DEVELOPMENT OF A PEDIATRIC CARDIAC AND RESPIRATORY ASSIST SYSTEM

Inspired TherapeuticsMerritt Island FLis developing a simplecost effectivemechanical circulatory supportMCSsystemINSPIRETMdesigned as a single driver with interchangeable pumps for multiple pediatric and adult cardiopulmonary indications and operational settingsThe goal of this phase I study is to continue development and demonstrate feasibility for pediatric left ventricular assist deviceLVADsupport in a clinically relevant ovine modelCurrentlyoverchildren are hospitalized every year with cardiopulmonary dysfunction or congenital heart defects with limited therapeutic support options availableThe number of children listed for heart transplant continues to growannuallyand is associated with amortality rate while hoping for a donor organwhich is the highest wait list mortality rate of any organ in the USIn responseclinicians depend on adult devices and multiple device systemsdrivers and pumpsto treat a variety of life threatening clinical indicationswhich increases costcomplexity of implantdifferent anatomic fit and fixation challenges and surgical proceduresand post operative managementincreased human errorsand increases the risk of significant adverse eventsthrombusbleedingdevice exchangeThese factors have resulted inmortality rates in pediatric patientsandltyears oldrequiring life saving MCS therapyTo address these limitationsthe Inspired Therapeutics systemINSPIREis being designed to operate a family of interchangeable extracorporealmagnetically levitated pumps configured for multiple clinical indications includingshortup todaysand long termgreater than one yearventricular supportand cardiopulmonary supportextracorporeal membrane oxygenationintegrated respiratory assistcardiopulmonary bypassThe advantages of the INSPIRE system will be improved hemodynamic performance to minimize adverse eventssimplified user interface to minimize human errorsdisposable components to reduce cost byreduced surgical and post operative complexity for improved pediatric patient outcomes and quality of lifeand ease of manufacturing suitable for commercializationIn this SBIR phase I proposalwe will complete the design and fabrication of the INSPIRE systemdriver and pumpand demonstrate feasibility for pediatric LVAD therapyIn a future phase II studywe plan tocomplete engineering development to achieve a design freeze of a clinical grade system in compliance with Good Manufacturing PracticesGMPfor human quality implantdemonstrate efficacy and biocompatibility of the system by completing Verification and initiating ValidationVandamp Vtestingincluding a blood trauma studyandinitiate long term safety and reliability testing of the universal MagLev system for LVAD use in a chronicday pediatric animal modellambstudyThe phase II experimental data will be followed by completion a Good Laboratory PracticesGLPcompliant pre clinical study to support an application to the Food and Drug AdministrationFDAfor clinical trials in pediatric patients with cardiopulmonary dysfunctionOur long term goal is to successfully translate the simplelow cost INSPIRE system into clinical practicewhich may help to standardize and expand the use of MCS therapies for pediatric and adult patients suffering from cardiopulmonary diseases Inspired TherapeuticsMerritt Island FLis developing a simplecost effectivemechanical circulatory supportMCSsystem comprised of an integratedwearable controller with embedded motorbatteryand interchangeable pediatric extracorporealmagnetically levitated pumpsCurrentlytherapeutic support options for pediatric patientsannually with cardiopulmonary dysfunction or congenital defectsare severely limited by dependence upon adult devicescomplex surgical and post op careand external connections resulting in high mortality ratesin pediatric patientsunderyrs oldThe 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