1. Enabling the Heart to self-regenerate
Enabling the Heart to self-regenerate
Alan Remen
Chief Executive Officer

2. Transformational IP
MyoStim’s patents hold the pioneering ability to convert stem cells to heart muscle cells through electrical stimulation replicating the body's own natural method of creating a heart from stem cells.

3. Validation
“This invention could be regarded in the future as one of the most important developments in the fight to reduce death from heart failure“
Dr. Juan Chachques,
Director of Surgical and Clinical Research at Broussais and Pompidou Hospitals
in Paris, France
"This truly has the potential to be a landmark invention in the field of heart failure treatment"
Nov 6th David Holmes, M.D.,
Chairman of Cardiology, Mayo Clinic

4. Business Model
MyoStim has a distinct advantage in its business model. The company has identified the right product mix that will supply it with revenue streams starting from its first year of operations and moving on as it expands and obtains FDA approval for its Heart Repair Pacemaker.

5. MyoStim Introduction
MyoStim is developing a set of products to target three market opportunities, leveraging our IP related to electrical stimulation.

6. Electrical Stimulation Peripheral Artery Disease (PAD)
Markets
Electrical Stimulation
Heart Failure
Peripheral Artery Disease (PAD)
Cell Cultures

7. Investment Opportunity
$5.5 million launches the MyoStim Lab and Limb Stimulators that will finance the $15 million clinical trials for the Heart Stimulator
Cell culture industry is $4.97 billion today on the way to be $20 billion in 7 years - immediately addressable: $480M
Limb ischemia market exceeds $2.2 billion worldwide today -Immediately addressable - $2B
The heart failure market exceeds $40 billion today.  CRT/ICD pacers alone - $4.2 billion.  CHF drugs $8 billion – immediately addressable $4.2B.

8. Product Line 1 2 3
Doubles the production of cell cultures with half the amount of growth factors & media
Converts pluripotent stem cells to cardiomyocytes (beating heart muscle cells)
Reduces use of animal based products (FDA recommendation)
Cell Culture Stimulator

9. Market Cell Culture Market Size Expected Growth Target Customer
$4.97B global market
Expected Growth
5 – 6 X increase in demand is forecasted for next 4 yrs
Target Customer
15,000 commercial or academic research laboratories hosting researchers, technicians, & other employees
Market Opportunities
Immediately addressable Market = $480M
1st year “likely to purchase” market size projected to be $5M
Market Fit
Increased costs for cell culture supplies & need for superior cell proliferation has created the need for more efficient tools
Go To Market Strategy
Researchers,
Low volume production
High Volume - bioreactors

10. Product Line 3 2
Blood Flow Stimulator – Limb Salvage (PAD)
Stimulates muscle tissue or muscle scar tissue to activate the release of angiogenic (blood vessel forming) proteins.
Forms new blood vessels in ischemic or scarred areas
Induces reperfusion

11. Market Peripheral Artery Disease (PAD) Market Size Expected Growth
$15.5B global market
Expected Growth
13.1% per year
Target Customer
Diabetes & Wound Healing Specialists
Vascular Surgeons
Peripheral Limb Specialists
Market Opportunities
Immediately addressable market - $400 M
1st year “likely to purchase” at $3.8M
Sales start in Jan 2013
Market Fit
Increasing no. of patients requiring treatment for PAD
Another line of defense in avoiding amputation of a limb
Maybe one of the least painful treatments for advanced PAD
Go To Market Strategy
Instrument will be leased not sold – KCI model
Clinical Unit delivered to Limb Salvage Professionals
Home unit to individuals
Medicare reimbursement code: G0281

12. Product Line Implantable Pacemaker – REPAIRS the heart1 2 3
Recruits stem cells to damaged area
Converts recruited cells into heart muscle cells
Stimulates the creation of new blood vessels
Increases contraction strength of muscle
Ensures heart remains on beat

13. Market Cardiac Rhythm Management (CRM) Market Size Expected Growth
$4.1B global market
Expected Growth
6.97% compound annual growth
Target Customer
Electrophysiologists
Cardio-Thoracic Surgeons
Implanting Cardiologists
Market Opportunities
Immediate Addressable Market = $4.1B
1st year “likely purchase” projected at $280M
Sales start in 2016
Market Fit
Superior alternative to every known pacemaker & defibrillator
Expected to be at the forefront of heart failure treatment options
Go To Market Strategy
Usher the product through Phase 1 & 2 Clinical trials
Put the CRM division on the market

14. leases/pay-per-use of cell culture stimulators
Product Roll-out
Cell Culture Stimulator
leases/pay-per-use of cell culture stimulators
Revenue
Costs
marketing, manufacturing, legal
2013
Blood Flow Stimulator
Sales / lease of blood flow stimulators
Revenue
Costs
marketing, mfg, clinical trials, distribution
2017
Pacemaker
pacemaker implantations revenue
Revenue
marketing, mfg., clinical trials, distribution
Costs

15. Clinical/Regulatory Milestones
2012
2013
2014
2015
2016
2017
2018
Lab
Stimulator
Blood Flow Stimulator
Pacemaker
No Clinical Studies Required
Product Dev
Pre-Clinical Testing
OUS Human Use/ Feasibility Trial
CE Mark
OUS Commercialization
510(k) Approval
Product Development
IDE
Trial in US
PMA Approval
US Commercialization for Limb Salvage
Lab-Use Approval & Commercialization
Product Dev

16. Competition Cell Culture Industry Blood Flow Stimulation Market
2010 sales estimated $2.5 million
Offers similar electrostimulation product to research laboratories
Ability to culture a variety of cells that are electrically coupled in vivo
Shown to only marginally improve cell proliferation
Demonstrated lack of marketing expertise
Willingness of laboratories to purchase the competitively inferior product proves that there is an immediate market
Blood Flow Stimulation Market
2010 sales = $25.9 million
SmartPReP system allows physicians to rapidly prepare highly concentrated, autologous Platelet Rich Plasma (PRP)
Enriched with growth factors to naturally stimulate the body's healing process for bone and soft tissue wounds
SmartPReP 2 BMAC technology platform, a point-of-care device
Requires 15 minutes to process and concentrate adult stem cells from a small aspirate of autologous bone marrow
Both applications have shown promising results in the treatment of cardiovascular and peripheral artery disease

17. Potential Exits Cardiac Rhythm Management
2010 Overall Revenues: $15.8 billion 2010 Cardiac Rhythm Revenues: $5.268 billion
Core Businesses: Cardiac Rhythm Management, Cardiac surgery, Neurological and Diabetes, Vascular and Spinal/Navigation/ENT
2010 Revenues: $5.16 billion
2010 Cardiac Rhythm Revenues: $3 billion
Core Businesses: Cardiac Rhythm Management, Atrial Fibrillation, Neuromodulation, Cardiovascular
2010 Revenues: $300 million
2010 Cardiac Rhythm Revenues: $300 million
Core Businesses: Cardiac Rhythm Management
2010 Revenues: $7.8 billion
2010 Cardiac Rhythm Revenues: $2.18 billion
Core Businesses: Cardiovascular Group, Cardiac Rhythm Management, Electrophysiology, Endoscopy, Urology/Women’s Health, Neuromodulation

18. Competitive Advantage Lab Professionals Patients Medical Providers$
Clinical IP
Lab Professionals
Cost reduction for raw materials
Increased production
Patients
Decreasing
Hospitalization time
Medical costs
Insurance premiums
Medical Providers
Cost reduction
hospital
procedures

19. Competitive Advantage Cell Culture Stimulator Without Stimulation$
Clinical IP
Cell Culture Stimulator
Without Stimulation
With Stimulation

20. Competitive Advantage Pacemaker Blood Flow Stimulator 20m 100m$
Clinical IP
Pacemaker
Blood Flow Stimulator
Stimulates heart muscle growth
Significant improvement in patient health
Stimulates Angiogenesis
Stimulates Arteriogenesis
Improves wound healing
Less painful treatment than competing products 
20m
100m

21. Competitive Advantage Scientific Advisory Board$
Clinical IP
Patent #
Patent Description
Life
US 6,988,004
Method for Inducing Angiogenesis by Electrical Stimulation
12 years
US 7,341,062
Method for Providing dynamic Cellular Cardiac Support
14 years
US 7,483,749
Method of Enhancing Myogenesis by Electrical Stimulation
15 years
Scientific Advisory Board
Composed of a number of leading scientists who either hold patents for MyoStim use or are working on potentially new patentable medical innovations.
Patent Due Diligence Legal patent reviews on file that MyoStim has a patent portfolio likely to stop infringers and are free to practice our methods and products in clinical trials without worry of infringing on anyone else’s patents.

22. Selected Proforma (in millions of $)
Financials
Selected Proforma (in millions of $)
2012
2013
2014
2015
2016
Sales
$2.1
$6.4
$17.5
$40.2
$75.2
Gross
85%
91%
95%
EBITDA
($1.2)
($1.1)
$4.0
$23.3
$52.5
Net
$3.1
$13.7
$19.5

23. Management Chief Executive Officer - Alan Remen
Over 25 years as a serial entrepreneur forming and running companies. Has served as Chairman, CEO, President & VP Business Development, VP Sales & Marketing. Has experience in aerospace, agriculture, data communications, telecommunications, industrial instrumentation and out- sourced engineering services industries.
Mr. Remen earned his degree in Business from San Diego State University after his service in the United States Marine Corps.
Chief Technical Officer - Howard Leonhardt
Serial entrepreneur and founder of two medical device companies, where he served as Chairman, CEO, CTO and President. Founded World Medical Manufacturing Corporation in 1986, which was acquired by Arterial Vascular Engineering, Inc. In 1999, founded Bioheart, which later become a public traded company (BHRT).
Mr. Leonhardt holds an honorary Doctorate Degree in Biomedical Engineering from the University of Northern California.

24. Management Chief Operating Officer - Bill Olson Acting VP Sales
Previous positions with Deloitte Consulting, GE Medical, and Guidant. At Guidant, Mr. Olson was a sales representative for the Cardiac Rhythm Management division working with physicians who implanted pacemakers, defibrillators, and cardiac resynchronization therapy devices that treat Congestive Heart Failure. As Vice President of Corporate Development at FoxHollow Technologies, Mr. Olson was a part of a company that went from $35M in sales to over $200M in sales, and lead much of the sale process to ev3 for $780M. ev3 was subsequently acquired by Covidien for $2.5B in Upon the acquisition of FoxHollow by ev3, serial entrepreneur and cardiology legend John B. Simpson (FoxHollow founder), recruited Mr. Olson to found Sawtooth Labs with him as it's founding CEO. 
Mr. Olson is a summa cum laude graduate in Computer Science, Information Systems, and Operations & Strategic Management from Boston College and an MBA graduate from Harvard University.

25. Scientific Advisory Board
Chairman – William T. Abraham, M.D., F.A.C.P., F.A.C.C
Dr. Abraham serves as a Professor of Internal Medicine and Chief of the Division of Cardiovascular Medicine of The Ohio State University College of Medicine. Dr. Abraham is an Adjunct Professor of Physiology and Cell Biology. He serves as Deputy Director for Clinical and Translational Research of Dorothy M. Davis Heart and Lung Research Institute. Dr. Abraham serves on the editorial boards of several major journals including the Journal of Cardiac Failure, Congestive Heart Failure, and Journal Watch Cardiology. He is also a Scientific Reviewer for such publications as Circulation, the European Heart Journal and the Journal of the American College of Cardiology. He served as Director of Cardiokine, Inc. He held faculty appointments at the University of Colorado, the University of Cincinnati, and the University of Kentucky. Dr. Abraham is a member of the committee to update the American College of Cardiology/ American Heart Association Heart Failure Guidelines. He has received grants from the National Institutes of Health, the American College of Cardiology, and the Aetna Quality Care Foundation . He has been recognized as one of the "Best Doctors in America" for six consecutive years. He earned his medical degree from Harvard Medical School in Boston, Massachusetts, following which he completed his residency in Internal Medicine and fellowships in Cardiology and Heart Failure/Cardiac Transplantation at the University of Colorado Health Sciences Center.

26. Scientific Advisory Board
Dr. Schwarz has served as Medical Director of the Cardiac Support Program and Co-Director of Cardiac Transplantation at Cedars-Sini.

Dr. Schwarz is board certified in internal medicine by the American Board of Internal Medicine and in cardiology/cardiovascular diseases by the American Board of Internal Medicine in Cardiology/Cardiovascular Diseases. His primary clinical interests are end-stage heart failure, cardiac transplantation, interventional cardiology and sexual function in cardiac disease.

A clinician and scientist, Dr. Schwarz has presented and lectured all over the world. He has written more than 70 articles for peer-reviewed publications and eight book chapters on cardiovascular medicine.

Dr. Schwarz earned his medical degree from Philipps-University in Marburg, Germany, receiving medical doctor titles from Philipps-University Marburg and from the University of Vienna, Austria. He received his doctorate from the University of Technology in Aachen, Germany. Mr. Olson’s previous
Ernst Schwarz, MD, PhD, FESC, FACC, FSCAI

27. Scientific Advisory Board
Juan C. Chachques
European Hospital Georges Pompidou Paris, France Dr. Juan C. Chachques is the Director of Cardiac Research at the Alain Carpentier Foundation, and cardiac surgeon at the HEGP. He graduated of MD at the Faculty of Medicine of Rosario, Argentine. He obtained MS and PhD at the University of Paris, France. After clinical and surgical cardiologic training in Broussais Hospital of Paris, he gained expertise in experimental and clinical procedures for the treatment of heart failure. He developed Cardiac Bioassist surgical techniques, e.g. latissimus dorsi dynamic cardiomyoplasty, dynamic aortomyoplasty, atriomyoplasty. More recently he developed cell-based and tissue engineered procedures for myocardial support and regeneration, i.e. cellular cardiomyoplasty and bioartificial myocardium. He is a clinician and surgical scientist with expertise in myocardial diseases and valve repair procedures. He pursues his research interests in the integrative electrophysiology and cellular biology, the goal is to use in-vitro and in-vivo functional electrostimulation for cardiomyogenic stem-cell conditionning in order to create a dynamic cell based cardiac support. He is the founder and president of the Cardiac Bioassist Association. His further clinical research focuses on e-medecine and in the development of clinical trials for heart failure patients, e.g. the MAGNUM Trial: Myocardial Assistance by Grafting a New Upgraded bioartificial Myocardium.

28. Scientific Advisory Board
Dr. Jorge Genovese
Research Professor in the Department of Surgery at the University of Utah. He formerly served as Research Associate Pittsburgh Medical Center of Cardiac Stem Cells Therapies of the McGowan Institute. Dr. Genovese received his M.D. from the School of Medicine of Buenos Aires University, where he also obtained his Ph.D. after completing a thesis on TGF-Beta, an important growth factor involved in cell development and regeneration. He has been Vice-President of the Tissue Engineering Society International and is a member, among other institutions, of the Latin American Biomaterials and Artificial Organs Society and a founding member of the Latin American Association of Tissues Banks. He is Honorary President of the Tissue Engineering Committee at the National Academy of Science and Medicine of China. Dr. Genovese is a member of the editorial board of J. Stem Cells and the advisory board of Basic and Applied Myology.

29. Inventory & Distribution
Investment
$5,500,000
Product Development
Pre-Clinical Studies
First foreign clinical patient in registry trial
Inventory & Distribution
Funding
2012 – 2017
Capture market share of cell culture & blood flow stimulators while completing FDA
Phases I-III clinical studies
Exit Strategy
5-7 year exit window
End Valuation = 4-5X Revenue