mhealthpharma pitch deck - 2016-06-01
TRANSCRIPT
Copyright 2016. mHealthPharma Inc. All rights reserved.
Copyright 2016. mHealthPharma Inc. All rights reserved.
How it All Started
Steven Orlov, MD Protocol for study of mobile app to treat
chronic disease as part of Graduate course
Leonid Orlov Experienced Computer
Programmer
Alex Berlin Business, Software
Engineering and Start-up expert
Founded July 2015
Team: Co-Founders / Directors • Dr. Steven Orlov , Co-Founder
• MD (Endocrinology) from University of Toronto • MSc in Clinical Epidemiology from McMaster University • Multiple research publications (New England Journal of Medicine, Diabetes Care)
• Alex Berlin, Co-Founder • Software Engineer and Architect with 30+ years experience • Experience in managing distributed technology teams of 30+ people with department
budgets of $5-10M/year • Startup experience (Multex); Digital marketing expertise
• Leonid Orlov, Co-Founder • Computer programmer with 25+ years experience • Experience with rapid application development • Experience with scientific startups (Plasma Plus)
• Isaak Karaev, Independent Director, Board Member, Active Early Advisor • Serial Entrepreneur, Founder and CEO of Multex, Instant Information, InfoNgen, AlfaNgen • Raised funding in the $10s of millions • 4 Exits
Copyright 2016. mHealthPharma Inc. All rights reserved.
Team: Advisors
Medical / Regulatory • Dr. Leonid Poretsky – Chief of Division of Endocrinology, Lenox Hill Hospital, NYC • Dr. David Orlov – MD (Anesthesiology), expertise in Health Economics • Dr. Richard Lipsky – Co-Owner, Meadowlands Hospital Medical Center, New Jersey • Gary Howard – Eight successful FDA approvals for medical applications/devices
Technology/Business • Dimitry Poretsky – CEO of MainStar - Asset and Maintenance Management • Dmitry Rapoport – Entrepreneur and technologist, Tooltwist • Michael Berganovsky - Expert technologist, computer scientist and engineer • Felix Rabinovich – Experienced technologist, manager and entrepreneur • Valentin Chernyak – Software architect and engineer
A focused team of founders and committed advisors, employees and contractors bringing expertise in key required areas of medicine, technology, clinical trials and FDA regulations.
Copyright 2016. mHealthPharma Inc. All rights reserved.
• mHealthPharma Inc. (mHP) was formed to design, build, market and sell FDA-cleared mobile prescription therapies for the management of chronic diseases
• First product being developed is a mobile health (mHealth) product for patients with hypertension (high blood pressure)
Copyright 2016. mHealthPharma Inc. All rights reserved.
Company Mission
SOURCES: World Health Organization, U.S. Department of Health
Copyright 2016. mHealthPharma Inc. All rights reserved.
Problem • Hypertension is the leading risk factor for mortality and
healthy life-years lost worldwide
• Affects 1 in 3 U.S. adults (70 million)
• Despite effective medications, only half (52%) of these people have their blood pressure (BP) under control • Infrequent BP checks during scheduled appointments • No utilization of remote patient monitoring
(home BP) • Therapeutic inertia (physicians lack BP data to
make decisions)
• Existing mHealth apps for hypertension lack evidence for medical effectiveness • They have not been shown to lower blood pressure
Copyright 2016. mHealthPharma Inc. All rights reserved.
Medical Context
SPRINT Trial (NIH Sponsored – November 2015)
• Treatment of hypertension reduces the risk of cardiovascular disease outcomes: • incident stroke (by 35 to 40%), • myocardial infarction (by 15 to 25%), • heart failure (by up to 64%)
• Targeting a systolic blood pressure <120 mm Hg vs <140 mm Hg: • Lower rates of major cardiovascular events (HR 0.75, p <0.001) • death from any cause (HR 0.73, p = 0.003)
• The implementation of the 2014 JCN8 Hypertension Guidelines for U.S. adults between the ages of 35 and 74 years could potentially prevent about 56,000 cardiovascular events and 13,000 deaths annually, while saving costs.
SOURCES: Randomized Trial of Intensive versus Standard Blood-Pressure Control.N Engl J Med 2015; 373:2103-2116 Cost-Effectiveness of Hypertension Therapy According to 2014 Guidelines. N Engl J Med 2015; 372:447-455.
Copyright 2016. mHealthPharma Inc. All rights reserved.
mHealthPharma’s mobile app for patients with hypertension - myHTN
Solution myHTN
Copyright 2016. mHealthPharma Inc. All rights reserved.
Evidence-Based Clinical Guideline Recommendations
• Recommendations based on latest (2014) Evidence-Based Guidelines for Management of High Blood Pressure in Adults (JCN8, JAMA), and can be updated
• BP measurements from FDA-Approved personal blood pressure device
Solution myHTN: Evidence-Based
Copyright 2016. mHealthPharma Inc. All rights reserved.
Enhanced Doctor-Patient relationship through timely, proactive alerts/notifications
Evidence-Based Clinical Guideline Recommendations
Solution myHTN: Connected to Physician
5.3mmHg ↓BP / 6 mo.
• Validated effectiveness (BP reduction) assessed through randomized controlled trial • Immediate attention to obtain FDA clearance
Copyright 2016. mHealthPharma Inc. All rights reserved.
Evidence-Based Clinical Guideline Recommendations
Solution myHTN: FDA Cleared
Mobile Prescription Therapy Prescribed by Health Care Practitioner
Copyright 2016. mHealthPharma Inc. All rights reserved.
Evidence-Based Clinical Guideline Recommendations
Solution myHTN: Prescribed by Physician
5.3mmHg ↓BP / 6 mo.
Copyright 2016. mHealthPharma Inc. All rights reserved.
Evidence-Based Clinical Guideline Recommendations
myHTN:
5.3mmHg ↓BP / 6 mo.
The first mobile prescription therapy for hypertension
www.mhealthpharma.com/info
Offer product as Mobile Prescription Therapy
• Prescribed by physician • Covered by CMS (Medicare/Medicaid) / private insurers • Approach market by convincing practicing
physicians to use the product / prescribe it to their patients
Does not replace your doctor and hypertension drugs • Complements the relationship, improves compliance, provides timely notification & recommendations
Product Differentiation: Mobile Prescription Therapy
Copyright 2016. mHealthPharma Inc. All rights reserved.
Not just a technology startup • Active participation of medical research experts • Dr. Steven Orlov, Dr. Leonid Poretsky, Dr. Richard Lipsky and Dr. David Orlov
Clinically validated measurement and algorithmic management • According to 2014 JNC8 Hypertension Guidelines • Medication tracking and personalized BP analysis Proprietary data processing methodology • Alerts/notifications (to patients and physicians) for treatment
adjustment based on data mining and analytics
Product Differentiation: Medical Research Expertise
Copyright 2016. mHealthPharma Inc. All rights reserved.
Copyright 2016. mHealthPharma Inc. All rights reserved.
Product Differentiation: Patent-Pending Proprietary Methodology
Patent-Pending Technology • Patent filed with US Patent and Trademark Office (Feb 2016) • Medical Condition Management System
Randomized clinical trials to demonstrate efficacy
Competitive advantage in FDA approval process • File as Class II Medical Device • Dedicated team focusing on FDA documentation and process • Past experience with 8 successful FDA clearances of software-based
medical devices • Reduce time, effort and cost of FDA application by leveraging
technology and automation in producing required documentation
Product Differentiation: FDA Cleared and Clinically Validated
5.3mmHg ↓BP / 6 mo.
Copyright 2016. mHealthPharma Inc. All rights reserved.
Top 10 Chronic Diseases for mHealth Innovation
Business Scalability: Multiple Chronic Diseases
SOURCE: Topol EJ. Transforming medicine via digital innovation. Sci Trans Med, 2010; 2, 16cm4.
Copyright 2015. mHealthPharma Inc. All rights reserved. Copyright 2016. mHealthPharma Inc. All rights reserved.
Copyright 2016. mHealthPharma Inc. All rights reserved.
• Will grow to $26B by 2017 according to MIT Technology Review
http://www.technologyreview.com/view/532661/mobile-medical-apps-a-market-on-the-move/
• May grow to $84.8B by 2020 according to Innovative People (Innoppl) White Paper Report
http://innopplinc.com/whitepaper/the-top-10-ways-mobile-technology-is-revolutionizing-healthcare-in-2015.php?gclid=CNOtg-qBjccCFQktaQodXKYO4A
• Expected to grow at compounded annual growth rate of 33.5% from 2015 to 2020 according to Allied Market Research
https://www.alliedmarketresearch.com/mobile-health-market
mHealth Market Forecasts
Copyright 2016. mHealthPharma Inc. All rights reserved.
mHealth Market Forecasts
Mar 12 2016 “Things are looking app”
http://www.economist.com/news/business/21694523-mobile-health-apps-are-becoming-more-capable-and-potentially-rather-useful-things-are-looking
SOURCES: Medical Expenditures Panel Survey, Agency of Healthcare Research and Quality
Copyright 2016. mHealthPharma Inc. All rights reserved.
http://meps.ahrq.gov/mepsweb/data_files/publications/st404/stat404.shtml
Hypertension Market Size: U.S. Only
Total Available Market
• 70M People
• $25B/year spent on anti-hypertension medications
Served Addressable Market (suitable patient w/ mobile device ~60%)
• 40M People
• Total Market Potential – $4.8B • 40M People x $120/year*
*Annual Cost: $2,600/year $2,500/year
SOURCES: Business Insights. Cardiovascular Market Outlook to 2016 http://download.bioon.com.cn/view/upload/201303/16084307_4163.pdf
US
Germany
UK
Italy
France
Spain
Japan
Copyright 2016. mHealthPharma Inc. All rights reserved.
Hypertension Market Size: U.S.+EU5+Japan
$4.8B
$1.9B
$1.5B
$1.5B
$1.0B
$1.2B
$2.9B
US Market Potential: $4.8B Global Market Potential: $14.5B
Subscription Model • Monthly cost, similar to other prescription medications • Covered by CMS (Medicare/Medicaid) / private insurers
Marketing and Advertising Revenue • Sharing anonymized user data (pharma, insurers, researchers) • Serving ads
Cost Covered out of Billings for Telemedicine • Physicians use platform to bill for remote patient monitoring
Copyright 2016. mHealthPharma Inc. All rights reserved.
Commercial Models
Market as a medical device • Patients
• Digital marketing campaign – Web, Twitter, YouTube, Facebook, WebMD
• Social networking between patients, family, friends, caregivers, etc.
• Physicians • Educate medical community through medical
journals, conferences and door-to-door sales • Payers
• Medicare / Medicaid / Private insurers
Strategic partnership with:
• pharmaceutical companies • health insurance companies
Copyright 2016. mHealthPharma Inc. All rights reserved.
Marketing
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To reach 1M patients • Need 5.6K MDs (less than
2% of MDs who treat HTN) Assumptions • US – 800K MDs • 300K Internal Medicine (IM) • 1000 patients / IM MD • 300 patients / MD have HTN • 180 patients / MD in addressable market
SOURCE: Statistica.com, Young A (2011) Census of US Physicians . J Med Regulation.
Milestones: Market Penetration and Subscription Revenue
0
60
120
180
240
0
500
1,000
1,500
2,000
Reve
nue
Run
Rate
($M
illio
ns)
Use
rs (T
hous
ands
)
Free users Paying Users Revenue run rate
Copyright 2016. mHealthPharma Inc. All rights reserved.
Mobile Prescription Therapy vs. Conventional mHealth Apps
Copyright 2016. mHealthPharma Inc. All rights reserved.
Go To Market Strategy
Iterate every 3-6 months
• Many smartphone apps that contend they address hypertension make medical claims without clinical validation or FDA approval according to a report in Journal of American Society of Hypertension
http://www.modernhealthcare.com/article/20141224/BLOG/312249932 http://www.ashjournal.com/article/S1933-1711(14)00899-7/pdf
Consumers have a strong tendency to download and favorably rate apps that are advertised to measure blood pressure and heart rate, despite a lack of validation for these apps. There is a need for greater oversight in medical app development for HTN, especially when they qualify as a medical device.
J Am Soc Hypertens 2015;9(2):130–136.
Copyright 2016. mHealthPharma Inc. All rights reserved.
mHealth Landscape
• Numerous non-effective apps of entertainment value • iBP, Withings, Blood Pressure Checker • MediSafe • Tactio Healthcare
• Medically Effective / Clinically Validated • Existing anti-hypertensive medications • WellDoc – BlueStarTM (for diabetes)
Copyright 2016. mHealthPharma Inc. All rights reserved.
mHealth Landscape
Copyright 2016. mHealthPharma Inc. All rights reserved.
mHealth Landscape
• BlueStarTM by WellDoc – first FDA-approved mobile prescription app • Helps patients with type 2 diabetes
Copyright 2016. mHealthPharma Inc. All rights reserved.
• WellDoc Inc, Facts: • Formed in 2005 by an MD. Based in
Baltimore, MD • Obtained FDA approval for their app (2014) • Reportedly raised $27M prior 2014 • Raised $20M from Merck in 2014 to actively
market BlueStarTM
• Recent partnership with Samsung - $22M raised • Covered by Ford Motors, Rite Aid, Dexcom and
other Fortune 500 companies • Prices their app at around $2400/year
• Roughly corresponds to 1/3 of cost of medications
Case Study: WellDoc
• MedisafeTM - Leading mobile app for medication management and pill reminders
Copyright 2016. mHealthPharma Inc. All rights reserved.
• Medisafe Inc, Facts: • Formed in 2012. Based in Boston, MA • Free app from App Store/Google Play
• Store / remind user-entered meds • Revenue model based on collecting user data for
marketing • Over 2.2 M downloads, taking 220M meds • Simple BP Study – Reported 20mmHg SBP
reduction • Reportedly declined $25M acquisition offer;
raised $6M • Several important contrasts to mHealthPharma
Case Study: MediSafe
Copyright 2016. mHealthPharma Inc. All rights reserved.
Comparison with Selected Products
Patient Reminders
Patient Alerts
Biometric Tracking/ Analytics
Physician Decision-Aids
Clinical Trial
Prescription Therapy
Cost
Scales to Multiple Chronic Diseases
- - -
- - - - - - - 0 - -
Copyright 2016. mHealthPharma Inc. All rights reserved.
Product Development
Product Development Initial
prototype definition
Pilot clinical trial definition
FDA submission
Published Product v1.0
Full-scale clinical trial
Software Development Initial
prototype Pilot trial
ready FDA ready Full-scale ready Version 2.0 work
FDA Documentation Through all phases of definition, design, development,
testing and clinical validation
Clinical Validation Pilot clinical
trial FDA
submission Full-scale
clinical trial
Patent Protection Prepared and Submitted Patent Application Patent Issued
Completed To Be Completed In Progress
Pre-Submission Completed
• Current Team • 3 Co-Founders; 1 Independent Board Member • 4 Senior Software Engineers; 1 Graphic/UI Designer • 1 Highly Experienced FDA Specialist • External Mobile Development Vendor (Tooltwist)
• 4 Mobile Developers with medical app experience
• Working towards starting Pilot Clinical Trial in Q3 2016 • Developed initial prototype – mobile and web • Filed patent application - USPTO patent-pending • Gained initial traction with FDA (510(k) pre-submission) • Organizing pilot clinical trial protocol / logistics
Copyright 2016. mHealthPharma Inc. All rights reserved.
Team and Progress Update
PHASE 2 Series A Round: $6M-10M. • Publish free App for download • Conduct full scale Clinical Trial • Publish and promote Clinical Trial results • Grow Marketing and Sales teams with expertise to sell product to the doctors/healthcare providers • Launch marketing campaign across multiple channels • Establish and work towards goals and track progress
for: a. Number of downloads b. Number of regular users c. Number of participating doctors d. Number of paying users – 1K, 10K, 100K, 1M
• Generate revenue. Achieve profitability. • Identify and start building products for other
chronic diseases
PHASE 0 Self-funded. COMPLETED. • Developed working prototype
of the mobile and back- end components
• Filed patent application (USPTO)
• Achieved traction with FDA • Downloadable through the
Apple App Store • Ready to start Pilot
Clinical Trial (30 patients)
Copyright 2016. mHealthPharma Inc. All rights reserved.
PHASE 1 Friends, Family & Angels: $250K-300K • Complete Pilot Clinical Trial • Improve , adjust and tune
product based on results • Implement additional product
functionality • Clear product with FDA • Ready to start full-scale Clinical
Trial. • Recruit sales, marketing and
bus-dev leader with industry experience
• Pursue foreign fillings of the patent (Q4 2016)
• CONTACT INFO
• Steven Orlov - [email protected]
• Alex Berlin - [email protected]
• Leonid Orlov - [email protected]
• General - [email protected]
Thank You!
Copyright 2016. mHealthPharma Inc. All rights reserved.
Evidence-Based Clinical Guideline Recommendations
myHTN:
5.3mmHg ↓BP / 6 mo.
The first mobile prescription therapy for hypertension