Michael Cerminaro, Thrombolex - Family of Endovascular Catheters | LSI USA '24

Michael Cerminaro  0:04  
I'm Michael Cerminaro. I'm co founder, president and CEO of this wonderful company called Thrombolex. We're very excited about the business. It's been a great week here at LSI. Had a really interesting meeting earlier this week with a venture capitalists who said something that stuck with me. He said, like being an entrepreneur of a startup is one of the most difficult things that you can do. He said that 90% of these companies don't make it, which I think everybody here probably knows. He also said, one of the main reasons is because these are companies that in the first several years, you feel like you're walking around in darkness, and it's easy to feel like you've been buried. And he said, it's those entrepreneurs who are thinking outside of the box, who are disruptors, who really change their mindset and understand they haven't been buried that just been planted in thrombo, Lex was planted in 2016. And since 2016, we are now a revenue early revenue company, we develop interventional tools that face off against the venous thrombo embolic. Market. We've got a disruptive platform technology with a breakthrough therapy. And we've demonstrated absolute best in class clinical and safety data relative to our technology. And we face off against a large and growing market opportunity. So what's the problem? The problem is that in the venous thromboembolic market, there's a tremendous unmet clinical need. It's a disease state that's defined by very high mortality, very high morbidity. It affects over 900,000 people in the United States alone. It's one of the leading causes of mortality. Every six minutes in the United States, somebody dies from a blood clot. In the more important aspect of this. It's the number one cause of preventable death in the hospital. So what's the solution? The solution is a novel pharmaco mechanical, licensed technology, an over the wire drug delivery catheter that has a expandable nitinol infusion basket at the distal end that many physicians have called elegantly simple. It's a true platform technology. And today, we have for purpose built devices that are FDA approved for the treatment of pulmonary embolism. For purpose built devices that are FDA approved for the treatment of deep vein in Arterial thrombosis. And as importantly, in early revenue, we have an 89% gross profit margin. We have a highly experienced management team with a bold vision to change the treatment pathology for venous thromboembolic disease. These are folks that have been around the cardiovascular space for decades, they've been involved in the very first development of the very first cardiovascular stent, the very first drug eluting stent, and the very first TAVR platform, as well as the very first interventional technology for treatment of venous thromboembolic disease. As a result of this experience management team, we've been able to bring to market state FDA cleared devices on a budget of less than $30 million. We've recently received a grant from the state of Pennsylvania Department of Health, that's actually going to allow us to increase our manufacturing capacity by fourfold and no cost to thrombolytics. And today we're seeking 15 to $20 million in what will be our first institutional round of funding. In terms of our reimbursement, the number of years ago, as a result of our ability to fragment clot, we received brand new fragmentation codes from CMS that have increased reimbursement for us over 100% for the treatment of deep vein thrombosis and over 150% for the treatment of pulmonary embolism. We have a robust global intellectual property portfolio with 25 granted patents 13 published patents and 12 patents pending and we have a clean freedom to operate opinion. at the tail end of 2022, we completed our pivotal clinical study called rescue. The purpose of that study was to treat acute pulmonary embolism. That was a study that developed and created the absolute best clinical and safety data in our industry. And compared to any contemporary PE clinical study to date. We haven't rested on our laurels and we recently developed a brand new breakthrough therapy which is an on the table treatment for pulmonary embolism. in the cath lab, as a result of that we've launched a brand new clinical study called Rapid PE. The therapy calls for a significantly shorter treatment time, about 30 minutes in the cath lab on the table, no ongoing infusion, we've eliminated completely the need for an ICU stay, we've reduced the lytic dosage to only four milligrams, and that compares to 100 milligrams approved by the FDA for systemic thrombosis. As a result, we believe we're driving a paradigm shift in the treatment of pulmonary embolism. They're really important aspect here that gives me a tremendous amount of excitement is the interventional penetration that we've seen across the entirety of the cardiovascular space. If you think about mi today, 90% of these patients are getting some form of interventional treatment. For triple A stent grafts it's 70%. For heart valve replacement, I can remember less than 10 years ago, you had to be on your deathbed or you couldn't survive open heart surgery, otherwise, you couldn't get that type of treatment. Today, 85% of heart valve replacements are being done with a TAVR or interventional technology in our space for the treatment of venous thromboembolic disease. It's only 13% interventional penetrated, there's a massive opportunity for this to grow to 2030 40% over the next decade, in what's going to get you there an easy to use technology that's better in terms of clinical data and safer. We face off against a very large and growing market opportunity. The current market opportunities well over a half a billion dollars a year. If interventional penetration grows to just 35% over the next several years, that creates a US market that's over $1.6 billion. That's a global market opportunity of over 3 billion. And if the data continues to be as impressive as our rescue data, we're gonna have an opportunity to increase our average selling price, which today is the single lowest ASP in our industry, that's going to drive even further total addressable market opportunities for us. We've got very strong early growth in terms of revenue. Last year, we received our FDA clearance for the treatment of pulmonary embolism. And as a result, we saw a 60% growth in revenue. So far this year, in the first two months, we've seen a 209% increase in revenue, and we're on our way to continue triple digit growth. I mentioned earlier, we have an 89% gross profit margin. We also have a pathway to another two to 300 basis points of margin improvement simply from ongoing growth in our revenue. That's going to lead us towards a very quick insurer short breakeven timeline less than three years. And we're going to see continued growth and accelerated profitability within our business. In summary, we've developed and disruptive platform technology with a breakthrough therapy approach scalable manufacturing capabilities, robust intellectual property, we face off against a large and growing market opportunity. And we've developed a technology that is helping patients and giving them better quality of life. We're seeing better outcomes, and we're hopeful that we're going to see significantly better mortality. And as a result, we feel like we're holding in our hands and opportunity to potentially change the world. So thank you