Xandem Technology LLC — Department of Health and Human Services STTR Phase I: NIDA

Description

DESCRIPTION provided by applicant This proposal investigates the use of a novel passive personal monitoring system to stem the tide in the epidemic of deaths due to unintentional opioid drug overdoses In the U S in opioid drug overdoses including prescription pain relievers and heroin caused deaths a number that has increased dramatically over the past two decades A person who overdoses on an opioid drug can have their breathing slow and then stop during sleep leading to anorexic brain damage or death We propose PlusOne a non contact whole home breathing monitor that is always on and provides early detection of severe respiratory depression and sends an alert in time for intervention to prevent death The overall goal of this project is to develop a beta prototype and to validate the technology in human subject studies This validation will provide the foundation for early commercialization of a consumer respiratory monitor and provide the background for future clinical trials performed in Phase II in order to request FDA regulatory approval for a clinical device Currently at risk patients who live or sleep alone are at high risk for overdose death because periodic visits or monitoring is insufficient to detect an overdose soon enough to prevent death No other non contact breathing sensor or wearable sensor provides robust protection as people donandapos t plan an overdose and thus donandapos t plan to wear or position themselves to be monitored after an overdose PlusOne has been tested with bench studies and preliminary human subject studies The device has shown that it is accurate to within bpm compared to a current clinical standard capnograph and that it can monitor breathing across an entire home The steps outlined in this Phase I proposal will validate the feasibility of the technology through successful development and implementation of real time processing algorithms a human subject study performed on sleeping individuals with sleep conditions i e obstructive sleep apnea restless leg syndrome etc and month long deployments in the homes of healthy subjects Successful completion of these aims will provide verification and validation of the robustness of the solution we propose as well as the commercial viability for deployment in the homes of at risk individuals By initially targeting the market of patients in or recently in rehabilitation treatment we believe PlusOne can achieve a $ million annual revenue and decrease unintentional opioid drug overdose deaths by more than PUBLIC HEALTH RELEVANCE In drug overdoses caused deaths in the US half were due to prescription medications including from prescription opioid medications Opioid drugs inhibit the bodyandapos s breathing processes causing respiration to be depressed or stop completely We will develop PlusOne a radio frequency based whole home non contact breathing monitor that sends alerts to caretakers or if a personandapos s breathing rate falls to a dangerously low level within the home providing an opportunity to save the personandapos s life