Szilvia Endrenyi Presents Rethink Medical at LSI Europe '23

Transcription

Szilvia Endrenyi  0:05  
Good morning to everyone. I'm Szilvia Endrenyi, CEO and co founder of Rethink Medical, a Spanish startup company focused on the development of new medical solutions based on nursing experience. Productive control was born as a new paradigm for urinary catheterization in order to demonstrate that a simple, very smartly designed device can actually lead to a Husker revolution and can have a very important social impact to urinary catheterization is a basic procedure used in case of incontinence and urine retention. The catheter itself is a tiny tube that is inserted into the bladder, and then attached to the urine collecting bag fixed the patient legs. It was invented in the 1930s and seen and very fast, it became one of the most frequently used medical devices on Earth. It resolves the basic problem which is urine drainage, but unfortunately, it immediately creates additional difficulties. These are linked to the quality of life of the patient, mainly due to the usage of the bags. It is also linked to a possible bladder reflex which means chronic incontinence later on, and other problems like blockage leakage pain, all these things lead to frequent emergency visits a very high grade of dependency and in very, very high risk of infection. These infections are difficult to prevent, why? Because they are multifactorial. This means that they are linked to the catheterization itself, but they have different root causes, they can be linked to the product design itself, which means biofilm creation on the devices vote or bounce created in the bladder, or they can also be linked to human processes human errors, like nonseptic insertion technique, or simply leaving the drainage system open, where all the micro organisms can enter directly. At the end of the day, this creates a heavy Economic and Clinical burden, we are talking about more than 27 people that has to die for this reason and more more than 900 million costs per year. Welcome to T-Control the first and only urinary catheter with a fully integrated urine controlling system which enables us to close and open the urine flow at any moment according to the needs. This new functionality enables us to do different things. First, we can improve the insertion technique, because there will be no accidental spillages. And then we can even enable patients to use the device without the urine collecting bags. At the same time, believe it or not directly or indirectly we can address almost all the root causes of infection. And then that way we can offer a safe, efficient device which is very user friendly. It promotes active lifestyle, and it can also be used by people with poor hand dexterity, and visual impairment. As this is a real tangible device. I encourage all of you to approach me after the presentation and look at it by yourself. The product has already passed different preclinical tests, I would like to highlight only some of them. This is an in vitro validation model where we managed to compare our device with the gold standard and demonstrates that we can significantly reduce biofilms without using any Nova material. This makes us think that we could prevent infections by 35%-30%. We have also done some user tests. This one be nurses, for example, with professional nurses that could try the product and compare it with different insertion techniques. We managed to demonstrate that we can significantly reduce contamination, we can avoid accidental spillages and the mental effort they have to use when inserting the catheter is much lower. At the end of the activity. This was the best rated insertion method among all the possible methods. We also tested the product with patients so we invited patients who were already catheterized they know what they live with the catheter is and we put on the table all the possible catheters, accessories or the devices they can use now in Europe or in the US, they compared the devices and they confirmed that T-Control is safe to use. It's very easy to use, it adds value and that it can actually improve their quality of life, which is very important for us because this patient journey is extremely long and tough. They lose quality of life from time psychological, physical, social, even labor point of view and they are not only affected by the basic illness with which they have but they are also very much affected by the device that they are using. We are currently involved in clinical validation activities. We have unfortunately no results yet. But I would like to highlight here that we have a very prestigious in International Consortium behind all these clinical proposals, we are focusing on acute and chronic patients and the main endpoints are related to infections quality of life, usability and cost effectiveness. T-Control is expected to be the competition in all these segments, I would not. I don't want to enter into the details here but I would like to highlight one thing which is the shows of infection, which is the real hot topic now. So yes, there are innovative catheters on the market. But still, they are unable to really reduce infections, they can show some positive results during the first week, but they have a manufactory approach. And still we have a lot of unmet needs. A lot of needs still unmet on the market. From my point of view, our product is widely protected in other countries where there is an important commercial interest. And from a regulatory point of view, we expect the certification both in the US and the EU, next year. We are already communicating with the authorities and the notified body right now. We believe that this market can disrupt can be disrupted by any solution that meets basic basically three criteria, decontrol definitely needs them. It has to be a new clinical approach, which means multifactorial infection. The design of the product has to be based on the right consensus involving nurses, doctors and patients do and there should be a pricing shift. So we should start comparing unit prices, we have to talk about the overall cost of the patient per month for example. For this reason, we elaborated an early phase cost effectiveness model. And we managed to demonstrate that even with the premium pricing model that we like to apply, we can generate significant savings to the healthcare system. After all these activities, our plan is to launch the product in 2025 in collaboration with commercial license partners, who could be responsible for promotion and distribution, and to could offer us a relatively fast scale up because the needs on the market are very, very similar in other countries. Our aim is not to approach the already existing enormous urinary catheter market, we would like to find a niche market, we will find our patients and we will apply a premium price that gives enough margin both for us and our commercial partners. Regarding the financial projections, thanks to the initial payment to be received for the exclusive commercial rights. We expect to reach breakeven relatively fast and later on our income is related to the sales related royalty payments. Right now taking into account all the risks or the possible delays, we are looking for 1 million euros this will be co finance partially a grant we just received from the European Union. And as one of the better valuated startups, the amount of this grant is 1.5 million euros. And to put all this in place, we have a full very motivated, very ambitious team with experience in nursing and also with a very deep knowledge in regulatory, scientific and commercial fields. So my last message is help us to reshape bladder care. Invest in your future self because as I mentioned, we all will be in the same situation at some point of our lives. Thank you very much