had simply approached as part of a market research. Most of the feedback was very helpful, I was impressed by the willingness to discuss with us and give us feedback on the product, for example - just like you, thank you again! Perhaps you can already speak of a community, we will definitely expand these activities in the future so that we develop a product that optimally fits the needs of patients and parents.
That's what I would advise every founder in this field to do - go out as early as possible and find out what everyday life is actually like for the doctors and patients to whom you want to offer added value. In the healthcare sector, this is often not readily apparent.
In Germany, it is always demanded that startup founders devote 100% of their time to the startup. I have often seen health startups seeking external advice from female physicians and contact with hospitals. Wouldn't it be desirable here for financial backers to provide more support, especially for startups where the founders are still working in the clinic and are thus closer to the later target group?
Many good ideas come from the practice, because there you are confronted with the problems of patients or customers and can assess whether an idea solves a real customer problem. There, you also have direct access to talk to colleagues or patients and get initial feedback or even test prototypes, not to mention the contacts that you can probably use very well on your later path. At some point, though, you can't do a startup "on the side" anymore, it's way too much work. It's often underestimated how much work it is to write a good business plan or get investors excited about the idea - it really is a full-time job. Most investors will also demand that you dedicate yourself fully to your idea - otherwise it is not credible that you are really convinced of it.
I have often experienced in the university environment that young scientists have great ideas, but these are only pursued until publication (goal habilitation, professorship, etc.). In this context, I once called for the creation of the clinician founder, analogous to the clinician scientist (mixture of researcher and clinician). By this I mean, as mentioned above, clinicians who found or participate in the founding of a start-up in addition to their clinical work in order to develop DiGAs, for example, and who could also directly transfer research results into clinical application. This could also be done directly by universities in the form of "start-up" grants. Here, sums of 5000-10000 euros are sometimes sufficient to create a website, build a prototype or have time for a good business plan. What do you think?
I think you can start up from anywhere and with any background - no one can do a startup alone, you have to find the right partners to work with later anyway. Especially from clinical practice you have a lot of good ideas. It is best to test the ideas - as you say, for example in the form of a prototype - on a small flame to see if there are customers and the idea has a future; or what needs to be improved before the customers find it good. I think a "Transfer-Founding-Grant" is a good idea, it can help to get started. At some point, the founders will take care of the startup with more and more time - all the better if there is already initial feedback or initial data that confirms the concept.
Okay! And what are you going to do with the 12 million euros? Is there going to be a clinical trial now?
We will invest the Series A funding in further clinical investigations and product development to make MyopiaX® even simpler and more effective for patients. The clinical development aims to demonstrate efficacy and safety in children and adolescents affected by progressive myopia. To this end, we are launching a clinical study this year in several centers across Europe.
Thank you very much and all the best to you!
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