Juliana Elstad, Vibrato Medical - Non-Invasive Therapeutic Ultrasound Device | LSI USA '24

Juliana Elstad  0:03  
Hello everyone. My name is Juliana Elstad. I'm CEO of Vibrato Medical, a company where we use ultrasound as a therapy to treat peripheral arterial disease. And it's more advanced for chronic limb threatening ischemia or CL TI. CL Ti is a major vascular disease. These patients have chronic pain in their legs. They also have non healing wounds, leading to gangrene. 1/5 of these patients gets amputation within a year of diagnosis, and half within five years. There are over 200 million patients with peripheral arterial disease worldwide, and 18 million in the US, of which 2 million have chronic limb threatening ischemia, or CLT. Ai. There is a strong clinical need in the peripheral arterial disease. current therapies, surgical or endovascular have substantial rate of repeated procedures and complications. More over 20% of patients don't have even these options. They're literally called not option patients. This is costly disease. This interventions cost about 50,000 per patient. In fact, there are so many patients looking for better solutions. And US healthcare system spent so much money on this patience that this disease gets attention of high profile media, there is a strong need for a better therapy, a therapy that could produce better clinical outcomes. A therapy that doesn't have complications, that is preferably non invasive, the therapy that is cost effective. So let me introduce limb Sonic, a device that uses ultrasound at the levels above those of diagnostic imaging, but below those of thermal ablation. Limb Sonic provides this therapeutic ultrasound that promotes vasodilation and vessel growth. It is a array of ultrasound transducers, wrapped around patients calf created acoustic field and treating tibial arteries, the collateral vessels and micro vessels in the muscle, leading to better perfusion, oxygenation and ultimately better clinical outcomes. The device is powered by integrated user interface and power generator, which monitors coupling of transducers and patient compliance. Our feasibility study produced outstanding and statistically significant results. It was a 12 patient study. Each patient received 90 minutes of therapy five days a week, for a total of 30 to 40 treatments over approximately six weeks. In this clinical study, tool perfusion increased by mean 180%. And this increased perfusion was maintained even when ultrasound was turned off. Each patient improved. We also measured oxygenation over the period of six weeks of therapy, the oxygenation total food oxygenation improved by 17% which was statistically significant. We also improve patient's quality of life and receive excellent feedback from the patients about the therapy. We did not have any complications or serious adverse events. Moreover, behind this statistics, there are real patients, patients whose pain went away patients whose wounds healed. Some of the patients in the study were not option patients. Some other patients had lost their leg before the study and we were saving the other leg. The results of this study were presented at the major vascular conference. Viva in fact We are the only company not only last year but in the history of Viva conference that was selected for the late breaking clinical trials. With its first feasibility study, we also presented that American Heart Association Conference that hear more over, we are very fortunate and grateful to have multiple awards from three different NIH Institute's. All of this testified to the solid science and established mechanism of action behind our therapeutic approach. Today, Medicare spends $12 billion annually on CLEIO patients. Current intervention costs on average 50,000 per patient. With vibratos approach, we do not need operating chrome the therapy can be delivered to patients homes or an office substantially saving money to the healthcare system and providing favorable economics. Looking forward, we are currently finishing an arraignment in our second randomized multicenter clinical trial called concerto, after which we will do the pivotal study called Symphony leading to the dinar 510 K submission. In parallel, we also improve our device adding conditional features, making it smaller and even more user friendly. Today, we have raised 9 million in series A and non diluted funding. We anticipate our series B to be 20 to 25 million. We have a very skilled management team. Each member of the management team has decades of med tech experience working at the large as well as startup medical device companies. Our stellar board of directors is chaired by palvelut, Managing Partner and CEO of Sv health. Cumulatively, over the course of our careers, we have raised over a billion dollars, had multiple successful exits and took therapies from early stage all the way to commercialization. So in summary, we are targeting large market with strong clinical needs. Powers solution is based on established mechanism of action, and we demonstrated statistical significance in early feasibility status. We have robust IP portfolio with issued patents, and more in process. We are a VC backed and our management team have strong track record of execution. We offer an opportunity to get to a large clinical market in a relatively fast and efficient way. So if you're an investor interested in producing high returns, while helping patients, please contact us. Thank you for your time and attention.