Targeted Cerebral Spinal Fluid (CSF) Drug Delivery - Enclear Precision System

Project Summary EnClear Therapies is performing research for a National Institutes of Health NINDS Phase I/II Small Business Innovation Research (SBIR) Parent Grant: 1R44NS135792-01 to develop a novel CNS drug delivery system. EnClear Therapies’ device precisely controls the flow of cerebrospinal fluid (CSF) to address the issue of overcoming the blood brain barrier (BBB) for drug delivery. The system utilizes two access points, the lumbar thecal sac and cerebral ventricle, and a precision pump for controlling the rate and direction of CSF flow between them. The system is capable of controlling CSF flow precisely by utilizing our Sensor Array to understand patients’ physiologic responses and allow the system to adjust drug infusion rate, CSF flow rate, flow direction and to “oscillate” drug concentration over specific tissue targets through a rapid flow reversal mechanism. The device will be used multiple types of CNS therapies including for gene therapies, such as anti-sense oligonucleotides (ASO) for Frontal Temporal Dementia. EnClear Therapies is a small business who will use this supplement to hire a Hispanic male, who is from a socially disadvantaged group as defined by the U.S. SBA. This Long-Term employee will contribute to the completion of the parent Phase I/II SBIR award ongoing research Aims. The immediate impact of this administrative supplement will be to increase diversity at EnClear Therapies and in the United States Small Business workforce. The long- term impact of this administrative supplement will be to help this particular individual hired to contribute to the ongoing research, develop more skills, and launch a successful career as an entrepreneurial-minded independent engineer.