Award Abstract # 2027721
SBIR Phase I: MouthLab - A Medical Tricorder Optimized for Real-time, Rapid Assessment of COVID-19 Patients And Those At Risk

NSF Org: TI
Translational Impacts
Recipient: AIDAR HEALTH, INC.
Initial Amendment Date: May 21, 2020
Latest Amendment Date: May 21, 2020
Award Number: 2027721
Award Instrument: Standard Grant
Program Manager: Anna Brady
abrady@nsf.gov
 (703)292-7077
TI
 Translational Impacts
TIP
 Dir for Tech, Innovation, & Partnerships
Start Date: June 1, 2020
End Date: November 30, 2020 (Estimated)
Total Intended Award Amount: $256,000.00
Total Awarded Amount to Date: $256,000.00
Funds Obligated to Date: FY 2020 = $256,000.00
History of Investigator:
  • Sathya Elumalai (Principal Investigator)
    selumalai@aidar.com
Recipient Sponsored Research Office: AIDAR HEALTH, INC
3402 BIRCH HOLLOW RD
PIKESVILLE
MD  US  21208-1839
(443)875-6456
Sponsor Congressional District: 02
Primary Place of Performance: Multisensor Diagnostics (DBA Aidar Health)
2000 Eastern Avenue
Baltimore
MD  US  21231-3036
Primary Place of Performance
Congressional District:
07
Unique Entity Identifier (UEI): JEMYBJLDN1T3
Parent UEI:
NSF Program(s): SBIR Phase I
Primary Program Source: 010N2021DB R&RA CARES Act DEFC N
Program Reference Code(s): 096Z, 8034
Program Element Code(s): 537100
Award Agency Code: 4900
Fund Agency Code: 4900
Assistance Listing Number(s): 47.041
Note: This Award includes Coronavirus Aid, Relief, and Economic Security (CARES) Act funding.

ABSTRACT

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) project is to advance the development of a novel, rapid COVID-19 symptoms assessment and real-time monitoring tool for individuals as well as infected patients and their care providers. The ability to detect all the early/progressive COVID-19 symptoms are invaluable to limit the rapid spread of disease and reduce the overwhelming demand for healthcare facilities, medical supplies, and front-line personnel. Currently, clinical care for COVID-19 is limited to hospitals and traditional healthcare facilities. Unfortunately, physicians still use temperature or subjective symptom data as the sole predictor of infection/disease status. This project will demonstrate a hand-held device to measure 10+ vital health parameters relevant to COVID-19 in just 30 seconds, and a cloud-based triage platform that leverages AI and machine learning algorithms to create a unique remote-monitoring solution for people who are infected or susceptible to life-threatening complications due to COVID-19.

This SBIR Phase I project proposes to customize a device and platform for remote detection and management of COVID-19. This project will advance the development of a device design for remote use and modify the communication protocol to allow the platform to function reliably, even in areas with low cellular network connectivity. Secondly, the project will design a user interface to include a health status indicator via a weighting system optimized for specific parameters (e.g. breathing rate, SpO2, spirometry, temperature). This will enable even general users to understand their health/disease trends based on underlying data and analytics. The proposed project aims to build secure APIs for integrating with existing EMRs to provide data to health systems and federal agencies. Finally, the project will develop an integrated COVID-19 surveillance/triage dashboard for providers and military medics to receive real-time biometric data across populations and geographies to ensure timely intervention and treatment modification.

This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.

PROJECT OUTCOMES REPORT

Disclaimer

This Project Outcomes Report for the General Public is displayed verbatim as submitted by the Principal Investigator (PI) for this award. Any opinions, findings, and conclusions or recommendations expressed in this Report are those of the PI and do not necessarily reflect the views of the National Science Foundation; NSF has not approved or endorsed its content.

Multisensor Diagnostics (DBA Aidar Health) is a healthcare technology and digital medicine company with the mission to enhance the quality of life of patients with chronic conditions. The company has designed and developed a rapid vital health assessment device, MouthLab, that non-invasively measures 10+ vital health parameters including oral temperature, non-invasive blood pressure, respiratory rate, respiratory flow cycle morphology, pulse rate, ECG, oxygen saturation (SpO2), heart rate, heart rate variability, and basic lung functions in just 60 seconds. The data from the device is then sent via cellular network to a secure HIPAA-compliant cloud database, where the data is processed using proprietary algorithms. This data is then available and can be securely accessed by the users for overall health monitoring using a mobile application.

Broadly, the NSF SBIR Phase I project enabled the customization of the MouthLab (ML) device, and the patient mobile application (app), as well as building a novel physician surveillance system for remote detection and management of SARS-CoV-19 (COVID-19). This project advanced the development of the new device design for remote use through the design and execution of the Bluetooth module within the MouthLab device, allowing the reliable functioning of the solution, even in areas with low cellular network connectivity. The project funding also supported the conceptualization and implementation of a health status indicator on the patient mobile app, thereby enabling the general public who might not have the medical or scientific background to better understand the status of their daily health based on objective data collected using the MouthLab device. More importantly, the project helped develop an integrated COVID-19 surveillance/triage web dashboard for physicians through facilitating real-time transmission of key patient biometric data to ensure timely intervention, treatment modification, and prevention of potential complications at a very early stage.

The global COVID-19 pandemic has brought a sense of renewed urgency towards the development and deployment of high-quality, patient-centric, remote monitoring solutions. The societal benefits of this project are substantial. From a public health standpoint, remote monitoring can help avoid healthcare settings being inundated with patients, especially chronic patients who are susceptible to severe complications when they become infected with COVID-19. The MouthLab solution can also help prevent the spread of COVID-19 by allowing infected patients to be triaged and monitored at home rather than visiting an emergency room or clinic, thereby enabling better healthcare resource allocation and risk reduction. The MouthLab device and its supporting software can streamline the assessment and monitoring of symptom progression over days by creating a comprehensive snapshot of an individual?s health. Using the MouthLab remote monitoring solution, we aim to provide improved health outcomes for users through precision medicine, smarter engagement and tracking tools for care providers and caregivers, drug/treatment validation tools for biopharmaceuticals, and cost-effective solutions for payers. 

This project has laid the foundation for the MouthLab solution to emerge as a potent digital health tool that can enable multiple drug-development goals ? greater scientific understanding, more patient centric assessments and improved access to clinical trials which has been significantly disrupted by the pandemic. Ultimately, by leveraging the capabilities of MouthLab, we aim to create a new kind of personalized healthcare experience for users with a primary focus on virtual clinical trials and chronic disease management.

 


Last Modified: 01/26/2021
Modified by: Sathya Elumalai

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