The objective of this proposed effort is to provide pediatricians and neonatologists with a miniature, precision, programmable drug infusion system designed specifically for use in newborn and children. The system will facilitate pediatric infusion therapies, will be convenient and comfortable in use, and will reduce morbidity and mortality associated with dosing errors. In this effort, Sarcos proposes to adapt its MicroPiston pump technology to design, test, and commercialize a small size, lightweight, precise and programmable drug infusion system for administration of medications in newborn and pediatric patients, for hospital and home treatments. The system will also find applications in administration of anticoagulants, thrombolytics, insulin, pain control and protein-based medications. Proposed phased approach, based on the already existing Sarcos' proprietary micropiston technology, is cost effective and maximizes probability of successful outcome. In Phase I, detailed system specifications will be defined, adaptation of the core pumping units, development of a remote programmer and testing of the prototype infusion system prototype system will be accomplished. In subsequent Phase II, clinical studies, regulatory submission / clearance and pilot production will be completed, and system commercialization will be initialized. Development work and subsequent system evaluations and studies will be performed in close collaboration with clinicians.
When fully developed and commercialized, the pump will be used in both hospital and home settings for pediatric (including newborn) patients, as well as for other applications where precision, programmable parenteral administration of non-diluted (low volume) medications is desired, (continuous anticoagulation, thrombolysis, pain control, administration of protein drugs or releasing factors, or baseline and postprandial delivery of insulin in diabetic patients). 10-15% of all newborn in the United States (approx. 400,000 - 600,000 patients) require continuous coverage by neonatologist and they will be the primary candidates for the proposed system.
