Video Transcription
Oriol Iborra 00:04
Thank you very much. So my name is Oriol Iborra, and I'm the CEO and co-founder of Nimble Diagnostics, where we aim to become the standard of care for the monitoring and management of patients with implanted stents. Briefly, stents are these small, metallic mesh tubes that are used to reopen blocked arteries and restore the correct flow of blood to the heart. Stents are especially useful in heart conditions like heart attack, especially in heart failure, but they also have many other indications in cerebral, vascular, peripheral diseases, or in pulmonary, renal, etc. That means that stents are one of the most implanted devices in the world. In fact, more than 50 million people currently have a cardiac stent today, and more than 4 million new stents are being implanted each year. The problem is, once implanted, stents can become blocked or damaged again, which puts the patients' lives at risk and affects up to a third of the patients during the first years after implantation. The problem that we are solving at Nimble is that today, the only way to know that an implanted stent is working properly is through a very complex, expensive, and invasive procedure called catheter angiography, which requires anesthesia, sedation for the patient, lots of X-ray radiation, and hospitalization of a few days after the procedure. All of that means that this technique cannot be used as a screening tool for asymptomatic patients that may be at risk, which increases the incidence of serious complications like having a second heart attack, stroke, or even sudden death that could be avoided only if we knew that there was an underlying problem with the stent. That's why we've developed Nimble, the first-in-class medical device for the non-invasive and non-ionizing monitoring of implanted stents. But how does our device work? Our device has two antennas that go on top of the skin, just near the stent location. One of the antennas will send a microwave signal that will bounce off the stent, and the other one will catch it, and our algorithms will process this signal in seconds, presenting only the clinically relevant information to the clinician. So if the stent is blocked, at what percentage we can quantify for the first time this number; if the stent is broken, what type of fracture, the simple fracture, the complete fracture. Now you have two pieces of the stent; we do not generate an image that the expert needs to interpret. And so this device, our technology can be adopted in any clinical setting, being GP's clinical practices, private clinics, or hospitals. This technology has already been patented, with one patent granted in the EU and a positive freedom to operate analysis, as well as two patents submitted and one in drafting stages, as well as the algorithms registered in notarial deposit. All of these to bring a technology that can, for the first time, introduce personalized care in these patients. Currently, we see the technology being used in three specific instances in the patient journey. First, after stent implantation, right after it, so you can confirm that the procedure has gone well, that the stent is working properly implanted, and then you can discharge the patient safely at home. Secondly, because many hospitals still perform this invasive procedure, catheter angiography after six months of implantation, just to know that everything is working well, and we can substitute those specific angiographies with our technology. And most importantly for us, the monitoring over time of these patients so we can detect complications early on and adopt the right treatment at the right time to decrease the serious complications, so decrease mortality, heart attacks, and hospitalizations. We have evaluated the technology pre-clinically, and we are now doing our first in-human study. It's ongoing in 120 patients in our hospital based in Barcelona, but we already have a large network of hospitals across Europe that want to participate in our future clinical trials and want to test our technology further at the competitive level. Currently, clinicians only have standard imaging techniques at their disposal, being MRI, ultrasounds, or CTA scans, but all of these have complications. First of all, none of that works to quantify the problems in stents, so you don't know if the stent is blocked a little bit or it's blocked a lot, so you can't act upon it. But starting with ultrasound, for example, you cannot use it to detect this. It's costly. You need expert clinicians to interpret the images as well with the CTA and MRI, and these two already have waiting lists that are so long that even if you could use it, you can't. But if you could use these technologies to monitor stents, you couldn't accommodate millions of people suddenly just to have screening for this condition. So this leaves us with a very large and growing market opportunity; just for the cardiovascular application, this is an over 8 billion total addressable market. But that's not all for us because our technology is a pipeline and can be implemented in any metallic implant. So in the future, we will also test different types of stents, not just cardiac stents, but neurovascular, renal, pulmonary stents, but also other metallic implants like valves or sensors that can get calcified. For example, prostheses can get infected, etc., and you can monitor that non-invasively and in the far future as well. We also have industrial applications, veterinary applications, and the aim of reducing the technology so you can be used at home for the patient itself. To capture this market, we have a highly scalable commercialization strategy, starting with a beachhead approach in Spain, which is our home market, but getting to Europe quite fast, first through Germany, thanks to the reimbursement pathway that's very clear, and then moving across Europe and the US, with distribution, all licensing with OEMs. The model itself is selling the device directly through bank leases, probably, and an annual recurring fee for the maintenance of the device. And then you have a SaaS business model attached to it, so you can get a fee for each measurement taken at each visit. The main clients will be hospitals, of course, but also private clinics, primary care facilities, and CRO companies that need to test their product with our technology. This will have a massive budgetary impact across healthcare systems around the world. We have calculated through independent studies that we can decrease 25% of heart attacks, 37% of hospitalizations, and up to 65% of premature deaths in these patients, as well as avoid non-productive procedures and optimize drug spending. All of that will mean that approximately we can save up to 1.6 million per year per hospital using our technology. And all of that is thanks to our amazing team, composed of clinicians, engineers, experts in commercialization strategy, as well as supported by a large key opinion leader network, especially from Professor Val, who is a co-founder and KOL in cardiovascular diseases in Europe, and Professor Peter Friedl as a KOL in the US. Stanford is already a serial entrepreneur and has already commercialized 14 startups sold to large OEMs, so we have the experience and the team needed to move this forward. So now we are in the process of raising our Series A round. We are looking for at least 12 million, but at maximum 15 million for this Series A round, and we are looking for one lead investor to put between 3 and 5 million euros ticket. The other 8 to 9 million have already been committed, mainly by the European Investment Bank fund, and to date, we have raised a little bit over 5 million euros, 1 million from our seed round, and a little bit over 4 million from public funding strategy. So if you want to help us make a painless, easy-to-use, fast, and accessible standard diagnostic for everyone, please don't hesitate to ping me in my email. Thank you.
