Dawn Bitz Present Lazzaro Medical at LSI USA '23

Transcription

Dawn Bitz  0:05  

Good afternoon. My name is Dawn Bitz I'm of the President of Lazzaro Medical. So before we get started at Lazzaro Medical, I want to pause. Everyone in this room is doing something essentially in unison. And you're not even thinking about it. We're all breathing. And we're not thinking about it. But for 40 million people in the United States alone, they can't breathe. And every breath they take is important. It's vital. And they take them, they take something, they don't take something for granted that we take for granted every single day. However, about 20% of those patients actually have a disease that we say is one of the most common diseases that you likely have never heard of. And that disease is called tracheal  bronchial Malaysia, or TBM, for short. And what happens with TBM is that as we age, genetic factors, of course, as well, smoking, obesity, immune, corticosteroids and other inflammatory issues actually cause the cartilage and our trachea to decompose or to change its structure. The strike is become very flaccid, they become flattened. As you can see in the image here. Likely COVID is going to have an effect on this as well in the future. And about 8 million people alone have tracheal bronchial Malaysia, with about 4 million of those patients actually having a severe enough form to warrant surgery. However, the challenge up until this point is that the surgery was horrific. The surgeon would literally have to cut you from stem to stern, open up your ribs to be able to access the back of your trachea. Now unfortunately, many of those patients couldn't survive or even be eligible for that surgery. Until Lazaro medical came along. We have pioneered and developed and we are the innovators of an entire breadth of solutions for tracheal bronchial Malaysia. The first step was actually to pioneer a minimally invasive robotic procedure to treat TBM. That was actually pioneered by our co founder Dr. Richard Lazzaro, one of the world leaders in robotics, particularly in the thoracic space. Now, interestingly about this procedure specifically is that this is solely a surgical intervention. No pharmaceuticals can actually treat tracheal bronchial Malaysia, because it is fundamentally a structural mechanical issue with your trachea. And because it is so critical and so delicate, really only a robotic procedure can actually achieve this. And we have actually pioneered that first minimally invasive robotic procedure. In addition to that we actually develop the protocol through Dr. Lazaro to diagnose this disease through a dynamic CT. But we didn't stop there, we actually went on to design a scaffold system that actually goes on the back of your trachea to reinforce your trachea. Now, that's our first product entry. I'll tell you a little bit more about it very shortly. Additionally, we're in the process of developing with a strategic partner in our future, an entire training academy to drive an understanding of the disease, as well as to train the physicians and the surgeons how to actually treat this disease. And then through our series, series, A or upcoming series A, that will actually continue to start the engine on our entire platform, where we'll actually continue to develop our diagnostic tool as well as a double lumen endotracheal tube with optics. Now, we filed patents, of course, on all of our product portfolios, we'll talk about the specifics on the LM scaffold. But before I move on, we've actually just recently filed six patents on our diagnostic scope in preparation to go forward with our Series A now I don't want you to hear from me. I want you to hear from patients. And actually, I'm going to read you something. So this is from one of our patients. Not sorry, not not one of our patients, but this is from a very active social media group of patients who are seeking treatment for TBM. And this came in physically this morning. Hi, everyone. I am so new to this and I feel really lost. I just found out that I have tracheal bronchial Malaysia. She goes on to say this feels like it's been an uphill battle, figuring out what's going on with me. Now that I have a diagnosis, I have no idea where to go from here. I'm sad. I'm angry for the life I'm leaving behind but also at the same time. I'm hopeful because she has a diagnosis. This is actually one of Dr. Lazzaros patients for two years. Prior to her receiving our surgery, she was on mechanical ventilator. Tim talked about the need and the challenges that occur with patients on mechanical ventilation. She experienced that. Two weeks post surgery, this was her we gave back her life. How was that for lungs? How was that for airflow. Over Christmas, she sent us video of her singing in church. We have so many stories of patients who have actually had this procedure who are now taking back their life. We're entering the market with our very first product here within the next roughly nine months. It's our LM scaffold system, as you can see basically demonstrated here that scaffold goes on the outside of the of the trachea, and the bronchial is to help reconstruct those, those vital organs. FDA 510 K submission is targeted for the summer with commercialization early 2024. I talked about the fact that we have an issued, issued patent on this, we have a pending patent, we have an entire offensive and defensive prep patent strategy as well. And the great thing is, is that this product is actually there are existing DRGs for reimbursement. And this product is estimated to reduce 50% of the operating room time, taking a very, very lucrative DRG for a hospital and making it even more lucrative. And our seed round includes some key strategics. In the robotics as well as in the hospital space. We have a very experienced management team. As you can see here, a couple of them are joining me here in the room, if you'd like to speak to them further, including our CTO, which has an has a history of optics and photonics and AI, really the one driving a lot of our technological advancements for a diagnostic and our double lumen tube. When we talk about what Lazzaro Medical is bringing to the table, number one, we're bringing to the table, an entirely untapped market worth about $40 billion in the US alone, treating a disease that affects many, many people, including probably many that you know, in your day to day lives, patients that have chronic cough that just won't go away, that have COPD, that is refractory to the pharmaceutical interventions, it's just not going away. There's a high likelihood that those patients actually are suffering from tracheal bronchial Malaysia, we're bringing an entire comprehensive suite of products through our platform, opening up a market that is pure white space not only for our investors, our business, our patients, our hospitals and our physicians. This is a surgery that can only be done essentially robotically in a very lucrative way. We have a 510K path through approval on our first product with line of sight and a completed sub q with the FDA in very positive in a very positive way. And by the way, the FDA has identified TBM as a disease that needs treatment. So we feel like we've got some good strong tailwinds. It's patented, and again, existing DRGs that are covering this procedure today with a technology that we're bringing to the table to increase that, that profitability by reducing surgical time by 50%. I invite everyone in this room, your friends, your colleagues to join us at our table in the innovation pavilion, table 10. To learn more about how we're wrapping up our current seed round today. Today our seed round is 5.5 million, 3 million of that has been essentially circled and completed between strategics the additional $2.5 million of that is outstanding we saw circled a chunk of it but looking to complete that and then we are in the on the precipice of opening up our Series A Thank you very much