Jon H. Hoem, Pacertool - Improving Cardiac Resynchronization Therapy | LSI Europe '22

Transcription

Jon. H Hoem  0:07  

So, Pacertool is an emerging Norwegian medical device company, targeting heart failure patients. And we are developing a precision medicine approach to heart failure. As you know, heart failure is a big unmet medical need. We're talking about 26 million patients a year, roughly out of those, every one in five will be a candidate for heart failure. So, as you know, this technology was introduced in the mid 90s. And it's, through several studies shown reduce mortality, reduced hospitalization, and improved quality of life. What is not that well known is that in this same patients, you actually can have with the same patient technology, you can have deaths and complications. And as you see from this slide, this roughly affects 10 or 30 to 40% of the patients. 60% of the patients have an enormous effect of resynchronization therapy. And some of these patients are also, you know, super responders. We think that we have a unique opportunity in a dedicated targeting device for precision medicine with a medical device for these patients. As you know, all of us are having suits on one size really doesn't fit all. And today, that jacket, obviously it works for 60% of the patients. And what we are trying to do is to come to a paradigm shift, where it really affects all of us and can help all of the heart failure patients. That's what we're trying to do. Now, the offering that we are developing consists of three main components. Number one, it's a catheter that goes into the left ventricle. It's a proprietary single use device, we're developing a single amplifier that takes the signals from the amplifier or from the catheter into the amplifier, and you have a full suite that the implanting physician will look at when they do the implantation of the pacemaker. So what we're looking at here is operator in the pendant biomarker that enables him or her to look at if this biomarker is prolonged. In that case, you have dyssynchrony. Or if it's shortens, that patient could have the potential for resynchronization. And that's what we're looking at. This is preclinical data that we have done in Oslo at the University Hospital in Oslo. So, we have completed a proof of principle clinical study in 45 heart failure patients that undergo therapy for with the current indications. And as you see here, the accuracy is extremely good for the buyer market 98% accuracy, that converts with two and a half years follow up to dramatic differences in outcomes. So the patients that don't have potential for synchrony are dying earlier, whereas the patients would synchrony. And the effect of the therapy really survives. So this gives us a very, very good feeling that we have something that is unique for these patients. So this is our coming years how they look like we have a good starting point. With a catheter, we just filed our pre sub A. And it's soom that we'll get feedback on that submission by the end of the year. And that will in next year, enable us to execute on our clinical trial, or our filing of the clinical trial. And then father fighting candles here at the end of the year. That leads into the first in patient full integrated clinical trial in 2024. And with the 510 K clearance also at the end of the year. And then over the next years we'll go into a soft launch in the US and market access from 2026. We recently completed a market study verification study in the US looking at how we could enter the market. The total addressable market is more than a billion. This market grows by roughly 4.2% a year which is very encouraging for us And as we'll see, we'll start to do a soft launch from 2025. And then over the years, use existing reimbursement codes, and expand with new clinical data, and hopefully be able to partner with a corporate in the US to expand the market. So, we are, and we believe we are one of the few companies that are addressing this triangle, which we call the p3 triangle. So we are addressing the needs of the patients to reduce their heart failure burden. We are reducing the cost for the payers at the same time as we are helping the providers to provide care more efficiently and grow the pacing market for the providers and manufacturers. We have a very solid team in Norway. Consistently, I'll send records on who's here in the audience, together with experience medical device professionals that over decades have launched medical device products worldwide, both in Japan, Europe and the US. We have recently been so lucky to recruit outstanding scientific advisory board consisting of these four individuals. They have a long track record in the signing clinical trials, both in Europe and the US. And we have merged the field of CRT implantations with physiological pacing, that will vary very happy to have them on board to help us with our clinical trial strategy. So what's the investment rationale? This company is one of the few that have a 510 K pathway to the market, have existing reimbursement codes that we can use inpatient, and also outpatient if we differentiate diagnosis to treatment with more than three days. And we believe we have a unique exit opportunity. Because none of the corporates currently have a solution that is addressing this unmet need of a great team. We have found our IP and that's really the fundamental Familien forward. We're currently raising a smaller round and will as part of this. We're raising a 10 million US farm next year to fund the strategy that you just saw. So thank you very much for your attention, and we would love to meet with you during the conference.