Empowering Personalized Healthcare
Aidar Health has developed the FDA-cleared and CE-Mark approved MouthLab device, a non-invasive, hand-held, home monitoring tool that measures multiple medical parameters such as – Temperature, Blood Pressure, Heart Rate, Heart Rate Variability, Pulse Rate, SpO2, single-lead ECG, Respiratory Rate, Breathing Pattern/Respiratory Flow Cycle Morphology, and basic lung functions in 30 seconds. The captured data is transmitted using cell network/4G-LTE to our secured HIPAA-compliant cloud. In the absence of cellular connectivity, the MouthLab Device uses the in-built Bluetooth module to transmit the data wirelessly to our cloud using the mobile data. The processed data are displayed in real-time to the user on their personalized mobile application, Aidar Care, and to their care provider’s using a modular web application, Aidar Connect. The Aidar Care is a personalized user-facing mobile application that is used to display the user’s vital signs. The user can view all the measurements collected from the device, with the associated timestamps and navigate to other views that allow them to enter calibration values, manage their calendar, input subjective information, complete daily/personalized surveys, view their profile information. The Aidar Connect, is a web-based surveillance or monitoring dashboard that enabled the physicians and their support staff to monitor the conditions of their patients on a real-time basis and risk stratify the patients based on the deterioration or deviation from their baseline. The company has developed a disease agnostic machine learning algorithm, Aidar Signs, a composite health index in order to help the lay users of the MouthLab device monitor their health.
One of the major factors that differentiates the MouthLab device from other offerings is its ability to measure 10+ vital parameters seamlessly in a non-obtrusive manner in 60 seconds. In terms of usability, the device is significantly simpler – the device assimilates into the life flow of a user seamlessly without requiring the user to change their behavior compared to other wearables which demand a marked behavioral change from the user. This ultimately leads to significantly improvement adherence for the patients who are currently burdened with 5-6 devices on a daily basis. Our team has developed the MouthLab device with a strong focus on patient-centric design and usability as we understand that user adoption of the device is particularly dependent on the comfort levels of the user/patient with the device. Additionally, the scientific basis of the MouthLab device is centered on utilizing the potential of saliva and breath – a medium that is easily accessible, basically non-depletable and holds tremendous promise for medical analysis – to collect vital signs and ultimately to also obtain biochemical and biophysical measurements. In principle, many non-invasive measurements could be obtained by leveraging saliva, breath, light and RF impedance spectroscopy to detect asymptomatic or/and pre-symptomatic conditions through regular vital signs measurement. This is a key differentiator of the MouthLab device as access to breath and saliva provides the unique flexibility for the device to function as a ‘platform’ – allowing for the scope to perform research and development (R&D) activities to continuously enhance the capabilities of the device.
In terms of target customers, our primary focus is serving hospitals and health systems. The FDA-clearance for the Mouth Lab solution has accelerated demand from hospital systems across the country. Our immediate focus is to leverage the MouthLab and associated solutions for virtual care models to manage patients remotely as they transition from acute to post-acute care. The MouthLab along with the technology platform is layered with personalized care pathways to manage patients with heart failure, coronary artery disease, and respiratory illnesses. Aidar aims to support the "home hospital or Hospital at Home" initiative through biomarker-based remote monitoring to lower healthcare costs—through reductions in length of stay, readmissions and emergency department visits, among other measures—and to improve patient outcomes by enabling clinicians to remotely monitor patients and intervene up to 21 hours in advance of when a medical crisis would have otherwise occurred. Additionally, the MouthLab monitoring system can be also reimbursed using the Remote Physiological Monitoring (RPM) and Chronic Care Management (CCM) Services with a 60:40 revenue sharing with the providers and health systems. Aidar will provide its modular disease management solution (MouthLab device, Aidar Care app and Aidar Connect Dashboard) to providers and health systems to manage their patients and will charge on a per member per month (PMPM) basis. This would allow Aidar to receive recurring revenue for our platform and insights, in addition to the device lease costs.
As part of the FDA-clearance process, the MouthLab device has undergone rigorous clinical studies and has been used by more than 100 subjects for all the vital health parameters it measures. Additionally, as part of the IRB-approved study, the device was piloted with over 70 patients at the step-down ward of the Johns Hopkins Medical Institute (JHMI). The user expressed satisfaction in terms of usability and the series of bench and clinical studies conducted in order to validate the accuracy of respiration rate, pulse rate, blood oxygen saturation, blood pressure, ECG and heart rate, temperature, forced expiratory volume (FEV1) and peak expiratory flow (PEF) proved that the measurements from the MouthLab device were on par with gold-standard devices. The clinical studies that are now underway as part of the Heart Failure study at WakeMed and the COVID-19 study as part of the federal contract from BARDA would provide validation with respect to improved patient outcomes and standard of care.
The versatility of the MouthLab device to measure 10+ vital parameters in 60 seconds accompanied by the simplicity of use makes it unique to address chronic populations. Additionally, the range of commercial applications and use-cases that it can potentially help with makes it one of a kind in its group.