Jani Tirronen, Maculaser - Restoring Retinal Health | LSI Europe '24

Jani Tirronen 00:02
Yes, my name is Jani Tirronen. I'm the CEO and co-founder of Maculaser. We are one of the leading biomedical engineering and eye research laboratories in Finland. We focus on developing technology to treat retinal diseases. Retinal diseases are the leading cause of blindness and the biggest unmet need in ophthalmology. There are 300 million people affected, with a direct healthcare system cost of 400 billion euros, and the treatments are missing. Macular degeneration happens when there's too much oxidative stress and accumulation of damaged toxic aggregates.

So, to summarize, several different systems relate to lifestyle; there are no wide-scale, effective vision improvement treatments available. Wet AMD, which is 10% of macular degeneration cases, is being treated with late-stage anti-VEGF injections. You take injections every one to two months. 50% of the patients stop responding after two years of treatment. Dry AMD, which is 90% of cases, hasn't had any treatments at all. In the last year, two U.S.-based companies called Apellis brought their injections to the market. These treatments help with some small morphological benefits, but not long-term visual improvements.

There has been over 10 years already merging hypotensive treatment possibilities. It's called therapeutic heat shock inducing laser therapy, or non-damaging laser treatment. In this modality, the target is being heated with a non-damaging laser due to precise temperature. This heating quickens the cells' natural repair response; the main mechanisms and our therapeutic targets are the induction of heat shock proteins, activation of autophagy, and activation of antioxidant defense systems. This is a well-studied field, with over 100 different clinical trials already. In our latest preclinical study, we were able to show this phenomenon with our precise retinal heating and activate these targets.

So now to the fundamental problem with current heat shock inducing lasers. There are already a couple of them on the market. The actual real tissue temperature is unknown, so the clinical use is limited. There are differences in individuals, in pigmentation, blood circulation, and with older people, also ocular opacity. So using the same laser power, you get random results. The target is always to heat the retinal tissue to the exact same temperature. We also showed that the same laser power leads to lesions in other parts of the retina and beneficial effects elsewhere.

So, Maculaser's breakthrough solution is real-time temperature control of the tissue. During these non-damaging laser treatments, we can always hit the exact therapeutic heat shock response with every patient and with every retinal area. The conventional treatments without this method have to use a very low power setting for safety reasons, and these treatments are ineffective.

How do we do it? We have built a sensor system to be combined with non-damaging laser systems. We add flashes of light. These flashes generate an electric response in the retina. We measure that response with our system, and the sensor data is then transformed into temperature in real-time. When we know the temperature, we can adjust the laser power accordingly and individually.

So the end product is a non-damaging laser with thermal dosimetry, a very traditional, conservative class II medical device operated in the retina specialist office environment. The procedure takes 90 seconds, and the whole procedure takes approximately 10 minutes.

To summarize our value proposition: when we have a safe and efficient, non-invasive treatment, we can start treating these AMD patients early, before these last hope late-stage treatments. In the later phases, we can also reduce the amount of anti-VEGF drugs. Our system is true platform technology. Our current clinical pipeline targets several different retinal diseases, AMD being the primary target, followed by dry AMD and then some subcategories such as geographic atrophy. In addition, diabetic macular edema and central serous chorioretinopathy (CSC) are our targets.

After a successful preclinical trial phase and a 20-patient usability trial with real patients, we are now proceeding to the pilot trial starting this year, and immediately after that, a multi-site pivotal trial with wet AMD patients. The classification in the EU is a class IIb device, and we're targeting early 2027 for market entry in the United States as a class II device, still discussing the actual pathway, then overall, 510(k).

So the main assumptions here are that we will win this game or be a really successful company if we can affect any of these diseases or reduce the number of injections. Our current business model, based on our market research, is 2000 euros per patient procedure fee per year per patient. That's approximately 110% of the current treatment cost. The device itself, we plan to sell for 6000 euros.

Our current core team is a biomedical engineering team, combined with quality, regulatory, and clinical expertise from the west. We have talked with six retina specialists and key opinion leader doctors. So we're currently raising 6 million euros. It sounds like a small amount, but with that money, we will run two separate trials, get to the CE mark for EU market entry, and prepare for FDA approvals. We already have a couple of follow-up tickets and are still trying to find the right investor. Thank you.