Video Transcription
Olivier Benoit 00:02
So hello everybody. My name is Olivier Benoit. I'm the CEO and co-founder of Ciliatech. Ciliatech is a French company, VC-backed med tech startup which develops a new device for glaucoma surgery. We are still in a pre-commercial stage, but I hope not for very long, because we are waiting for the CE mark at the beginning of next year, as well as the IDE approval. I'm coming here today because, like most of the other companies, we're looking for money, and we're looking for 20 million to finance the launch of sales in Europe and also the registration in the US. So we'll be speaking about glaucoma. What is glaucoma? In a nutshell, it is usually a question of elevated intraocular pressure (IOP). When the IOP is too high, it will eventually damage the optic nerve, and the visual field is unfortunately degraded until complete blindness. So this is the first cause of irreversible blindness in the world. It is also called the silent sight stealer because this is a very asymptomatic, painless disorder, but it can roll out for years and years. The patients usually don't know they have glaucoma until the moment they are diagnosed or if they start to experience some visual difficulties. The only thing we can do to monitor glaucoma is to play on the IOP level and to reduce it to the normal level. The usual course of treatment that the patient will undergo will be first to be prescribed eye drops to reduce the IOP or laser treatments. Unfortunately, when it is not working any longer, then the patient will have to go for surgery. This is where we come into play. We've developed a new device which is shaped like this. It is a one-piece flat-shaped implant made of flexible, hydrophilic acrylic, and it goes in that place in the body, in the supraciliary space. It is positioned out of the anterior chamber of the eye with no cleft and no cyclodialysis, no protrusion into the anterior chamber of the eye. To place the device in that location, we also developed a bespoke, dedicated surgical technique where we are also avoiding entering into the anterior chamber. So you will ask me, what's the point with the anterior chamber? This is a very tiny volume, which is certainly the most active place in the eye. So when you stay out of the anterior chamber, you are simply safer. Number one, you have less peri- and post-operative risk. The second thing is that the patient comfort is improved after the surgery. The last element, which is very positive, is that we are not depending on the conformation of what is called the angle, which is the shape formed between the iris and cornea. We are the only device which is implanted from the outside of the anterior chamber and does not rely on the angle conformation. So we can treat, as you see, what is called the open angle, as well as the narrow angle, which is exclusive to our device. Here you see the results of a first clinical trial we've conducted with our first generation of device. Again, that's a matter of IOP. You see the IOP baseline is high at 24.6 and decreases strongly and sustainably for up to three years. You see the same for the medications. The patients used to have two medications on average at baseline, and it came down to 0.5 at three years. After three years, still two-thirds of the patients are off medication. Based on those results, we developed the second generation of the device, where we have improved both the collection and the drainage capacity, which we tested as well. You see we have the same pattern, the same strong reduction of IOP. We go a little bit lower, a couple of millimeters less than the previous generation. And look at the drugs; they are also very flat. We are currently collecting the two-year data, specific to this study. We had two groups, the light and the dark green, which correspond to the narrow and the open angle groups. You can see that the curves are exactly overlapping. This means that the product really delivers the same whether it is open or narrow angle. There would be much to say about the outcomes of those studies, especially concerning safety. The safety profile is excellent, but I don't have the time to tell you all the details, so I'm jumping to the glaucoma market. The glaucoma market size reported in the market reports is about $800 million in 2023, expected to double by 2028, so quite a good growth. It is interesting to note that two-thirds of the market in value is in the US. That's the reason why everyone wants to be there. But also the out-of-EU and US markets in these reports are still vastly underexplored. There is a good reason for that: narrow angle patients are a low percentage here in Europe and in the US, but they have a high prevalence when you go to Asia, and these types of reports are not covering those countries. This presents quite a good potential for us. Overall, it is quite an active market. There have been several acquisitions in the past years, ranging from two to five, almost $500 million each. As a company, we were set up in 2017, and since then, we raised capital up to six million. The first step was to do all the proof of concept. We've enrolled more than 100 patients in our studies. So far, the proof of concept is confirmed in both open and narrow angle patients, and we could also develop some patents. We have today five patents solely owned by the company. Once the proof of concept had been confirmed, we discussed with our investors and decided to go to the market. We raised additional money to finalize the design to be ISO 13485 certified and to do all the work until the CE mark. What we did on top is that we've been discussing with the FDA to prepare for the IDE. So now we are very optimistic that at the beginning of next year, we shall be on the European market and have the right to start our clinical trial in the US, which will be a full PMA. That's why we're looking for money, and the proceeds will be used to support the sales launch, of course, additional headcounts coming to the team, and roll out the PMA in the US. I want to end the speech by speaking about my team because this is certainly the best assurance for success. I'm very proud and happy that some unique talents have joined the team recently, and I am very grateful to them that they chose us among other opportunities. Now we have a very good set of competencies and expertise in product development, quality assurance, regulatory assurance, sales and marketing, and medical affairs. I think we are well-equipped for the future. To conclude, we have a market that is growing, which is always looking for safer, more performing solutions. We have a good technology to propose to the surgeons to cover the needs of the market, especially in uncovered areas, and we have a good team to execute. So today we are just excited; we cannot wait to get the CE mark, to visit our first customers, and to deliver our first implant to our patients, hopefully at the beginning of next year. If you want to know more about the company, don't hesitate to reach out. Otherwise, I thank you for your attention. Applause.
