Pablo Fernández, Polimerbio - Biodegradable Polymer-Based Medical Devices | LSI Europe '24

Pablo Fernández 00:02
Good morning, everyone. My name is Pablo, and I am the CEO of Polimerbio. It's a pleasure to be here with you all, presenting how we want to disrupt and be a game changer when it comes to treating urethral strictures. Polimerbio is a company that was founded six years ago as a spin-off of the University of the Basque Country in Spain. Our purpose is to develop new biodegradable medical devices based on the knowledge that we have on polymer chemistry. Basically, we can play with the mechanical and physicochemical properties of these compounds in order to develop tailor-made solutions in the medical field.

When we started discussions some years ago with different medical specialties, we decided to start in the field of urology, specifically with a disease called urethral stricture. In this disease, there is an abnormal growth of tissue that is blocking the flow of urine from the bladder to the outside. Current management of the disease consists of two different steps. In the first one, the doctor performs a surgery called urethrotomy, basically to cut and remove the tissue that is restricting the flow of urine. Then, the physician places a Foley catheter in the urethra of the patient for one to four weeks.

Here is the problem: Foley catheters are associated with poor quality of life for the patients. As you can see in the picture, it's extremely bothersome for patients to have a Foley catheter in the urethra for one to four weeks, and they cannot control when they want to urinate, for instance. Apart from that, from a medical perspective, Foley catheters are also associated with urinary tract infections that may be serious in some cases. Even more relevant with urethral strictures, on average, half of the patients will enter into a vicious cycle of new strictures two to four years after this procedure, which generates high long-term costs for healthcare systems.

So what is the solution that we have developed for these patients? It's a tubular, corrugated, biodegradable intraurethral stent that is intended to be used for adult male patients to assist in the regeneration of tissue after urethrotomy. In other words, we want to replace current catheters in the postoperative management of the patient, meaning that the patient will go to the hospital, the doctor will place our stent instead of the Foley catheter, and the patient will go home and forget about the disease because the stent is going to biodegrade.

We have successfully finished the preclinical trials and have promising results. Last week, we got the approval to start the first in-human multicenter clinical trial regarding intellectual property based on the PCT positive opinion that we received last year. We are now entering the national phases in selected countries worldwide.

Let me summarize our value proposition based on four pillars. Number one, we are going to launch the first biodegradable stent to manage postoperative urethral strictures. Number two, because of our specific and corrugated design, and the high biocompatibility that the product has shown during clinical and preclinical trials, our objective is to avoid this vicious cycle of strictures. Number three, we are going to improve patients' quality of life because we have the potential to replace current catheters and their associated adverse effects. Number four, this technique is going to be quite reproducible, meaning that it's going to be easy to implement for most urologists.

Looking at the market opportunity, just for your reference, there are around 160,000 severe urethrotomies in Europe per year. This is a market that is going to grow in the coming years, reaching about half a billion by 2030, combining the US and Europe. This growth is driven basically by population aging and a high demand for innovation in this field.

Regarding competition, as I have mentioned, we are the first company developing a biodegradable stent for the urethra. I will focus on the Foley catheters because the vast majority of procedures are done using these Foley catheters. We cannot compare against them when it comes to price because they are cheaper than us; however, if we think about cost-effectiveness and long-term savings, we may play a role here. If we can avoid this vicious cycle of strictures, we have designed all the clinical trials considering that the endpoints will improve the quality of life of the patients and that we will have a very good safety profile.

Looking at the go-to-market strategy, it involves securing a partnership model with a medical device company or a distributor that is interested not only in our first product but also in other biodegradable medical devices that we will develop in the future. Focusing on the main milestones for the upcoming years, in 2025 we would like to finalize the clinical trial so that we can get the CE mark and start launching in Europe. In parallel, we will go to the FDA to ask for the PMA process that we have already assessed. Then, in 2026, our objective is to expand commercial operations in key European countries, gain market traction, and expand our KOL network. Hopefully, by the end of the year, we will have FDA clearance so that in 2027 we can start the launch in the US market and expand to other relevant countries in the world.

Apart from that, let's evaluate a potential exit once we have enough traction. This wouldn't be possible, of course, without a committed team that has strong capabilities in clinical, regulatory, and preclinical areas. Now we are focusing our efforts on the commercial side of the company, trying to incorporate new talent in this regard.

Before finishing, let me highlight the reasons to believe in our project. First of all, our technology is the core of the company. It's easy to use, convenient for the patient, cost-saving, and sustainable because we are decreasing the waste generated during surgeries. As I have mentioned, we have a team that is really engaged with our purpose to become the standard of care in urethral strictures. Let me say that we are reliable to some extent; we have very good preclinical data, and we can start recruiting patients for the first in-human clinical trial. Finally, we have strong funding and a track record because we have raised so far more than 3.6 million euros, combining equity grants and loans.

Before moving to the next point, let me say that we are officially kicking off a financing round that will be around 3 to 4 million euros, so I would be more than happy to have an off-site meeting with you to discuss potential partnerships or investment options. Thank you very much for your attention.