SBIR-STTR Award

Technologies for OUD Prevention, Control and Supportive Care - Development of Patient/Caregiver mobile application and Provider Dashboard
Award last edited on: 8/1/2022

Sponsored Program
SBIR
Awarding Agency
NIH : NIDA
Total Award Amount
$276,150
Award Phase
1
Solicitation Topic Code
279
Principal Investigator
Sathya Elumalai

Company Information

Aidar Health (AKA: Multisensor Diagnostics LLC)

2000 Eastern Avenue Unit 2 & 3
Baltimore, MD 21213
   (667) 225-0471
   N/A
   www.aidar.com
Location: Single
Congr. District: 03
County: Baltimore City

Phase I

Contract Number: 1R43DA053870-01
Start Date: 9/15/2021    Completed: 8/31/2022
Phase I year
2021
Phase I Amount
$221,150
Pain is an important issue for both society and health care. The increasing frequency of individuals with chronicpain as the result of chronic diseases and postoperative pain have directly led, over the past two decades, to theover-prescription and misuse of opioids. In early 2019, an estimated 130 people per day were dying from opioid-related drug overdoses, 2 million people were misusing first-time opioid prescriptions, and almost 33000 deathswere attributed to overdosing with synthetic non-methadone opioids in the USA alone. Even though respiratorydepression and complete respiratory arrest are the major causes of mortality with opioid overdose, there iscurrently a serious knowledge gap in our understanding of the underlying mechanisms of opioid pain relief andrespiratory depression by opioids, and how these mechanisms differ from each other. Aidar Health's ground-breaking technology offers a rapid medical assessment device, MouthLab, which non-invasively measures 10+vital medical parameters in under 60 seconds, and an enterprise platform that leverages data science, to createa new kind of precision medicine through clinical-grade monitoring, at home. A point-of-care solution such asMouthLab is fundamental in understanding the impact of prescribed opioids and synthetic drugs, its impact onthe underlying chronic condition and effectiveness of mitigation strategies. Powered by AI and machine learning,Aidar's proprietary software would be able to provide deeper, real-time insights of subtle changes in physiologyto assist the provider with decisions related to drug titration, treatment changes, adjunct therapies before anyadverse event can occur. MouthLab's ability to combine a wide-ranging spectrum of cardiopulmonarymeasurements (i.e. SpO2, Heart rate, Heart rate variability, Respiratory Rate, Respiratory Flow CycleMorphology, Spirometry), would be able to solve the problem of lack of real-time health insights which wouldhave significant relevance to providers in the treatment development process through the collection of multiplebiomarker data linked to opioid-induced respiratory depression. This product creates a fundamental shift in thetechnology employed at home by identifying early warning symptoms through a multiparameter approach andfacilitates understanding of the underlying mechanisms linking pain relief with control of breathing to identify paintherapies with minimal or no respiratory side effects. The novelty is affirmed with two approved patents and thefreedom to operate analysis that found no prior art of concern. The goal of this project is to develop softwareinfrastructure that would enhance the progressive and holistic monitoring of users experiencing OUD. By the endof this award, the company will test and validate the newly developed software capabilities in a small cohort ofpatients and controls at TentHouse Health & Wellness. Our solution has a validated business model (throughover 100 consumers at Johns Hopkins Hospital and with 6 Pharmaceutical customer interviews) that drive valuefor patients, physicians, biopharmaceuticals, and payers. A successful development of this product is forecastto create 43 new jobs (2022) with an annual payroll exceeding $11.5M. As a direct result of this award, thisinnovative product can reach the U.S. market in 2022, with $123M in projected revenue by 2025. Our mission isto empower the uses and improve the quality of life of every individual with OUD. MouthLab will essentially belike a "˜Check Engine' light for individual with OUD.

Public Health Relevance Statement:
NARRATIVE Pain is an important issue for both society and healthcare. In the USA, the annual burden on society has been estimated at $560-$635 billion. The increasing frequency of individuals with chronic pain as the result of chronic diseases and postoperative pain have directly led, over the past two decades, to the over prescription and misuse of opioids. Using Aidar's rapid health assessment device, MouthLab, we aim to measure 10+ vital health parameters and by developing unique software capabilities we offer providers and caregivers the access to user- level data and key health insights, in real-time, for early detection of health deterioration and timely intervention at home. By removing the barriers to clinical care and research, we are in parallel capturing the largest digital dataset on human health and disease, which will transform our understanding of health, behavior, and OUD-related mitigation strategies.

Project Terms:
Accounting ; Adult ; 21+ years old ; Adult Human ; adulthood ; Pain management ; Pain Control ; Pain Therapy ; pain treatment ; Analgesics ; Analgesic Agents ; Analgesic Drugs ; Analgesic Preparation ; Anodynes ; Antinociceptive Agents ; Antinociceptive Drugs ; pain killer ; pain medication ; pain reliever ; painkiller ; Opioid Analgesics ; opiate analgesia ; opiate analgesic ; opiate pain medication ; opiate pain reliever ; opioid analgesia ; opioid anesthetic ; opioid pain medication ; opioid pain reliever ; opioid painkiller ; Arts ; Breathing ; Respiratory Aspiration ; Respiratory Inspiration ; inspiration ; Award ; Awareness ; Biological Products ; Biologic Products ; Biological Agent ; biopharmaceutical ; biotherapeutic agent ; Cardiovascular system ; Cardiovascular ; Cardiovascular Body System ; Cardiovascular Organ System ; Heart Vascular ; circulatory system ; Chronic Disease ; Chronic Illness ; chronic disorder ; Clinical Research ; Clinical Study ; Communities ; Cues ; Cessation of life ; Death ; Heroin ; Diacetylmorphine ; Diamorphine ; Disease ; Disorder ; Pharmaceutical Preparations ; Drugs ; Medication ; Pharmaceutic Preparations ; drug/agent ; Emergency Situation ; Emergencies ; Exercise ; Fentanyl ; Actiq ; Duragesic ; Fentanest ; Fentyl ; Phentanyl ; Freedom ; Liberty ; Goals ; Health ; Health behavior ; health related behavior ; Heart Rate ; Cardiac Chronotropism ; Hospitals ; Human ; Modern Man ; Interview ; Libraries ; Life Style ; Lifestyle ; Light ; Photoradiation ; Lung ; Lung Respiratory System ; pulmonary ; Mission ; Moods ; mortality ; Nurses ; nurse ; nutrition ; Occupations ; Jobs ; Professional Positions ; Overdose ; Pain ; Painful ; Postoperative Pain ; Post-operative Pain ; pain after surgery ; post-surgical pain ; postsurgical pain ; Legal patent ; Patents ; Client satisfaction ; Patient Satisfaction ; Patients ; Drug Kinetics ; Pharmacokinetics ; Physicians ; Physiology ; pressure ; Probability ; Problem Solving ; Quality of life ; QOL ; Questionnaires ; Shock ; Circulatory Collapse ; circulatory shock ; Signal Transduction ; Cell Communication and Signaling ; Cell Signaling ; Intracellular Communication and Signaling ; Signal Transduction Systems ; Signaling ; biological signal transduction ; Societies ; Computer software ; Software ; Spirometry ; Street Drugs ; Surveys ; Survey Instrument ; Technology ; Testing ; Time ; Unemployment ; jobless ; joblessness ; out of work ; unemployed ; Voice ; Friends ; Generations ; Measures ; Caregivers ; Care Givers ; Businesses ; Healthcare ; health care ; Mediating ; Uninsured ; TimeLine ; chronic pain ; Data Set ; Dataset ; Caring ; Titrations ; base ; improved ; Chronic ; Clinical ; Medical ; Link ; Training ; insight ; Ventilatory Depression ; Respiratory Depression ; depressed breathing ; depression of breathing ; Individual ; Fostering ; Opioid ; Opiates ; Measurement ; Drug usage ; drug use ; mental state ; mental status ; Morphology ; tool ; Supportive Therapy ; Supportive care ; machine learned ; Machine Learning ; Knowledge ; Frequencies ; System ; respiratory ; Visit ; Cardiopulmonary ; Prescription medication misuse ; non-medical prescription drug use ; nonmedical prescription drug use ; prescription drug misuse ; prescription misuse ; misuse of prescription only drugs ; American ; early detection ; Early Diagnosis ; experience ; cohort ; Self Efficacy ; phrases ; Prevention ; Devices ; Reporting ; Social Support System ; Support System ; Deterioration ; Modeling ; behavioral health ; craving ; outreach program ; Property ; QOC ; Quality of Care ; response ; develop software ; developing computer software ; software development ; Adverse Experience ; Adverse event ; Intervention Strategies ; interventional strategy ; Intervention ; Provider ; Pharmaceutical Agent ; Pharmaceuticals ; Pharmacological Substance ; Pharmacologic Substance ; Effectiveness ; Low income ; Symptoms ; Adherence ; Data ; Improve Access ; Collection ; Enrollment ; enroll ; Non-Malignant ; nonmalignant ; Monitor ; trend ; Characteristics ; Process ; Development ; developmental ; point of care ; Behavioral ; Health Professional ; Health Care Professional ; Healthcare professional ; virtual ; digital ; functional outcomes ; Outcome ; Expectancy ; innovation ; innovate ; innovative ; addiction ; addictive disorder ; therapy development ; develop therapy ; intervention development ; treatment development ; loved ones ; clinical care ; evidence base ; Biological Markers ; bio-markers ; biologic marker ; biomarker ; product development ; heart rate variability ; overdose death ; overdose fatalities ; prescription opioid ; licit opioid ; opiate medication ; opioid medication ; prescribed opiate ; prescribed opioid ; prescription opiate ; Secure ; synthetic drug ; mobile application ; mobile app ; mobile device application ; Emergency Department Physician ; ED Physician ; ER physician ; Emergency Physician ; Emergency room physician ; biophysical properties ; biophysical characteristics ; biophysical characterization ; biophysical measurement ; biophysical parameters ; precision medicine ; precision-based medicine ; Data Science ; informal caregiver ; Informal care giver ; Caregiver support ; Care giver support ; improved outcome ; opioid use ; opiate consumption ; opiate drug use ; opiate intake ; opiate use ; opioid consumption ; opioid drug use ; opioid intake ; data access ; dashboard ; Longitudinal trends ; Long-term trends ; Longer-term trends ; Longerterm trends ; Longterm trends ; opioid epidemic ; opiate crisis ; opioid crisis ; opioid overdose ; opiate overdose ; opiate related overdose ; opioid drug overdose ; opioid induced overdose ; opioid intoxication ; opioid medication overdose ; opioid poisoning ; opioid related overdose ; opioid toxicity ; pain relief ; relieve pain ; health assessment ; opioid misuse ; non-medical opioid use ; nonmedical opioid use ; opiate misuse ; side effect ; social determinants ; sociodeterminant ; software infrastructure ; electronic consent ; e-Consent ; eConsent ; remote monitoring ; Home ;

Phase II

Contract Number: ----------
Start Date: 00/00/00    Completed: 00/00/00
Phase II year
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Phase II Amount
$55,000