Tyler Melton Presents Corveus Medical at LSI USA ‘23

Transcription

Tyler Melton  0:00  

Hi everyone, my name is Tyler Melton, I'm CEO and co founder Corveus Medical. At Corveus Medical, we're creating a catheter solution to treat patients heart failure patients in the outpatient setting and a quick procedure. Through one generation technology, we can give these patients a solution to their congestive heart failure, where they currently have little to no effective options on the market. To date, we've tested our devices designed for ease in preparing for our first in human study later this year. I don't need to tell you all at heart failure is massive. And it essentially affects everyone in some capacity, up to 6 million Americans are affected. Half of them do not respond to current therapy. And essentially this causes massive expenditure. So the system 35 billion a year. Many of those are a lot of that is coming from readmission costs and terrifying enough, half these patients die within five years. And some literature says 90% up to 10 and 10 years. Their heart just cannot keep up with with they're essentially pumping their blood up blood to their system. And over time that creates congestion, which essentially builds up pressure in the chest causing sensation of drowning. This increases our heart failure over time, but also continually brings them back to the hospital remitting them and worsening the progression of the disease. A nerve is essentially driving this issue that as the heart weakens as nerve over activates in a fight or flight response to help the patient. But over time that creates congestion, as it as it accumulates in the in the heart and into the lungs essentially create this, this feedback loop which is deteriorating our patient and lowering the quality of life. Current treatments on market do not do not address the nerve interaction in the volume directly. As I said medication which the $50 billion market does, does it affect some patients positive benefit, but half of them are refractory over time. VADs of course are implantable and do more of a bridge to transplant but of course transplant in LVAD are invasive and not all patients are used them. And of course with transplant there's a supply and demand issue. Removing this the neurobiologist discussing has been shown over across all these studies to show significant benefit with little to no adverse events reported. These studies were temporary nerve blocks they were surgical lysis and catheter ablation. One study particular I want to point out is this one, where they surgically lyse this nerve and 10 class three heart failure patients over that one year they observed them and over time, all 10 patients were from class three to two to one with little to no adverse events recorded. So we created this solution to address this nerve and this issue. This nerve is located around t 10. And you're in the thoracic cavity so it's not directly on the heart. Our device seen here can find the nerve prior to the procedure, we use a bipolar RF ablation to target that zone. And we create a durable effect we remove as much of the nerve as possible because nerves do regrow over time. Also with our way that we can, essentially with a needle platform, we can also affect other nerves long term. This is essentially how it works, our device goes in using a vein. We sent a small stimulation pulse out to make sure we're in the right location to the right nerve. Once we see the response, we're looking for it we have a small micro pumps needle that comes out and then re stimulates again to make sure that we're again in the right location. We then use bipolar RF energy to ablate that nerve and then we test one more time prior to leaving to make sure that nerve is deactivated. We then retract the needle and our device is pulled out and the patient procedures. Once done, it basket dilates the gut and it pulls the fluid from the chest back to the stomach where it once belonged. We created a device to make sure that we read all requirements for physician adoption for procedure confirmation, making sure they're confident leaving the O R that they were successful, to collateral damage making sure we have controlled ablation zone. As many of you are aware with other procedure with ablation procedures. Collateral Damage is a known issue. We want to make sure we are alleviating that. But also we're extracardiac meaning we do not affect the heart directly. We do not affect potentially other treatments and other options for cardiologists. Our patent strategy is essentially twofold, we want to make sure that we're protecting our device and the procedure itself. We currently have a PCT file which protects the procedure. We also have a non provisional filed, which protects our device itself. We've also received word recently that we're a Notice of Allowance for that second patent and we expect that to be granted in the coming months. work last year device we talked the FDA about six months ago and we're continually talking to them and a few months again, and essentially we're closer device will create barriers to entry and traditional transitional reimbursement during our trialing. We've also worked with reimbursement expert to find transitory codes while we get ours long term. Our solution offers value across the board of course for patients helping their quality of life, given cardiologists other way to treat these patients but also importantly reducing hospital costs as well as a quality penalties which as we are aware with are important to many large institutions. The heart failure markets massive, we're going to start with the moderate heart failure patients that were sent the 5 million class two and class three, we'll pull that down to the 60,000 half PEF patients with repeatedly hospitalizations with no complications, once we're successful will grow to those with complications and other comorbidities and eventually to all these patients who are non responsive to current therapy. Today, we perform successful preclinical testing over the last few years where we verified the anatomy and cadavers. Over iterative testing, we provide five acute studies over 12 porcine models, where we were able to test our Factom form device on a target nerve. We also performed a chronic say to make sure that safety over time with C, we use our device in three animals and we performed three procedures and each and essentially overtime, absorb them and at the end, there were no there was no hematoma scene and they were all healthy and survived. And this year, we are raising for our first in human study to ablate, the splenic nerve using our trans vascular approach. We were founded in 2020 during the TMC Biodesign program, and essentially been supported by institutions like Y Combinator, med tech innovator receives roadman. And right now we're at the Center for device innovation at the Texas Medical Center. I just mentioned our preclinical testing to date. And funding wise we have raised 900,000 In a pre seed round. And I'm happy to announce we just received our Phase One SBIR as well. Our seed rounds will get us to our first inhuman data. Essentially, we are raising one and a half. To do that. We're going to do about three to five patients and tests on the acute efficacy setting and follow up for safety. We'll use that data to raise our eventual series A We're a small team, but we're agile. We have skill sets across the board from our engineer coming from Johnson and Johnson recommended us from our main cardiovascular advisor. Mike Mike was my physician and co founder Sean come up who has experience in cardiovascular ablation as well as at UCSF leading up ablation hospital and myself I have a background in business and engineering and spent some time in pharmaceutical consulting. We're also supported by experts in the industry. Dr. Cohn has been pivotal since the beginning of our of our inception to essentially help us get to where we're at today and lead us forward. Dr. Levy Klein is an advanced heart failure specialist who has given us his expertise, as well as Dr. Jochen George has been pivotal in helping us prepare for our first in human study later this year. Also going to be the next to biomedical has been fantastic and our engineering approach and Tasha bond who is leasing here today, as well as let our quality charge. And lastly, Viva toI has helped with our reimbursement strategy. And she also did the original abdomen and tabber codes. And then lastly, Michael Bucha has been fantastic with this planet pre clinic, our preclinical and our clinical study. To summarize our devices ready for our first inhuman testing after all, after 15 animals, we are ready to bring this down and test it on our first patient. We've talked to the FDA and we understand our regulatory pathway. And we've defined our market in our user base, or raised whereas in one and a half million to start that first study. We'd love to chat later. Thank you