PowerPoint Presentation

September 18, 2015

The Companys Technology,Hints Of Its Potential Applications, And Examples Of Its Ongoing Or Proposed Clinical Trials. sam.eletr@rhythmdiag.com Jeff.Marshall@rhythmdiag.com 2 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.

All-In-One MultiSenseTM Wearable Strips Enable Real Time Comprehensive Health MonitoringFor Both Diagnoses And Follow Ups

ECG Traces/ArrhythmiasO2 SaturationHeart RateHR VariabilityRespiratory RateRelative Resp. Depth BP VariationsTemperature Activity And Position More To Come

Data that yield these parameters are monitored simultaneously during sleep or activity, without the burden of cumbersome wires or devices. They are either recorded for later analysis, or transmitted in real time, to the cloud, or as desired.

No Other Technology Can Do All This

ResMed ApneaLink

Philips RespironicsAlice PDX

Cardionet MCOTMasimo Rad87

CardioSpy HolterUnobtrusiveWear and forgetAt hospital/home Or on the go

All In OneMultiSenseTM Strip

Sleep Lab Setup,(Breathing And Finger O2Sat.)With A Single Recording/Transmitting

To Replace All This And More

Records data that now yield nine physiological parameters after downloading via USB, or when communicated by Bluetooth in real time to smart devices or the cloudTHE COMPANYS GOAL,AS DEFINED AT ITS FOUNDING IN AUGUST 2012:5MultiSenseTMIs 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 ChangesIn Blood Pressure And Temperature

Sleep ECG, HR 54Walking ECG, HR 90Jogging ECG, HR 134

SQTRP

PTQSRMultiSenseTM Detects, And Records/Transmits, Raw, Low-Noise, Diagnostic-Quality, ECG DataUncompromised 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 OnRelative Physical Activity And Upright Or Various Sleep Positions

Relative Physical Activity/Attitude 10 min windowCorresponding ECG 10 seconds windowRecording Relative Activity May Improve Diagnostic YieldIn The Event Of ECG Anomalies, ArrhythmiasFor Example. Was The Subject Asleep Or Running?WalkBrisk walkWalk Upright Supine: Left/Right Front/back

Position detection 7

MultiSenseTM ECG at max Heart Rate Up Treadmill Incline To Target Heart Rate

Activity LevelWalking On Treadmill Zero InclineCorresponding, simultaneous, V1 Signal from commercial 12 lead ECGMillivoltHere MultiSenseTM Detects And Records/Transmits Quality ECG Simultaneously With Increasing Relative Effort As Subject Strains Up A Treadmill Incline (Green Trace) Consistent, low noise ECG signals at high activity levels and elevated heart rate

Standing StillMultiSenseTM Detects, And Records/Transmits, Raw ECG Data Good Enough To Identify ArrhythmiasSubject 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.

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 MultiSenseTMAre Analyzed For Arrhythmias By Licensed, Third Party, FDA-ApprovedSoftware. MultiSenseTM Detects, And Records/Transmits, Raw ECG Data Good Enough To Identify Arrhythmias(Cont.)

604203603002401801204800Breath was held for15 sec (red arrow)45 sec (black arrow)Time(sec.)MultiSenseTM Respiration Rate And Depth Amplitudes Correlate With Same From Standard Belt/Pressure MonitorVernier beltAmplitudeMultiSenseTM Amplitude

MultiSenseTM was worn by subject simultaneously with belt/gas pressure monitorMultiSenseTM O2Sat. Tracks Finger O2Sat. Device While Providing Patient Position & Respiratory WaveformRespiratory Waveform &

Orange Line Indicates Patient Immobile, Lying On BackMultiSenseTM Breathing Waveform Indicates Depth Fluctuations That Explain O2Sat. ChangesMultiSenseTM Chest StripMasimo Finger DeviceMultiSenseTM Strips Characterize Sleep Disordered Breathing Through Fluctuations In Several Physiological ParameterOrange 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 PatternsHere, Physiological Parameters During Normal Sleep

Here, each peak is a breath Time scale is expanded to show each breathOxygen Saturation steady in normal sleepBreathing rate and depthHeart rate variability

MultiSenseTM Strips Easily Characterize Sleep PatternsHere, Physiological Parameters In Apnea-Interrupted Sleep

No BreathingNo other technology can provide all this from one deviceOxygen Saturation fluctuates with breathing interruptionsSo do breathing rates and depthsAs does heart rate to compensate

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.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 (Cont.)

Proprietary Software Enables Instant Viewing (Cont.)The focus here is on the number of Ventricular Trigeminies/Hour,same interpretations as in previous three pages (slides)AFib events are monitored simultaneously with heart rate, oxygen saturation, respiration rate and amplitude and activity level/position for comprehensive health assessment

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

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Ongoing And Proposed Validation StudiesReal-World Clinical Testing Of MultiSenseTM

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.)

UCSF Department Of CardiologyThe Chopra Center

Ongoing And Proposed Validation StudiesReal-World Clinical Testing Of MultiSenseTM (Cont.)

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)

The Chopra Center

Ongoing And Proposed Validation StudiesReal-World Clinical Testing Of MultiSenseTM (Cont.)

Clinical Trial, Self-Directed Biological Transformation Initiative (SBTI) (Data Collection Complete; Data Analysis Ongoing).MultiSenseTM 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 bodeswell for appeal of Strip in personal monitoring. Ongoing And Proposed Validation StudiesReal-World Clinical Testing Of MultiSenseTM (Cont.)

The Scripps Translational Science Institute Clinical TrialMultiSense 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 StudiesReal-World Clinical Testing Of MultiSenseTM (Cont.)

Stanford Center for Sleep Sciences and MedicineMultiSense 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 StudiesReal-World Clinical Testing Of MultiSenseTM (Cont.)

The University of Texas MD Anderson Cancer CenterPossible 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.27Collaboration With PhysIQ Ongoing And Proposed Validation StudiesReal-World Clinical Testing Of MultiSenseTM (Cont.)

(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 post-discharge patients.

Intellectual PropertyHigh Probability Of Freedom To Operate in Crowded Landscape Explored At The Start17 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 CoverElectronic CircuitryCompound Adhesive StripsOpticsAlgorithmsApplications29Peter Scull, Patent CounselHamilton DeSanctis and Cha Lakewood, CO

Competitive Landscape Chest Patch Startups iRhythm Technology Zio Patch Vital Connect, Health Patch Corventis Nuvant - Others Conventional ECG / Holter Compact Portable ECG, Pen, AliveCor, ECG Check, HeartCheckClothing Embedded Sensors Hexoskin, HealthwatchOne 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

Finger Oximeters Dozens Or More, Expensive,Single Parameter Sensors OR