Brian Murray Presents Medality Medical at LSI USA ‘23

Transcription

Brian Murray  0:00  

Good morning everybody. My name is Brian Murray and I'm the CEO of Medality Medical. We're a medically medical device research company with a patented platform technology with a number of transformative applications. We are currently pursuing a minimally invasive surgical solution for type two diabetes. Medality story began with Dr. Mark Andrew our founder, and our founder and an ophthalmologist became dissatisfied with the tools available to him. We go became he became dissatisfied with the tools available to him to perform cataract surgery. He developed a technology that allowed the successful removal of cataracts without changing the surrounding tissue. That is when targeted cell separation and extraction technology was born. It is a patented platform technology that has a number of transformative applications which I will describe throughout the course of this presentation. It works by passing a warm low pressure pulse stream of saline or cross the opening with a with a with a rounded non cutting cannula, and it just aggregates targeted soft tissue cells, such as fat cells into small clusters. The temperature, pressure and frequency of the pulsation of the saline flow or patented key parameters to successfully disaggregate such cells. Does this aggregate a cluster of cells are drawn into the stream of saline in the cannula and immediately delivered into a collection canister without harming the surrounding connective tissue, blood vessels or nerves. The cannula is part of a three component system that also includes a console and a single use sterile treatment kit. Following the successful cataract application, Dr. Andrew targeted the technology for the removal of subcutaneous fat liposuction for body contouring. It was then observed that the non invasive and gentle nature of the technology previous to highly viable fat cells that can be reinjected to generate a lasting fat graft in breast reconstruction and in face rejuvenation. Dr. Andrew then expanded the application of the technology to remove visceral fat from the mesentery long thought to be a significant cause of metabolic diseases such as type two diabetes, and cardiovascular diseases, among others. In 2017, Medality received an NIH grant for a baboon study and successfully demonstrated that this technology could safely and effectively remove mesenteric visceral fat from the baboons are minimally invasive technology is the only known procedure today available to remove such fat without jeopardizing the life of the patient due to potential damage to the surrounding organs, blood vessels and nerves. Thus providing the first important proof of concept as such a surgical intervention may be feasible in humans. Importantly, the procedure reduce market metabolic benefits and previously insulin. In previously insulin resistant male obese baboons, reversing insulin resistance and promoting significant weight loss. These results suggested that meaningful clinical benefits may be achieved with mesenteric visceral lumpectomy, which have otherwise failed with other surgical procedures. In light of these positive results, and significant market opportunity addressing the global type two diabetes pandemic Medality redirected its efforts to concentrate on the removal of mesenteric visceral fat in order to improve glycemic control and people with type two diabetes is well understood that visceral fat plays a critical role in the metabolic syndrome visceral fat is more likely to raise the risk for serious medical issues such as heart disease, Alzheimer's stroke, high cholesterol and type two diabetes is also responsible for inflaming the body's tissues and organs and narrowing the blood vessels, thus elevating blood pressure. Second, in 2021, an estimated 537 adults worldwide and 37 million people in the US and as of 2019, we're living with type two diabetes. Diabetes is a progressive disease that is associated with obesity, high blood pressure and elevated cholesterol. When diabetes and other related risk factors are not controlled, they can lead to long term complications such as heart attacks, strokes, blindness, kidney failure, and amputations. Even though many people suffering from diabetes have access to state of the art medical care, a great number of them still do not achieve the therapeutic levels required to reduce the risk of complications, which creates a significant economic burden on society. They therefore represent a population with a need that modalities minimally invasive technology addresses. Based on the success of the baboon trial, Medallia obtained an FDA approval for it first in humans Trial partly funded by an NIH grant. The trial is being conducted at the University of Texas Health Science Center at San Antonio under the direction of Dr. Ralph defronzo, a world renowned endocrinologist to trials primary endpoints are to demonstrate that the NVL procedure is safe and effective evidence by improving glycemic control and no adverse consequent note no significant adverse consequences. The trials are designed for 10 to 12 subjects with a 12 month follow up period for each subject who has completed the Enrollment phase 60% of the subjects have completed their 12 month follow up with one subject completing 18 months. It is a simple procedure completed in less than two hours after a laparoscopic examination to visualize the abdominal cavity and assess the surgical field a one and a half to two and a half inch abdominal incision is made to directly access the area. The visceral fat is then successfully extracted from the mesentery. This this slide you see in front of you presents the before and after images of removal of the visceral fat in a human subject. As you can see the fat has been extracted and the surrounding blood vessels are intact. Not getting this to go. We have another slide here. I'm not moving I can keep talking for that. Oh, there it is. Okay, great. This charter before now this chart indicates that the ratio of the amount of fat removed in millimeters from the mesentery divided by the length of the bow in centimeters is directly correlated to the improvement in a one say confirming positive impact on glycemic control in humans. Preliminary results in subjects were an average ratio of point seven six milliliters per centimeter of fat was removed show a market improvement in glycemic control, a reduction of 1.4% and A1C at 12 months accompanied by a 56% improvement in blood glucose levels and target range measured by a continuous glucose monitor. In addition to such improvement and glycemic control, we observed a reduction in blood pressure of 15 millimeters of mercury and 27 milligrams per deciliter and total cholesterol. These overall improvements have also been observed observed in one patient on her 18 month visit. These promising results I'll be the small sample show a clear positive association between the removal of mesenteric visceral fat and reduction of blood glucose blood pressure and cholesterol levels while being well tolerated. Thus making this procedure a potentially viable adjunct option for the management of metabolic diseases for for people with type two diabetes. Further research is planned for larger cohorts to confirm these results and prepare an FDA application for commercialization. The company's regulatory strategy is being undertaken by MCRO, or CRO, who are CEOs also overseeing the first human trial for us. Prior to modalities initiative of removing mesenteric fat, it received a 510 K clearance from the FDA and demonstrated the success of the technology over other standard lipo liposuction procedures and removing subcutaneous fat to improve body contouring through a clinical trial to technologies we use safely and effectively to remove such fat from over 2000 patients since 2013. As I previously as I previously mentioned, due to the general nature of the technology, the harvesting of highly viable fat cells from subcutaneous fat as possible. Such fat contains very little blood and provides a very robust harvest of clean stem cells that are naturally embedded in fat without requiring any processing to autologous fat transfer application also received a 510 K clearance by the FDA and produce federal favorable results in breast reconstruction, wound healing and facial rejuvenation modalities and processes submitting his third NIH grant application to fund a study focused on addressing hypertension. The technology has demonstrated in one baboons that it can it be used to remove parry renal fat located around the kidneys, and that is linked to hypertension. And in conclusion, the company has two FDA 510 K cleared applications and growing aesthetic markets. It has obtained two NIH grants to support the removal of mesenteric visceral fat, and is in a process of submitting a third application to address the solution for hypertension. This is the only technology that safely removes visceral fat from the mesentery and has demonstrated very promising results very promising role in addressing the Type Two Diabetes pandemic. The company is seeking to raise 15 to $20 million to fund a 50 subject interim trial. This presentation is a short review of Medality's platform technology and we're happy to discuss our company and our strategy was anybody following this presentation thank you very much