Josh Vose, Tulavi Therapeutics - In Situ Forming Hydrogel Technologies | LSI USA '24

Josh Vose  0:04  
My name is Josh Vose. I'm the CEO of Tulavi Therapeutics. I'm here to tell you this morning about why we are driven to advance peripheral nerve care. We have a suite of innovative insight to forming hydrogel technologies that are tailored to meet the individual needs of each nerve and expand accessibility in nerve care. Now, I think you're probably asking yourself who needs peripheral nerve care? Answer is frankly, a lot of us between traumatic and decompressive surgeries over a million cases a year that impact peripheral nerves and peripheral nerve pain, and amputations. There's an IT population of over 2 million individuals in the US 80% of whom have post amputee pain, with an incidence of over 230,000 additional cases including major limb and digital amputations. So Why care about peripheral nerves? Well, the answer is, outcomes really aren't that great. If you have a limb or a finger amputated, chances are about three and four that you are going to have chronic pain postoperatively 20% of decompression so things like carpal tunnel and cubital tunnel syndrome, undergo revision from inflammation 50% of traumas have long term symptoms from scarring and adhesions. Now, why is this? Well, frankly, the need for innovation in peripheral nerve care has never been greater. The treatment options that have been in the marketplace for nearly three decades are insufficient, and they're limited to specialists. Like the best way to describe a number of these solutions is a hodgepodge of stuff. fairly crude polymeric and biologic tubes and wraps that require microsurgery procedures that take hours to put these devices in place. I'd like to show you our technology and the difference here. So this is a cadaver hand with a digital nerve that's been exposed using our hydrogel as a wrap to protect the nerve post surgery. So the gel is delivered into a silicone form. It is so easy. The surgeon puts it in and gets really the gel sets up rapidly. It's so easy. I mean honestly, it's nice that it's so fast that you don't have to like sit there and wait and get frustrated a peels off the form very quickly. That's not only as a technological leap forward in the field, it will expand expand accessibility in the field beyond microsurgery. Now it's really quite easy to manufacture and deliver. It's a polyethylene glycol hydrogel that's delivered via double barrel syringe, fast and intuitive procedure. We've tailored the individual needs of the individual performance of the compound to the needs of the procedure being done, such that the time to resorption in the body matches the physiologic need of the procedure. There's a polymer solution accelerator solution that are delivered via double barreled syringe through a mixing tip to form the hydrogel. Now our technology addresses the four key elements of nerve care. Number one it blocks axonal escape so prevents neuroma formation and strongly adheres to the nerve and perfectly conforms to it. It cushions with a non compressive protective layer. It eliminates friction because it's hydrophilic. And it optimizes recovery because it's permeable to nutrients but not to the cells that form scar tissue. It's a fast and intuitive application. surgeons do it under direct visualization. It's fast acting and completely sutureless. Our adaptive hydrogel has tailored absorption rates to optimize recovery for our rap product. It resorbs in eight weeks for our cap to prevent neuroma formation after amputation and it absorbs in eight months. We're going to address the outcomes and access gap in peripheral nerve care. So it's designed for clinical need and outcomes as I described. Moreover, it's designed to expand accessibility the polymer is well known to FDA it's easily manufactured at scale has very high gross margins. We're targeting three key markets that represent over a $2 billion opportunity. neuroma prevention alone is over a billion dollars adhesion reduction 400 million and nerve repair post transaction is over a billion dollars as well. The company was founded by Dr. Curran bright unknown nerve expert and Fred Khosravi. First market and aroma Prevention's over a billion dollars. This is targeting post amputation pain So after a limb or a finger is amputated, simply go and cap the nerve. We fit in already to an existing reimbursement landscape as an adjunct to a micro surgical procedure that's going to be our beachhead market. This is our first product that we're waiting on FDA clearance for right now. We know this product works. We've done over six animal studies more than 200 Animals showing zero neuroma formation compared to controls. Our second product, the rap the Velo rap will replace existing solutions already in the market. This market is severely under penetrated. You see there only about 10% has been captured the represents a $400 million opportunity targeting cubital tunnel, carpal tunnel, decompressions and traumatic injuries. We know this product works as well in more than 100 animals across five studies zero adhesion formation. You can see here the color gel at the time of application with the nerve running through it. The coloring clears after a few days, and then eight weeks later, a clean and preserved nerve with no adhesions. The final market our final product is the link product. This is for transected nerve repair. So rejoining two nerves without microsurgery. We are past preclinical proof of concept with this product treated over 20 animals with sciatic nerve transection on a percent success rate. We're very excited about this product. This represents over a $1.2 billion opportunity competing against legacy products. key milestones we are past proof of concept establishing preclinical safety and efficacy for LA and velhos. So the cap and the rap, as well as now the the gaps repair product link. We have six issued patents 10 pending patents in the US and multiple new submissions underway. We have an exciting product pipeline in East stem as well as drug delivery beyond other hydrogel applications. We're waiting on our first de novo clearance right now our second de novo is being submitted next week. For the rap. We've raised over $30 million to date led led by leading venture firms including ascension and de los capital incept and a med ventures. We're looking to raise $30 million to accelerate our commercial plan to expand our product line and to generate clinical evidence. We have an outstanding board of directors and a bright future ahead. Welcome you to join us. Thank you