Yuval Mandelbaum Presents Discure Technologies at LSI USA '23

Transcription

Yuval Mandelbaum  0:05  

everyone, good afternoon. My name is Yuval Mandelbaum and the CEO of Discure. Now don't have too many people here but by raise of hand, who here knows someone suffer some back pain. There we go, it's enough for the statistics. So four or five Americans suffer from back pain along their lives. And we really see that, you know, it touches all of us. So when we look at Back Pain the leading cause for for low back pain is a disease called degenerative disc disease. And degenerative disc disease is associated about 40% of all low back pain cases, has an addressable market of $8 billion. However, it doesn't have great solutions, the existing treatments really boiled down to invasive back surgery, and opioids, typically both together. And remarkably, none of the existing solutions actually treat the problem. At best, they mask the symptom. And we wanted to change that. So we developed a minimally invasive device that actually allows us to heal the disc, reduce the pain and restore function to the patient coming in quite a bit earlier, and avoiding starting that vicious cycle of opioids and eliminating the need for invasive back surgery. So quick look at the intervertebral disk, this is a very large a vascular organ. It doesn't have blood supply coming directly in rather, there are cells that secrete a negatively charged protein that creates an electric potential differential between the inside of the disk and the outside environment. And that creates a draw of fluid and nutrients and oxygen from the outside inward, giving the disk its volume and giving the cells their nourishment. However, in the disease state, we see that the these cells start to die out. And so that negative charge dissipates. And that pumping function starts to fail. So we have less fluid coming in, causing the disc to deflate, and lead to mechanical pain. As there's less suspension, we see that there's less nutrition coming in and oxygen. So these cells start to be in an anaerobic environment produce lactic acid creating burn. And in general, there's less inflow of fluid, so there's less outflow. So we've got an accumulation of metabolites and cytokines, leading to toxicity and inflammation. And all of that together really contributes to this vicious cycle until it this completely dries up and collapses. So we understood that the problem here is in that pumping function. And we developed a proprietary electrode that we inject under local anesthesia in an outpatient setting. And that is connected to an IPG or implantable pulse generator, implanted in a pocket in a subcutaneous pocket in the backside of the patient. And that actually allows us to actively control the inflow of fluid, so we can relieve that mechanical pain and inflate the disk. But again, perhaps more importantly, we can also actively control the inflow of oxygen in nutrition, allowing these cells to repopulate and allowing us to accelerate the healing of the tissue and really reversing degenerative disc disease. And we've been able to show that we take a disease disc, and we take it back to a healthier state. So if we look at the procedure here, we basically take an intradiscal and needle that is 21 gauge needle, we insert it under local anesthesia in an outpatient setting, under a jazz copy, we slot our electrode down that needle into the center of the disk, we then remove the needle keeping the electrode in place and this is a very fine 0.05 millimeter coil titanium electrode. And it allows us to restore that natural negative charge, allowing us to draw back in the fluid and nutrients and oxygen, reviving those cells and inflating the disk while also pushing out the metabolism byproducts and taught and cytokines reducing toxicity. So the electrode is connected to an implantable pulse generator, which and where each IPG can really accommodate up to four channels going into four separate levels in the lumbar spine into four discs. And it also collects in real time data from these discs and has an AI component where we can control it where the system can autonomously control the treatment parameters. Or also the physician can remotely see these this data coming in and control the parameters of the treatment remotely. So we've completed development of the system with a group not far in the Bay Area, which has now allowed us to move forward into a clinical studies that were starting quite shortly in the second half of this year. With however, we have done a very robust preclinical package as well. We've completed 15, preclinical studies, with leading institutions worldwide, really showing that we can reverse the process of degeneration. And to quickly look at a few of these. We've done a few long term bioreactor studies in this case, these are porcelain discs. And we have seen that when we take fresh porcelain this in this case, we generate them using a drill function, drilling a hole through the annulus which is the outer of the disk and into the nucleus. We then place these disks in a bioreactor under complex loading, which is basically a smart waiting mechanism simulating day to day pressures on, on on the disk, simulating the pressures on a human spine. And what we saw is 21 days in, we saw that the treated discs had grown and water content, but also maintain the healthy boundaries and form of the disc. While the non treated disc had continued to degenerate, we could even see that in the non treated arm, you could actually see the path of the drill through the analyst the outside and into the nucleus. While on the treated arm, we couldn't even find the entry point into this thick layer of the annulus. And if you look at this left column MRI, this is a non treated disc, you can see on the bottom, that blocks black spot that is an entry point of the drill into the disc, we couldn't see those in the treated arm discs. And also in the histopathology of the drill site, you could really see the reconnection of the layers. But we also wanted to support the structural findings with gene expression tests. And we ran RT PCR. And we saw that we had a vastly statistically significant downregulation of key inflammation and degradation and pain biomarkers with a corresponding upregulation of regenerative and anti inflammatory markers. And this really correlates very strongly to pain in patients. So this was extremely encouraging. We've seen the same results. In bovine and human disc studies. This is from a human disc study. We've run long term vivos, both in sheep and in and in pigs at Colorado University and Hadassah and Jerusalem. And we saw that treated this rolling water content. While non treated this continued to degenerate and ultimately collapse. Overall, the fact that we that we were actually treating the problem and not just the symptoms has really resonated well with the industry. We've received a number of awards and last few months, we've received an award for best in technology and spine care at Nasse. The North American spine society from a panel of orthopedic surgeons and neurosurgeons, we were ranked first. Really at the top of a few competitions of startups and med tech innovator and Tector we got a breakthrough device designation from FDA despite the preclinical stage, we've been publishing in some of the top journals in our field. And last year we oversubscribed around that was led by two hospital networks in the US joining our existing investors in j&j. With respect to FDA, so we got the breakthrough. We've also been put on the 510 K de novo path rather than the high risk PMA based on the risk analysis, and short procedure time. The FDA also agreed to the design of our first in human study, which will be 15 patients with six months of follow up and an open label study. Very broad IP portfolio 21 patents issued in the US and Europe, covering both the core both the core technology as well as pipeline applications. With with horizon till 2038 extremely experienced team with our founder Yossi grows, inventing a number of medical device companies exiting a handful of those with accumulated exits in the last few years of about 1.5 billion. And Dr. Hudson sir Hana comes to us from j&j where for 15 years he was in charge of new innovation. In the field of spine. There are sort of a team truly has extensive experience of between 15 to 30 years in implantable by electronics. But also the case that clinical advisory board has started with really Kol individuals led by Dr. Steven Hawk Schuler, the founder of Texas Back Institute. And to date we've raised 6.5 million from j&j, the hospital networks, VCs and families. And we're currently raising a Series A of 8 million that will allow us to complete the first in human study and get into our pivotal study. We've secured a lead investor and terms for the series A we have less than half of the rounds still to allocate. And overall, we're just extremely excited about our potential and the potential to help millions of people suffering from debilitating back pain. And if you'd like to be a part of our journey, I'd welcome you to come and find me after this. Thank you so much.