Inspired Therapeutics (Merritt Island FL) is developing a simple, cost-effective, mechanical circulatory support (MCS) system (INSPIRETM) designed as a single driver with interchangeable pumps for multiple pediatric and adult cardiopulmonary indications and operational settings. The goal of this phase I study is to continue development and demonstrate feasibility for pediatric left ventricular assist device (LVAD) support in a clinically-relevant ovine model. Currently, over 14,000 children are hospitalized every year with cardiopulmonary dysfunction or congenital heart defects with limited therapeutic support options available. The number of children listed for heart transplant continues to grow (600 annually) and is associated with a 17% mortality rate while hoping for a donor organ, which is the highest wait-list mortality rate of any organ in the US. In response, clinicians depend on adult devices and multiple device systems (drivers and pumps) to treat a variety of life-threatening clinical indications, which increases cost, complexity of implant (different anatomic fit and fixation challenges and surgical procedures) and post-operative management (increased human errors), and increases the risk of significant adverse events (thrombus, bleeding, device exchange). These factors have resulted in 50-70% mortality rates in pediatric patients (<10 years old) requiring life-saving MCS therapy. To address these limitations, the Inspired Therapeutics system (INSPIRE) is being designed to operate a family of interchangeable extracorporeal, magnetically levitated pumps configured for multiple clinical indications including: short (up to 30-days) and long-term (greater than one-year) ventricular support, and cardiopulmonary support (extracorporeal membrane oxygenation, integrated respiratory assist, cardiopulmonary bypass). The advantages of the INSPIRE system will be improved hemodynamic performance to minimize adverse events, simplified user interface to minimize human errors, disposable components to reduce cost by 50%, reduced surgical and post-operative complexity for improved pediatric patient outcomes and quality of life, and ease of manufacturing suitable for commercialization. In this SBIR phase I proposal, we will complete the design and fabrication of the INSPIRE system (driver and pump) and demonstrate feasibility for pediatric LVAD therapy. In a future phase II study, we plan to (1) complete engineering development to achieve a design freeze of a clinical-grade system in compliance with Good Manufacturing Practices (GMP) for human quality implant; (2) demonstrate efficacy and biocompatibility of the system by completing Verification and initiating Validation (V&V) testing, including a blood trauma study; and (3) initiate long-term safety and reliability testing of the universal MagLev system for LVAD use in a chronic 30-day pediatric animal model (lamb) study. The phase II experimental data will be followed by completion a Good Laboratory Practices (GLP) compliant pre-clinical study to support an application to the Food and Drug Administration (FDA) for clinical trials in pediatric patients with cardiopulmonary dysfunction. Our long-term goal is to successfully translate the simple, low-cost INSPIRE system into clinical practice, which may help to standardize and expand the use of MCS therapies for pediatric and adult patients suffering from cardiopulmonary diseases.
Inspired Therapeutics (Merritt Island FL) is developing a simple, cost-effective, mechanical circulatory support (MCS) system comprised of an integrated, wearable controller with embedded motor, battery, and interchangeable pediatric extracorporeal, magnetically-levitated pumps. Currently, therapeutic support options for pediatric patients (14,000 annually with cardiopulmonary dysfunction or congenital defects) are severely limited by dependence upon adult devices, complex surgical and post-op care, and external connections resulting in high mortality rates (50-70%) in pediatric patients (under 10 yrs old). The proposed INSPIRE system features a single driver and family of pumps being commercially-developed to provide cardiopulmonary support for multiple clinical indications and settings to improve pediatric patient outcomes and quality of life.
