Doug Evans 0:04
I'm looking forward to telling you about Lungpacer's FDA designated Breakthrough Therapy, which is designed to help acute care patients regain independent breathing faster, and also improve their cardio their pulmonary and the respiratory health faster as well. It all starts with mechanical ventilation. And while truly life saving for patients it also comes at great costs in flicks mental and physical trauma on their bodies, which prolongs their time. On mechanical ventilation, it increases the risk of death. And these are our most costly patients in the health care system today, approaching $100 billion each year. When when we're breathing as we're sitting here today, our diaphragm muscle moves down and out of the way creating space around our lower lungs and they fill with air ventilators work differently. Because the diaphragm doesn't move, the lower lungs are collapsed. And so a ventilator uses pressurized air to expand the lungs. Those two fundamental differences lead to several problems for these patients. The first of which is associated with the diaphragm muscle, which is used to contracting 25,000 times per day. And often sedation or weakness prevents this muscle from working in these individual patients. And it can atrophy at an extraordinary rate losing up to 50% of its muscle mass in just two days. And this prolongs these patients time on the mechanical ventilator. In addition, single setting on a mechanical ventilator can cause both a high pressure, an x over expansion of the upper lungs and a low pressure a D recruitment of the lower lungs at the same time. And even short term exposure to make chemical ventilation for instance, during a surgical procedure has been shown to affect your mortality. The longer you're on a ventilator, the more likely you are to get an infection. This extends your time in the hospital and drives additional costs and also impacts your mortality as well. And 50% of patients on ventilation will have some form of a cognitive injury. And for some, this is lifelong. And this will also impact their chances of dying earlier. And the diaphragm muscle, it's contraction actually preloads blood to our heart. So these acute care patients don't have that benefit of this circulatory assistance. In addition, the pressure that's exerted from the ventilator into the lungs compresses the blood vessels, they're making it more difficult for the heart to circulate blood. So these two factors work against the heart creating additional stress and hardship for it to do its job. And a majority of patients will say that their touch on mechanical ventilation was worse than death. A third of them will actually experience very difficult time breathing, they express it as intense and frequent thirst for air. And that will lead to post traumatic stress up to months after they've left the hospital. And life on a ventilator is traumatic for a patient. I know this, I witnessed it with my son. And this is the hard part of the story to tell. But he was on a ventilator for over a week and why he ultimately weaned he tragically passed away several weeks later. And often in our business. It is true that tragedy can bring about great change. And that's what we hope to do along pacer so I'm going to change and create a better future for these patients. So our first device arrow pace consists of the nerve stimulation catheter, the stimulation console and an airway sensor. The catheter is placed the same way a central line is placed through the subclavian or the left jugular vein and it's extended down in the superior vena cava. signals are sent to the diaphragm muscle to help them contract. When that happens, the muscle gets exercise stay strong or can get stronger. The lungs fill the way we naturally breathe from the bottom with less harmful pressure from the ventilator. And the system can be used with any ventilator. Our first product arrow pace is designed for patients who fail to wean. And our second product era Nova is designed to be used at an early time point to protect these patients from complications. Arrow pace uses a series of physical therapy sessions daily for these patients to help rebuild the diaphragm muscle strength so they can regain independent breathing. Aaron Nova uses continual stimulations from the onset to keep the diaphragm active and strong to fill the lungs more safely and to hopefully improve the health of the patient's cognitive function as well as their cardio and pulmonary function. Now our first product is currently The under FDA review, so details of the data are embargoed during that process. But our clinical data shows that lung patient therapy can improve the diaphragm muscle strength of these patients can wean more patients in a 30 day period than the current standard of care today shortens the time these patients are all mechanical ventilation by several days and reduces the risk of re intubation. So we're looking forward to FDA approval and launch of this product in 2025. Era Nova will be starting its phase two trial later this year. And preclinical, early preclinical and early clinical data has shown that this technology, if used early, can prevent die from Muscle Atrophy can mitigate lung injury can improve cognitive health and in fact, has been shown to be neuro protective and increases cardiac output and heart rate variability. So together we with the data that we have from over 400 patients at our preclinical studies that have been presented in 92 scientific presentations. Sorry about that, as well as 24 publications. We, we are very confident that our technology will be able to transform the acute care treatments of these patients. The initial products will address a 2.5 million patients each year that are in the ICU on mechanical ventilation that the total addressable market value for this group is is exceeding $22 billion. Now we model a very conservative less than 5% market adoption in seven years. As an inventor of angio SIL, which is shown on this slide. I know how challenging it can be to build a distribution channel and bring new and innovative technologies to the market. Yet at 5% market penetration in seven years, this company will be generating a billion dollars in revenue, providing a great return for our investors and also saving billions for the health care system. Our products are going to be directed towards environments of patients that are in high acuity disease states, as well as limited hospital resources. So our value proposition of saving time, and reducing the need for additional procedures should be highly compelling. These patients are treated under existing DRGs. And we will be applying for a new technology add on payment which should be ready by the time we launched the product in 2025. We have a very seasoned battle worn leadership team, a world class clinical advisory board. And we're building a large international intellectual property portfolio which has over 130 patents today and more coming. We'll be raising our Series C in q1 next year to support the commercialization of the aerospace product. And we are looking forward to bringing about one of the biggest changes and respiratory support since the introduction of the mechanical ventilator. We are striving to reduce the trauma that these patients face every day and reduce them morbidity that they suffer after their time on mechanical ventilation. At the same time, we believe we can save the healthcare system second significant amount of money. So we ask that you join us in leveraging this amazing data that we have on our product addressing this $22 billion market opportunity and building a better future for patients like my son. Thank you
CEO Lungpacer Medical: We are developing a novel therapeutic solution for preserving the integrity and strength of the diaphragm muscle, protecting and improving lung and cognitive function, and increasing cardiac output in critically ill patients who require mechanical ventilation. The proprietary Lungpacer system activates the diaphragm using a temporary, minimally invasive, nerve stimulation approach that will save many lives, improve surviving patient outcomes and greatly reduce hospital care costs.
Board Chair TELABio (NASDAQ:TELA), a commercial stage medical technology company focused on designing, developing and marketing a new category of natural tissue reinforcement materials that are purposefully designed to address unmet needs in soft tissue reconstruction.
Board Member WhiteSwell Medical, a private company dedicated to improving treatment of acute decompensated heart failure (ADHF), a primary cause of repeat hospitalization and emergency room visits.
Former Board Member Intact Vascular: Founded in 2011, Intact Vascular developed minimally invasive peripheral vascular products designed to optimize peripheral balloon angioplasty results in the treatment of peripheral artery disease. Acquired by Philips Medical for $360M in 2020.
Former Chief Operating Officer of Kensey Nash Corporation (NASDAQ:KNSY) based in Exton PA, which was acquired for $360M by Royal DSM. Accomplished business leader, strategist, and inventor in the medical device and regenerative medicine field. Results driven leader with experience in growing revenue and EBITDA performance by balancing organic growth initiatives and acquisitions. Serial innovator with 100 issued US patents that cover products which have been used in over 15 million patients world-wide and generated greater than $4 billion in end-user sales.
CEO Lungpacer Medical: We are developing a novel therapeutic solution for preserving the integrity and strength of the diaphragm muscle, protecting and improving lung and cognitive function, and increasing cardiac output in critically ill patients who require mechanical ventilation. The proprietary Lungpacer system activates the diaphragm using a temporary, minimally invasive, nerve stimulation approach that will save many lives, improve surviving patient outcomes and greatly reduce hospital care costs.
Board Chair TELABio (NASDAQ:TELA), a commercial stage medical technology company focused on designing, developing and marketing a new category of natural tissue reinforcement materials that are purposefully designed to address unmet needs in soft tissue reconstruction.
Board Member WhiteSwell Medical, a private company dedicated to improving treatment of acute decompensated heart failure (ADHF), a primary cause of repeat hospitalization and emergency room visits.
Former Board Member Intact Vascular: Founded in 2011, Intact Vascular developed minimally invasive peripheral vascular products designed to optimize peripheral balloon angioplasty results in the treatment of peripheral artery disease. Acquired by Philips Medical for $360M in 2020.
Former Chief Operating Officer of Kensey Nash Corporation (NASDAQ:KNSY) based in Exton PA, which was acquired for $360M by Royal DSM. Accomplished business leader, strategist, and inventor in the medical device and regenerative medicine field. Results driven leader with experience in growing revenue and EBITDA performance by balancing organic growth initiatives and acquisitions. Serial innovator with 100 issued US patents that cover products which have been used in over 15 million patients world-wide and generated greater than $4 billion in end-user sales.
Doug Evans 0:04
I'm looking forward to telling you about Lungpacer's FDA designated Breakthrough Therapy, which is designed to help acute care patients regain independent breathing faster, and also improve their cardio their pulmonary and the respiratory health faster as well. It all starts with mechanical ventilation. And while truly life saving for patients it also comes at great costs in flicks mental and physical trauma on their bodies, which prolongs their time. On mechanical ventilation, it increases the risk of death. And these are our most costly patients in the health care system today, approaching $100 billion each year. When when we're breathing as we're sitting here today, our diaphragm muscle moves down and out of the way creating space around our lower lungs and they fill with air ventilators work differently. Because the diaphragm doesn't move, the lower lungs are collapsed. And so a ventilator uses pressurized air to expand the lungs. Those two fundamental differences lead to several problems for these patients. The first of which is associated with the diaphragm muscle, which is used to contracting 25,000 times per day. And often sedation or weakness prevents this muscle from working in these individual patients. And it can atrophy at an extraordinary rate losing up to 50% of its muscle mass in just two days. And this prolongs these patients time on the mechanical ventilator. In addition, single setting on a mechanical ventilator can cause both a high pressure, an x over expansion of the upper lungs and a low pressure a D recruitment of the lower lungs at the same time. And even short term exposure to make chemical ventilation for instance, during a surgical procedure has been shown to affect your mortality. The longer you're on a ventilator, the more likely you are to get an infection. This extends your time in the hospital and drives additional costs and also impacts your mortality as well. And 50% of patients on ventilation will have some form of a cognitive injury. And for some, this is lifelong. And this will also impact their chances of dying earlier. And the diaphragm muscle, it's contraction actually preloads blood to our heart. So these acute care patients don't have that benefit of this circulatory assistance. In addition, the pressure that's exerted from the ventilator into the lungs compresses the blood vessels, they're making it more difficult for the heart to circulate blood. So these two factors work against the heart creating additional stress and hardship for it to do its job. And a majority of patients will say that their touch on mechanical ventilation was worse than death. A third of them will actually experience very difficult time breathing, they express it as intense and frequent thirst for air. And that will lead to post traumatic stress up to months after they've left the hospital. And life on a ventilator is traumatic for a patient. I know this, I witnessed it with my son. And this is the hard part of the story to tell. But he was on a ventilator for over a week and why he ultimately weaned he tragically passed away several weeks later. And often in our business. It is true that tragedy can bring about great change. And that's what we hope to do along pacer so I'm going to change and create a better future for these patients. So our first device arrow pace consists of the nerve stimulation catheter, the stimulation console and an airway sensor. The catheter is placed the same way a central line is placed through the subclavian or the left jugular vein and it's extended down in the superior vena cava. signals are sent to the diaphragm muscle to help them contract. When that happens, the muscle gets exercise stay strong or can get stronger. The lungs fill the way we naturally breathe from the bottom with less harmful pressure from the ventilator. And the system can be used with any ventilator. Our first product arrow pace is designed for patients who fail to wean. And our second product era Nova is designed to be used at an early time point to protect these patients from complications. Arrow pace uses a series of physical therapy sessions daily for these patients to help rebuild the diaphragm muscle strength so they can regain independent breathing. Aaron Nova uses continual stimulations from the onset to keep the diaphragm active and strong to fill the lungs more safely and to hopefully improve the health of the patient's cognitive function as well as their cardio and pulmonary function. Now our first product is currently The under FDA review, so details of the data are embargoed during that process. But our clinical data shows that lung patient therapy can improve the diaphragm muscle strength of these patients can wean more patients in a 30 day period than the current standard of care today shortens the time these patients are all mechanical ventilation by several days and reduces the risk of re intubation. So we're looking forward to FDA approval and launch of this product in 2025. Era Nova will be starting its phase two trial later this year. And preclinical, early preclinical and early clinical data has shown that this technology, if used early, can prevent die from Muscle Atrophy can mitigate lung injury can improve cognitive health and in fact, has been shown to be neuro protective and increases cardiac output and heart rate variability. So together we with the data that we have from over 400 patients at our preclinical studies that have been presented in 92 scientific presentations. Sorry about that, as well as 24 publications. We, we are very confident that our technology will be able to transform the acute care treatments of these patients. The initial products will address a 2.5 million patients each year that are in the ICU on mechanical ventilation that the total addressable market value for this group is is exceeding $22 billion. Now we model a very conservative less than 5% market adoption in seven years. As an inventor of angio SIL, which is shown on this slide. I know how challenging it can be to build a distribution channel and bring new and innovative technologies to the market. Yet at 5% market penetration in seven years, this company will be generating a billion dollars in revenue, providing a great return for our investors and also saving billions for the health care system. Our products are going to be directed towards environments of patients that are in high acuity disease states, as well as limited hospital resources. So our value proposition of saving time, and reducing the need for additional procedures should be highly compelling. These patients are treated under existing DRGs. And we will be applying for a new technology add on payment which should be ready by the time we launched the product in 2025. We have a very seasoned battle worn leadership team, a world class clinical advisory board. And we're building a large international intellectual property portfolio which has over 130 patents today and more coming. We'll be raising our Series C in q1 next year to support the commercialization of the aerospace product. And we are looking forward to bringing about one of the biggest changes and respiratory support since the introduction of the mechanical ventilator. We are striving to reduce the trauma that these patients face every day and reduce them morbidity that they suffer after their time on mechanical ventilation. At the same time, we believe we can save the healthcare system second significant amount of money. So we ask that you join us in leveraging this amazing data that we have on our product addressing this $22 billion market opportunity and building a better future for patients like my son. Thank you
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