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.

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. © 2020 Valencell, Inchttps://valencell.com/patents/
Agenda
• Valencell overview
• Biometric monitoring for medical wearables
• Case studies
• Key take-aways

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. © 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. © 2020 Valencell, Inchttps://valencell.com/patents/
Numerous health & medical use cases supported by PPG

6. Biometric Monitoring for
Medical Wearables

7. © 2020 Valencell, Inchttps://valencell.com/patents/
Just because something can be worn,
it doesn’t mean it’s truly wearable...

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. © 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. Valencell
Case Studies

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. © 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. © 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. © 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. © 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. © 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. Thank You!