Benjamin Pless, Celero Systems - Monitoring Chronic Conditions | LSI Europe '22

Transcription

Ben Pless  0:06  

Good afternoon. My name is Ben Pless. And I'm very happy to be here today. I'm the CEO of Celero Systems. And I'm going to talk to you today about a new a new platform that we're developing. It's a ingestible device. The patient can swallow it once a week it resides in the body for a week. From inside the body. It monitors physiological parameters and particular respiration and cardiac activity. It communicates with the outside world allowing for predictive analytics to improve healthcare. But it also has the ability to deliver drug if necessary, for particular conditions. This is a platform technology that can be used for a number of indications. The one that I'm going to talk to you about today is for opioid safety, where the product can detect opioid induced respiratory depression and deliver an opioid antagonist to reverse the condition to save the patient's life. So the problem is, the current treatments for opioid overdose are inadequate. The standard of care is to deliver Naloxone, but this requires a third party to identify that the patient is having an overdose, find the medication and deliver the medication to save the patient's life. The majority of patients unfortunately, are alone and unobserved when they die. And there has been a big need in the marketplace for an autonomous drug delivery system that can detect and deliver an opioid antidote. So the way the rRescue RX the first product that we're developing, it's called the Rescue RX works is the patient who is at risk would take the capsule, as I mentioned before it stays in the body for a week during that period of time, it completely unobtrusively monitors a patient's respiration. If the patient has a respiratory depression, it delivers a drug called now aledine, which is a very potent opioid antagonist, thereby bringing the respiration back. But very importantly, in the patients that we will be treating, which are pain patients who are prescribed high dose opioids, the data alone provides the physician the ability to adjust the medication and perhaps avoid the need for the nalmefene to be used at all. After a week, the wings, which are the residency mechanism on the device detached from the device passes through the body and the patient can take another device for continuous protection. So the first market that we're looking at are pain patients who are prescribed high dose opioids. In the United States, there are 9 million pain patients who are at risk of overdose per the CDC, 3 million of those who are at extremely high risk of overdose because they're on benzodiazepines, they have had another previous opioid overdose, or they're, you know, they have mental issues, which make it difficult for them to maintain their opioids in a safe manner. So this is a very large market. And I'll talk to you a little bit more about about that. We have interviewed numerous actual pain patients who are on high dose opioids and the pain physicians that they see. And one of the things that is terrific about this product is the pull from the marketplace. What we found is both the patients love the idea for the safety and the physicians who are the pain physicians that would be prescribing it, understand that they will have lower liability and greater patient safety. So it's a product that is going to have a lot of traction. The practice today is to co prescribed nasal Naloxone for patients who have high dose opioids. This is a nasal Naloxone is a great medication. But if there's no one there to deliver the medication, it doesn't do the patient any good. In the future. What we have is the rescue RX and that will be prescribed for the patients and it will autonomously monitor the patient and deliver the Nalophene as required. The opioid antagonists market today is about a $500 million a year market. It is growing at about a 20% compound annual growth rate and is anticipated to be a $2 billion dollar a year market and 2028 Five years on the marketplace and we anticipate the rescue RX will have a billion dollar opportunity. And that is just with a 10% penetration into the high risk patients using the product just one month a year. So where are we in the product development? We've been working very closely with our clinical partners at the Rockefeller Neuroscience Institute. And we have shown by doing sleep studies with our sensor that we have excellent correlation between monitoring physiology from inside the body compared with the polysomnography study that the patient gets during their sleep study. So, on the right hand side, you can see the the graph showing the correlation between the ground truth from the polysomnography study and the data collected from the ingestible sensor. Above that, you can see the overlay between the polysomnography waveforms and the waveforms from the Celero ingestible sensor, which shows excellent correlation. We've also done full proof of concept testing in large animal studies showing the full performance of the system. The blue line in that graph is the respiration rate as detected by the Celero systems device. And as you can see, at about 10 minutes, a morphine overdose is given to the pig, the respiration collapses, the device detects that delivers the nalorphine, and the breathing is restored. That's the basic functionality of the product. And what we're working on right now is moving that from the animal research into the human research. So what are the advantages of an ingestible system? The ingestible system is completely unobtrusive. Once a patient takes it, it is out of sight out of mind 100% compliance, you don't have to worry about wearables, you don't have to worry about patches, the patient can be monitored for very long periods of time in an unobtrusive fashion, we get comprehensive monitoring capabilities, and the ability to deliver drugs in a needle free fashion. So the product development sequences, you know, the the goal of the company is to develop the rescue RX, which has the drug delivery that's on the right hand side, that's a the billion dollar a year opportunity. And it's a 505 b two pathway through the FDA along the way, what we're working on right now is to get a denovo 510 K approval for the ingestible monitor without the drugs. So that's also an opioid opioid safety product because of the data part and can be used for other digital health opportunities. So right now, what we're doing is we're raising a $7 million round, it's about a 25 to $30 million project from this point forward. We would prefer to do a $7 million convertible note into the next round, but a price round was certainly something that we would talk to about as well, for $7 million we get to the FDA approval on that denovo 510 K for the health dx. And then it puts us about a year away from being able to commercialize the Rescue RX. We have a great team. There's myself I've been working in medical devices for I always like to say over 25 years, but it's considerably over 25 years. Craig Patterson is my CFO and business development guy. He's also been in the space for a long time. And Dan Basher is just a terrific developer who's done both implantable and robotic devices. We have a group of founders that includes Bob Langer, Jeremy Ruskin and Gio Traversa out of MIT and Brigham and Women's Hospital, and MGH and a great selection of intellectual property patents that we have licensed out of MIT and the hospitals. So in summary, we have a novel ingestible platform, a first indication which is a billion dollar per year opportunity, unique opportunities for other large markets, strong patent portfolio and an excellent management team with a history of success in the space. Look forward to speaking with other anybody here who might be interested in this opportunity and enjoy the rest of the show. Thank you