Chris Springate, ARC Medical - Temporary Barrier Film for Surgical Adhesions | LSI USA '24

Chris Springate  0:03  
These are large markets. There's a large unmet medical need for surgical adhesions. In the US alone, we have over 20 million surgeries every year that would benefit from our products, total addressable markets of over $6 billion. We've put together a really compelling data package we've treated for surgical orthopedic patients under compassionate use with really favorable results. We undertook a large clinical safety study with 76 healthy volunteers and we've proven out the safety of our liquid medical devices. In addition, in head head comparisons in a well established preclinical animal model of adhesions, we've shown there was superior efficacy compared with three of the currently top marketed products. In addition, we have seven separate patent families which provide exclusivity until 2039 and beyond. And so today, the most common complication after any surgery are these internal surgical adhesions, and these are abnormal fibrous growths that form inside the body. After the surgeries. Following a knee or shoulder surgery. Many of these patients end up with a stiff knee or frozen shoulder that can walk down stairs without assistance or even necessarily get their arm up to change their shirt by themselves. It's even more serious after gynecological surgery, many of these women become infertile due to surgical adhesions. Anybody undergoing abdominal surgery is at risk for small bowel obstruction due to the adhesions. And this results in an emergency expensive surgery to then go in and cut these adhesions apart. And so we have the only product which is a liquid at the end of the surgery, it's easily and rapidly applied into the surgical site that liquid flows through an entire surgical area. It sets up as a temporary physical barrier film that coats all the tissues and organs and this prevents the formation of the surgical lesions throughout that entire surgical area. We're the only company with a product like this. And so for our lead medical devices, we have 10 mils of gel coat applied into the joint at the end of an orthopedic surgery and we have two mil two milliliters per kilogram body weight for our IP code at the innovative gynecological or abdominal surgery. We're focused on three large markets the US, Japan and Europe. And so within four to five years of launch and ramp up within these territories, we see the go to market is trading over two and a half million surgeries annually for sales of over one and a half billion dollars. Our products confer a number of competitive advantages including within the subdominant gynecological landscape. So we've shown again, in this preclinical model head to head comparisons, we have superior efficacy compared with film gel, and then one non performing liquid product that's on the market. In addition, as a liquid that flows just like water, our product is really fast and easy to use. In the US, we're going after surgical adhesions within the orthopedic space first, this is the largest and fastest way to major market approval in the US. In the US we have over 2 million knee and shoulder surgeries every year. And with no direct competitors. The indirect competitors, if you will, are really twofold. One is there's painful daily physiotherapy where patients have to flex their near their shoulder to continuously break apart these adhesions. And the second is to have a read operation or a procedure to break apart or to license adhesions and of course this is expensive for the health care system. In addition to the seven separate patent families that we have, and these seven seven separate patent families, they provide exclusive and until 2039 and beyond in the US under the hatch Waxman act, we expect that last patent to expire in approximately 2041. We also have complexity trade secrets around how we chemically modify and ultra purified the polysaccharide that is a key component for liquid medical device. We also have complex and trade secrets around the physical chemical structure of our polysaccharide. We're currently running a systematic process we're in discussions with several very large Japanese medical device companies and similarly several very large European medical device companies to partner in those territories are Ark will be providing exclusivity for partners within those territories. In exchange, our partners will be paying full freight to run the clinical trials in their territories and be paying Ark upfront and milestone payments on their development and then royalties on their sales we expect to complete a deal in Japan and separately a deal in Europe prior to the end of 2024. And so in the Japanese partnership our partners will be our partner will run an abdominal efficacy surgical patient clinical trial. In Europe, our partner will run a gynecological efficacy surgical patient clinical trial. In both of these territories, we will obtain approval for gynecological and abdominal open laparotomy and laparoscopy surgeries. These clinical trials then count as pilot clinical trials for the developing In the US, Ark we'll be using the proceeds from current financing or the upfront payments from the partners to pay for an orthopedic proof of concept efficacy clinical trial. And so this space you know, preventing surgical complications it's been active with m&a is including several multi silver recent multibillion dollar transactions. Our experienced leadership team has done this before Allison Crowe in the bottom right hand side of your screen are VP clinical. She has been instrumental in designing and then leading the clinical trials that resulted in approvals for three surgical adhesion prevention products. Dr. Robert Litchfield, our chief medical officer he leads a team of 17 surgeon, key opinion leaders, they all have recent relevant clinical trial experience. We raised 18 million to date and equity remarkably, we've matched this dollar for dollar with non dilutive funds from both revenues and grants. So Use of Proceeds from our current $50 million financing, it's to undertake the proof of concept efficacy clinical trial and orthopedic data readout is in one year, complete the European partnership. Data read out from that as two years launches in three years and it's to complete the Japanese partnership. So data readout is in three years with lunch and approximately four years in Japan. So in summary, here are the key takeaways. We have a large unmet medical need and markets through the prevention of surgical adhesions. We have compelling efficacy and safety data. So we have the four orthopedic surgical patients already treated the favorable outcomes, very large safety trials 76 healthy volunteers proving up the safety of medical devices and superior efficacy in a preclinical model against three of the currently top market products. We have seven separate patent families providing exclusivity until 2039 In the US likely 2041 as well as complexity trade secrets, these products will never be easy to copy. And our professional leadership and clinical teams have done this before. We have three key near term value driving milestones one is undertake the orthopedic proof of concept efficacy clinical trial data read out in one year, complete the partnerships in Japan and Europe. receive those upfront payments and then initiate the gynecological and abdominal efficacy surgical patient clinical trials in our partners territories