If you are planning to start a new manufacturing business, the first thing you will need is a business plan. Use our Lanzor - medical equipment manufacturing business plan example created using upmetrics business plan software to start writing your business plan in no time.
Before you start writing your business plan for your new medical equipment manufacturing business, spend as much time as you can reading through some examples of manufacturing business plans. Reading some sample business plans will give you a good idea of what you’re aiming for and also it will show you the different sections that different entrepreneurs include and the language they use to write about themselves and their business plans.
We have created this medical equipment manufacturing business plan example for you to get a good idea about how a perfect manufacturing business plan should look like and what details you will need to include in your stunning business plan.
Central Medical Gas Distribution System
MedicalGasDistributionSystemisacentralsupplysystemtosupplyamedicalgas(O2,N2O,N2),medicalair,andmedicalvacuumtoeachwardofhospitalsafelyandconvenientlythroughacentralsupplypipingfrommedicalgassupplysources.
•Thesystemhasathoroughgoingcolorcoordinationaccordingtothekindofgas.
•Anaudio-visualmonitoringsystemcapableofcheckingthesituation
Market Survey cum Detailed Techno Economic Feasibility Report on Multispecial...Ajjay Kumar Gupta
A specialty hospital is dedicated to specific sub-specialty care (paediatric centres, oncology centres, psychiatric hospitals). Patients will often be referred from smaller hospitals to a speciality hospital for major operations, consultations with sub-specialists and when sophisticated intensive care facilities are required. These hospitals have highly trained specialists, high-end technology and provide round the clock services. These hospitals are able to do specialised tests, undertake dialysis for acute renal failure, provide ventilation to patients with respiratory failure and render intensive care to critically ill patients. These hospitals undertake research and have adequate library facilities. These hospitals concentrate on a particular organ of the body and provide medical care e.g., cancer, dental, psychiatry, T.B. etc.
Tags
Best Multi Speciality Hospital in India, Business plan for Hospital, Business Plan for Indian Health Care Industry, Business start-up, Children's hospital, Detailed project report hospital, Detailed Project Report on Multispecialty Hospital, Diagnostic Center, Download free project profile on Multispecialty Hospital, Feasibility report on Multispecialty Hospital, Free Project Profile on Multispecialty Hospital, Healthcare, Hospital business plan India, Hospital Planning in India, Hospital project proposal, Hospital project report, Hospital requirements, Hospital set up cost in India, Hospital set up requirements, Hospital start up Multi specialty hospital, Hospitals Integrated Business Plan, How Can Start Own Business as a Hospitality Industry, How does one start a hospital?, How to open Multispecialty Hospital, How to open your own hospital, How to prepare project report for new hospital, How to start a hospital business, How to Start a Hospital Business Startup Business, How to Start a Multispecialty Hospital Business, How to start a successful Hospital business, How to start Multispecialty Hospital, How to start your own hospital?, Medicare, Mental hospital, Most Profitable Multispecialty Hospital Business Ideas, Multi Speciality Hospital, Multispeciality Hospital Detailed Project Report, Multispecialty Hospital Based Profitable Projects, Multispecialty Hospital Business, Multispecialty Hospital Detailed Project Report, Multispecialty Hospital Industry in India, Multispecialty Hospital Projects, New hospital business plan, Nursing Home, Opening a new hospital, Opening Multi specialty hospital in India, Planning for New Hospital, Planning for New Hospital, Prefeasibility Report for Setting up of Diagnostic Centre, Pre-feasibility Report on Specaility and Multi-Speciality Hospitals, Pre-Investment Feasibility Study on Multispecialty Hospital, Preparation of Project Profiles, Private hospital business plan, Project report on Multispecialty Hospital, Project Report Required for Multi Speciality Hospital, Project report super speciality hospital
OPD is the mirror of the hospital, which reflects the functioning of the hospital being the first point of contact between the patient and the hospital staff.
Patients visit the OPD for various purposes, like consultation, day care treatment, investigation, referral, admission and post discharge follow up. Not only for treatment but also for preventing and promotive services like, health check up, Immunisation, Physio-therapy and so on.
Central Medical Gas Distribution System
MedicalGasDistributionSystemisacentralsupplysystemtosupplyamedicalgas(O2,N2O,N2),medicalair,andmedicalvacuumtoeachwardofhospitalsafelyandconvenientlythroughacentralsupplypipingfrommedicalgassupplysources.
•Thesystemhasathoroughgoingcolorcoordinationaccordingtothekindofgas.
•Anaudio-visualmonitoringsystemcapableofcheckingthesituation
Market Survey cum Detailed Techno Economic Feasibility Report on Multispecial...Ajjay Kumar Gupta
A specialty hospital is dedicated to specific sub-specialty care (paediatric centres, oncology centres, psychiatric hospitals). Patients will often be referred from smaller hospitals to a speciality hospital for major operations, consultations with sub-specialists and when sophisticated intensive care facilities are required. These hospitals have highly trained specialists, high-end technology and provide round the clock services. These hospitals are able to do specialised tests, undertake dialysis for acute renal failure, provide ventilation to patients with respiratory failure and render intensive care to critically ill patients. These hospitals undertake research and have adequate library facilities. These hospitals concentrate on a particular organ of the body and provide medical care e.g., cancer, dental, psychiatry, T.B. etc.
Tags
Best Multi Speciality Hospital in India, Business plan for Hospital, Business Plan for Indian Health Care Industry, Business start-up, Children's hospital, Detailed project report hospital, Detailed Project Report on Multispecialty Hospital, Diagnostic Center, Download free project profile on Multispecialty Hospital, Feasibility report on Multispecialty Hospital, Free Project Profile on Multispecialty Hospital, Healthcare, Hospital business plan India, Hospital Planning in India, Hospital project proposal, Hospital project report, Hospital requirements, Hospital set up cost in India, Hospital set up requirements, Hospital start up Multi specialty hospital, Hospitals Integrated Business Plan, How Can Start Own Business as a Hospitality Industry, How does one start a hospital?, How to open Multispecialty Hospital, How to open your own hospital, How to prepare project report for new hospital, How to start a hospital business, How to Start a Hospital Business Startup Business, How to Start a Multispecialty Hospital Business, How to start a successful Hospital business, How to start Multispecialty Hospital, How to start your own hospital?, Medicare, Mental hospital, Most Profitable Multispecialty Hospital Business Ideas, Multi Speciality Hospital, Multispeciality Hospital Detailed Project Report, Multispecialty Hospital Based Profitable Projects, Multispecialty Hospital Business, Multispecialty Hospital Detailed Project Report, Multispecialty Hospital Industry in India, Multispecialty Hospital Projects, New hospital business plan, Nursing Home, Opening a new hospital, Opening Multi specialty hospital in India, Planning for New Hospital, Planning for New Hospital, Prefeasibility Report for Setting up of Diagnostic Centre, Pre-feasibility Report on Specaility and Multi-Speciality Hospitals, Pre-Investment Feasibility Study on Multispecialty Hospital, Preparation of Project Profiles, Private hospital business plan, Project report on Multispecialty Hospital, Project Report Required for Multi Speciality Hospital, Project report super speciality hospital
OPD is the mirror of the hospital, which reflects the functioning of the hospital being the first point of contact between the patient and the hospital staff.
Patients visit the OPD for various purposes, like consultation, day care treatment, investigation, referral, admission and post discharge follow up. Not only for treatment but also for preventing and promotive services like, health check up, Immunisation, Physio-therapy and so on.
Biomedical Engineering Department in HospitalDrKunal Rawal
Biomedical Engineering Department, Meaning, Definition, Biomedical Engineering Services, Scope of Bio Medical Engineering, Disciplines under Bio Medical Engineering, Six Responsibilities of Biomedical Engineering, Roles of Biomedical Engineer, Functions of Bio Medical Engineering in Hospital
Hi Friends
This is supa bouy
I am a mentor, Friend for all Management Aspirants, Any query related to anything in Management, Do write me @ supabuoy@gmail.com.
I will try to assist the best way I can.
Cheers to lyf…!!!
Supa Bouy
Cardiac Holter Monitor Market PPT: Demand, Trends and Business Opportunities ...IMARC Group
According to the latest report by IMARC Group, the global cardiac Holter monitor market reached a value of US$ 386 Million in 2020.
A cardiac Holter monitor is a battery-operated portable electrocardiography (ECG) device that records the heart rhythm continuously for around 24 to 48 hours.
It consists of a monitor, software and electrodes, which aid in interpreting the recorded data, determining if the heart is getting adequate oxygen and diagnosing conditions concerning irregular cardiac rhythms, such as tachycardia, arrhythmia and atrial fibrillation.
Biomedical Engineering Department in HospitalDrKunal Rawal
Biomedical Engineering Department, Meaning, Definition, Biomedical Engineering Services, Scope of Bio Medical Engineering, Disciplines under Bio Medical Engineering, Six Responsibilities of Biomedical Engineering, Roles of Biomedical Engineer, Functions of Bio Medical Engineering in Hospital
Hi Friends
This is supa bouy
I am a mentor, Friend for all Management Aspirants, Any query related to anything in Management, Do write me @ supabuoy@gmail.com.
I will try to assist the best way I can.
Cheers to lyf…!!!
Supa Bouy
Cardiac Holter Monitor Market PPT: Demand, Trends and Business Opportunities ...IMARC Group
According to the latest report by IMARC Group, the global cardiac Holter monitor market reached a value of US$ 386 Million in 2020.
A cardiac Holter monitor is a battery-operated portable electrocardiography (ECG) device that records the heart rhythm continuously for around 24 to 48 hours.
It consists of a monitor, software and electrodes, which aid in interpreting the recorded data, determining if the heart is getting adequate oxygen and diagnosing conditions concerning irregular cardiac rhythms, such as tachycardia, arrhythmia and atrial fibrillation.
According to the latest report by IMARC Group,The global artificial heart-lung machine market reached a value of US$ 319.3 Million in 2020.An artificial heart-lung machine (HLM), also known as a cardiopulmonary bypass pump, refers to an apparatus that performs the function of both the heart and lungs during open-heart surgery or a transplant. It ensures that the blood receives oxygen and removes carbon dioxide before the blood is pumped back into the body.
Artificial Heart Lung Machine Market PPT(2021- 2026) : Global Trends, Scope, ...IMARC Group
According to the latest report by IMARC Group, the global artificial heart-lung machine market reached a value of US$ 319.3 Million in 2020.
An artificial heart-lung machine (HLM), also known as a cardiopulmonary bypass pump, refers to an apparatus that performs the function of both the heart and lungs during open-heart surgery or a transplant. It ensures that the blood receives oxygen and removes carbon dioxide before the blood is pumped back into the body.
World’s first one wrist ecg band and other revolutionary products from Europe’s fastest growing biotech company in $142b market investment opportunity with 28x return in 3 years
Clinical Operations Recruiting Open House - Billerica ExpansionDavid Anderson
On July 28th, EMD Serono showcased the growth of our Global Research and Development headquarters located in Billerica, MA. The Clinical Operations Team hosted our recruiting vendors. The team highlighted:
- the patient centric approach of our trials
- desired innovative talent profiles
- projected growth
- continued investment in biopharmaceutical R&D
This report provides comprehensive information on the therapeutic development for Cerebral Infarction (Brain Infarction), complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for Cerebral Infarction (Brain Infarction) and special features on late-stage and discontinued projects.
http://www.researchmoz.us/cerebral-infarction-brain-infarction-pipeline-review-h1-2015-report.html
Medical Lab Business Plan Example | UpmetricsECorp
The medical lab business plan outlines the strategic framework for establishing and operating a successful medical laboratory. It encompasses market analysis, financial projections, regulatory compliance, operational procedures, and marketing strategies. The plan aims to provide quality diagnostic services, meet healthcare needs, and ensure sustainable growth in the competitive healthcare industry.
Tracxn Startup Research — Life Sciences Landscape, October 2016Tracxn
There were 20+ acquisitions in this space in 2016; IBM’s $2.6B acquisition of Truven Analytics, and Affymetrix’s acquisition by Thermo Fisher Scientific for $1.6B were the largest M&A events for the sector this year.
The 10 most innovative pharma and life sciences solutions providers jan 2018Merry D'souza
With great enthusiasm Insights Success has selected some of the most prominent organizations around the globe in the issue of “The 10 Most Innovative Pharma and life sciences Solution Providers 2018,”
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Medical equipment manufacturing business plan example
1. Lanzor Medical Equipments
BUSINESS
PLAN
Alleviating Pain • Restoring Health • Extending Life
Prepared By
John Doe
(650) 359-3153
10200 Bolsa Ave, Westminster, CA, 92683
info@upmetrics.co
https://upmetrics.co
2. Table of Contents
Executive Summary 5
Lanzor Medical's Business 6
Overview 6
Mission 6
Market and Opportunity 6
Commercialized Products 6
Products Under Development 7
Competition 7
Competitive Advantages 7
Marketing and Distribution 7
Company 8
Management & Advisors 8
FRANK MARTIN 8
EVGENY SHAMAN 8
CHEN BARAK 8
DOV GAL 9
KIMBERLY PATRIC 9
ROBERT STODDARD 9
Board of Directors 9
Scientific Advisory Board and Clinical Investigators: 10
Professional Services: 10
Financial Summary 10
Projected Revenue 11
Chart 11
Projected Net Income 11
Chart 11
Background 13
The Heart 14
Coronary Artery Disease (CAD) 14
Diagnosing CAD 14
Treating CAD 14
Catheter-Based Procedures 15
Products and Technology 16
Commercialized Products 17
SmartFlowTM Console 17
1 / 42
3. 17
SmartFlow CFR/FFR Module 17
SmartFlow Multiple lesionTM Module 18
SmartFlow PTC Module 18
Products Under Development 18
SmartFlow@ Pressure Guide Wire (Consumable Product) 18
Smartflow Renal 19
Imaging 19
Myocardial Perfusion (Distal Vascular Bed) 19
Product Acquisitions 19
Intellectual Property 19
Markets and Marketing 21
Potential Markets 22
Number of Cath Labs 22
Number of Cam Procedures 22
Spending on Oath Lab Equipment 22
Patient Base 23
Economic Impact 23
Market Potential 23
Interest in Physiologic Data 23
Competition & Competitive Advantages 23
Direct Competitors 24
Indirect Competitors 25
Summary of Competitive Advantages 25
Marketing Strategy 25
Pricing Strategy 25
Sales and Marketing Strategy 25
Sales Forecast 26
Operating Strategy 27
Milestones 28
Commercialization 28
Regulatory Approval 28
Reimbursement 28
Manufacturing and Distribution 28
Risks 29
Market Risks 29
Competitive Risks 29
R&D Risks 29
2 / 42
4. Legal Risks 30
Company and Management 31
Company 32
History and Structure 32
Office Locations 32
Professional Services 32
Management and Advisors 32
Management 32
FRANK MARTIN 33
EVGENY SHALMAN 33
CHEN BARAK 33
DOV GAL, D.V.M. 33
Board of Directors 34
FRANK MARTIN 34
GIDEON TOLKOWSKY 34
HILLEL BACHRACH 34
SHMUEL EINAV 35
Scientific Advisory Board and Clinical Investigators 35
TAKASHI AKASAKA 35
RAFAEL BEYAR 35
BERNARD DE BRUYNE 36
Organization Chart 36
Key Open Positions 36
Financial Plan 37
Key Assumptions 38
General Assumptions and Notes 38
Revenue Assumptions 38
Expense Assumptions 38
Financial Projections 38
Revenues 39
Chart 39
Net Income 40
Chart 40
Summary Income Statement($000) 40
Capital Requirements a Use of Proceeds 41
Exit Strategy 41
3 / 42
5. Easy to use Business Plan Software
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[YEAR] Business Plan | Lanzor Medical Equipments 4 / 42
7. Lanzor Medical's Business
Overview
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We design, develop, and are selling unique solutions for the $4.2 billion global
market for catheter-based equipment to diagnose and treat cardiovascular
disease. Our clinically proven and FDA and EU approved SmartFlow®
products represent the next generation in interventional cardiovascular
procedures, designed to improve outcomes in the 8 million catheter-based
Mission
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Achieve and maintain world leadership in the diagnosis and treatment of
coronary artery and renal artery disease through novel interventional
applications of computational fluid dynamics and related advanced principles.
Market and Opportunity
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Our primary target is coronary artery disease (CAD), a blockage of
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
deaths per year in the U.S. and 6.9 million deaths worldwide. In the U.S., over
$58 billion is being spent annually to treat CAD.
Commercialized Products
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Our products, designed to improve the treatment of narrowing
arteries due to coronary artery disease, are based on the principles of
Computational Fluid Dynamics. Using our proprietary algorithms, we are able to
measure various parameters with unprecedented accuracy and ease. Our
commercially available products include:
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[YEAR] Business Plan | Lanzor Medical Equipments 6 / 42
8. Products Under Development
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We are developing additional modules that will significantly improve the
evaluation and treatment of additional cardiovascular conditions. In all cases,
existing tools are unreliable, difficult to use, expensive, and frequently lead to
poor treatment decisions. We believe that Florence's products for treating the
following conditions will become essential tools in the cath lab:
Competition
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A number of technologies for diagnosing vascular disease currently exist:
Direct Competition: RADI Medical Systems (a Swedish company) and
JOMED (a Swiss company) have competitive pressure-based systems.
However, SmartFlow is the only product capable of measuring CFR and
Competitive Advantages
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Our competitive advantages include:
SmartFlow® product benefits relative to competing technologies:
Real-time, more accurate, quantitative functional assessments;
Safer, easier, faster, and more economical than competing procedures;
Marketing and Distribution
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We are now shipping and installing SmartFlow® products. We are developing a
small direct sales force to market SmartFlow to leading cath labs worldwide. In
parallel, we are developing strategic regional distribution channels, some of
which are now in place. In the future, we plan to establish distribution
partnerships to leverage the global sales, marketing, manufacturing, and
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[YEAR] Business Plan | Lanzor Medical Equipments 7 / 42
9. Company
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Lanzor Medical, Inc., was incorporated in 2000 as a Delaware C corporation. It
is a wholly-owned subsidiary of Lanzor Medical, Ltd., an Israeli company
founded in 1997. Corporate and marketing activities are conducted from our
Wellesley, MA headquarters, while R&D is conducted in our Israeli office. We
employ 13 full-time employees and 7 part-time employees and consultants.
Management & Advisors
FRANK MARTIN
President and CEO
He Has many years of domestic and international experience in medical devices,
biotech and medical electronics. He held several senior domestic and international
management positions at Becton-Dickinson and Abbott Labs before becoming a
founder and builder of medical device companies, including PLC Systems,
CorMedica, and Advanced Biomedical. Mr. Martin serves on the boards of NMT
Medical, Inc. (Nasdaq¬NMTI) and several private medical device companies.
EVGENY SHAMAN
Chief Scientist,
He earned his Ph.D. in applied mathematics at Moscow University, with special
expertise in viscous flow and computational fluid dynamics. He has 30 years of
industrial experience in the aerospace and cardiovascular fields, where he
developed his exceptional know-how in vascular mechanics, hemodynamics, and
the interaction of flow and the vessel wall. Dr. Shalman is responsible for the
research activities of Lanzor Medical.
CHEN BARAK
VP Operations
He is a graduate of The Technion Israel and University of Texas, Southwestern
Texas, in biomedical engineering. She has 12 years of academic and industrial
experience in the cardiovascular field. Dr. Barak is responsible for clinical and
regulatory affairs, as well as Israeli operations.
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[YEAR] Business Plan | Lanzor Medical Equipments 8 / 42
10. DOV GAL
VP Clinical Affairs
He has 19 years of academic and industrial experience in the cardiovascular field,
with expertise in clinical research and clinical marketing, as well as commercial
experience in medical products. He has held appointments at Harvard and Tufts
Medical Schools.
KIMBERLY PATRIC
Director
Global Marketing and Sales has 13 years of sales and marketing experience
domestically and internationally in the medical device industry. Prior to joining
Lanzor, she held various senior positions with interventional cardiology device
companies including Endosonics and JOMED. She is a graduate of the University
of Massachusetts with dual degrees in business administration and political
science.
ROBERT STODDARD
CFO
He 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 as
CFO of Damon Biotech and Abbott Biotech. He is the Founder and President of
RMS Associates, a consulting firm specializing in providing financial services to
high tech companies. Mr. Stoddard is a graduate of Princeton University and a
CPA.
Board of Directors
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Frank Martin, Chairman, and CEO, Florence Medical
Gideon Tolkowsky, Founding Partner, Veritas Venture Partners
Hillel Bachrach, President & CEO, Orex Computed Radiography
Shmuel Einav, Ph.D., Berman Professor of Biovascular Engineering, Tel
Aviv University
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[YEAR] Business Plan | Lanzor Medical Equipments 9 / 42
11. Scientific Advisory Board and Clinical Investigators:
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Takashi Akasaka, M.D., Ph.D., Kawasaki Medical School, Japan
Rafael Beyar, M.D., D.Sc., The Technion Israel Institute of Technology,
Haifa, Israel
Bernard De Bruyne, M.D., Ph.D., OLV Hospital, Aalst, Belgium
Carlo DiMario, M.D., Ph.D., San Raffaele Hospital, Milan, Italy
Professional Services:
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Gross, Kleinhendler, Hodak, Halevy, Greenberg and Co, legal council
Nath & Associates, PLLC, intellectual property counsel
Financial Summary
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We expect to achieve profitability in 2004 on strong revenue growth
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12. Projected Revenue
Pressure Guide Wire Renal Option PTC Option
Smart Flow Processor Multiple Lesion Option
2012 2013 2014 2015 2016
0
25.00k
50.00k
75.00k
Projected Net Income
Net Income
2012 2013 2014 2015 2016
-10.00k
0
10.00k
20.00k
Our summary P&L forecast, in thousands, is as follows:
2012 2013 2014 2015 2016
% of
revenue
Revenues
SmartFlow Processor 200 1,743 3,560 4,988 6,364 10%
Multiple Lesion Option 52 156 260 390 520 1%
PTC Option 52 260 650 1,300 2,600 4%
Renal Option - 60 360 660 1,200 2%
Pressure Guide Wire - - 14,910 30,660 50,800 83%
[YEAR] Business Plan | Lanzor Medical Equipments 11 / 42
13. 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%
Gross Margin 164 1.565 13.326 26,916 45.803 74%
54% 71% 68% 71% 74%
Operating Expenses
Operations 169 270 859 1,470 2,438 4%
Research &
Development
1,224 1,858 2,784 3,867 5,951 10%
Sales & Marketing 587 1,239 2,785 4,265 6,503 11%
General &
Administrative
316 614 1,727 2,570 3,267 5%
Depreciation 62 95 134 161 223 0%
Total Operating
Expenses
2,358 4.076 8.289 12,333 18.382 30%
Non-Operating Income
(Expense)
160 250 180 215 470 1%
Income Before Tax (2,034) (2,261) 5,217 14,798 27,891 45%
Tax (40%) 0 0 369 5,919 11,156 18%
Net Income (2,034) (1,011) 4,848 8,879 16,734 27%
2012 2013 2014 2015 2016
% of
revenue
We 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 initial
products, continued R&D, and the acquisition of complementary products.
[YEAR] Business Plan | Lanzor Medical Equipments 12 / 42
14. 2.
Background
The Heart
Coronary Artery Disease (CAD)
Diagnosing CAD
Treating CAD
Catheter-Based Procedures
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15. The Heart
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The human heart is a fist-sized
muscle consisting of four chambers: the
left and right atria, and the left and right
ventricles. The right atrium receives
oxygen-depleted blood from the body
Coronary Artery Disease (CAD)
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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 of
cancer combined. Worldwide, CVD caused 16.7 million deaths in 2000.
Approximately 1 in 5 Americans - nearly 62 million - has one or more types of
CVD. Of the various forms of CVD, Coronary Artery Disease (CAD) is by far
Diagnosing CAD
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Many tests and procedures are available for diagnosing heart conditions
including CAD. In approximate order of evasiveness, common diagnostics
include:
Electrocardiogram (ECG): The ECG records electrical activity in the
Treating CAD
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Many surgical and non-surgical treatments for CAD have been developed:
Lifestyle: When detected early enough, CAD can often be treated
through lifestyle changes. Some important changes include a low-fat,
low-cholesterol diet, regular exercise, and smoking cessation.
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[YEAR] Business Plan | Lanzor Medical Equipments 14 / 42
16. Catheter-Based Procedures
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Interventional procedures such as PTCAs are catheter-based. In a typical
coronary angioplasty procedure, the patient is sedated and an incision is made
in a major artery under a local anesthetic, usually the femoral artery in the
groin. A sheath is placed at the location of the incision to enable the insertion
and removal of catheters with minimal damage to the tissue. A catheter is then
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[YEAR] Business Plan | Lanzor Medical Equipments 15 / 42
18. Start Writing here...
Lanzor Medical's core technologies revolve around providing better, faster, and
cheaper techniques for diagnosing and treating Coronary Artery Disease
(CAD). As such, we believe that our SmartFlow® product line will set new
standards in interventional cardiology, and will become indispensable in the
4,000 interventional cath labs worldwide.
Commercialized Products
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At 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 how
fluids and gasses behave as they flow through or around various structures.
CFD was originally developed for the aerospace industry to study airflow over
aircraft wing surfaces; it has since been applied to many areas, including
SmartFlowTM Console
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The SmartFlow Console is our core hardware platform. It consists of a medical-
grade computer, including a touch-screen monitor and keyboard.
We offer numerous software modules designed to measure specific
physiological parameters, described below.
SmartFlow CFR/FFR Module
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Coronary Flow Reserve (CFR) and Fractional Flow Reserve (FFR), described
in section 2.3, are physiological measures
important in the diagnosis of stenosis. In
clinical practice today, CFR is measured
with a flow guidewire, while FFR is
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[YEAR] Business Plan | Lanzor Medical Equipments 17 / 42
19. SmartFlow Multiple lesionTM Module
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Very often, patients will have multiple stenoses, or lesions, within a single
coronary artery. Treating all of the lesions introduces unnecessary risks and
costs, since some of the lesions may be relatively insignificant. However,
obtaining an accurate evaluation of the severity of each lesion using
conventional diagnostic tools is impossible due to blood flow interference
SmartFlow PTC Module
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Existing techniques for measuring FFR have one serious drawback: they
require repeatedly administering vessel dilating drugs to induce maximum
hyperemia or maximum blood flow conditions. These drugs introduce additional
costs and risks, require more time and skill, and can sometimes lead to
inaccuracies due to the difficulty of determining the appropriate dosages.
Products Under Development
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Our R&D team, in collaboration with our U.S., European, and Israeli clinical
research centers, is at work on several interrelated projects. These projects are
expected to add substantially to our SmartFlow product family and provide
sustained growth. Our new products will be launched over the next three years.
In addition, we are actively seeking a strategic product acquisition that has the
SmartFlow@ Pressure Guide Wire (Consumable Product)
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Guidewires are an integral component of all interventional catheterization
procedures. The ability to accurately assess hemodynamic parameters during
procedures, enabled by pressure guide wires (PGWs), will grow in importance.
We have designed and patented our own proprietary SmartFlow PGW, which
offers superior handling characteristics at a lower cost than currently available
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[YEAR] Business Plan | Lanzor Medical Equipments 18 / 42
20. Smartflow Renal
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Renal Artery Stenosis (RAS) is the root cause of hypertension in 20-50% of
hypertensive patients with cardiovascular disease. It is also a significant cause
of reduced renal (kidney) function.
However, only 50-60% of patients with RAS benefit from treatment; in addition,
the condition of 10-15% of patients may actually be impaired by the treatment,
Imaging
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We have a research collaboration with a European manufacturer of
Quantitative Coronary Angiography equipment in which SmartFlow data will be
overlaid onto angiography images. Additional parameters (i.e., vessel wall
shear stress and absolute flow) are calculated in our imaging product,
combining physiological measurements with imaging (QCA).
Myocardial Perfusion (Distal Vascular Bed)
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One of the remaining challenges in interventional cardiology is in the diagnosis
and treatment of microvascular disease. This refers to impaired myocardial
perfusion (blood flow) in the smallest arteries and capillaries that directly feed
the heart's muscle tissue (distal vascular bed). In some cases, this can be an
outcome of angioplasty procedures, when small fragments of plaque or platelet
Product Acquisitions
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In order to fully utilize our talent, resources, and global distribution channels,
we are actively seeking to acquire more complementary products. Several
candidates have been identified. Because these products have not yet been
selected, they are not included in the Projected P&L, and $4,000,000 is set
aside as an Acquisition Reserve throughout the forecast period.
Intellectual Property
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[YEAR] Business Plan | Lanzor Medical Equipments 19 / 42
21. Start Writing here...
We have two patents issued (with 164 total claims) and eight patents pending
in the U.S., Europe, and Japan. Our intellectual property covers a range of
applications in coronary and peripheral vessels utilizing our core technology of
computational fluid dynamics and our proprietary pressure wire.
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23. Potential Markets
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The worldwide coronary cath lab equipment market is currently $4.2 billion, of
which 60% is in the U.S. The potential market for the SmartFlow® product
family is driven by the number of interventional cath labs and the number of
procedures performed in these labs. The following section highlights key facts
and figures for our markets, including spending trends.
Number of Cath Labs
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According to research firm Frost & Sullivan, there were 6,000 cath labs
worldwide in 19%, the latest year for which complete figures were available:
1996 Global Cath Lab Distribution:
Number of Cam Procedures
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IMV, an independent research firm, surveyed 1,550 U.S. cardiac cath labs in
2001 and estimated that 3.75 million cardiac and non-cardiac procedures were
performed 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,
femoral, and extremity cases.
Spending on Oath Lab Equipment
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According to Business Communications, Inc., worldwide spending on cardiac
catheter products is expected to be $4.2 billion in 2002:
Worldwide Spending on Cardiac Catheter Products (S Billions)
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[YEAR] Business Plan | Lanzor Medical Equipments 22 / 42
24. Patient Base
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As described in the Background chapter, cardiovascular disease (CVD) is the
leading cause of death in the U.S., claiming 958,775 lives in 1999, versus
549,838 deaths due to all forms of cancer combined. Worldwide, CVD caused
16.7 million deaths in 1999. Approximately 1 in 5 Americans - nearly 62 million
- has one or more types of CVD. Of the various forms of CVD, Coronary Artery
Economic Impact
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The economic cost of CAD and other cardiovascular diseases is extremely
high. However, almost half of the economic cost of CAD is due to the indirect
costs of lost productivity:
2010 U.S. Estimated Cost of Treating CAD ($ Billion)
Market Potential
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As described above, approximately 8 million interventional cardiovascular
procedures are performed annually worldwide. If we achieve a 10% utilization
rate in these procedures, our disposable products alone (the pressure guide
wire, initially priced to distributors at $210 each) represent a total revenue
potential of $168 million per year.
Interest in Physiologic Data
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Interest in physiologic data has grown rapidly in the past three years as more
interventionalists begin to understand the forces at work in the formation of
stenotic disease. The SmartFlow product family provides clinical information
that other modalities (such as angiography) cannot yield, especially in coronary
arteries with a diffuse disease or multiple lesions. At the recent American Heart
Competition & Competitive Advantages
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[YEAR] Business Plan | Lanzor Medical Equipments 23 / 42
25. Direct Competitors
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Our direct competitors are firms offering technologies for measuring blood flow
and pressure within the coronary arteries. Thus, our principal competitors are:
RADI Medical Systems AB
Founded in 1985, RADI is a
European manufacturer and
marketer of pressure guide wires
and related technologies. Although
RADI focuses on pressure guide
wires, it also offers the
RADIAnalyzer, designed to measure
FFR and CFR. The device has been
cleared by the FDA and has
received a CE mark. We currently
use RADI's Pressure Wire pressure
sensing guide wire, and plan to
continue doing so until we have
completed the development of our
own proprietary guide wire
technologies.
JOMED N.V.
Founded in 1991, JOMED is a
European manufacturer and
marketer of products for
cardiovascular intervention. The firm
has 1,200 employees and offers
over 2,000 products. Although the
corporate focus is on coronary
stents, the company does offer
physiology products. The product
line is considered to be outdated
since a separate system is required
for each CFR and FFR. A new
system that provides simultaneous
CFR/FFR is in development. We
currently use JOMED's WaveWire
pressure sensing guide wire and
plan to continue doing so until we
have completed the development of
our own proprietary guide wire
technologies. We have also entered
into a distribution partnership
agreement with JOMED. We believe
that our measurement technologies
are far superior to JOMED
technologies, and view them as a
supplier, a distribution partner, and
a potential acquirer.
use of a pressure wire only. Our SmartFlow Multiple Lesion and SmartFlow
PTC drug-free FFR products are unmatched by competitors. In addition, the
SmartFlow Pressure Guide Wire, under development, has superior handling
and cost advantages. These products are expected to establish Florence's
breakthrough technology as the market leader.
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26. Start Writing here...
Indirect Competitors
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Indirect competitors include the various technologies available for diagnosing
cardiovascular stenosis. All of the following technologies are visual, and thus
subjective, means of evaluating stenoses; as such, they all produce imperfect
measurements:
Summary of Competitive Advantages
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We have significant business and clinical advantages in many areas relative to
competitors due to the following attributes:
Product Advantages: Our technologies have many advantages over
competing technologies:
Marketing Strategy
Pricing Strategy
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We will employ value-based pricing, rather than cost-plus based pricing. Our
current views on achievable pricing are as follows:
Product
End
User
Distribu
tor Comments
Sales and Marketing Strategy
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Our marketing strategy will be highly targeted. The community of leading
interventional cardiologists is small and tightly-knit. If we are able to enlist a
small number of the leading interventionalists to use our products, others will
follow quickly. Therefore, the bulk of our marketing efforts will consist of:
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27. Sales Forecast
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Direct revenues from instrumentation sales are expected to be relatively
modest. However, instrumentation drives disposables sales, so acquiring a
substantial installed base is important to our success.
Disposables are the key to our long-term growth. Unlike our software and
instrumentation products, these are not limited by the number of cath labs -
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[YEAR] Business Plan | Lanzor Medical Equipments 26 / 42
29. Milestones
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We have gained significant momentum since our founding, and intend to
remain aggressive as we go to market:
When Corporate Personnel R&D
Sales 8
Business
Commercialization
Regulatory Approval
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We received FDA and CE Mark clearance to market the Florence SmartFlow in
June 2001. A 510K was cleared in October 2001 for an upgraded version of
SmartFlow including our new Multiple Lesion software. Our Pulse Transmission
Coefficient (PTC) software was cleared by the FDA in February 2002.
Registration of our products in Israel has been completed and is planned for
Reimbursement
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Medicare and Medicaid reimbursement for pressure and flow measurements
were approved in the U.S. effective January 1, 1999. The CPT codes for
physiology measurements are reimbursable when performed with either
therapeutic intervention or with angiography.
The inclusion of CPT codes for physiological assessment by CMS (Centers for
Manufacturing and Distribution
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All of our hardware manufacturing is performed by OEM partners. The
SmartFlow Console and stand are manufactured at a cost of goods of $6,500.
We have identified and qualified additional manufacturers to take over the
production of the console in the event that our current supplier cannot meet our
needs. All suppliers are ISO 9000/9001 approved, as is Florence Medical.
Risks
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[YEAR] Business Plan | Lanzor Medical Equipments 28 / 42
30. Risks
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We believe that we have taken prudent steps to address the most significant
risks facing us, and plan to continue mitigating risks as they are identified.
Market Risks
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Cardiologists do not
adopt our products
It is well understood and acknowledged that
angiograms are an imperfect measure of coronary
blood flow; our products provide critical data to
enable more accurate diagnosis and more effective
treatment.
Competitive Risks
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Competitors copy our
products
We have several patents issued and pending
covering our core technologies and methods.
We will aggressively file for additional intellectual
property rights, both in the US. and abroad.
R&D Risks
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Product development
costs more or takes longer
than expected
We have proven, through our development of
the SmartFlow product line, our ability to
develop innovative products quickly and
economically.
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[YEAR] Business Plan | Lanzor Medical Equipments 29 / 42
31. Legal Risks
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Product flaw resulting in
product liability suits
This is a risk in all life science companies. The
stringent safety requirements of the regulatory
approval process help to ensure that products
are safe before they are marketed. As product
safety is integral to our business, we have
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33. Company
History and Structure
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Lanzor Medical, Inc., was incorporated in 2000 as a Delaware C corporation. It
is a wholly owned subsidiary of Lanzor Medical, Ltd., an Israeli company
founded in 1997. Corporate and marketing activities are conducted from our
Wellesley, MA headquarters, while R&D is conducted from our Israeli office.
We currently employ 13 full-lime employees and 7 part-time employees and
Office Locations
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The company is headquartered in Wellesley, MA. The area has a strong
medical technology base and talent pool that includes Abbott Labs, AbioMed,
Biogen, Boston Scientific, DynaGen, Genzyme, Millennium Pharmaceuticals,
PolyMedica, Sepracor, and Thermo Cardiosystems, as well as a number of
teaching and research hospitals including Harvard Medical School's Brigham &
Professional Services
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Corporate Counsel
Osnat Levin
Gross, Kleinhendler, Hodak, Halevy, Greenberg & Co.
Management and Advisors
Management
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34. FRANK MARTIN
President and CEO
Mr. Martin has many years of domestic and international experience in medical
devices, biotech, and medical electronics. He held several senior domestic and
international management positions at Becton-Dickinson and Abbott Labs before
becoming a founder and builder of medical device companies including PLC
Systems, CorMedica, and Advanced Biomedical. Mr. Martin serves on the boards
of NMT Medical, Inc. (Nasdaq-NMTI) and several private medical device
companies.
EVGENY SHALMAN
Chief Scientist
Dr. Shalman earned his Ph.D. in applied mathematics at the Moscow University,
with special expertise in viscous flow and computational fluid dynamics. He has 30
years of industrial experience in the aerospace and cardiovascular fields, where he
developed his exceptional know-how in vascular mechanics, hemodynamics, and
the interaction of flow and the vessel wall. Dr. Shalman is responsible for the
research activities of Lanzor Medical.
CHEN BARAK
Vice President, Operations
Dr. Barak is a graduate of The Technion Israel and University of Texas,
Southwestern Texas, in biomedical engineering. She has 12 years of academic
and industrial experience in the cardiovascular field. Dr. Barak is responsible for
clinical and regulatory affairs, as well as Israeli operations.
DOV GAL, D.V.M.
Vice President, Clinical Affairs
Dr. Gal has 19 years of academic and industrial experience in the cardiovascular
field. He has held senior R&D, marketing, and clinical positions in start-up biotech
and medical device companies, and was a consultant in the biopharmaceutical
industry. Dr. Gal holds D.V.M. and M.B.A. degrees and has completed a research
fellowship in interventional cardiology at Tufts Medical School. He has also held
appointments at Harvard and Tufts Medical Schools.
And Many more people those we have listed in first chapter 'Executive Summary'
[YEAR] Business Plan | Lanzor Medical Equipments 33 / 42
35. Board of Directors
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FRANK MARTIN
Chairman and CEO, Lanzor Medical.
GIDEON TOLKOWSKY
Co-Founder of Lanzor Medical and Founding Partner
Veritas Venture Partners, Israel's pioneering venture capital firm. He began his
involvement in venture capital in 1981 through the US-based venture capital firm of
Adler & Company, and later through Elron Electronic Industries in the US and
Israel. He was a manager of Athena Venture Partners from co-founding it in 1985
until its dissolution in 1997 and has managed Veritas' funds since 1990. Mr.
Tolkowsky is a board member of Aisys (Chairman) and Lanzor Medical (Co-
Founder) and is a past board member of Accord Networks (Nasdaq), ESC Medical
(Nasdaq; now Lumenis) (Chairman), Harmonic Lightwaves, M-Systems Flash Disk
Pioneers (Nasdaq), and Ubique, among others. He holds a BS. in aeronautical
engineering from The Technion in Haifa and an MBA from Wharton. Mr. Tolkowsky
serves as a member of the International Executive Board of Wharton.
HILLEL BACHRACH
President & CEO
Orex Computed Radiography. Mr. Bachrach has over 25 years of global medical
device management experience, with emphasis on marketing, sales, and business
development. He has held executive management positions at Odin Medical
Technologies, ESC Medical Systems, Candela Laser Corporation, General Electric
Medical Systems, and Baxter International. Mr. Bachrach holds a B.S. in Electrical
Engineering from The Technion and an M.B.A. from Kellogg Graduate School of
Management at Northwestern University.
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36. SHMUEL EINAV
Co-Founder of Lanzor Medical and Berman Professor of Biovascular
Engineering, Tel-Aviv University
Professor Einav joined the Faculty of Engineering of Tel-Aviv University in 1974.
His expertise is in the fields of cardiovascular bioengineering and biomedical
engineering education. He is best known for his research on blood flow through
heart valves, coronary circulation, blood-tissue interaction, and blood flow
dynamics and turbulent characteristics in occluded arteries. He is a Distinguished
Visiting Scholar at Caltech and has held visiting professorships at UCLA, Berkeley,
and MIT. Professor Einav earned his B.S. in Mechanical Engineering and his M.S.
in Nuclear Engineering from The Technion, Haifa, and his Ph.D. in Biomedical
Engineering from SUNY at Stony Brook.
Scientific Advisory Board and Clinical Investigators
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We have assembled a world-renowned team of interventional cardiologists who
act as clinical investigators and advisors. The investigators below are active
participants in our clinical, scientific, and strategic efforts. An extensive
bibliography of articles and abstracts is available upon request.
TAKASHI AKASAKA
M.D., Ph.D
Dr. Akasaka is the Director of the Cardiac Catheterization Laboratory and
Associate Professor, Division of Cardiology, at the Kawasaki Medical School in
Japan. He is also a Lecturer, The First Department of Medicine, Osaka City
University School of Medicine. Dr. Akasaka earned his M.D. at Wakayama Medical
College and his Ph.D. at the Osaka City University School of Medicine.
RAFAEL BEYAR
M.D., D.Sc
Dr. Beyar is Dean of Medicine and Professor of Medicine and Biomedical
Engineering at The Technion Israel Institute of Technology in Haifa, Israel. His
research interests include cardiovascular dynamics and function, coronary flow
and its relationship to ventricular function, coronary metal stents and the
interaction with the arterial wall, interventional cardiology, and three-dimensional
imaging and analysis of cardiac function. Dr. Beyar earned his M.D. at Sackler
Medical School and his D.Sc. in Biomedical Engineering at The Technion.
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37. BERNARD DE BRUYNE
M.D., Ph.D
Dr. De Bruyne is Associate Director of the Cardiovascular Center of OLV Hospital
in Aalst, Belgium. As an interventional cardiologist, his main interests lie in the
physiology of coronary atherosclerosis and of myocardial perfusion. In a dose
collaboration with Dr. Nico Pijls, he described and validated the concept of
coronary pressure-derived fractional flow reserve, a method that is now widely
applied in catheterization laboratories to evaluate coronary stenosis physiology.
Organization Chart
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Our organizational structure through the first quarter of 2003 is as follows. As
the company grows, we may shift to other roles as necessary to better ensure
the success of the company.
Key Open Positions
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Our current staffing priorities are the following positions:
Clinical Specialist - Prior successful cath lab experience is critical.
Clinical Specialist, Europe - Prior successful cath lab experience is
critical.
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[YEAR] Business Plan | Lanzor Medical Equipments 36 / 42
39. Key Assumptions
General Assumptions and Notes
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Financial Scope: Our financial projections are essentially based on that
of a "pure startup", and the Company's existing financial condition are
incorporated as an approximation only. Audited financials reflecting the
Company's FY 2001, and Unaudited Q12002 financials are available
separately upon request
Revenue Assumptions
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Market and Share Growth:
Our sales volume forecasts are as follows:
Product 2012 2013 2014 2015 2016
Expense Assumptions
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Cost of Goods: Unit cost of goods for our products are projected as
follows:
Product 2012 2013 2014 2015
201
6
Financial Projections
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[YEAR] Business Plan | Lanzor Medical Equipments 38 / 42
41. Net Income
Financial Year Net Income
2012 -2000
2013 -2500
2014 5000
2015 8000
2016 18000
Net Income
2012 2013 2014 2015 2016
-10.00k
0
10.00k
20.00k
Summary Income Statement($000)
Our summary P&L forecast is as follows:
Year1 Year2 Year3 Year4 Year5
% of
revenue
Revenues
SmartFlow Processor 200 1,743 3,560 4,988 6,364 10%
Multiple Lesion Option 52 156 260 390 520 1%
PTC Option 52 260 650 1,300 2,600 4%
Renal Option - 60 360 660 1,200 2%
Pressure Guidewire - - 14,910 30,660 50,800 83%
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%
Gross Margin 164 1.565 13.326 26,916 45.803 74%
54% 71% 68% 71% 74%
[YEAR] Business Plan | Lanzor Medical Equipments 40 / 42
42. Operating Expenses
Operations 169 270 859 1,470 2,438 4%
Research & Development 1,224 1,858 2,784 3,867 5,951 10%
Sales & Marketing 587 1,239 2,785 4,265 6,503 11%
General & Administrative 316 614 1,727 2,570 3,267 5%
Depreciation 62 95 134 161 223 0%
Total Operating Expenses 2,358 4.076 8.289 12,333 18.382 30%
Non-Operating Income (Expense) 160 250 180 215 470 1%
Income Before Tax (2,034) (2,261) 5,217 14,798 27,891 45%
Tax (40%) 0 0 369 5,919 11,156 18%
Net Income (2,034) (1:i1) 4,848 8,879 16,734 27%
Year1 Year2 Year3 Year4 Year5
% of
revenue
Capital Requirements a Use of Proceeds
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We 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 following
priorities:
Exit Strategy
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We will pursue several possible exit strategies:
Be acquired: Companies that would benefit by acquiring Lanzor include:
Medical device companies:
American Medical Systems (Nasdaq: AMMD; Market Cap: $0.8
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