Anthony Ruben Presents Blue Halo BioMedical at LSI USA ‘23

Transcription

Anthony Ruben  0:05  

Good morning, everybody. Thank you for coming out. I'm Tony Ruben, CEO of Blue Halo Biomedical. We were formed in 2019. For the sole purpose of commercializing our device, the Blue Halo Coil Catheter, which is a fully internal male urinary catheter and which we feel is kind of the first new catheter since the Foley was introduced in 1935. What probably solve is a very real problem of Kotti catheter associated urinary tract infections. And we do that by fully draining the bladder. We also addressed a very real problem with hai hospital acquired infections, we use a proprietary technology, we have a focused strategy, professional team and lean operation. I don't think there's too many urologists in the room. So let me go over Kati, briefly. It's a $36 billion dollar a year problem. And if you're chronically catheterized, there's about a 90% chance you'll have an infection. Even if you're in the hospital for one day with a procedure, there's about a 5% chance you'll have an infection 13,000 deaths annually in the US 7 million hospital visits. It's a big deal. Okay, so what do we do? How do we work? The traditional catheter is basically a tube that subdivided with basically half of the capacity used to seat it in the prostate with a inflatable balloon, ours is seated directly into the bladder, allowing full drainage. And because we don't need any external bags or anything, it allows users to have full range of bodily functions. So essentially, if you think of your toilet, if you don't flush it overnight, you go in in the morning and you see a little ring of bacteria, that's what happens in the bladder that's not fully drained. So we fully drain the bladder. And in previous studies we've shown that we believe or we can reduce Kotti by about 80%. Higher quality of life and basically in six words for better flow, better outcome better lives. People ask who wins and who loses. In our case everybody wins. Patients have dramatically improved quality of life when we did a feasibility study. One of our subjects unbeknownst to us when skiing at Beaver Creek and was featured on Beaver Creek website is feature the day which skier the day which we joke is our Viagra commercial. But patients can do anything you're physically able to urologists using an existing reimbursement CPT code, make more money, hospitals, and this wasn't initially our Bullseye market. But hospitals have come to us saying we think your device can be a powerful tool in the fight against hai hospital acquired infections, giving them more reimbursement and more money. We've talked to a number of malpractice insurers for actively tracking our results and upon our clinicals will become a lot more directed, perhaps in our use. So of course, the healthcare system addressing us $36 billion dollar a year problem is impacted. Our company has a very simple de risk model of success focusing only on our core competencies we currently received or we're currently in clinical trials having received an IDE from the FDA last year we expect our clinical trials to be completed in q3 2023. We're using we're working with the largest clinic in Texas, the second largest in Florida and we're at the IDI adding t crossing stage with the Mayo Clinic and a major teaching hospital. We're working very closely with the FDA towards a PMA because we're fully internal they felt that was a better path than a 510 K and who are we to argue we have patents pending in the US internationally, and then we expect to commercialize. We expect $10 million run rate with less than 2% of urologists inserting less than half of their traditional catheters with us. Breakeven within six months from launch $20 million run rate in two years and 40 million in three years. We have a number of well thought out commercialization strategies, first working with our clinical urologist, of course. And then as part of our founding group, we have two Board Certified Clinical urologists and they've personally volunteered to go personally detail the largest 25 to 35 practices in the US. Additionally, a number of non affiliated neurologists have talked to us and are very interested in publishing and speaking on our behalf after the clinical results come out. I mentioned hospitals a couple times. We've had a former president of one of the hospital groups approach us and say, you know, we think your product will be an important tool in fighting hai he's become an investor and will be our hospital chain evangelist. And of course, we're working with third party distributors. Core to us as the neurologist, our end customer, they traditionally haven't been treated well by the medical device community. And part of our marketing strategy is to offer them five star concierge level service you Each of them literally is worth a million dollars to us, both of you think about it and present value of cash flows or in terms of exits. So not only is it the right thing to do, it's the right thing for our company to do. Our team, our founding team is made up of a balance of four, as I mentioned, two board certified neurologist and two seasoned business professionals. Dr. Gaines. Hammond is our inventor, currently practicing neurologist, board certified serial entrepreneur. Dr. Byron Hodge is an internationally recognized researcher and clinician. I'm serving as CEO and Rogers Kervin. Again, serial healthcare intrapreneur is our head of business development, the total addressable market, we're dealing with his large $5 billion. In the US alone, there's 250,000 chronically catheterized patients, 4 million men receive catheters in hospital visits each year and the self Kath market is an astounding 90,000, just on Medicare market that we probably won't directly attack, we expect to have about $33 million in sales by year three. And from a buyer perspective, there's just with a modest market share in the US a $2 billion value creation or raise which is miniscule for this group is currently about 500,000, most of which will be done by our existing shareholders. And upon completion of our clinical studies, we'll be looking to raise one to $2 million, which will fund our commercialization, including working capital, enhancing our business development and all the regulatory support that we require. So again, why blue halo, we solve a real problem by fully draining the bladder, which leads to a dramatic reduction in Kotti, which then leads to dramatically improved outcomes quality of life and materially reduce costs for the system. Our company has a focused D risk business plan. We have a skilled, experienced and balanced management team, our capital needs are minimal. We again run a very lean operation and lead to cashflow positive shortly after commercialization. And again, the interest from the community has been tremendous. Thank you for your interest and attention. And if anyone has any questions, I'm happy to answer them. Thank you