September 18, 2015

The Companys Technology,

Hints Of Its Potential Applications,
And Examples Of Its
Ongoing Or Proposed Clinical Trials.

RDS DEVELOPS, MANUFACTURES AND SELLS

Unobtrusive Band Aid-Like Strips

Called MultiSenseTM

That either record, or transmit in real time,

over a five to ten days period,
the simultaneous time courses of nine or more
physiological parameters.
2

All-In-One MultiSenseTM Wearable Strips

Enable Real Time Comprehensive Health Monitoring
For Both Diagnoses And Follow Ups
ECG Traces/ArrhythmiasData that yield
these
O2 Saturation
parameters
Heart Rate
are monitored
simultaneously
HR Variability
during sleep or
Respiratory Rate
activity, without
Relative Resp. Depth
the burden of
BP Variations
cumbersome
wires or devices.
Temperature
They are either
Activity And Position
recorded for
More To Come
later analysis, or
transmitted
No Other Technology Can
Do All This in
real time, to the

THE COMPANYS GOAL,

AS DEFINED AT ITS FOUNDING IN AUGUST 2012:
To Replace All This

With A Single

And More

Recording/Transmitting
All In One

MultiSenseTM Strip
Sleep Lab Setup,
(Breathing And
Finger O2Sat.)

ResMed ApneaLink

Masimo Rad87

Philips Respironics
Alice PDX

Cardionet MCOT
CardioSpy Holter

Unobtrusive
Wear and forget
At hospital/home
Or on the go
Records data that
now yield
nine physiological
parameters after
downloading via USB,
or when

MultiSenseTM Is No Longer Just A Goal

Over 750 MultiSenseTM Strips have been
manufactured and tested already, many
in clinical trials. RDS has also setup a
manufacturing operation with an Asian
subcontractor. Upon financing, it will
have the capacity to produce Strip in
lots of 10,000 a month, or more.
Initially, these are intended to supply
clinical trials at leading U.S. institutions
where IRB approvals have already been
granted or are being considered.
The Strips, designed for low
manufacturing cost, consist only of:
Three ECG Electrodes,
Photo-Diodes, Photo-Detectors, An
Accelerometer, A Thermo Sensor, and
commercial electronic components in
proprietary circuitry.

Affixed To Chest With A Proprietary,

Composite, Double-Backed,
Throw-Away, Adhesive Assembly,
MultiSenseTM Is Unobtrusive,
Comfortable,
And Water-Proof.
It Enables Determinations of:
Heart Rate And HR Variability.
It Enables Identification of
Arrhythmias,
Derivations of
02Sat., Respiratory Rates And Depths,
Physical Position And Relative Activity,
As Well As Changes
In Blood Pressure And Temperature
5

MultiSenseTM Detects, And Records/Transmits,

Raw, Low-Noise, Diagnostic-Quality, ECG Data
Sleep ECG, HR 54
R
T

P
Q

Walking ECG, HR 90

Jogging ECG, HR 134

P
Q
S

Uncompromised signal whether sleeping, walking or jogging.

Consistent detection of P waves enables identification of a
large number of Arrhythmias.

MultiSenseTM Detects And Records/Transmits,

Together With ECG Data, Information On
Relative Physical Activity And Upright Or Various Sleep Positions
Relative Physical Activity/Attitude 10 min window
Walk

Brisk walk

Upright
Supine:
Left/Right
Front/back

Walk

Corresponding ECG 10 seconds window

Recording Relative Activity May Improve Diagnostic Yield

In The Event Of ECG Anomalies, Arrhythmias
For Example. Was The Subject Asleep Or Running?

Activity Level

Here MultiSenseTM Detects And Records/Transmits

Quality ECG Simultaneously With Increasing Relative Effort
As Subject Strains Up A Treadmill Incline (Green Trace)

Up Treadmill Incline To Target Heart Rate

Walking On Treadmill
Zero Incline

Standing Still

Millivolt

MultiSenseTM ECG at max Heart Rate

Consistent, low noise ECG signals at high activity levels

and elevated heart rate
Corresponding, simultaneous,
V1 Signal from commercial
12 lead ECG

MultiSenseTM Detects, And Records/Transmits, Raw

ECG Data Good Enough To Identify Arrhythmias
Subject wore a MultiSenseTM Strip over a four days period.
The proprietary software package readily picked up from the long
ECG trace this 14 seconds period of super ventricular tachycardia.

MultiSenseTM Detects, And Records/Transmits, Raw

ECG Data Good Enough To Identify Arrhythmias
(Cont.)

Same subject, same long ECG trace as in previous slide included 17 PVCs
Over the four days (not particularly abnormal). 3 are shown below.

ECG Traces From

MultiSenseTM
Are Analyzed For
Arrhythmias By
Licensed, Third Party,
FDA-Approved
Software.

Vernier belt
Amplitude

MultiSenseTM Respiration Rate And Depth Amplitudes

Correlate With Same From Standard Belt/Pressure Monitor

60

300

360

420

480

Time
(sec.)

MultiSenseTM
Amplitude

Breath was held for

15
sec (red
120
180arrow)
240
45 sec (black arrow)

MultiSenseTM was worn by subject simultaneously

with belt/gas pressure monitor

MultiSenseTM O2Sat. Tracks Finger O2Sat. Device

While Providing Patient Position & Respiratory Waveform

Respiratory Waveform &

Orange Line Indicates Patient Immobile, Lying On Back

MultiSenseTM Chest Strip

Masimo Finger Device

MultiSenseTM Breathing Waveform Indicates Depth Fluctuations That Explain O2Sat. Changes

MultiSenseTM Strips Characterize Sleep Disordered Breathing

Through Fluctuations In Several Physiological Parameter
Orange color trace
indicates subject is
asleep on the back.
Amplitudes illustrate
respiration gasps.

Green trace indicates

O2Sat. fluctuations
Blue trace is transit
time between heart
beat and blood pulse
arrival under Strip, an
indicator of BP
variation.
Vertical blue bars are
proportional to each
breaths amplitude.

MultiSenseTM Strips Easily Characterize Sleep Patterns

Here, Physiological Parameters During Normal Sleep

Here, each peak is a breath

Oxygen Saturation steady in normal sleep

Breathing rate and depth

Heart rate variability

Time scale is expanded to show each breath

MultiSenseTM Strips Easily Characterize Sleep Patterns

Here, Physiological Parameters In Apnea-Interrupted Sleep

No Breathing

Oxygen Saturation fluctuates with breathing interruptions

So do breathing rates and depths

As does heart rate to compensate

No other technology can provide all this from one device

Proprietary Software Enables Viewing Cardiac Anomalies

Summary of Pause Anomalies in a several days run. Each blue bar represents an hour; bar
Height is the number of anomalies in that time, pauses in this case. Clicking on a bar (red
line) lists all pauses in that hour in the window to the right; clicking on an event in that
widow (blue), displays the original trace (below), to enable verification, as needed.

Proprietary Software Enables Instant Viewing (Cont.)

Here, analysis of run focuses on Atrial Fibrillations. Each blue bar represents an
hour; bar height the number of AFibs in that hour. Clicking a bar (red) lists all
AFibs in that hour in the window to the right; clicking on an event in that window
(blue), displays the original trace (below), to enable verification, as needed .

Proprietary Software Enables Instant Viewing

(Cont.)

The focus here is on the number of Premature Ventricular Contractions/hour,

same event interpretations as in previous two pages (slides)

Proprietary Software Enables Instant Viewing

The focus here is on the number of Ventricular Trigeminies/Hour,
same interpretations as in previous three pages (slides)

(Cont.)

Proprietary Software Enables Instant Viewing

The focus here is detecting the AFib burden of a patient following
Ablation Therapy.
Same interpretations as in previous four pages (slides)

AFib events are monitored simultaneously with heart rate,

oxygen saturation, respiration rate and amplitude and activity
level/position for comprehensive health assessment

(Cont.)

Ongoing And Proposed Validation Studies

Real-World Clinical Testing Of MultiSenseTM
UCSF Department Of Cardiology Studies Of
Induced PVCs In Pigs
Dr. Yasuaki Tanaka, M.D. (Study completed)
This was a study to develop an animal model of human
cardiomyopathy (CMPY) by inducing
premature ventricular contractions (PVCs) in pigs.
MultiSenseTM Strips, used on 10 pigs, allowed data
collections as long as two days. Other, more bulky
devices rubbed off the pigs in minutes.
This test highlights possible research applications in
animal studies of human disease.

Ongoing And Proposed Validation Studies

Real-World Clinical Testing Of MultiSenseTM

(Cont.)

UCSF Department Of Cardiology

Clinical Trial To Validate MultiSenseTM As An
Ambulatory Detector Of Cardiac Arrhythmias
Dr. Gregory Marcus, M.D (Study ongoing)
The results so far have provided positive feedback regarding
the quality of the data and the patients comfort and
acceptance. They have also highlighted the importance of
matching the third partys licensed, FDA-approved,
arrhythmia detection software to specific characteristics of
the MultiSenseTM electronics.
This work will be ongoing, as additional Clinical Trials
will be made possible by new financing
.

Ongoing And Proposed Validation Studies

Real-World Clinical Testing Of MultiSenseTM (Cont.)
The Chopra Center
Clinical Trial, Self-Directed Biological Transformation
Initiative (SBTI)
(Data collection completed; data analysis ongoing)
.

MultiSenseTM Strips were used in the intervention study (SBTI)

to examine the effects of a comprehensive whole system
approach to wellbeing on key biochemical, physiological, and
psychosocial endpoints. The study was sponsored by UCSD
with collaborators from Harvard, The Scripps Institute, Duke
University, the Chopra Center for Wellbeing, Mount Sinai
Hospital-NY, and UCSF,
.
(Continued)

Ongoing And Proposed Validation Studies

Real-World Clinical Testing Of MultiSenseTM (Cont.)
The Chopra Center
Clinical Trial, Self-Directed Biological Transformation
Initiative (SBTI)
(Data Collection Complete; Data Analysis Ongoing)
.

MultiSense Strips were used in this study on a total of 100

patients. Each patient wore the Strips three times during the
study for up to 7 days. It was a prime opportunity to collect
data on many people, and feedback about their experiences.
Data analysis is currently being done by PhysIQ, a significant
partner in RDS future plans. This study provided important
validation data, as to the practicality of the Strips, whose
applications were done by non-company personnel, based on
a short video and written instructions. Users response bodes
well for appeal of Strip in personal monitoring.
TM

Ongoing And Proposed Validation Studies

Real-World Clinical Testing Of MultiSenseTM (Cont.)
The Scripps Translational Science Institute Clinical Trial
MultiSense Strip Cardiopulmonary Data During Sleep and Wake Cycles
(Study Approved starting date October/November 2015)

RDS is sponsoring a clinical study to evaluate

MultiSense for diagnosis of obstructive sleep apnea.
Patients to undergo overnight sleep studies in a sleep lab
wearing MultiSense for up to seven days during a period
spanning before, during, and after an overnight
polysomnagraphy. MultiSense Data will be compared to
conventionally scored polysomnagraphic data, including
determination of Apnea-Hypopnea Index (AHI) and
Respiratory Disturbance Index (RDI) that are important
diagnostic criteria for sleep apnea. This is an important
validation study for the sleep diagnosis market.

Ongoing And Proposed Validation Studies

Real-World Clinical Testing Of MultiSenseTM (Cont.)
Stanford Center for Sleep Sciences and Medicine
MultiSense Strip Cardiopulmonary Data During Sleep and Wake Cycles
(Study Approved starting date contingent on Company financing)

The Stanford Center for Sleep Sciences and Medicine is

the birthplace of sleep medicine, and has driven
considerable growth in sleep research and treatment. Its
Director, Dr. Emmanuel Mignot, and his staff have tried
out MultiSense. Based on their review of RDS data,
they have proposed a partnership to develop
MultiSense as a diagnostic device for medical sleep
disorders, as well as a sleep research tool. RDS views
this as a key validation of its potential in the sleep
analysis market. The study is awaiting RDS funding.

Ongoing And Proposed Validation Studies

Real-World Clinical Testing Of MultiSenseTM (Cont.)
The University of Texas MD Anderson Cancer Center
Possible Uses of MultiSense Strips in Cancer Research
(with possible NIH funding)

Preliminary discussions with researchers there have

explored the use of MultiSense Strips in studies of
patients with head and neck cancers undergoing chemo
and radiation therapy. The object would be the continuous
monitoring of patients' vital signs to better understand the
body's response to cancer treatment, and develop new and
improved regimens. A researcher at that institution has
already worn a Strip. His extremely positive response and
the collected data have initiated the preparation of an NIH
grant application.

Ongoing And Proposed Validation Studies

Real-World Clinical Testing Of MultiSenseTM (Cont.)
Collaboration With PhysIQ (http://www.physiq.com).
PhysIQs data analytics platform tracks and integrates
multiple vital signs to detect clinically meaningful changes
against an individual baseline. They are responsible for
MultiSenseTM data analyses in the Chopra Study mentioned
above, and in the USAID-sponsored Ebola Grand Challenge
Grant with the Scripps Institute (and RDS).
PhysIQ had previously developed their own set of biosensors
for their data analytics platform. Based on the data quality of
MultiSense they are no longer using these. This has led to
the Ebola Grand Challenge partnership, as well as to a joint
business development involving clinical studies aimed at
validating the monitoring of postdischarge patients.

Intellectual Property
High Probability Of Freedom To Operate in
Crowded Landscape Explored At The Start
17 Separate Categories of Subject Matter
identified as Patentable, combined into:
5 Individual U.S. patents applications (all published)
2 PCT foreign patents filings in major markets.

Patent Applications Cover

Electronic Circuitry
Compound Adhesive Strips
Optics
Algorithms
Applications

Peter Scull, Patent Counsel

Hamilton DeSanctis and Cha
Lakewood, CO
29

Competitive Landscape
Dozens Or More, Expensive,
Single Parameter Sensors
Finger Oximeters
Conventional ECG / Holter
Chest Patch Startups
iRhythm Technology Zio Patch
Vital Connect, Health Patch
Corventis Nuvant - Others
Clothing Embedded Sensors
Hexoskin, Healthwatch
Compact Portable ECG, Pen,
AliveCor, ECG Check,
HeartCheck

OR

One MultiSenseTM Useable

In A Broad Range Of Markets:
Combination Of Over 8 Parameters
Obtained Simultaneously From
Same Sensor
Higher Quality ECG Signal
Blood Oxygen Saturation And ECG
Measured Together On Chest
And Used To Derive Respiratory,
Activity, And Position Information
Small Size, Wireless, Comfortable,
Unobtrusive, Waterproof,
Reusable If So Desired
Amenable to Fast Manufacturing
Ramp-up