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Best practices in using wearable biometric sensors to prove medical use cases

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The use of wearable devices in health and medical use cases is growing rapidly along with the number and capabilities of wearable devices. The sensor technology embedded in wearables today rivals the capabilities of regulatory-approved medical devices, and in many cases enables new and different use cases than we’ve seen possible before. This session will highlight the best practices we’ve seen emerging recently from real-world projects proving the efficacy of wearable devices in health and medical use cases in the areas of cardiovascular conditions, neurological disease, pain management, and other areas of interest. We’ll also explore the potential pitfalls to avoid and key things to consider when using wearables in proving out your medical use case.

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Best practices in using wearable biometric sensors to prove medical use cases

  1. 1. Best practices in using wearable biometric sensors to prove medical use cases: How to navigate the maze of proving your groundbreaking idea will work Dr. Steven F. LeBoeuf President & Co-founder © 2020 Valencell Inc.
  2. 2. © 2020 Valencell, Inchttps://valencell.com/patents/ Agenda • Valencell overview • Biometric monitoring for medical wearables • Case studies • Key take-aways
  3. 3. © 2020 Valencell, Inchttps://valencell.com/patents/ Hearables Wrist Devices Armbands/Patches Valencell is the company that 1st made PPG truly wearable and suitable for virtually any activity and form-factor PPG before Valencell • Accurate only in hospitals or low activity settings • Didn’t work outdoors (sunlight contamination) • Not part of what people already wear PPG after Valencell • Accurate during virtually any activity • Accurate indoors and outdoors • Integrated within popular consumer form-factors
  4. 4. © 2020 Valencell, Inchttps://valencell.com/patents/ Our partners trust Valencell to enable biometric use cases no one else can Valencell transforms the science of wearable biometrics to enable impactful health outcomes. Valencell provides scalable biometric sensor solutions for wearables, hearables, and health & medical devices Valencell has unmatched expertise & experience in biometric wearables
  5. 5. © 2020 Valencell, Inchttps://valencell.com/patents/ Numerous health & medical use cases supported by PPG
  6. 6. Biometric Monitoring for Medical Wearables
  7. 7. © 2020 Valencell, Inchttps://valencell.com/patents/ Just because something can be worn, it doesn’t mean it’s truly wearable...
  8. 8. © 2020 Valencell, Inchttps://valencell.com/patents/ Medical wearables make the most impact in ambulatory medical use cases • Medical wearables are most relevant for medical devices that must reliably work during everyday life activities, where traditional medical benchmarks cannot function • The definition of “regular life activities” and the required “measurement acuity” are dictated by the intended use (the use case) and the medical claims • Often (although not always) wearable biometrics substantially improve measurement flexibility at the expense of some degree of measurement acuity vs Flexibility Accuracy
  9. 9. © 2020 Valencell, Inchttps://valencell.com/patents/ Four key modes of biometric monitoring are used in medical wearable use cases • Core biometric  replaces an unwieldy medical grade device  PPG-BP monitoring • Proxy  provides a suitable surrogate metric  HRV monitoring for pain therapy • Augmentation  augments monitoring  HRV for enuresis monitoring; sensor fusion • Screening  screens for a potential medical condition  PPG-AFib screening
  10. 10. Valencell Case Studies
  11. 11. © 2020 Valencell, Inchttps://valencell.com/patents/ Valencell – core biometric monitoring Challenge Solution Result • 1/3rd of Americans are hypertensive, but less than ½ of Americans know they have the disease • Cuff-based blood pressure (BP) monitoring technology is cumbersome and non-ambulatory • There is no direct way to measure BP without a cuff • Valencell developed a machine learning model to connect to dots between >15,000 photoplethysmography (PPG) datasets and manual BP readings • This technology was applied to multiple popular form-factors, suitable for ambulatory monitoring • Cuff-like performance has been demonstrated in a 100+ human subject validation study • Evaluation kits are now available for companies building medical wearables • Product development efforts with industry partners are currently underway Valencell provides PPG-based, cuffless blood pressure monitoring technology to the medical marketplace for integration within popular consumer form-factors. Pain Management
  12. 12. © 2020 Valencell, Inchttps://valencell.com/patents/ Sana health – proxy monitoring Challenge Solution Result • Richard Hanbury developed the first device using EEG to save his life after a terrible car accident • EEG electrodes not viable in a wearable device outside the lab • Find a proxy for EEG that could work in a scalable device • Valencell Benchmark® Sensor System embedded in Sana Health mask for HRV biofeedback • Now evaluating a combination of HRV metrics for measuring pain, stress, and relaxation • Product launched in 2020 as general wellness product targeted at stress management (513g) • Great product and customer reviews • Currently in FDA approval process for several indications, including fibromyalgia Sana is a non addictive simple mask and headphones you wear on your head. The device uses audio visual stimulation to increase balance between the left and right side of your brain leading to greater relaxation and pain relief.Sana Health Mask Pain Management
  13. 13. © 2020 Valencell, Inchttps://valencell.com/patents/ GOGO band – augmentation Challenge Solution Result Meet GOGO band, the world’s most advanced solution designed to help keep your child dry and stop bedwetting for good. • Develop wearable solution that can identify physiological signals that predict bedwetting is about to occur (not after) • Device must be comfortable enough for kids to wear during sleep • Tested numerous solutions on the market and “only Valencell was able to maintain 90%+ heart rate metrics efficiency” • Accurate biometric signals from Valencell sensor combined with a Gogo band training sensor and machine learning algorithm • Awakens child before bed-wetting episode • GOGO Band’s Intelligent Predictive Alarm System (IPAS) achieving 75%+ predictive dry rate – better than any other solution on the market GOGO Band Enuresis
  14. 14. © 2020 Valencell, Inchttps://valencell.com/patents/ Kenzen - augmentation Challenge Solution Result Heat stress tracking system for predictive, preventative worker safety • Develop wearable solution that can predict and prevent heat stress in field workers • Device must be accurate for real-time monitoring and alerting, while being rugged enough to survive field work environments • Sensor fusion – incorporated real-time skin temp, environment temp, activity tracking, and heart rate • Valencell Benchmark® BW4.0 sensor system for accurate, real-time biometric monitoring • Commercializing world’s first body heat sensor system • Kenzen is now deploying their system in worksites around the world today Kenzen Patch Heat Stress
  15. 15. © 2020 Valencell, Inchttps://valencell.com/patents/ Apple Watch – screening Challenge Solution Result • Atrial Fibrillation (AFib) impacts > 5 million Americans and increases risk of stroke by 5X • In addition to the significant mortality risks of AFib, the estimated US cost burden is >$3B • Continuous monitoring for AFib is expensive and requires uncomfortable ECG electrodes • A machine learning model was developed to connect the dots between hundreds of thousands of PPG datasets and ECG reading • The machine learning algorithm was integrated into the Apple Watch • Apple Watch Series 4 product launched in 2018 • Combined with an ECG spot-check, the solution has demonstrated sufficient accuracy for FDA approval The Apple Watch atrial fibrillation monitor combines PPG screening with an ECG spot-check.
  16. 16. © 2020 Valencell, Inchttps://valencell.com/patents/ Key take-aways • Companies have seen the best results when starting off with a well-conceived use case • The use case drives the: -- accuracy requirements -- long-term wearability required -- measurement reliability -- viable sensor modalities -- key human factors considerations -- contextual sensing required -- medical claims • The marketplace has proven that it’s OK to trade sensor wearability over sensor acuity for ambulatory use cases • The regulatory strategy naturally flows from the desired medical claims • It always takes a LOT more data than you think – both for building the solution and then for validating the solution
  17. 17. Thank You!

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