Nishit Pancholi, Jointechlabs - Point-of-Care Regenerative Medicine Therapies | LSI Europe '22

Transcription

Nishit Pancholi  0:05  

Thank you, James. Hello everyone. My name is Misha Pancholi. I'm the co-founder of jointechlabs, a regenerative medicine solutions company, we provide FDA cleared technology that empowers natural therapies using regenerative stem cells to eliminate pain and suffering. Body fat is an excellent source of stem cells. What is allowed under the FDA guidelines is processing of this lipo aspirate or body fat down to the level of injectable micro fat, rich fraction of the stem cells preserved in their native niche. This micro fat can be used for a variety of personalized regenerative medicine procedures that have several clinical applications. There are several life enhancing minimally invasive procedures that can be done using micro fat. I'm sure each one of us has seen you know, family and friends suffer from joint problems, chronic non healing ulcers or the use of synthetic materials for a lot of aesthetic and reconstructive procedures. The world is aging, we will double our aging population to 1.5 billion by 2050. So there'll be more and more degenerative problems. All of these and and more can be addressed by using autologous which means your own body cells, not only to eliminate pain and suffering, but also to make and feel much better without any side effects. So what is the bottleneck the way we cannot empower such region at the same procedure procedures at this moment as a standard of care because of its lack to be done at the point of care. Currently, available options are either to build a lab in every doctor's office which is impractical, or to use certain complicated expensive devices that often need a procedure room to operate. Therefore, that restricts the ability of such regenerative medicine procedures to less than 10% of what can be done otherwise. The jointing lab solution for this problem is a range of patented portable affordable medical devices for the US and worldwide market. For the US market. We have an FDA cleared portable disposable medical device called as mini TC, that isolates micro fat at the point of care, which is already being used in a lot of orthopedic sports medicine, aesthetic and reconstructive procedures. For the worldwide market, we have a portable affordable system called as mini stem system, which is essentially a dual function device is does everything what mini TC does isolates micro fat, but also because of the regulatory structure around the world, we can also isolate up your stem cell version using mini stem and that will be available in EU and rest of the world. We have a very aggressive patent strategy with 10 Plus patents granted in the US and worldwide several pending patents and PCT is across the globe, and everything belongs to Jointechlabs. Now the FDA clearance that we have is actually pretty broad, but we're choosing to focus on four primary target markets, which is aesthetic and reconstructive surgery with a regenerative medicine tam of about $6 billion. Ortho biologics are the use of biological treatments for orthopedic and sports medicine conditions, which has a tam of about $5 billion. And of course wound healing with a regenerative component of $5 billion. So this is the basic competition in the United States, the product called lipid gems introduced about four years back, very cumbersome, expensive device, somebody needs to shake the device for about 45 minutes. So all in all, we come in with much better pricing, affordability as well as the ease of use. This is the US the rest of the world landscape where there are a couple of devices that deal only with SPF, they don't do micro fat. So essentially, there is no product in the world that does both micro fat and stemcell version which is SPF, and we are the only ones in the world. So in summarizing the the qualities that we have it's portable, standardized device. We can do both microphone and stemcell. Depending on the regulatory structure of each country, there is no capital cost. And we can use this device as a platform for individual therapies, which I'll explain. We keep our cost of production low and our margins are more than 70% on both the devices. And we have already in the commercial phase in the United States with revenues since late last year. We do produce or manufacture in the US and we have a scalable production capability. We are already working with several US and worldwide distributors, we are about entering out licensing deals and will keep growing across the globe. So all in all, we have an FDA clearance you're already a commercial company in the United States generating revenue and we are growing across the globe. With CE mark and other regulatory approvals coming next year. I want to just shift the focus a bit where we I'd want to explain how we will become an ecosystem of regenerative medicine therapeutics,

so on left is what you see what's available today and already commercializes existing devices. But what we're also doing is building pipeline therapeutic products or biologics using our device as a platform. Our first therapeutic that we have been working on since the past three years, is osteoarthritis critical therapy, which combines the stem cells from our device at the point of care with a hydrogel. And we already have done preclinical studies using NIH funding. And we've penned we are waiting for a pending of phase two approval for NIH clinical studies, which should go through FDA Fast Track program called as armet, which is specific to regenerative medicine. Our second clinical therapeutic product using our devices as a platform is for wounds where we use a cool 3d bioprinting technology, where again, we combine the cells from our devices and use a biopolymer and 3d print on site. To create a wound batch. We have done some preclinical studies at renowned institutions in the US and worldwide. We have an efficient team of professionals, Dr. Nathan gates is my co founder is the CEO more than 30 years of experience in the stem cell and biotechnology space. I have a background in medicine, and we have a great team around regulatory quality marketing and sales. We do work with renowned experts across the globe in the business, clinical and scientific space. This is just a general timeline flow. From where we got the FDA clearance we established US based manufacturing our quality management system. We launched commercial sales late last year, we already are an ISO certified company, we are going as I said for you expansion under seamark, which we should get by q1 of 2023. And also expanding to other geographies across the world. So all in all in about the next two to three years, we will be omnipresent across the globe, with our devices as slowly but surely developing the clinical therapeutic platforms that I mentioned. We do project the revenues to hit about 50 million within the next four to five years with our existing devices products and also the clinical therapeutic platforms that will be introduced within the next three to four years. We have done all of what you saw in the 2 million that we have raised so far. We will be launching late last late later this year. Our our Series A we do intend to raise 5 million on a 20 million valuation primarily for us and global expansion and to lead our clinical therapy development. We will be excellent candidates. All the major med tech companies are still on the sidelines in the regional medicine space watching for the best product to come out. And I think we bit the dual functionality of our devices and the and the therapeutic platform we will have we will be excellent choices for licensing and potential acquisition by big med tech or Pharma. Thank you, I hope we can you can join us in our journey to you know kind of become the best regenerative medicine company in the world. And I'll be happy to answer any questions