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Enabling the Heart to self-regenerate

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Presentation on theme: "Enabling the Heart to self-regenerate"— Presentation transcript:

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 heart
1 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

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