Video Transcription
Simone Bottan 00:02
Simon, good morning, everyone. My name is Simone Bottan, I'm the CEO and co-founder of Hylomorph. Our mission is to prevent infection in implantable medical devices. I
Simone Bottan 00:10
want to start by telling a very short story. My four-year-old kid last year got an ear infection. He was prescribed oral antibiotics, but they didn't work, so he was then prescribed a stronger cocktail of more potent antibiotics. They finally worked, but they were very hard on him. They knocked him down for a few days. Bacteria are becoming resistant to our existing drugs, and antimicrobial resistance is one of the top 10 global healthcare challenges that humanity will have to face in the next decade, according to the WHO. This is real, and this is happening now; we have to act, unless we want this to become from a threat into an actual global crisis. In fact, we know that infection has the power to collapse hospitals and entire nations. We have seen that during COVID. It's not a virus or a bacteria that's the problem. It's the infection that it creates that hospitalizes patients. It costs hundreds of thousands of dollars to treat, and it requires an insane amount of infrastructure and human resources. But most of all, infection, when it occurs, increases the risk of death. It doesn't matter whether you're young or old, weak or athletic, rich or poor. Infection does not discriminate. I'm sure you're all very familiar with this picture, but I want to look at it from a different perspective. This is state-of-the-art, 21st-century technology to prevent infection in the operating room. At the end of the day, it's all about aseptic control, measurements, masks, gloves, and so on, and delivering systemic antibiotics as a prophylactic. We have to innovate on prevention. At Hylomorph, we believe we can do better, and we can advance infection prevention by doing two main things: by delivering antimicrobial drugs right on top of the implants, instead of systemically, and by setting the stage for the use of newer, more potent drugs. Hylomorph was born out of disbelief with the goal to become a global leader for safer surgery and long-term patient health through biomaterial science. We are a spin-off of the Swiss Federal Institute of Technology in Zurich. We have raised about 20 million USD so far in equity financing and non-dilutive grants, and our work has been acknowledged by several national and international recognitions. One in 10 people in the Western world will receive at least one implant during their life. That makes about 80 people in this event. I ran the statistics earlier this morning. I'm talking about cardiac rhythm management devices, neuromodulators, orthopedic implants, reconstructive surgery implants, and so on. You name it; they all have their own incidence of infection. Generally, the more complex the procedure, the higher the incidence. Our first focus is on cardiac rhythm devices and neurostimulators. They amount to about 2.5 million devices worldwide per year, half of them in Europe and the US alone, and they're bound to double in the next few years, thanks to the exponential growth of the neuromodulators field. From an industry standpoint, Medtronic is the only player out there that has done something meaningful to advance infection prevention. Their blockbuster product is called TyRx, an antibiotic-eluting envelope to deliver a pair of antibiotics on top of cardiac implantable electronic devices. They have proven clinical and cost benefits in large clinical trials. Their adoption has grown exponentially in the last few years. Reimbursements are becoming available in various healthcare geographies worldwide. However, TyRx is mainly used only in high-risk patients. And while I do acknowledge that Medtronic has done an excellent job in opening a new market, they have also failed in progressing any further, as TyRx is still the same as it used to be about 10 years ago when it was developed, and the antibiotics it uses are 50 to 60 years old. At Hylomorph, we have created Vesta, the world's first modular, fully resolvable, antibiotic-eluting envelope for the local, sustained drug delivery of antimicrobial drugs around implants, so right where it is needed, at the time when it is needed. With Vesta, we can not only match the state of the art in antibiotic elution, but we can also unlock the potential of the future of this field, mainly thanks to three key differentiators. Number one, its modularity and flexibility allow the loading and dosage of virtually any drug. Number two, its soft tailoring to the device allows switching from one target device to another surgical field. And number three, last but not least, it is very cost-effective to manufacture. In Vesta, we combine several patented technologies that we have developed from various and adapted from various industrial fields, from polymer manufacturing, textile industry, industrial design, and pharmaceutical formulation. When we combine them, at the end of the day, what we obtain is a very flexible, cost-effective, and scalable drug-eluting platform to address broad-spectrum indications. It all seems very easy when you see it on a slide, but trust me, it requires a massive amount of technology and know-how, especially to keep costs under control, and especially to achieve the very detailed specifications that I'm going to tell you in a second. So what we can do with Vesta is achieve a very rapid elution of the antimicrobial drugs in the first few minutes after surgery. We can keep this concentration beyond the minimum inhibitory concentration, so high enough to kill bacteria in the surgical pocket for seven to 10 days, and then it is fully resolved in three months' time. Our journey started a few years back when my co-founders and I met doing research on biomaterials with our first product. We went from lab to clinics in less than five years, and we've been awarded the Innovation Award by the European Heart Association. We've had several interactions with the FDA, a full submission done last year, and very detailed feedback received both from the agency and some large industry players. Thanks to this know-how that we have collected in these years, we have outlined a clear path forward. We know what needs to be done and how to do it to achieve our next big milestones, which are FDA clearance and US market launch in the next two years, for which we're currently fundraising. Believe me when I say that there are just very few teams out there that can navigate the complexity of infection prevention. It is a very complex field in which you have to know a blend of technical, regulatory, clinical, and entrepreneurial know-how. We have it thanks to the focus and commitment that we have put in until now. We also coordinate more than 60 people in many parts of Europe and the US and various external resources. We have put together a strong team of active collaborators with track records in similar fields. Last but not least, we work with clinical advisors that see infection on a daily basis. So in closing, ladies and gentlemen, we do not want to stop here. Cardiac neuromodulators are just the first target, the tip of the iceberg for us. We foresee a future where all implant manufacturers will have to provide advanced strategies for infection prevention in all surgical fields. We want to be a driver and leader of this change. We also have a number of aces up our sleeves, including the use of AI for infection control and the use of newer drugs to fight antimicrobial resistance. But I'm short on time, so please talk to me if you want to know more. For the time being, if you want to contribute to prevent the next upcoming global infection crisis, we are the right ship to sail on board. Thank you very much. Applause.
