SBIR Phase I: Development of wearable medical device to detect and treat opioid overdose.

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is a novel wearable medical device providing on-demand field delivery of naloxone for intervening in instances of opioid overdose or similar medical emergencies. CDC data indicates opioid overdose was the leading cause of death for Americans under 45, responsible for claiming over 80,000 American lives in 2022. Naloxone delivery represents the current standard method for acutely stabilizing the effects of opioid overdose, but approximately 69% of opioid overdose deaths occur without a bystander present to administer the intervention. This project proposes a wearable device that integrates an external non-invasive sensor coupled with a drug delivery system capable of delivering a subcutaneous injection of naloxone upon opioid overdose. This poses the potential to save 50,000 American lives due to opioid overdose each year. This Small Business Innovation Research (SBIR) Phase I project is to develop and validate two components for a novel external system to detect and intervene during instances of opioid overdose, using sensor-derived measures of oxygen saturation and respiratory rates. A novel self-contained wearable mechanical, low-power drug delivery mechanism and a novel naloxone formulation will be developed and validated for stability under simulated use conditions. The first component, a self-contained patch-based drug delivery platform, will be designed and validated for reliable mechanical delivery, enabling multiple consecutive doses of custom naloxone within the physical and power constraints of the wearable system. The naloxone formulation will be validated for stability during accelerated age testing at elevated temperatures indicative of daily wear conditions. The components will be integrated into a prototype system with the company’s algorithm integrating heart rate, respiration, and oxygenation to complete a prototype system suitable for future human use. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.