Charles Virden, VitalTE - Innovative Drug Delivery Systems | LSI USA '24

Charles Virden  0:05  
VitalTE is a vitality restoration business primarily in the hormone space, sexual hormones in particular, estrogen and testosterone are our target molecules. All of the issues with your vitality are related to your hormone delivery, or lack thereof. This all came about for me personally, approximately 10 years ago, when I had a ruptured posterior cord off my mitral leaflet, I was a surgeon, I'm a plastic surgeon by trade. With over 40,000 patients and a 30 year career, I lost my vitality. with sleep apnea being overweight, being old and tired. I became acutely aware of my own vitality, and as such had to fix that I got my heart fixed. But my hormone levels were female. In the process of understanding the hormone business, it became obvious that this is a trickier business, but a huge addressable market. And it needed some clarification and some fixing.

My company in particular, I'm going to start at the bottom. My invention happened to be a device that puts pellets into the subcutaneous space in a dramatic fashion, which is radically different than the way it's currently done, produces a patient centric improvement in drug delivery. And it's also an easier procedure for the providers to put in. We have an intellectual property covering both the method and also the device itself for the the atraumatic trocar. I have a great team around me, don't worry, I'm not necessarily the smartest one in the group on this one. And our team understands exits and entrances into the biotech and med tech world. Let's talk briefly about what's the addressable market for hormone therapy. It's staggering. It has to do with menopause and andropause, it's a $23 billion industry. It's currently done by about 13 to 15,000 physicians in our country, roughly patients spend about $1,500 per year, and they're about 200 million people eligible for hormone replacement therapy, but only about 20 million partake. So the addressable market is huge. The service of a market is excellent. It affects most of the population after the age of 50. And it all really stems back to your vitality. This is the 510 K exempt device I created it's a blunt tip, most of the trocars. In the market, all the trocars of the market were sharp razor tip, including a bullet tip profile, the atraumatic trocar pushes tissues apart after hydrating the tissue in the method. This allows for the pellet to be seen and absorbed rather easily. So it created a market where the subcutaneous tissue became a reliable delivery plane. And we have about 13,000 procedures done. We've dropped complications from 8% down to less than 1%. And we have a lot of happy patients who have become some of my investors. Recently, we had the four biggest companies come to us hoping that my device could be stolen. I had an infringer, we had to defend the infringement and we did successfully and now they're paying royalties gratefully. And the other four companies now are in discussions with us two licenses trocar. There are 2 million procedures done annually. With our revenue potential. We're looking at about an $8 million ceiling for this particular portion of our company. The thing I want to discuss with you briefly is pelleting. How many in here have heard of pelleting. What it's about right? Hormone Replacement can be creams, patches, gels, and shots. Pellets are the smallest proportion of hormone replacement for a reason. It requires a medical procedure done by medical providers. And it's not quite an easy procedure to do. The old way of doing it with what's called the trocar. It's a device that accesses the body. It was only done with sharp instruments. What they didn't understand that I did as a plastic surgeon is that little yellow space that has fat and microvasculature and vessels are all critically important to leave alone. And when you don't damage that tissue when you place pellets in a row. They're seen very clearly and you get a very predictable delivery of the hormone itself. We have a manufacturing partner now these these are made through me Medline, and the kits are competitively priced. For the same exact cost you get the better mousetrap. We dominate that market and we're looking forward to getting additional revenue, our current revenue is around strand a million for the past year. And with these deals being signed in the next 90 days, we expect that to grow considerably. With this comes the second phase of our company, which is putting our first company out of business. And I know that sounds funny, but bear with me. Hormone replacement has to do with your own receptors being saturated with hormone in pellet form, the pellets broken down by your immune system, little creatures called macrophages go in and they take that pellet away in a very systematic fashion. When that fat is not disturbed. The ideal procedure would not to be doing a procedure, it would be to doing a long acting injectable that does not exist, but we have created one. Over the last nine months, we partnered with a company that makes what are called hydro gels. The hydro gels are a library of how you're on ik acid based delivery systems. And what we can do is coat the small molecule with through a through a procedure called core shells verification, mix it with the hydrogel and then create a log large scale distribution with the same delivery profile as a pellet. But now you can do it with an injection. This is not meant to be understood by you all. It's meant to say that the scientists that have looked at that looked at loading density gel strengths baseline gels enzymes. This basically says the injectable acts like the pellet, that's the most important thing you can take away. This is what we're trying to do. The future of hormone replenishment is to avoid the spikes in therapy, which is rapid rises and rapid falls, so you don't get your symptom relief. But when you have pellets in place, which is the blue background, you have essentially this rapid rise in a slow decline over a four to five month period, which fixes the entire problem of the complication rate and also the compliance rate. This is probably our strongest slide. We have the next generation for pellet delivery, both the method and the path and then the trocar our patented. And the formulas for estradiol and testosterone products are already written and in in the patent office. And we've created a manufacturing process that can withstand this giant market. We have a couple other products to talk about, that are already being looked at. Could you imagine taking the supplement market, including vitamins and minerals and such and putting them into a long acting delivery, where people don't have to have the GI side effects but can get the delivery in a pellet in a in a in injectable form. And that includes also off label medicines such as metformin and a tour of a statin. So we're looking at those as well. From a long term injectable standpoint. We're looking to raise 4.7 million getting us through animal studies. The majority of its in research and development, there's a small amount towards our general administrative and patent writing side. We have a team of excellent people including tech founders, tech eggs, hitters, smarter people than me and hormones, attorneys that understand the regulatory expertise involved in getting these projects finished. These are the companies that might be interested in our exit. And I look forward to answering any questions you might have after the talk. Thank you very much.