Dawn Bitz, Lazzaro Medical - Restoring Healthy Breathing for TBM Patients | LSI USA '24

Dawn Bitz  0:03  
I am Dawn Bitz. I am with Lazzaro Medical. Before we actually get into the presentation, I just want you to pause for a moment your breathing. Now, not everybody can, can say that they many people, they take that for granted, or we take it for granted, because we don't have to think about it. Now I want you to take another moment, take a breath in. Hold that breath in. Now imagine if you were part of the 40 million people that couldn't breathe. And that gasping sensation that happens after you kind of come to the end of your breath, and they can't get that breath. What's very interesting, about 40 million of those patients who have been diagnosed with some form of asthma or COPD, is that really, about 20% of those actually have a disease that you've likely never heard of. And that's a disease called tracheal, bronchial Malaysia. Now, tracheobronchitis Asia, big word small acronym TBM, likely affects about 8 million patients in the US alone. And of those 8 million patients, about 4 million of those patients actively are suffering from a disease that so severe, it's actually causing a quality of life issue. And it's quite an and or it's causing potentially their their ultimate demise. So let me read a very quick excerpt from the very active social media group, the Facebook group of the TBM patients, it's difficult to process when something is stolen from you something as seemingly trivial as a piece of jewelry, missing money from your wallet, or something substantial, like your health shattered by a thing called normalcy. That's what it's like living with TBM. And that's a direct quote from a patient. So TBM is basically you can see here you have your healthy trachea should look nice and open and healthy and capable of creating breath for you. However, as we age, as we get exposed to COVID, as we get exposed to corticosteroids, GERD, all these things, smoking, that actually cause inflammation in the trachea, what happens is the cartilage infrastructure can actually start to break down. And as it starts to break down, you get full acidity in your trachea. And unfortunately, it starts to collapse upon itself and it's manifested very first symptoms tend to be chronic cough. So raise your hand, anybody you know, that's got a chronic cough that just won't go away. Grandmother, Father, personal may be your own person. Think about all of those patients. Now think about those patients that have COPD, but aren't getting better, they're getting worse. They're getting all the right treatments. But unfortunately, they continue to progress in their disease state. Likely the problem is structural with their airways and not something that can be pharmaceutically treated. So at Lazaro medical, what we have done is we've really embraced this whole disease state of TBM. First and foremost, we actually devised a robotic procedure to actually correct tracheal, bronchial Malaysia. So instead of having a big incision that went from stem to stern, to actually open up your ribs to get access to the backside of your trachea, where we treat TBM, we actually have devised a robotic procedure and partnered with some very large robotic company in the medical device industry to really highlight this disease, then what we've done is we've actually developed a scaffold system. And that scaffold system is currently pending FDA, we got line of sight to FDA submission towards the end of the calendar year with 2025 commercialization of this product, it's a 510 K pathway. That's actually some of the milestones that we've achieved since the last time we were held here at LSI. We've had successful pre submission meetings with the FDA, we've got a pending pre submission meeting, we've had a successful feasibility study and animals in the preclinical setting, we've got a pending GLP study, all of which will support that FDA submission. We've also continued to develop, um, training and opportunities to help propagate the knowledge about this disease as well as the treatment options. And then as an organization, we continue to develop ongoing products from a portfolio standpoint to really help treat this disease. But really, it's the patients that we started talking about that we need to really highlight. This is actually one of our patients. Now, today, the physicians have to use a surgical square piece of mesh, they have to trim it they have to MacGyver it they have to be able to finesse it with very highest skill set that they have in their in their skills and only really the top point 1% of physicians can actually do this procedure today because of that MacGyvering but with our technology, really any thoracic surgeon that's robotically trained can do this and get these results. So this is Kathy Kathy was a patient or is a patient with TBM. She was on a mechanical ventilator a homecare ventilator for two years prior to her surgery. This was Cathy after her surgery within two weeks It might have been a little hard to hear is a little faint, but she screens at the top of her lungs. How was that for lungs? How was that for airflow that was two weeks after surgery. So when we're talking about an anatomical fix with a structural medical device that we created a Lazaro medical, that we can get into the hands of really any surgeon, any thoracic surgeon robotically inserted and get those kinds of results. This is essentially a representation of our technology. Again, FDA submission later Later here in 2020. For commercialization early 2025. We of course, have a full patent suite, we've got a great strong 510 K pathway. We have existing DRG and CPT codes, and we have a seed round that's full of strategics. Those strategics include entities like the Mayo Clinic Northwell Health also, again, a large robotic player in the marketplace, we've raised a total of $5 million. Today, we have a pending a very impending $2 million NIH direct to phase two grant that should be awarded within the next couple of weeks. And we have an outstanding $3 million for a total of $10 million seed round, to continue to drive this product to the marketplace. Again, a very well established group of medical team business as well as clinical advisors. And of course, from a summation standpoint, we've got a very large market about $40 billion completely untapped results that actually speak for themselves as you can see a clear FDA pathway through a 510 K as well as patents and reimbursement. With that being said, please join us come see our technology table three. We would love to have you. Thank you very much