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Problem Tech Solves

Tech Brief

The gap driving growth in the home healthcare and remote diagnostics market is two-fold; i) Traditional first line diagnostics (stethoscope, blood pressure monitor, ECG monitor, lung monitor, etc) must move into the home. Accelerated by the Covid-19 pandemic, the need for more robust home healthcare services is no longer in question, as is the need to address significant staffing shortages at in-person hospitals and clinics. ii) The trajectory of the healthcare industry to begin prioritizing patient convenience and a trend within the general population's desire to better manage their own healthcare at home with high user experience, coupled with the providers need for FDA-approved, peer-reviewed, clinical-grade remote diagnosis (as opposed to consumer devices). Nanowear's SimpleSense, uniquely addresses both by allowing physicians to have multi-parametric, scored and summarized clinical-grade patient data trended over time while the patient is in the comfort of their own home. As opposed to a brief point solution reading of blood pressure or ECG for example, now a physician and RN has trended data of a routine cardiopulmonary workup enabling remote diagnosis from continuous blood pressure, ECG, heart sounds, hemodynamics, respiration, lung volume, pulse oxygenation and actigraphy in a time synchronous fashion. This first of its kind digital workup and reporting summary give an individualized picture of each patient's heart, lungs, central vascular and hemodynamic systems; systems that shouldn't be monitored with disparate devices since these systems are contiguous. The platform's machine learning diagnostic ability in multiple diagnostic areas continues to grow stronger with each patient.

Tech Differentiators

There are many connected care and wearable + software platforms in the market today. But Nanowear has the only superpower from Krypton -- the ability to continuously and time synchronously assess the heart, lungs, central vascular and hemodynamic systems in clinical grade with a single cloth device and seamless patient AND provider experience. Nanowear's SimpleSense, therefore, does not have a true mirror or competitor as there isn't a single device that provides an equivalent multitude of services. Other tools and platforms do not replace ALL first line diagnostic tools at once (stethoscope, blood pressure line, ECG monitor, hemodynamic monitor, lung monitor, pulse oximetry and actigraphy). A patient or provider network openly struggles with sending multiple health tools home that are rife with human error and compliance, let alone that these disparate tools do not "talk" to the same back-end. Nanowear's unique and patented nanosensor technology, captures 85 biomarkers every millisecond. Because of the time synchronous, multi-parametric biomarkers and high fidelity signal quality provided, SimpleSense' ability to fuel machine learning diagnostics such as hypertension and worsening heart failure can be validated. This means that physicians are able to see summarized scores of clinical grade data over a trended period, making it easier to diagnose conditions, while reaching more patients in their homes in remote communities in addition to reducing practitioner workflow, particularly when nursing staffing issues are at significant peril. Because the SimpleSense garment is made of cloth, it is comfortable, reusable, scalable and more affordable than most wearables, and certainly implantable devices.


Smart Textile Sensor System for Health Monitoring and Continuous Blood Pressure, enabling Machine Learning-based Hypertension Digital Diagnostic Sites: Westchester Medical Center, Maimonides Medical Center, Clincept Clinical Services, Penn State Health Q2 2021 - Q3 2022 - NY, NJ, PA, GA Objective: To develop and validate a machine learning-based, multi-parameter algorithm for estimating Blood Pressure in hypertensive patients using SimpleSense. 260 patients. Published in Nature Scientific Reports https://clinicaltrials.gov/ct2/show/NCT05473702 ------- Evaluation of Non-Invasive Assessment for Post RFAL Procedure Monitoring Using the Nanowear Wearable Multiple Sensor Vest Sites: Inmode surgical centers in NY, NV, MO, CA Q4 2020 - Q4 2021 Objectives are to prescribe SimpleSense to identify complications post surgical procedure. 93 patients. Published in Aesthetic Surgery Journal https://clinicaltrials.gov/ct2/show/NCT04721405 ------- Nanowear Heart Failure Management Multi-sensor Algorithm (NanoSENSE) Sites: Penn State Milton S. Hershey Medical Center, Medical University of South Carolina and Hackensack University Medical Center Q3 2019 -- ongoing (paused from 2020 to 2022 due to Covid) Study objectives validate a multi-parameter ML algorithm for the detection of worsening heart failure. 29 patients Published in JAMA, Journal of Cardiac Failure, Cardiac Failure Review and Heart Rhythm Society https://clinicaltrials.gov/ct2/show/NCT03719079 ------- The Nanowear Wearable Covid-19 Observational and Analysis Trend (NanoCOAT) Sites: Hackensack Meridian, and Maimonides Medical Center Q3 2020 - Q4 2020 Patients diagnosed with Covid-19 and admitted to ER and wear SimpleSense for 48 hours to track cardio-pulmonary trends during recovery. 41 patients. https://www.clinicaltrials.gov/ct2/show/NCT04717024

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