Video Transcription
John Zak 00:02
Okay. Well, good afternoon, everyone. I'm going to start off by taking you through the journey that is TecTraum, from ideation to product development, through the rigors of clinical trials to today at full commercial readiness. We'll start off by watching a quick video. The
John Zak 00:17
brain is the world's most beautiful machine. It’s non-fire, 286 miles per hour, the brain uncovered the solar system, and it's where our soul lives. Yet we bang around, use it as a battery, and when it's concussed, our only advice is rest. Introducing the world's first concussion treatment Pro to cool for all of those beautiful machines in all of us.
John Zak 00:49
So obviously we're in the concussion space. But imagine a world where patients no longer have to wait to recover. Imagine a world where parents no longer sit idle while their child struggles. Imagine a world where the physician can deliver intervention to improve outcomes. TecTraum has developed the world's first concussion treatment that's designed to be safe, effective, and well tolerated by the patient. We achieved this through software-driven selective, localized cooling over the carotids to remove heat through tech-enabled heat mechanism transfer. Our pathway has taken us through two longitudinal, randomized studies done successfully at major institutions throughout the US. These are pediatric institutions, to name a couple of them, University of Michigan, Cincinnati Children's, former number one children's hospital in the country. We've been able to show clinical efficacy with just 230-minute treatments at six degrees Celsius, and this has allowed for a demonstrable and statistically significant change in clinical signs and symptoms. The regulatory pathway is the de novo pathway. It allows for special controls. Special controls allow for a higher burden of proof for those coming behind, and that will enable some level of market exclusivity for a period of time. We've achieved most of our regulatory milestones to date, with the only major milestone remaining being that market authorization, which we anticipate before the end of the year. TecTraum has been awarded the very first ever CPT reimbursement code from the American Medical Association. Keep in mind, this is before market authorization from the FDA, a highly unusual situation. Although we're still in negotiations with CMS, we've modeled this conservatively, and it shows payback to an institution in less than four months. There's a strong intellectual property estate that is for both the system and method for cooling the brain during injury. We've been issued in the US across the EU, Japan, China, Germany, France, UK, Italy, and now Australia as well. As you might imagine, these are massive markets with very, very large Tams. And in fact, in the US alone, there's a multi-billion dollar addressable market in the capital goods space, as well as in the yearly, annually recurring consumable space as well. Our marketing strategy, we've engaged with a large national firm in the US who has a proven track record with medical devices as well as with Ali Krieger, who is an international football star, women's football star. She is our go-to-market spokesperson. So I ask you, how would you value a technology in a company that has no immediate competition, has platform technology fully developed, first mover advantage in multi-billion dollar markets, was awarded FDA breakthrough designation by the FDA, clinical trials completed, published data, and is commercial ready? We've been well capitalized to date from inception to today, and the next opportunity to invest in the company will be timed at market authorization and it'll be used for inventory ramp. Thank you. We welcome any discussions with any strategics in adjacent spaces. You.
