Howard Leonhardt 0:00
Hi everybody, I'm proud to be presenting on behalf of our team that has developed technologies to regenerate organs. We believe people are better off keeping their own organs rather than getting a pig or cow, or sheep, or metal or plastic implant. We built a career around building metal and fabric implants. We built and developed the first aortic aneurysm repair stent graft, sold it to Medtronic, they have a billion dollars in sales each year for that product. We follow that up with the patenting and developing one of the first percutaneous heart valves. Also sold that to Medtronic, they combined it with the core valve technology. It's also one of the leading systems in the world. But along the way, we kind of changed our thoughts, that you're better off keeping your own organs if you can. And we've developed technologies to regenerate your own heart, regenerate your own heart valve, regenerate your aorta. And we're doing that in the same way that these organs are built in the first place. We all develop in our mother's womb, and when we're developing in our mother's womb, is a combination of bio electrics and biologics including stem cells that build our body. And what we're doing is delivering those same methods with the same type of biologic signaling and biologics and stem cells to regenerating organs in people that are older. First, we'd like to thank Scott and the entire team at LSI for holding this conference. What a great meeting emerging med tech right here in our hometown. We're based right here. And we're so proud to have this great meeting in our hometown. I hope you're enjoying our beautiful city here and and thanks to Scott and the whole team for hosting a great a great conference. So for us, we engage, as I said, the natural healing processes when you scrape your knee, a signal goes up to the brain that says injury. The brain sends a bioelectric signal a very specific bioelectric signal that causes the expression of STF1 and PDGF. These are stem cell homing factors, it seeps out from the area of your scraped knee or scraped elbow goes out into the bloodstream and your stem cells that are mostly found in the bone marrow percolate up out of the bone marrow and they migrate to your knee, we've all scraped her knee, we've all scraped our elbow. And when enough of those stem cells aggregate at the scrape knee, they start to starve. A signal goes to the brain saying, Hey, we're all here at the knee, tell us what to do. The brain sends a specific bioelectric signaling down, it reverses the polarity, changes the voltage, and converts those stem cells to new skin on the knee. We're harnessing those natural processes to create a new paradigm for treating human disease and aging. We've been doing this for 40. some years, we did our first heart regeneration case in 1988. We've had a lot of success and a lot of exits over the years. But now what we're doing is basically taking best Practices over 40 years. And we're on the brink of a major breakthrough, and being able to clearly demonstrate and above to show you that we've completed nearly 1000 Clinical patients so far. So this isn't just guessing that this works. We've proven that it works. The problem is, you can't expect to swallow a pill and have your post heart attack, heart, regenerate and turn into beating muscle. There's no pill in the world that's able to do that. The only way you can reverse heart failure and take a scar tissue in the heart and reconverted to muscle is by doing what what we're doing. Our solution is a convergence of biomechanics and biologics for organ regeneration and healing. This is one of our portable stimulators. We have over 800 patent claims for specific biologically signaling sequences and combination of biologically signaling sequences that express specific proteins related to regeneration. We have protein expressions that focus on growing new blood vessels and not just leaky blood vessels that are created with VEGF or vascular endothelial growth factor but matured blood vessels that have to endothelial lining that last over time and do not disappear. Many people know about the early work with Jeffrey Isner there with gene therapy for VEGF, well, like a lot of work, they
gave us a good start in that direction. They just didn't finish the work. We have finished the work we can create new blood vessels with true endothelial lining. We have a whole suite of signals for regenerating muscle, Klotho, fully statin S100 A. These are proven proteins that participate in muscle regeneration recovery, and we have the only patented bioelectric signaling sequences to get your gets your body to express those on demand. Then we have a whole suite of signals for nerve regeneration, Sonic Hedgehog, BDNF and IGF1 amongst others. And When nerve regeneration is necessary, we're able to affect that. We have different stimulators. So you know our technology is primarily software. It's the it's like the Microsoft we have the computer program that teaches stimulators to regenerate the body and we acquire stimulators from different vendors. We have one here in Anaheim, California Mettler electronics. We have one in Brazil that is building customized stimulators for us. And we have suppliers for implantable stimulators, but the key technology is programming just like your computer. The only time it does something good is when you put your Microsoft Word in or your Microsoft Excel or a program that turns that computer into something useful. What we have is the software that turns a ordinary stimulator into a organ regeneration technology. For very serious cases like heart failure, kidney failure, we combined bio electrics with biologics, we we start off trying to solve every problem, which is non invasive stimulation. I'm about to show you a data from our records dysfunction study with non invasive invasive stimulation and over 115 patients. We've had excellent results in reversing erectile dysfunction, and 89% of the treated patients had spectacular improvement of their function, meaning 11% did not so in that 11% where we did not succeed with non invasive bioelectric stimulation alone, where we're regenerating nerves growing blood vessels regenerating muscle, we introduced biologics which are also proprietary to us. And we've developed a mixed composition of basically stem cells and support factors that that affect repair. And we only revert to that if we can't succeed with non invasive stimulation. For us, it all started with the heart, we've raised and invested over $140 million over decades learning how to regenerate hearts. And in 2008, we put together an accelerator to explore whether all the money we spent in all the years we spent on regenerating hearts would apply to other organs. And now we've developed a full portfolio and heart and cardiovascular. One product second heart was a stent that has a pump inside of it a actual physical pump. And it was designed to offload the heart while we were regenerating hearts. Well, we met with a top heart failure doctors in the United States and they told us we want that product separate. So that's the one of only two products in our lineup that are actually not regenerative medicine. It is. It's a stent with a physical pump, and it's turned out to be a big hit in our lineup. That company alone has raised $13 million recently and is moving into clinical trials at Cleveland Clinic in Ohio State this quarter and has a lot of interest. It competes with a company called Abby Med that is has a $15 billion valuation. They're the one and only company in the US market with a similar pump. They have to tether to a motor with a drive line that's outside of their body. We're the first to develop a technology to do this with wireless power. Every other technology you see there relates to our core IP of bioelectrics and biologics. We have a technology for regenerating heart valves that we're really excited about. In the pressure sim technology. We're about to share data on 250 patients where you wear a wristband, and it treats hypertension without drugs, lowering the blood pressure by 10 to 19 millimeters of mercury just by wearing this bioelectric watch or wristband, a few minutes a day. We, we adopted that technology for regenerating hearts to regenerate and brains. And it started with cerebral sell for stroke recovery. And now we have a full lineup of products for non invasive treatment for improving memory for treating depression for treating addiction, stimulating your stomach, which also relates to improving your immune system, and your brain mood. And all of these are either in clinical trials or close to clinical trials.
Major organ regeneration is a category where we capture everything else. We're in our third clinical trial for bladder regeneration, we're in our third clinical trial for kidney regeneration. We've completed successful cases and have patents for treating inflammation. Instim is our technology for treating chronic inflammation, Ulcerative Colitis and Crohn's disease. And we have platforms for a vision recovery and knee recovery. Now our model is that we we get these things off the ground, we get the patents, we get the first inhuman data, and then we spend them out to be a standalone company with their own president, their own management team. And then they then seek a strategic partners with somebody like Medtronic that we've done in the past. When we sold our stent graft to Medtronic, we were at about 27 million in annual running rate of sales and they took it up to 1 billion in sales. Cosmetic and reproductive health. Most of our team is based on cardiologist and people working in the cardiovascular industry. We never thought we were going to be involved with straightening teeth and making skin look pretty and growing hair. But it turned out that the technology that we developed ended up being very useful for that. And now we're taking a little bit more serious and our hope is that we sell off some of these technologies for thickening up your hair and taking away wrinkles in your skin and straightening your teeth. ORTHODONTICELL is an example we've completed two clinical trials, we can straighten teeth in three months. Invisalign, the leader of teeth straightening is a $59 billion company that takes 24 months on average to straighten teeth, and 30% of the time teeth go back to being crooked again, we use bioelectric signaling to release the Ranko protein that loosens up the bone underneath the teeth so we can quickly straighten the teeth. And then we have a signal to release OPG that develops strength of bone to freeze the teeth position so that they stay straight after you've spent all that time and money to straighten the teeth. That's just one example. Stem Cell bra bioelectric bra that increases breast size. We just completed a study of 15 patients in Spain, 1/3 of the women wearing the bra just one hour every other day, increase their breast fullness by 20%, just by recruiting stem cells from their own body to their breast. We never thought we were going to be involved in cancer therapy, we're trying to stay exclusively focused on regeneration using this core IP. But while we were trying to regenerate organs, we found some signals that stopped blood supply and signals that stopped cell division. And now we have a platform for cancer. We have 12 issued patents for biological treatment of cancer. If you're familiar with Novocure $15 billion valuation company using electromagnetic therapy for cancer, less toxic than chemo and radiation. We've completed one feasibility study at UCLA for this we're about to launch another study at a major Cancer Center in Brazil and we're very excited about about the potential of using bio electric therapy to treat cancer forward. A number of our products have 510 K FDA approval, and they are moving to market right now the skin, the hair, the bladder, the teeth, are all ready to move to market. And the last thing I'm going to talk about because I'm out of time is the BOD stim suit. So one of our discoveries and it shows how our company works. We were going after Klotho because we identified Klotho as a powerful agent to regenerate muscle and post heart attack patients we wanted to express Klotho and in many studies have come out since 1997 at demonstrating the Klotho participates in muscle regeneration. It turns out Klotho is much more than muscle regeneration. In fact, it possibly is the most powerful anti aging protein ever discovered. If you are low on Klotho mice that are lower and Klotho die 30% younger mice supplemented with Klotho will live 30% longer if you're low on Klotho higher chance of dementia of Alzheimer's, higher chance of hypertension higher chance of calcification of arteries in the heart valves, higher chance of chronic inflimation. We are able with that BOD stem suit you put that suit on you wear it a couple of times a week, and we can elevate your Klotho levels 150 to 2,300%. If you vigorously aerobic exercise three times a week, you'll raise your cholesterol level 12%. And this is a technology that we're excited about the more we learn about Klotho though, we learned that it really is a magical challenge to me after this meeting, typing Klotho on anything typing Klotho on cancer Klotho or dementia Klotho, hypertension Klotho diabetes, if you're low on Klotho, your aging is accelerated you're, You're heading towards a path to go downhill rapidly. We all know people that are in our peer group that seem to age rapidly I can bet you that if you tested their K level you're gonna find that it's low. People that have normal Klotho level or higher. It's shown that we can set back many of these aging related disorders. Thank you for the time everybody
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