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Wearable Device for Automatic Delivery of Naloxone during Respiratory Arrest due to Opioid Overdose

Award Number: R43DA049622
ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/01/2020
PERIOD OF PERFORMANCE END DATE: 06/30/2022

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Wearable Device for Automatic Delivery of Naloxone during Respiratory Arrest due to Opioid Overdose - Abstract The United States is experiencing an epidemic of opioid use, which has been declared as a national emergency. During an overdose, the respiratory centers in the brain are suppressed. This leads to dangerous lowering of blood oxygen levels, loss of consciousness, and eventually respiratory arrest and death. There are many initiatives to reduce the death rate from opioid overdosing including providing naloxone, a medication that can rapidly counteract and reverse the effects of opioids, to known drug users, their caregivers, and first responders. Naloxone can be administered via intravenous infusion, intramuscular injection, or nasal spray during an overdose. However, rescuers are often not present at the time of overdose. The National Institute of Drug Abuse has identified the need for technologies to address the opioid crisis including interventions against respiratory depression and has released a specific request for SBIR applications to address this critical need. In response, BioSensics, in collaboration with Baylor College of Medicine (BCM), proposes to develop a wearable system for detection of respiratory arrest due to opioid overdose and automatic delivery of naloxone. The key components of the technology are 1) a wrist-worn device that detects respiratory arrest based on measures of blood oxygen levels, respiration rate, and heart rate; 2) a medication delivery device affixed to the thigh using biocompatible adhesive patches that automatically delivers naloxone intramuscularly when respiratory arrest is detected, and 3) a companion iOS/Android app that will be installed on the user's smartphone to contact an emergency call center with the user's GPS location when the system is triggered. The Specific Aims of this Phase I SBIR application have been designed to demonstrate the feasibility of naloxone delivery via a wearable patch, validate the physiological measures obtained from the connected wrist-worn wearable sensor, and evaluate technology acceptance from key stakeholders. These are the most appropriate aspects of the system to focus on in Phase I because BioSensics has already demonstrated the capability to build the other components of the system. For example, BioSensics has developed a medical alert senor and companion smartphone app; and has already completed technology and business services integration with a national emergency response call center. The significance of this project cannot be understated. On April 5, 2018, U.S. Surgeon General Jerome M. Adams, M.D., M.P.H., issued a statement urging broader distribution of naloxone into the community. Many other public health agencies including the Centers for Disease Control and the World Health Organization have echoed this sentiment. The use of wearable technology to identify opioid induced respiratory arrest in the field and automatically deliver a life-saving dose of naloxone could save thousands of lives. The combination of these technologies (i.e., wrist-worn blood oxygen monitoring coupled with an intramuscular auto-injector of naloxone) has never been proposed and represents a unique solution to the opioid overdose epidemic.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2020	BIOSENSICS LLC	57 CHAPEL ST	NEWTON	MA	02458	MIDDLESEX	USA	Drug Use and Addiction Research Programs	000	1	7/18/2023	NEW	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $348,832 )
2020	2020	BIOSENSICS LLC	57 CHAPEL ST STE 200	NEWTON	MA	02458	MIDDLESEX	USA	Drug Use and Addiction Research Programs	001	1	8/12/2020	NEW	-$251,242
2020	2020	BIOSENSICS LLC	57 CHAPEL ST STE 200	NEWTON	MA	02458	MIDDLESEX	USA	Drug Use and Addiction Research Programs	000	1	7/1/2020	NEW	$600,074
														Subtotal = $348,832

Grand Total All Awards = $348,832

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Wearable Device for Automatic Delivery of Naloxone during Respiratory Arrest due to Opioid Overdose

Award Number: R43DA049622

ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 07/01/2020

PERIOD OF PERFORMANCE END DATE: 06/30/2022

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