Presentation on theme: "Enabling the Heart to self-regenerate"— Presentation transcript:
1Enabling the Heart to self-regenerate Enabling the Heart to self-regenerateAlan RemenChief Executive Officer
2Transformational IPMyoStim’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.
3Validation“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 Hospitalsin 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
4Business ModelMyoStim 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.
5MyoStim IntroductionMyoStim is developing a set of products to target three market opportunities, leveraging our IP related to electrical stimulation.
7Investment Opportunity $5.5 million launches the MyoStim Lab and Limb Stimulators that will finance the $15 million clinical trials for the Heart StimulatorCell culture industry is $4.97 billion today on the way to be $20 billion in 7 years - immediately addressable: $480MLimb ischemia market exceeds $2.2 billion worldwide today -Immediately addressable - $2BThe heart failure market exceeds $40 billion today. CRT/ICD pacers alone - $4.2 billion. CHF drugs $8 billion – immediately addressable $4.2B.
8Product Line123Doubles the production of cell cultures with half the amount of growth factors & mediaConverts pluripotent stem cells to cardiomyocytes (beating heart muscle cells)Reduces use of animal based products (FDA recommendation)Cell Culture Stimulator
9Market Cell Culture Market Size Expected Growth Target Customer $4.97B global marketExpected Growth5 – 6 X increase in demand is forecasted for next 4 yrsTarget Customer15,000 commercial or academic research laboratories hosting researchers, technicians, & other employeesMarket OpportunitiesImmediately addressable Market = $480M1st year “likely to purchase” market size projected to be $5MMarket FitIncreased costs for cell culture supplies & need for superior cell proliferation has created the need for more efficient toolsGo To Market StrategyResearchers,Low volume productionHigh Volume - bioreactors
10Product Line32Blood 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 areasInduces reperfusion
11Market Peripheral Artery Disease (PAD) Market Size Expected Growth $15.5B global marketExpected Growth13.1% per yearTarget CustomerDiabetes & Wound Healing SpecialistsVascular SurgeonsPeripheral Limb SpecialistsMarket OpportunitiesImmediately addressable market - $400 M1st year “likely to purchase” at $3.8MSales start in Jan 2013Market FitIncreasing no. of patients requiring treatment for PADAnother line of defense in avoiding amputation of a limbMaybe one of the least painful treatments for advanced PADGo To Market StrategyInstrument will be leased not sold – KCI modelClinical Unit delivered to Limb Salvage ProfessionalsHome unit to individualsMedicare reimbursement code: G0281
12Product Line Implantable Pacemaker – REPAIRS the heart 123Recruits stem cells to damaged areaConverts recruited cells into heart muscle cellsStimulates the creation of new blood vesselsIncreases contraction strength of muscleEnsures heart remains on beat
13Market Cardiac Rhythm Management (CRM) Market Size Expected Growth $4.1B global marketExpected Growth6.97% compound annual growthTarget CustomerElectrophysiologistsCardio-Thoracic SurgeonsImplanting CardiologistsMarket OpportunitiesImmediate Addressable Market = $4.1B1st year “likely purchase” projected at $280MSales start in 2016Market FitSuperior alternative to every known pacemaker & defibrillatorExpected to be at the forefront of heart failure treatment optionsGo To Market StrategyUsher the product through Phase 1 & 2 Clinical trialsPut the CRM division on the market
15Clinical/Regulatory Milestones 2012201320142015201620172018LabStimulatorBlood Flow StimulatorPacemakerNo Clinical Studies RequiredProduct DevPre-Clinical TestingOUS Human Use/ Feasibility TrialCE MarkOUS Commercialization510(k) ApprovalProduct DevelopmentIDETrial in USPMA ApprovalUS Commercialization for Limb SalvageLab-Use Approval & CommercializationProduct Dev
16Competition Cell Culture Industry Blood Flow Stimulation Market 2010 sales estimated $2.5 millionOffers similar electrostimulation product to research laboratoriesAbility to culture a variety of cells that are electrically coupled in vivoShown to only marginally improve cell proliferationDemonstrated lack of marketing expertiseWillingness of laboratories to purchase the competitively inferior product proves that there is an immediate marketBlood Flow Stimulation Market2010 sales = $25.9 millionSmartPReP 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 woundsSmartPReP 2 BMAC technology platform, a point-of-care deviceRequires 15 minutes to process and concentrate adult stem cells from a small aspirate of autologous bone marrowBoth applications have shown promising results in the treatment of cardiovascular and peripheral artery disease
20Competitive Advantage Pacemaker Blood Flow Stimulator 20m 100m $ClinicalIPPacemakerBlood Flow StimulatorStimulates heart muscle growthSignificant improvement in patient healthStimulates AngiogenesisStimulates ArteriogenesisImproves wound healingLess painful treatment than competing products 20m100m
21Competitive Advantage Scientific Advisory Board $ClinicalIPPatent #Patent DescriptionLifeUS 6,988,004Method for Inducing Angiogenesis by Electrical Stimulation12 yearsUS 7,341,062Method for Providing dynamic Cellular Cardiac Support14 yearsUS 7,483,749Method of Enhancing Myogenesis by Electrical Stimulation15 yearsScientific Advisory BoardComposed 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.
22Selected Proforma (in millions of $) FinancialsSelected Proforma (in millions of $)20122013201420152016Sales$2.1$6.4$17.5$40.2$75.2Gross85%91%95%EBITDA($1.2)($1.1)$4.0$23.3$52.5Net$3.1$13.7$19.5
23Management 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 LeonhardtSerial 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.
24Management 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.
25Scientific Advisory Board Chairman – William T. Abraham, M.D., F.A.C.P., F.A.C.CDr. 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.
26Scientific 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 previousErnst Schwarz, MD, PhD, FESC, FACC, FSCAI
27Scientific Advisory Board Juan C. ChachquesEuropean 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.
28Scientific Advisory Board Dr. Jorge GenoveseResearch 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.
29Inventory & Distribution Investment$5,500,000Product DevelopmentPre-Clinical StudiesFirst foreign clinical patient in registry trialInventory & DistributionFunding2012 – 2017Capture market share of cell culture & blood flow stimulators while completing FDAPhases I-III clinical studiesExit Strategy5-7 year exit windowEnd Valuation = 4-5X Revenue