Gregory Grover Presents Karios Technologies at LSI USA '23

Transcription

Gregory Grover  0:04  

So everybody sticking around today. So Karios is technology that we invented with surgeons to protect patients. And so by starting with one problem, cardiac surgeons and issues they had in their surgery, we can actually access other problem areas in all these other areas. So, what problem are we addressing? We're addressing post surgical adhesions. This is scar tissue that develops whenever you have a surgical intervention. Just like when you fall down and scrape your knee or your elbow and you develop a scab. Well, the same thing happens internally whenever you have a surgery. Five out of the 10 most common surgical procedures have adhesions that formed after the operation. And the problem is is the only way to deal with these adhesions is to perform it hemolysis or removal and this leads to increased rates of injury and death. So the whole concept here is by preventing adhesions. Not only can we save patient lives, but we can save hospitals money. So this is an undervalued market that creates a huge opportunity. If you look at all the surgeries that are impacted by these adhesions, it's over $10 billion in the US we're first focused on the cardiac segment, that's over $2 billion. Greater than 70% of these patients develop post surgical adhesions. There'll be over a million surgeries by the year 2026 and 20%. Of those are unpredicted reoperations I want to say that again, 20% of the patients that receive a second cardiac surgery are reoperation. It's unpredictable. We're first focused on children with congenital heart defects and adults with ventricular assist devices. This is because these patients have a high frequency and likelihood of these reoperations on a planned schedule. So even experienced and successful team in place. myself I've done translated for other products through to the clinic. My co founder is a world renowned bio engineer, and we have a surgeon entrepreneur, and scientists on the team as well as the Chief of Cardiothoracic cardiothoracic surgery at UCSD. We also have people that have worked at the FDA, as well as translational hospitals such as St. Jude's and Boston Scientific, for example. So our solution is tissue shield. It's a protective barrier. And you can think of it like a temporary protective spray paint. So the surgeon holds it in their hand and sprays it directly on the site that they want to apply to. We have safety and efficacy in mice, rats and pigs on their hearts, as well as four peer reviewed publications and three pads with exclusive commercial licenses. Here we're showing the use of our clinical prototype and an adult pig model on a beating heart, you can see that it easily fits in the surgeon's hand and you can see the gel form so fast, there's some of it touching the top of the sternum, you can just wipe that away. So we know the cardiac surgeons want a solution because we've done a double blinded survey of 117 of them with an average amount of experience with 12 years. And here's some scary facts that we learned about this. 50% of these surgeons have aborted a surgery mid surgery because of the severity of these adhesions. 62% of these surgeons have not performed a life saving cardiac surgery on a patient because their concerns were that the the adhesions would be so severe that they would have to abort. 80% said that these adhesions negatively affect patient outcomes, and 99% believe that adhesions increased risk to patients. But really excitingly 84% said they would use a product like tissue shield if it was available. And I like showing this quote from Dr. Billy Cone or Dr. Houston as everybody at Houston calls him. He said if this product was available, he'd be using it on his patients. So the reason we're in the cardiac space is there's nothing to help these patients. So the standard of care is doing nothing. So other products that have been FDA approved for abdominal and pelvic uses tried to translate to the cardiac indication, but it failed. And these include films like we saw in an earlier talk, as well as some sprayable barriers. But the point here is, while these products exist, in other indications, their application to the heart to prevent post surgical cardiac adhesions was unsuccessful. So why are we succeeding where they failed? Well, we specifically went all the way back to the basics, we interviewed surgeons and asked them the properties that they wanted. Well, they told us they want to spray well, not a film, they said they want it ready to use. And they said one of the anti clogging. We also looked at the chemistry being used here with these materials that allows them to form that barrier. So we invented new chemistry with new polymers to address these issues of binding, low swelling. And to that end, we're fully synthetic, so we can scale up to 10s or hundreds of kilograms. And we have a long lifespan in vivo, meaning that when we're applied to the tissue we last six to eight weeks. While all these other degradable products only lasts two to seven days. And here we're showing our clinical prototype easily fits into the surgeons hand and is easily extrudable. So the point here is that other studies done in the abdominal space showing reduction of abdominal adhesions can save those hospitals greater than 40%. By applying that model was to adjustments based on what happens with cardiac surgery. We project that use of tissue shield can save us hospitals over $2.2 billion just in the cardiac space. Well, what are these benefits? Where are they getting the savings from? First less patient injury and less patient death? Second, we can read Reduce time and material costs for current and future operations. So typically when you have a reoperation case, that is your only case for the day, but when you have first operation patients, sometimes the surgeons can put two in a day, we also can decrease length of stay and the amount of complications. This leads to improve patient outcomes and satisfaction. We have a clear regulatory path we've met with the FDA a handful of times. So our goal is to be submitting our EFMs ID at the end of this year, and be applying for breakthrough device next year and submission of our PMA we've got great support from medical device executives, people with great experience in the regulatory and reimbursement space, as well as these groups that work great with these class three PMA cardiac devices. So our proposed clinical trial is in alignment with the FDA, they agreed and they like it. So the concept is a focus on patients with a high likelihood of reoperation. This leads to a quicker turnaround for the study, we're first focused on these congenital heart defect patients who have a Norwood procedure or BT shown a two to four weeks of life, they then receive a Glenn procedure usually three to four months later. This provides a tight window for us to go back in and assess those adhesions and show that our product had an impact for those patients. We're doing 20 patients 10 treatment 10 no treatment. And the clinical endpoints are adhesion and safety with secondary endpoints being some of those value proposition items that I mentioned on previous slide. And we're gonna be doing this at six to eight clinical sites. So the clear commercialization commercialization pathway We were founded in 2020. We already have preclinical data and scale up in place, targeting our first in human study, we've met with the FDA having CUSOs. When we applying for breakthrough device, we have three pads with exclusive commercial licenses as well as putting in our own patents right now. Currently, we're here trying to close out our seed round, which is oversubscribed. So we have a private funding of over 1.4 million grants over 1.2 million these grants include from the pediatric device consortiums, if you're here early, as well as from the NIH, NHLBI, pending we have $1.6 million in grants for just waiting for the final notice of award. So we're in a strong position here. But as we all know, this economic environment, we kind of just want to close out the seed round up to that 2 million. So the point here is that after each clinical study, we have a point or an inflection point for licensing opportunities. So you can see after our ID, our IP Sid, we can then follow that up either with a licensing deal or then move to a larger pivotal study. So what are the deals look like that occur in the space where they range from 150 to over almost $500 million. And these are some of the players that have products or verticals in this space and that have done these deals. I like to call it separate film which you saw on the previous slide, which was acquired by Baxter from Sanofi for $350 million. And omics biopharmaceuticals acquired by j&j for 438. So seed round $2 million round lead investor in place on a convertible note already 1.4 committed in the bank account. Not at SVB though, convertible note terms 5% interest 20% discount on a two year term with an $8 million cap. And the key value creation milestones are those regulatory submissions. We've already actually scaled up the manufacturing. So it's just polishing out those clinical trial sites to get that EFs ID approved. And so what I want to end with here is the point is surgeons want a solution this we've interviewed. So I showed you the survey data, but I've personally talked to over 150 surgeons, and over 75 of them are US pediatric and adult cardiac surgeons. So they want an answer to this problem. There is no competition in the cardiac space. The number of surgeries is growing globally, especially as the patient population ages and surgeries are becoming safer. So people are getting more and more reoperations. So this creates this issue where they have to deal with the scar tissue. We've de risked this with safety and efficacy and three animal models and we have three pets with exclusive commercial licenses. So this my lawyer makes me put up here so thank you so much for listening and have a great day.