Deborah Conley, Myocardial Strain Technologies - Non-Blood Contacting Heart Pump | LSI USA '24

Deborah Conley  0:04  
Thank you to LSI for the opportunity to present I'm Deb Conley, Managing Director and Chief Operating Officer for Myocardial Strain Technologies known as MYST. We have a novel life saving heart pump that leads to early recovery of the heart. It can be rapidly installed and provides diastolic augmentation, which improves heart filling. It is the only device demonstrated to promote the hearts early recovery. Our devices missed one missed one was developed to provide short term circulatory support for those experiencing acute heart failure of cardiogenic shock. Unlike other blood pumps missed one promotes early recovery. By not contacting the blood ms one also avoids the major complications. Blood pumps were developed to treat in stage heart failure and cardiogenic shock. These devices are becoming the standard of care for patients with acute cardiac failure refractory to medical management. These devices contact the blood and require anticoagulation to prevent stroke, such anticoagulation increased increases the risk for bleeding complications, yet, despite anticoagulation stroke and thromboembolism remains significant events. The greatest challenge in from mechanical circulatory support is cardiogenic shock unresponsive to medical therapy. Instituting initially instituting existing blood pumps in a timely fashion is often not possible. Even when successfully installed, they add risk for bleeding, stroke and infection. Furthermore, blood pumps have little direct benefit for the recovery of the heart. The purpose of these devices is simply to restore blood flow and rest the heart. The problems with these devices can be solved by our technology. missed one provide short term non blood contact and support that augments both the filling and the emptying of the heart with no need for anticoagulation. missed one immediately returns physiologic pulse otile blood flow. It's diastolic augmentation is the therapeutic effect that leads to early heart recovery. This device can be rapidly applied through a small incision without blood contact and leads to early recovery. We've conducted over 100 animal studies in which echo imaging is used as a principal tool. Here's an example of an animal model. In severe heart failure. The echo image shown visualizes the heart note that the right and left walls of the ventricles are not moving. The echo images echo emoji and on the left is the severely failing heart from the prior slide. The image on the right is the same heart now supported by missed one. Note that the device supports both right and left ventricles. using sophisticated software echo allows us to demonstrate how missed one augments heart filling which is the therapeutic effect that leads to early heart recovery. No other blood pump directly improves diastolic function and promotes functional heart recovery. Not only do we have compelling preclinical work our clinical results from Duke University Medical Center demonstrate ms technologies proof of concept. All x planet hearts were extensively evaluated by Dr. Keith Reimer a world renowned expert in cardiac pathology at Duke University Medical Center. No heart damage was found in any x planted hearts. Five patients were supported in the series. In in these five cases we distribute we demonstrated successful bridge to transplantation with long, long term survival. We demonstrated immediate return of normal hemodynamics following an acute myocardial infarction with cardiogenic shock. We demonstrated separation from cardiopulmonary bypass following open heart surgery. Notably, all bypass glass grafts were remained Payton without evidence of injury. We demonstrated three months of support a waiting bridge to transplant again, all x planted hearts demonstrated no evidence of injury to the heart muscle. Probably most impressive. An 18 year old girl suffering from acute myocarditis was supported for seven and a half days and recovered uneventfully. She is alive today with normal heart function as evidenced by recent echo. Here's one of our patients after one week of support awaiting heart transplant, he's sitting up talking with his mother able to walk in the room. This quality of life is not possible with other temporary devices. Although we're seeking funding for short short term support, our clinical experience demonstrates a much broader potential for Miss technology. cardiogenic shock remains a challenging clinical problem with high mortality. These patients are among the sickest in the hospital with nearly 50% dying. Existing blood pumps are becoming the standard of care but have had little impact on high mortality and add significant complications. The biggest problem is blood contact. The major complications of blood blood contact again are bleeding, stroke, infection and death. Furthermore, blood pumps deliver non physiologic flow and have no direct benefit for heart recovery. They focus on returning blood flow and unloading the heart. In contrast, our technology is easy to install does not contact the blood. Importantly, missed one augments heart filling of the ventricles, which is the key effect that promotes early cardiac recovery. Our patent portfolio provides protection for a strong competitive edge in the marketplace and encompasses a wide range of innovations aimed at enhancing cardiac function. Our focus extends to both adult and pediatric populations for acute recovery of the failing heart. A minimally invasive device is under development to enable Use by Interventional Cardiologist missed one would qualify for existing billing codes established by CMS, our strategic manufacturing and supply chain partners align our technology for competitive pricing, missed one will mitigate complications, improve outcomes and lower costs. The total addressable market is substantial and continues to grow. As our technology is adopted, the market share progression will broaden to include Interventional Cardiologist missed one is beyond concept the technology has been exclusively evaluated. Recent investigations include over 100, animal studies, and first in human use. Our patent portfolio is solid, we are completing design validations for FDA submission, funding is being sought for clinical trials to establish safety and efficacy for short term support and commercialization. Our business model is about creating the right connections. Our team includes a diverse group of renowned business advisors with extensive background in the medical device industry. Our clinical advisors are well known in the field, and three of which have had hands on experience with our device. We are aligned with experts small business, manufacturing and engineering partners who have unique innovative skill sets specific to our technology. The future of our companies promising we have a proven technology, patent protection and a strong team to lead us forward. Our technology addresses a large unmet clinical need missed one will capture a significant portion of the addressable market. The device will change the paradigm of short term Circulatory Support by leading to early heart recovery, not previously realized with other devices. Thank you for your time and your opportunity. We appreciate you visiting our website and connecting with us in the future. Thank you