# User-centric development of closed-loop therapy for opioid overdose

> **NIH NIH R44** · RESCUE BIOMEDICAL, LLC · 2022 · $319,995

## Abstract

Project Summary/Abstract
This Fast-Track SBIR proposal will help make significant inroads towards commercializing Rescue Biomedical
LLC's automatic antidote delivery device (A2D2) in order to combat opioid overdose-related deaths. Despite
increasing awareness of the dangers associated with opioids, there were more than 70,000 deaths due to
opioid overdose in 2020. In addition, the rising popularity of illegal synthetic opioids and social isolation due to
the ongoing COVID-19 pandemic is fueling a third wave of opioid-related deaths. Since these illegal drugs are
orders of magnitude more potent than morphine and can cause respiratory failure in minutes, there is very little
time for users to identify and respond to the symptoms of overdose with antidotes like naloxone. The proposed
A2D2 is a low-cost and simple subcutaneous drug delivery capsule that can automatically detect opioid-
induced respiratory failure and release naloxone in a closed-loop manner. It will extend the lifetime of
overdosed patients so that they can receive proper medical care.
In this Fast-Track SBIR proposal, Rescue Biomedical seeks to validate its hypothesis that there is a significant
demand for a wearable-implantable combinational device for automatically detecting and treating opioid
overdose. In Phase I, Rescue Biomedical will work with its collaborator at Indiana University School of
Medicine to quantify users' willingness to use wearable and implantable devices. Furthermore, clinicians and
other stakeholders (e.g., Licensed Chemical Dependency Counselor) will be identified to understand their
willingness to recommend advanced harm reduction devices. Finally, Rescue Biomedical will leverage the
cohort of these stakeholders to validate the overall system design to ensure high compliance and usability. In
Phase II, efforts will be focused on technical integration and performing a pivotal pre-clinical experiment to
demonstrate the closed-loop capabilities to reverse the effects of opioid overdose. Moreover, Rescue
Biomedical will focus efforts for commercialization including regulatory submissions for IND/IDE submission
and performing design verification and validation based on user feedback.

## Key facts

- **NIH application ID:** 10485478
- **Project number:** 1R44DA056277-01
- **Recipient organization:** RESCUE BIOMEDICAL, LLC
- **Principal Investigator:** Vy Le
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $319,995
- **Award type:** 1
- **Project period:** 2022-09-30 → 2025-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10485478

## Citation

> US National Institutes of Health, RePORTER application 10485478, User-centric development of closed-loop therapy for opioid overdose (1R44DA056277-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10485478. Licensed CC0.

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