Exercise as Medicine - Beneufit · and the pdFIT mobile application. pdFIT collects heart rate and...

NOTICE: Proprietary and Confidential CONTACT: Jeff Broderick, CEO [email protected] 415-260-5873 This material is proprietary to Beneufit, Inc. It contains trade secrets and confidential information which is solely the property of Beneufit, Inc. This material shall not be used, reproduced, copied, disclosed, transmitted, in whole or in part, without the express consent of Beneufit, Inc.

Exercise as Medicine®

NOTICE: Proprietary and Confidential ©2014 Beneufit, Inc. All rights reserved

About Beneufit

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Beneufit offers a chronic disease management platform designed for patients. By helping patients, Beneufit supports the efforts of pharmaceutical companies and healthcare providers by providing outcome-based services to their customers. !Our goal is to improve patient conditions, improve customer experiences and reduce healthcare costs by augmenting current treatment regimens with exercise. !Enjoy our study and contact us to learn more. !!Beneufit, Inc. 930 Montgomery Street, Suite 501 San Francisco, CA 94133 !415-500-2770 [email protected] @beneufit

mailto:[email protected]


Exercise as Medicine for Parkinson’s Disease Pilot Study

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Parkinson’s disease is a neurodegenerative disease affecting 5 million people worldwide. The disease is caused by death of dopamine-generating neurons in the brain’s Substantia Nigra. Symptoms include tremor, rigidity, slowness and postural instability. Medication only offers symptomatic relief for a period of time. No medication halts or slows down the progression of the disease. Recent studies suggest exercise increases dopamine D2 receptor expression.

®

The Goal: Improve patient

condition

The Study: 12 weeks of

“Exercise as Medicine”

The Problem: No cure, no way to stop or slow

progression

The results of this report were generated by Beneufit’s pdFIT™ membership over a 12 week period from May through July 2014 (Study Period). The pdFIT™ technology quantifies both inputs (exercise) and endpoints (recognized clinical parameters), providing for the first time a platform that can rigorously connect compliance with exercise programs to measurable clinical parameters. The results represent a significant step for Beneufit in achieving its goal of establishing its “Exercise as Medicine” thesis.

Beneufit’s pdFIT™ is a disease management solution for Parkinson’s patients. The goal of the program is to reduce symptoms, delay disease progression and improve quality of life by leveraging exercise. This is accomplished by prescribing specific exercise protocols designed for Parkinson’s disease patients and continuously monitoring patient health through a series of tests provided through the pdFIT™ app.


pdFIT™ For Parkinson’s Disease

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Desired Impact !Patient Health • Demonstrate increased motor

function • Demonstrate delayed disease

progression • Increase overall health

!Healthcare Platform • Improve population health • Reduce chronic disease

management costs • Empower patient to actively

manage their condition

Current Situation !Patient Concerns • How am I doing? • What should I be doing? • How can I better manage my

situation?

!Problems • Infrequent physician visits • Subjective symptom tracking • Snowflake disease - different

for every person

pdFIT™ Solution !Coached Exercise • Protocols optimized for

Parkinson’s disease • Personalized for patient

condition • Motivates and engages

!Measure Patient Health • Precise measurement of motor

conditions and cognition • All data accessible for review

and analysis • Data accessible to physicians


pdFIT™ Membership Results

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Study Results

• 12 week study period

• 25% increase in circleTap™ test scores (measure of manual dexterity)

• 38% increase fitFactor™ scores (measure of compliance to prescribed workout protocols)

!Beneufit Platform Benefits

• Patients test motor symptoms continuously and track longitudinally

• Patients motivated to exercise harder than they otherwise would

• Feedback loop motivates patients to improve their condition !!Healthcare Platform Benefits

• Precise and continuous measurement of compliance and symptoms

• Empower patients to actively manage their own condition

• Intimate, actionable and cost-effective understanding of patient health

Improved motor function and fitness level

Improved patient

engagement

Manage chronic disease while

improving patient health


pdFIT™ Pilot Study Data

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Results: Increase in motor function and fitness capacity

circleTap™ Test Trend

• 25% increase

!fitFactor™ Trend

• 38% increase

!Study Metrics

• 12 weeks

• Avg workouts/week: 2.24

• Avg circleTap™ tests/week: 1.43

This is important because the data suggests people with neurodegenerative diseases can reverse their trend and actually experience improvements in motor function when augmenting their existing treatment program with the right exercise regimen.


Pilot Study Demographics

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Gender Breakdown

• Male 67%

• Female 33%

!Average Age

• 70 years

!Disease Stage

• Newly diagnosed (under two years)

• Most but not all under PD medication

• All proactively manage their condition

!Average Maximum Heart Rate

• 166 beats per minute


circleTap™ Test: PD vs Control

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These charts show the effect of circleTap™ test progress longitudinally between the Parkinson’s disease (PD) group and the control group. The PD group shows improvement over time and clusters up and to the right while the control group experiences no perceptible improvement.


Definitions and Methodologies

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The precise biological basis of exercise's impact on chronic disease is unknown. However, our understanding of this relationship is greatly expanding due to the growing number of observational studies that have defined a strong correlation between exercise and reduced morbidity and mortality in chronic disease conditions. !Beneufit's mission is to empower people to improve their condition through exercise while supporting this important research in an open, ongoing fashion. !Beneufit quantifies the inputs of exercise and maps these inputs to clinically accepted chronic disease management endpoints, including recognized clinical management parameters such as manual dexterity (in Parkinson’s disease). Beneufit's fitFactor™ and circleTap™ test scores are our proprietary measures of exercise input and motor symptoms.


Pilot Study Protocols

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The protocol used in this pilot study is derived from a forced exercise protocol developed by Dr. Jay Alberts of the Cleveland Clinic featuring high-cadence cycling. The protocol was published in the 2011 study “It Is Not About the Bike, It Is About the Pedaling. Forced Exercise and Parkinson's Disease”. !The protocol is designed for a patient riding a stationary bike with wireless sensors and the pdFIT™ mobile application. pdFIT™ collects heart rate and cadence data over the exercise duration. The goal is to achieve a heart rate between 75% and 85% of maximum and cycling cadence of 90 RPM. !Beneufit has developed a series of cycling protocols designed to reach a large population of Parkinson’s disease patients. As part of the onboarding process, protocols are suitable for patients not accustomed to exercise. As a patient’s fitness level and abilities improve, they graduate to protocols longer in duration and more physically demanding. !This is an ongoing study and additional protocols featuring treadmills/walking and upper body movement using additional sensors are in the works.

1

1. Alberts JL, Linder SM, Penko AL, Lowe MJ, Phillips M. (2011) It is not about the bike, it is about the pedaling: forced exercise and Parkinson's disease. Exerc Sport Sci Rev. Oct;39(4):177-86.


Mobile App Workout Screen

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Features:

• Personalized target heart rate and cadence

• Actual heart rate and cadence

• Spark line with target crosshairs

• Access to analytics dashboard and circleTap™ test

• Protocol name

• Sensor signal strength

pdFIT™ app's workout screen


fitFactor™ Score

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!Beneufit's fitFactor™ score is a representation of how closely an individual follows a workout protocol that has been personalized to the individual’s level of fitness. Individuals are ‘coached’ to hit target heart rate and cadence rates throughout the exercise period. Bluetooth sensors track and display the individual’s actual heart rate and cadence on a second by second basis. The fitFactor™ score is defined algorithmically according to how closely an individual’s actual heart rate and cadence followed the prescribed level. !The fitFactor™ score thus is used to quantify individual performance and represents a measurement of effort and ability. The fitFactor™ score motivates users to continually improve and as success is achieved, new protocols at higher fitness levels are automatically provided through the pdFIT™ app. !The maximum fitFactor™ score is 100 (representing perfect compliance) and is weighted based on the number of minutes in a workout protocol, with 60 minutes being the maximum length of an exercise protocol. 60 minute protocols have a maximum achievable fitFactor™ score of 100, 30 minute protocols have a maximum score of 50, and 15 minute protocols have a maximum score of 25.


Dashboard's Workout Detail Screen

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Analytics:

• fitFactor™ score

• Personalized protocol

• Detailed chart

• Time in zones

Dashboard's Workout Detail Screen with fitFactor™ Score


The circleTap™ Test

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People with Parkinson’s disease, essential tremor, or other movement disorders involving tremor have changes in fine motor skills that are among the hallmarks of these diseases. !The ability to control one's own hand movement smoothly is an element of fine motor control referred to as manual dexterity. Fine motor skills such as manual dexterity can be measured and followed over time by a patient or his/her physician as one measure of clinical status. In the doctor's office, this is typically done by a physician asking an individual to touch his or her own nose, or touching an object the physician places as a target. The score on these tests thus becomes an element of clinical status. !The Beneufit circleTap™ test allows individuals to periodically assess manual dexterity and fine motor control on their own through the pdFIT™ app, via an iPhone or iPad. !To conduct the circleTap™ test, an individual must track and tap two targets labelled “1” and “2” in four separate 15 second intervals. This means the test takes about one minute to perform from start to finish.


The circleTap™ Test Screen

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Process: Four fifteen second tapping sessions

• Right hand close together

• Left hand close together

• Right hand far apart

• Left hand far apart

pdFIT™ app's circleTap™ Test Screen


The circleTap™ Test (continued)

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It is recommended that patients take the circleTap™ test before and after each workout. All results are accessible through the patient dashboard for longitudinal analysis. !Clinical studies have shown that individuals who engage in exercise protocols like those offered by Beneufit can improve their manual dexterity and fine motor control. !This improvement can be tracked and will result in improved circleTap™ test scores of a PD patient over time. Beneufit has made the circleTap™ test part of the pdFIT™ app to facilitate continuous measurement of exercise protocol compliance and its effect on manual dexterity. !Results from the Study Period show that improvement in dexterity, tracked with circleTap™ test scores, takes place over the course of months, underscoring the importance of a sustained exercise program.


fitFactor™ Score Progression

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During the Study Period, patients improved their fitFactor™ scores by becoming more compliant to a single protocol and/or progressing through more challenging protocols. !Individuals in the Study Period began with the easiest 15 minute protocol to baseline fitness monitoring before engaging in more challenging protocols. !In collecting data, Beneufit tracked and controlled for medication changes, learning curve of the circleTap™ test, changes in diet and exercise protocols outside those administered through the pdFIT™ app, and also tracked handedness and affected side. !The following individual workout charts illustrate how one person achieved proficiency and improved their fitFactor™ score over time.


fitFactor™ Compliance: Desired

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Chart 1 illustrates excellent compliance with the protocol for both heart rate and cadence. The heart rate is in a tight band at the center of the high and low heart rate zones throughout most of the 60 minute workout. Cadence is also very tight to the protocol through all warmup, steady and cool down phases. !The following slide (Chart 2) documents the level of compliance the patient was capable of at the start of the program.


fitFactor™ Compliance: Initial

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Chart 2 illustrates the level of compliance this patient had at the start of the program. There was difficulty in achieving a heart rate in the prescribed range. It was also difficult for this patient to achieve the prescribed 90 RPM without significant variability.


fitFactor™ Longitudinally

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This is a longitudinal view of the fitFactor™ score for a single patient during the 12 week Study Period. The chart shows a clear progression from early scores in the single digits or teens to scores routinely above 30 during the latter stages of the Study Period.


circleTap™ Test Longitudinally

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This chart shows the aggregate circleTap™ test score and the number of successful taps and unsuccessful misses for each test taken over a period of time. We analyzed this patients test results as it relates to their affected side and handedness in the next section.


Handedness/Affected Side Analysis

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!!We performed an analysis of handedness (right or left handed) and affected side for our members who provided us that information. For the purpose of illustration we are sharing one example. The data in the chart represents successful taps minus misses for each hand. !When parsing our handedness and affected side we get a much more focused understanding of motor function improvement. In the following example this person is right handed and right-side effected. !!!


Affected Hand: Individual

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Significant improvement is shown in circleTap™ test results with the affected hand and none for the other hand. Since this person is right handed the overall score is higher for the right land.


Next Steps: Large Study

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Research & Development

Private Beta

Product Launch

Pilot Study

Large Study

Research PD Product • Build advising team • Research protocols • Select sensors • Begin product

development • Develop partnerships • Initial outreach • Order sensors

Engage & Refine Product • Develop beta platform • Patient outreach • Receive sensors • Sign up beta patients • Distribute beta app • Onboard patients • Communicate with

patients • Iterate app & dashboard

Launch pdFIT™ Publicly • Release app & dashboard • Launch e-commerce

platform • Patient outreach • Test marketing • Refine onboarding

process • Refine protocols • Ongoing partner mgmt. • Iterate app & dashboard

Produce Pilot Study • Develop algorithms • Develop analytics tools • Migrate tools to

dashboard • Query patients for

additional data points • Report initial findings to

partners • Distribute study findings

Define and Produce Study • Healthcare platform

outreach • Define large study goals • Finalize requirements • Patient outreach &

onboarding • Modify app and backend

to accommodate additional data points

• Develop algorithms • Develop partnerships • Publish study findings

Beneufit is preparing for the next stage in our development. We are seeking additional patients and healthcare system stakeholders to become part of a much larger study. The Beneufit platform is currently being modified to accommodate the increased scope of the study. !This next phase will give patients more insight and control over their condition. This includes more inputs, more tests, more protocols, more sensors and more communication.


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The findings in the Study Period represent the first time specific exercise protocols were administered through a quantitative digital platform. The results from the Study Period mirror published reports of the impact exercise has on clinical parameters in Parkinson’s disease through proctored exercise trials. Measurements of manual dexterity increased over 25% during the 12 week Study Period. !!!In addition to the measurable increase in manual dexterity, Beneufit members experienced material improvements in quality of life factors including increased sleep, strength and control over symptoms. Increased manual dexterity is a big deal for Parkinson’s patients and can mean the difference between being able to brush your teeth, shampoo your hair and other important tasks related to independence. !!!The Beneufit platform does more than empower patients to improve their condition with exercise. By engaging both patients and healthcare platform stakeholders simultaneously, we have validated a holistic model that serves both equally. Given the right set of tools and feedback loops, patients are willing and able to manage their condition. The Beneufit chronic disease management model is positioned to revolutionize the way patients and organizations tackle this enormous problem. !!If you are a patient, researcher of healthcare system stakeholder and are interested in learning how we can help you please contact at [email protected].

Exercise and improvement in clinical outcome

quantified

Motivated patients

increase their quality of life

A new digital health model

developed and validated

Study Conclusions

mailto:[email protected]

Exercise as Medicine - Beneufit · and the pdFIT mobile application. pdFIT collects heart rate and...

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