A naloxone parachute: novel wearable dual-sensor regional oximeter to detect opioid-induced hypoxia and enable emergent naloxone rescue - sbir phase II

Ended Project Grant Awarded Last action

Award ID
R44DA051257
Recipient
Awarding agency
Obligated
$5,389,396

Award facts

Assistance listing
93.279 Drug Use and Addiction Research Programs
Completion date
Originally
Place of performance
Washington, USA

Award details come from USAspending.gov.

Description

As the agency reported it.

Abstract
Ayuda medical has the vision that no-one should DIE from a treatable medical emergency. Opioid overdoses (oods) are treatable with basic cardiopulmonary resuscitation (CPR), but they claimed over 250 lives each day in the US in 2020. Patients most at risk for OOD are people in treatment for opioid use disorder (OUD) or high impact chronic pain (hicp). The current standard of care to OOD is bystander response (medical or nonmedical), but the bystander needs to know that an OOD is occurring. We present a wearable medical diagnostic device to detect OOD and bridge the GAP to bystander intervention. Our device, parachute armband, will be worn continuously, and will monitor physiologic parameters that indicate OOD, then will use an on-device escalating tonal alarm to summon bystanders, as well as on- device speaker to verbally identify the urgency to get medical help. No wireless connectivity is required for these functions. The armband will also send a bluetooth alert to an adjunct mobile medical application (MMA) on the user's phone, that can reach designated contacts, previously chosen by the device user. This function requires mobile device connectivity, and that the MMA be downloaded prior to the medical event. Company has completed a phase i sbir, sponsored by national institute of drug abuse (nida), that showed the upper arm is a viable location for wearable oximeters, main components of novel device. The addition of phase i innovation corps enabled company to validate minimal viable product (MVP) key features, including escalating alarm and wireless alert. Together our phase i learnings allowed principle investigator (PI) to submit a breakthrough device designation (BDD) request to the FDA. This proposed phase II application will show feasibility of our novel device components to detect gas- induced hypoxia, compared to arterial blood gas (aim 1); sensitivity of device to detect intravenous remifentanil "OOD" and begin alarm algorithm (aim 2); and ability of device communications to send a real-time wireless alert (aim 3). These three aims support device safety and effectiveness. In aim 4, human factors and instructions for use (IFU) are specifically tested in our target population, persons with a history of OUD or OOD. Aim 5 likewise tests the device in our target population, but also adds our target use environment; IT will test device's wearability via 48HR and and two-to-four week take home studies. Together all five aims, along with non-clinical testing of device design and alarms, will support seeking class II marketing via a DE novo submission, with the device indicated for people who use opioids (pwuos) including hicp, and people with a history of OUD that are at risk for OOD. To date there is no FDA approved device to monitor for OOD. We offer a continuous monitor because stressors and triggers to opioid use can be unexpected. The DE novo submission will include data from studies designed for our target clinical scenario (acute opioid ingestion/ administration), and target use environment (ambulatory, at-home). Ayuda medical plans to have several discussions with the united states food and drug administration (FDA), throughout device development and phase II. BDD was submitted in Q3, 2021, and company plans to submit a q-sub clarifying our milestones to approval in Q4, 2021. We plan to use early gas hypoxia studies (aim 1A) to apply for investigational device exemption (IDE), and then perform clinical studies with opioid- specific protocols (aims 2 and 3). This includes feasibility (Q4, 2022) and pivotal (Q4, 2023) studies sponsored by phase II. Continuous interactions with FDA will align company milestones with FDA objectives. Commercialization strategy includes seeking federal medicaid coverage in tandem with FDA approval, as part of a dual-panel

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Original award $911,396
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Quick answers

Who received award R44DA051257?

R44DA051257 was awarded to Ayuda Medical, LLC by National Institute on Drug Abuse (National Institutes of Health) on May 1, 2022.

How much is award R44DA051257 worth?

$5,389,396 has been obligated on R44DA051257.

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