Transcription
Lanzor Medical EquipmentsBUSINESSPLANAlleviating Pain Restoring Health Extending LifePrepared By10200 Bolsa Ave, Westminster, CA, 92683John Doeinfo@upmetrics.co(650) 359-3153https://upmetrics.co
Table of ContentsExecutive SummaryLanzor Medical's Business56Overview6Mission6Market and Opportunity6Commercialized Products6Products Under Development7Competition7Competitive Advantages7Marketing and Distribution7Company8Management & Advisors8FRANK MARTIN8EVGENY SHAMAN8CHEN BARAK8DOV GAL9KIMBERLY PATRIC9ROBERT STODDARD9Board of Directors9Scientific Advisory Board and Clinical Investigators:10Professional Services:10Financial SummaryProjected RevenueChartProjected Net IncomeChart1011111111Background13The Heart14Coronary Artery Disease (CAD)14Diagnosing CAD14Treating CAD14Catheter-Based Procedures15Products and Technology16Commercialized Products17SmartFlowTM Console171 / 42
17SmartFlow CFR/FFR Module17SmartFlow Multiple lesionTM Module18SmartFlow PTC Module18Products Under Development18SmartFlow@ Pressure Guide Wire (Consumable Product)18Smartflow Renal19Imaging19Myocardial Perfusion (Distal Vascular Bed)19Product Acquisitions19Intellectual PropertyMarkets and MarketingPotential Markets192122Number of Cath Labs22Number of Cam Procedures22Spending on Oath Lab Equipment22Patient Base23Economic Impact23Market Potential23Interest in Physiologic Data23Competition & Competitive Advantages23Direct Competitors24Indirect Competitors25Summary of Competitive Advantages25Marketing Strategy25Pricing Strategy25Sales and Marketing Strategy25Sales ForecastOperating ory Approval28Reimbursement28Manufacturing and Distribution28Risks29Market Risks29Competitive Risks29R&D Risks292 / 42
Legal RisksCompany and ManagementCompany303132History and Structure32Office Locations32Professional Services32Management and Advisors32Management32FRANK MARTIN33EVGENY SHALMAN33CHEN BARAK33DOV GAL, D.V.M.33Board of Directors34FRANK MARTIN34GIDEON TOLKOWSKY34HILLEL BACHRACH34SHMUEL EINAV35Scientific Advisory Board and Clinical Investigators35TAKASHI AKASAKA35RAFAEL BEYAR35BERNARD DE BRUYNE36Organization Chart36Key Open Positions36Financial PlanKey Assumptions3738General Assumptions and Notes38Revenue Assumptions38Expense Assumptions38Financial Projections38Revenues39Chart39Net IncomeChart4040Summary Income Statement( 000)40Capital Requirements a Use of Proceeds41Exit Strategy413 / 42
Easy to use Business Plan SoftwareGet started using a business plan template is always the fastest way to write yourbusiness plan, but as you know, you can't just fill in the blanks along with a template. Youwill need a collaborative tool that guides you on every step of your planning.Upmetrics can help. With Upmetrics, you can easily bring your team to write aprofessional business plan with automated financial forecasts. You can also do:200 Sample business plansGet access to hundreds of sample business plans covering almostall industries to kick start your business plan writing. This helpsyou to get an idea how the perfect business plan should look like.View Sample Business PlansStep-By-Step GuideYou'll receive step-by-step instruction as soon as you select anybusiness plan template. We made business planning easy withprompt help and examples on every step of your business planwriting.See How It WorksConduct accurate financial projectionsDo not worry about not having accounting skills. With Upmetrics,Simply enter your sales and costs figures, and we'll prepare all ofyour monthly/quarterly and yearly financial projections.See How It Works[YEAR ] Bus ines s Plan Lanz or Medic al Equipments4 / 42
1.Executive SummaryLanzor Medical's BusinessManagement & AdvisorsFinancial Summary[YEAR ] Bus ines s Plan Lanz or Medic al Equipments5 / 42
Lanzor Medical's BusinessWe design, develop, and are selling unique solutions for the 4.2 billion globalmarket for catheter-based equipment to diagnose and treat cardiovasculardisease. Our clinically proven and FDA and EU approved SmartFlow products represent the next generation in interventional cardiovascularTo unlock help try Upmetrics! procedures, designed to improve outcomes in the 8 millioncatheter-basedOverviewStart writing here.Achieve and maintain world leadership in the diagnosis and treatment ofcoronary artery and renal artery disease through novel interventionalapplications of computational fluid dynamics and related advanced principles.To unlock help try Upmetrics! MissionStart writing here.Our primary target is coronary artery disease (CAD), a blockage ofthe arteries that supply blood to the heart, affecting over 12 million Americans.CAD is the number one killer in developed nations, causing over 500,000deaths per year in the U.S. and 6.9 million deaths worldwide. In the U.S., overTo unlock help try Upmetrics! 58 billion is being spent annually to treat CAD.Market and OpportunityStart writing here.Our products, designed to improve the treatment of narrowingarteries due to coronary artery disease, are based on the principles ofComputational Fluid Dynamics. Using our proprietary algorithms, we are able tomeasure various parameters with unprecedented accuracy and ease. OurTo unlock help try Upmetrics! commercially available products include:Commercialized ProductsStart writing here.[YEAR ] Bus ines s Plan Lanz or Medic al Equipments6 / 42
We are developing additional modules that will significantly improve theevaluation and treatment of additional cardiovascular conditions. In all cases,existing tools are unreliable, difficult to use, expensive, and frequently lead topoor treatment decisions. We believe that Florence's products for treating theTo unlock help try Upmetrics! following conditions will become essential tools in the cathlab:Products Under DevelopmentStart writing here.A number of technologies for diagnosing vascular disease currently exist:Direct Competition: RADI Medical Systems (a Swedish company) andJOMED (a Swiss company) have competitive pressure-based systems.help tryCFRUpmetrics!However, SmartFlow is the only product capableToofunlockmeasuringand CompetitionStart writing here.Our competitive advantages include:SmartFlow product benefits relative to competing technologies:Real-time, more accurate, quantitative functional assessments;To unlock help try Upmetrics! Safer, easier, faster, and more economical than competing procedures;Competitive AdvantagesStart writing here.We are now shipping and installing SmartFlow products. We are developing asmall direct sales force to market SmartFlow to leading cath labs worldwide. Inparallel, we are developing strategic regional distribution channels, some ofwhich are now in place. In the future, we plan to establish distributionTo unlock help try Upmetrics! partnerships to leverage the global sales, marketing, manufacturing,andMarketing and DistributionStart writing here.[YEAR ] Bus ines s Plan Lanz or Medic al Equipments7 / 42
Lanzor Medical, Inc., was incorporated in 2000 as a Delaware C corporation. Itis a wholly-owned subsidiary of Lanzor Medical, Ltd., an Israeli companyfounded in 1997. Corporate and marketing activities are conducted from ourWellesley, MA headquarters, while R&D is conducted in our Israeli office. WeTo unlock help try Upmetrics! employ 13 full-time employees and 7 part-time employeesand consultants.CompanyStart writing here.Management & AdvisorsFRANK MARTINPresident and CEOHe Has many years of domestic and international experience in medical devices,biotech and medical electronics. He held several senior domestic and internationalmanagement positions at Becton-Dickinson and Abbott Labs before becoming afounder and builder of medical device companies, including PLC Systems,CorMedica, and Advanced Biomedical. Mr. Martin serves on the boards of NMTMedical, Inc. (Nasdaq NMTI) and several private medical device companies.EVGENY SHAMANChief Scientist,He earned his Ph.D. in applied mathematics at Moscow University, with specialexpertise in viscous flow and computational fluid dynamics. He has 30 years ofindustrial experience in the aerospace and cardiovascular fields, where hedeveloped his exceptional know-how in vascular mechanics, hemodynamics, andthe interaction of flow and the vessel wall. Dr. Shalman is responsible for theresearch activities of Lanzor Medical.CHEN BARAKVP OperationsHe is a graduate of The Technion Israel and University of Texas, SouthwesternTexas, in biomedical engineering. She has 12 years of academic and industrialexperience in the cardiovascular field. Dr. Barak is responsible for clinical andregulatory affairs, as well as Israeli operations.[YEAR ] Bus ines s Plan Lanz or Medic al Equipments8 / 42
DOV GALVP Clinical AffairsHe has 19 years of academic and industrial experience in the cardiovascular field,with expertise in clinical research and clinical marketing, as well as commercialexperience in medical products. He has held appointments at Harvard and TuftsMedical Schools.KIMBERLY PATRICDirectorGlobal Marketing and Sales has 13 years of sales and marketing experiencedomestically and internationally in the medical device industry. Prior to joiningLanzor, she held various senior positions with interventional cardiology devicecompanies including Endosonics and JOMED. She is a graduate of the Universityof Massachusetts with dual degrees in business administration and politicalscience.ROBERT STODDARDCFOHe has extensive experience in early-stage medical device and biotech operations,financings, and mergers and acquisitions. Previously, he served as controller,treasurer, and CFO of the U.S. operations of Biogen, Inc., and more recently asCFO of Damon Biotech and Abbott Biotech. He is the Founder and President ofRMS Associates, a consulting firm specializing in providing financial services tohigh tech companies. Mr. Stoddard is a graduate of Princeton University and aCPA.Frank Martin, Chairman, and CEO, Florence MedicalGideon Tolkowsky, Founding Partner, Veritas Venture PartnersHillel Bachrach, President & CEO, Orex Computed RadiographyShmuel Einav, Ph.D., Berman Professor of BiovascularTo unlockEngineering,help try Upmetrics!Tel Aviv UniversityBoard of DirectorsStart writing here.[YEAR ] Bus ines s Plan Lanz or Medic al Equipments9 / 42
Takashi Akasaka, M.D., Ph.D., Kawasaki Medical School, JapanRafael Beyar, M.D., D.Sc., The Technion Israel Institute of Technology,Haifa, IsraelBernard De Bruyne, M.D., Ph.D., OLV Hospital, Aalst,BelgiumTo unlockhelp try Upmetrics! Carlo DiMario, M.D., Ph.D., San Raffaele Hospital, Milan, ItalyScientific Advisory Board and Clinical Investigators:Start writing here.Gross, Kleinhendler, Hodak, Halevy, Greenberg and Co, legal councilNath & Associates, PLLC, intellectual property counselTo unlock help try Upmetrics! Professional Services:Start writing here.Financial SummaryWe expect to achieve profitability in 2004 on strong revenue growthTo unlock help try Upmetrics! Start Writing here.[YEAR ] Bus ines s Plan Lanz or Medic al Equipments10 / 42
Projected RevenuePressure Guide WireSmart Flow ProcessorRenal OptionMultiple Lesion OptionPTC cted Net IncomeNet Income20.00k10.00k0-10.00k20122013201420152016Our summary P&L forecast, in thousands, is as follows:20122013201420152016% ofrevenueSmartFlow Processor2001,7433,5604,9886,36410%Multiple Lesion Option521562603905201%PTC Option522606501,3002,6004%Renal Option-603606601,2002%Pressure Guide Wire--14,91030,66050,80083%Revenues[YEAR ] Bus ines s Plan Lanz or Medic al Equipments11 / 42
20122013201420152016% 68%71%74%Operations1692708591,4702,4384%Research &Development1,2241,8582,7843,8675,95110%Sales & Marketing5871,2392,7854,2656,50311%General 62951341612230%Total -Operating Income(Expense)1602501802154701%Income Before 15618%(2,034)(1,011)4,8488,87916,73427%Total RevenueLess: Cost of GoodsGross MarginOperating ExpensesTax (40%)Net IncomeWe have sufficient funds to meet our operating objectives through Q2, 2003. To date, we have raised 5.5 million in venture capital led by Veritas Ventures.We are currently seeking 10 million in capital to finance the aggressive commercialization of our initialproducts, continued R&D, and the acquisition of complementary products.[YEAR ] Bus ines s Plan Lanz or Medic al Equipments12 / 42
2.BackgroundThe HeartCoronary Artery Disease (CAD)Diagnosing CADTreating CADCatheter-Based Procedures[YEAR ] Bus ines s Plan Lanz or Medic al Equipments13 / 42
The HeartThe human heart is a fist-sizedmuscle consisting of four chambers: theleft and right atria, and the left and rightventricles. The right atrium receivesoxygen-depleted blood from the bodyTo unlock help try Upmetrics! Start Writing here.Coronary Artery Disease (CAD)Cardiovascular disease (CVD) is the leading cause of death in the U.S.,claiming 958,775 lives in 1999, versus 549,838 deaths due to all forms ofcancer combined. Worldwide, CVD caused 16.7 million deaths in 2000.Approximately 1 in 5 Americans - nearly 62 million - has one or more types ofTo unlock help try Upmetrics! CVD. Of the various forms of CVD, Coronary Artery Disease(CAD) is by farStart Writing here.Diagnosing CADMany tests and procedures are available for diagnosing heart conditionsincluding CAD. In approximate order of evasiveness, common diagnosticsinclude:To unlockactivityhelp try Upmetrics! Electrocardiogram (ECG): The ECG records electricalin theStart Writing here.Treating CADMany surgical and non-surgical treatments for CAD have been developed:Lifestyle: When detected early enough, CAD can often be treatedthrough lifestyle changes. Some important changes include a low-fat,To unlockhelp try Upmetrics! low-cholesterol diet, regular exercise, and smokingcessation.Start Writing here.[YEAR ] Bus ines s Plan Lanz or Medic al Equipments14 / 42
Catheter-Based ProceduresInterventional procedures such as PTCAs are catheter-based. In a typicalcoronary angioplasty procedure, the patient is sedated and an incision is madein a major artery under a local anesthetic, usually the femoral artery in thegroin. A sheath is placed at the location of the incision to enable the insertionTo unlock help try Upmetrics! and removal of catheters with minimal damage to the tissue.A catheter is thenStart Writing here.[YEAR ] Bus ines s Plan Lanz or Medic al Equipments15 / 42
3.Products andTechnologyCommercialized ProductsProducts Under DevelopmentIntellectual Property[YEAR ] Bus ines s Plan Lanz or Medic al Equipments16 / 42
Lanzor Medical's core technologies revolve around providing better, faster, andcheaper techniques for diagnosing and treating Coronary Artery Disease(CAD). As such, we believe that our SmartFlow product line will set newstandards in interventional cardiology, and will become indispensable in theTo unlock help try Upmetrics! 4,000 interventional cath labs worldwide.Start Writing here.Commercialized ProductsAt the core of most of our products are the use of computational fluid dynamics(CFD) and related principles. CFD is the computer-simulated study of howfluids and gasses behave as they flow through or around various structures.CFD was originally developed for the aerospace industry to study airflow overTo unlock help try Upmetrics! aircraft wing surfaces; it has since been applied to manyareas, includingStart Writing here.The SmartFlow Console is our core hardware platform. It consists of a medicalgrade computer, including a touch-screen monitor and keyboard.We offer numerous software modules designed to measure specificTo unlock help try Upmetrics! physiological parameters, described below.SmartFlowTM ConsoleStart writing here.Coronary Flow Reserve (CFR) and Fractional Flow Reserve (FFR), describedin section 2.3, are physiological measuresimportant in the diagnosis of stenosis. Inclinical practice today, CFR is measuredTo unlock help try Upmetrics! with a flow guidewire, while FFR isSmartFlow CFR/FFR ModuleStart writing here.[YEAR ] Bus ines s Plan Lanz or Medic al Equipments17 / 42
Very often, patients will have multiple stenoses, or lesions, within a singlecoronary artery. Treating all of the lesions introduces unnecessary risks andcosts, since some of the lesions may be relatively insignificant. However,obtaining an accurate evaluation of the severity of each lesion usingTo unlock help try Upmetrics! conventional diagnostic tools is impossible due to bloodflow interferenceSmartFlow Multiple lesionTM ModuleStart writing here.Existing techniques for measuring FFR have one serious drawback: theyrequire repeatedly administering vessel dilating drugs to induce maximumhyperemia or maximum blood flow conditions. These drugs introduce additionalcosts and risks, require more time and skill, and can sometimes lead toTo unlock help try Upmetrics! inaccuracies due to the difficulty of determining the appropriatedosages.SmartFlow PTC ModuleStart writing here.Products Under DevelopmentOur R&D team, in collaboration with our U.S., European, and Israeli clinicalresearch centers, is at work on several interrelated projects. These projects areexpected to add substantially to our SmartFlow product family and providesustained growth. Our new products will be launched over the next three years.unlock help try Upmetrics! In addition, we are actively seeking a strategic productToacquisitionthat has theStart Writing here.Guidewires are an integral component of all interventional catheterizationprocedures. The ability to accurately assess hemodynamic parameters duringprocedures, enabled by pressure guide wires (PGWs), will grow in importance.We have designed and patented our own proprietary SmartFlow PGW, whichunlock help try Upmetrics! offers superior handling characteristics at a lower cost Tothancurrently availableSmartFlow@ Pressure Guide Wire (Consumable Product)Start writing here.[YEAR ] Bus ines s Plan Lanz or Medic al Equipments18 / 42
Renal Artery Stenosis (RAS) is the root cause of hypertension in 20-50% ofhypertensive patients with cardiovascular disease. It is also a significant causeof reduced renal (kidney) function.To unlockhelp tryHowever, only 50-60% of patients with RAS benefit fromtreatment;inUpmetrics!addition, the condition of 10-15% of patients may actually be impaired by the treatment,Smartflow RenalStart writing here.We have a research collaboration with a European manufacturer ofQuantitative Coronary Angiography equipment in which SmartFlow data will beoverlaid onto angiography images. Additional parameters (i.e., vessel wallshear stress and absolute flow) are calculated in our imaging product,To unlock help try Upmetrics! combining physiological measurements with imaging (QCA).ImagingStart writing here.One of the remaining challenges in interventional cardiology is in the diagnosisand treatment of microvascular disease. This refers to impaired myocardialperfusion (blood flow) in the smallest arteries and capillaries that directly feedthe heart's muscle tissue (distal vascular bed). In some cases, this can be anTo unlock help try Upmetrics! outcome of angioplasty procedures, when small fragmentsof plaque or plateletMyocardial Perfusion (Distal Vascular Bed)Start writing here.In order to fully utilize our talent, resources, and global distribution channels,we are actively seeking to acquire more complementary products. Severalcandidates have been identified. Because these products have not yet beenselected, they are not included in the Projected P&L, and 4,000,000 is setTo unlock help try Upmetrics! aside as an Acquisition Reserve throughout the forecastperiod.Product AcquisitionsStart writing here.Intellectual Property[YEAR ] Bus ines s Plan Lanz or Medic al Equipments19 / 42
We have two patents issued (with 164 total claims) and eight patents pendingin the U.S., Europe, and Japan. Our intellectual property covers a range ofapplications in coronary and peripheral vessels utilizing our core technology ofcomputational fluid dynamics and our proprietary pressure wire.To unlock help try Upmetrics! Start Writing here.[YEAR ] Bus ines s Plan Lanz or Medic al Equipments20 / 42
4.Markets andMarketingPotential MarketsCompetition & Competitive AdvantagesMarketing StrategySales Forecast[YEAR ] Bus ines s Plan Lanz or Medic al Equipments21 / 42
Potential MarketsThe worldwide coronary cath lab equipment market is currently 4.2 billion, ofwhich 60% is in the U.S. The potential market for the SmartFlow productfamily is driven by the number of interventional cath labs and the number ofprocedures performed in these labs. The following section highlights key factsand figures for our markets, including spending trends.To unlock help try Upmetrics! Start Writing here.According to research firm Frost & Sullivan, there were 6,000 cath labsworldwide in 19%, the latest year for which complete figures were available:1996 Global Cath Lab Distribution:To unlock help try Upmetrics! Number of Cath LabsStart writing here.IMV, an independent research firm, surveyed 1,550 U.S. cardiac cath labs in2001 and estimated that 3.75 million cardiac and non-cardiac procedures wereperformed in the U.S. in 2000. Of these, 3.40 million were cardiac procedures,while the remaining 0.35 million were primarily carotid, iliac, renal, aortic,To unlock help try Upmetrics! femoral, and extremity cases.Number of Cam ProceduresStart writing here.According to Business Communications, Inc., worldwide spending on cardiaccatheter products is expected to be 4.2 billion in 2002:Worldwide Spending on Cardiac Catheter Products (S Billions)To unlock help try Upmetrics! Spending on Oath Lab EquipmentStart writing here.[YEAR ] Bus ines s Plan Lanz or Medic al Equipments22 / 42
As described in the Background chapter, cardiovascular disease (CVD) is theleading cause of death in the U.S., claiming 958,775 lives in 1999, versus549,838 deaths due to all forms of cancer combined. Worldwide, CVD caused16.7 million deaths in 1999. Approximately 1 in 5 Americans - nearly 62 millionTo unlock help try Upmetrics! - has one or more types of CVD. Of the various forms ofCVD, Coronary ArteryPatient BaseStart writing here.The economic cost of CAD and other cardiovascular diseases is extremelyhigh. However, almost half of the economic cost of CAD is due to the indirectcosts of lost productivity:To unlockhelp try Upmetrics! 2010 U.S. Estimated Cost of Treating CAD( Billion)Economic ImpactStart writing here.As described above, approximately 8 million interventional cardiovascularprocedures are performed annually worldwide. If we achieve a 10% utilizationrate in these procedures, our disposable products alone (the pressure guidewire, initially priced to distributors at 210 each) represent a total revenueTo unlock help try Upmetrics! potential of 168 million per year.Market PotentialStart writing here.Interest in physiologic data has grown rapidly in the past three years as moreinterventionalists begin to understand the forces at work in the formation ofstenotic disease. The SmartFlow product family provides clinical informationthat other modalities (such as angiography) cannot yield, especially in coronaryTo unlock help try Upmetrics! arteries with a diffuse disease or multiple lesions. At therecent American HeartInterest in Physiologic DataStart writing here.Competition & Competitive Advantages[YEAR ] Bus ines s Plan Lanz or Medic al Equipments23 / 42
Our direct competitors are firms offering technologies for measuring blood flowand pressure within the coronary arteries. Thus, our principal competitors are:To unlock help try Upmetrics! Direct CompetitorsStart writing here.RADI Medical Systems ABJOMED N.V.Founded in 1985, RADI is aEuropean manufacturer andmarketer of pressure guide wiresand related technologies. AlthoughRADI focuses on pressure guidewires, it also offers theRADIAnalyzer, designed to measureFFR and CFR. The device has beencleared by the FDA and hasreceived a CE mark. We currentlyuse RADI's Pressure Wire pressuresensing guide wire, and plan tocontinue doing so until we havecompleted the development of ourown proprietary guide wiretechnologies.Founded in 1991, JOMED is aEuropean manufacturer andmarketer of products forcardiovascular intervention. The firmhas 1,200 employees and offersover 2,000 products. Although thecorporate focus is on coronarystents, the company does offerphysiology products. The productline is considered to be outdatedsince a separate system is requiredfor each CFR and FFR. A newsystem that provides simultaneousCFR/FFR is in development. Wecurrently use JOMED's WaveWirepressure sensing guide wire andplan to continue doing so until wehave completed the development ofour own proprietary guide wiretechnologies. We have also enteredinto a distribution partnershipagreement with JOMED. We believethat our measurement technologiesare far superior to JOMEDtechnologies, and view them as asupplier, a distribution partner, anda potential acquirer.use of a pressure wire only. Our SmartFlow Multiple Lesion and SmartFlowPTC drug-free FFR products are unmatched by competitors. In addition, theSmartFlow Pressure Guide Wire, under development, has superior handlingand cost advantages. These products are expected to establish Florence'sTo unlock help try Upmetrics! breakthrough technology as the market leader.[YEAR ] Bus ines s Plan Lanz or Medic al Equipments24 / 42
Start Writing here.Indirect competitors include the various technologies available for diagnosingcardiovascular stenosis. All of the following technologies are visual, and thussubjective, means of evaluating stenoses; as such, they all produce imperfectmeasurements:To unlock help try Upmetrics! Indirect CompetitorsStart writing here.We have significant business and clinical advantages in many areas relative tocompetitors due to the following attributes:Product Advantages: Our technologies have many advantages overTo unlock help try Upmetrics! competing technologies:Summary of Competitive AdvantagesStart writing here.Marketing StrategyWe will employ value-based pricing, rather than cost-plus based pricing. Ourcurrent views on achievable pricing are as follows:ProductEndUserDistributorTo unlock help try Upmetrics! CommentsPricing StrategyStart writing here.Our marketing strategy will be highly targeted. The community of leadinginterventional cardiologists is small and tightly-knit. If we are able to enlist asmall number of the leading interventionalists to use our products, others willfollow quickly. Therefore, the bulk of our marketing efforts will consist of:To unlock help try Upmetrics! Sales and Marketing StrategyStart writing here.[YEAR ] Bus ines s Plan Lanz or Medic al Equipments25 / 42
Sales ForecastDirect revenues from instrumentation sales are expected to be relativelymodest. However, instrumentation drives disposables sales, so acquiring asubstantial installed base is important to our success.Toourunlockhelp try andUpmetrics! Disposables are the key to our long-term growth. Unlikesoftwareinstrumentation products, these are not limited by the number of cath labs -Start Writing here.[YEAR ] Bus ines s Plan Lanz or Medic al Equipments26 / 42
5.Operating StrategyMilestonesCommercializationRisks[YEAR ] Bus ines s Plan Lanz or Medic al Equipments27 / 42
MilestonesWe have gained significant momentum since our founding, and intend toremain aggressive as we go to market:Sales 8BusinessTo unlock help try Upmetrics! WhenCorporatePersonnelR&DStart Writing here.CommercializationWe received FDA and CE Mark clearance to market the Florence SmartFlow inJune 2001. A 510K was cleared in October 2001 for an upgraded version ofSmartFlow including our new Multiple Lesion software. Our Pulse TransmissionCoefficient (PTC) software was cleared by the FDA in February 2002.To unlock help try Upmetrics! Registration of our products in Israel has been completed and is planned forRegulatory ApprovalStart writing here.Medicare and Medicaid reimbursement for pressure and flow measurementswere approved in the U.S. effective January 1, 1999. The CPT codes forphysiology measurements are reimbursable when performed with eithertherapeutic intervention or with angiography.To unlock help try Upmetrics! The inclusion of CPT codes for physiological assessment by CMS (Centers forReimbursementStart writing here.All of our hardware manufacturing is performed by OEM partners. TheSmartFlow Console and stand are manufactured at a cost of goods of 6,500.We have identified and qualified additional manufacturers to take over theproduction of the console in the event that our current supplier cannot meet ourunlock help try Upmetrics! needs. All suppliers are ISO 9000/9001 approved, as isToFlorenceMedical.Manufacturing and DistributionStart writing here.Risks[YEAR ] Bus ines s Plan Lanz or Medic al Equipments28 / 42
RisksWe believe that we have taken prudent steps to address the most significantrisks facing us, and plan to continue mitigating risks as they are identified.To unlock help try Upmetrics! Start Writing here.Cardiologists do notadopt our productsIt is well understood and acknowledged thatangiograms are an imperfect measure of coronaryblood flow; our products provide critical data toTo unlockhelp tryeffectiveUpmetrics! enable more accurate diagnosisand moretreatment.Market RisksStart writing here.Competitors copy ourproductsWe have several patents issued and pendingcovering our core technologies and methods.We will aggressively file forintellectualTo additionalunlock
the arteries that supply blood to the heart, affecting over 12 million Americans. CAD is the number one killer in developed nations, causing over 500,000 . [YEAR] Business Plan Lanzor Medical Equipments 11 / 42. Total Revenue 304 2,219 19,740 37,998 61,484 100% Less: Cost of Goods 140 654 6.414 11.082 15.681 26% 54% 71% 68% 71% 74%
