identify individuals who may be at risk...
TRANSCRIPT
Safe Harbor
The following presentation contains forward-looking statements that involve risks and uncertainties. Any statements made as part of this presentation that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the foregoing, when used in this presentation, the words “anticipate”, “believe”, “estimate”, “intend” and “expect”, and similar expressions are intended to identify such forward-looking statements. The Company’s actual results may differ materially from the results suggested by these statements. Factors that may cause or contribute to such differences include, but are not limited to, those discussed in the Company’s Form 10-K filed with the Securities and Exchange Commission.
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The Cambridge Heart Opportunity
Key components for success in place– $5.5B ICD market ready for MTWA patient identification– Exclusive co-marketing agreement with St. Jude Medical– Reimbursement in place– Significant IP and clinical validation with high barriers to
entry
Recurring revenue stream builds shareholder value – Razor/razor-blade model– High-margin disposables
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Mission
To identify individuals at risk of Sudden Cardiac Death and those who are not– Risk stratification and delivering appropriate care
Addresses a major public health problem– 10-15 million people at elevated risk
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Sudden Cardiac Death:Large USA Market Opportunity
5 MillionHeart Failure
1-2 Millionother
8 MillionPost MI
12 million at-risk individuals
Circulation 2/10/2006 Heart Disease and Stroke Statistics
300,000 – 400,000 SCD/Year
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MTWA: Stratify High-Risk vs. Low-Risk Patients
More effective at identifying at-risk SCD patients than invasive electrophysiology (EP) test
Extraordinary negative predictive value (NPV)
Ensure delivery of appropriate ICD therapy
HearTwave® II
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How do We Identify Patients at Risk of SCD?
MTWA + SAMMicrovolt T Wave Alternans Spectral Analytic Method
13 patents protect all components of the technology
Even Beats
Odd Beats
MeanValt
Valt
Q
R
S
T
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Clinical Validation
200+ publications in peer-reviewed journals
Industry-sponsored studies– ALPHA Study - Boston Scientific– ABCD Study – St. Jude Medical– MASTER Study - Medtronic
Patient Populations– Primary prevention (ejection fraction < 35%, no prior
arrhythmic event)– Post MI – Congestive heart failure – Syncope patients– Dilated cardiomyopathy patients
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Class IIa Guideline
American College of Cardiology/American Heart Assoc./European Society of Cardiology 2006 Guideline for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death (Developed in collaboration with the HRS and EHRA)
– Class IIaIt is reasonable to use T-Wave Alternans for improving the diagnosis and risk stratification of patients with ventricular arrhythmias or who are at risk for developing life-threatening ventricular arrhythmias. (Level of Evidence: A)
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CMS Supports Risk Stratification
....”Although SCD-HeFT demonstrated a statistically significant reduction in mortality, the absolute reduction was modest. In addition a relatively small proportion (21.4%) of the defibrillator group received an appropriate shock.”
“Since ICDs only treat ventricular tachyarrhythmias and cause adverse events, such as inappropriate shocks and worsening heartfailure, they should not be perceived as or projected to be ideal technology. Responsible use of ICDs should be encouraged.”
“Since the large proportion of patients who receive an ICD never received any therapy from their device, consideration of additional risk stratification methods would be reasonable.”
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CMS National Coverage Obtained
“CMS (Medicare) has determined that there is sufficient evidence to conclude that Microvolt T-wave Alternans (MTWA) diagnostic testing is reasonable and necessary for the evaluation of patients at risk of sudden cardiac death, only when the spectral analytic method* is used, and CMS is issuing the following national coverage determination (NCD) for this indication.” 93025 (3/21/2006)
* Cambridge Heart US Patent # 6,735,466 granted May 2004 11
Strong Private Coverage
Private payers followed CMS– WellPoint/Anthem BCBS– Aetna, Cigna, Humana– HCSC, BC/BS of NY, Horizon (NJ), Care First, MI, IA, SD,
MN, KS, Wellmark– Regionals: GHI, Tufts, Harvard Pilgrim, Med. Mutual of
Ohio, Health Net
52% of the covered livesRemaining private payers in progressStaff models targeted
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Primary Prevention &SCDHeFT/MADIT II Subset Focus
800,000 SCDHeFT/MADIT II(EF< 35%)
ICD market growth has stalled for multiple reasons
5 MillionHeart Failure
1-2 Millionother
8 MillionPost MI
12 million at-risk individuals
800,000SCDHeFTMADIT II
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Only 12.5% of SCDHeFT/MADIT II Patients Receive ICD Implants
CardiologistEcho, Nuclear
EPImplants ICDs
Why do only 12.5% receive ICD implants?
100,000 ICDs implanted in 2006 (US) for primary prevention patients
800,000 SCDHeFT/MADIT II Patients
?
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Cardiologists Recognize Need for Risk Stratification
“I want to be certain that my patient will benefit from an ICD; my patient is borderline or has differing EFs.”
“There are other factors to consider beyond EF.”
“ICD implantation is an invasive procedure that has its own set of risks.” (“1.0% in-hospital death rate” Circulation 2-14-06 p52)
“Many ICDs never fire. I don’t want my patient to undergo the procedure if they do not need to.”
“Some patients who I think should have an ICD refuse. I need a way to work with them so that we can arrive at a decision together.”
“I would rather optimize medication first.” 15
Spectral Analytic MTWA for Primary Prevention Population
Creates a Win-Win situation for all parties
70%
Non-negative
“Call to Action”
CardiologistEF Echo, Nuclear
MTWA
EPImplants ICDs
800,000 SCDHeFT/MADIT II Patients 30% Negative
Annual Annual MTWA MTWA TestingTesting
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St. Jude Co-marketing Agreement
SJM sells exclusively to cardiologists and EPs– Equipment sales
– Drive sensor usage
Increases MTWA visibility and acceptance
Financial terms– CAMH pays commissions to SJM
– SJM has annual minimum sales targets
– SJM purchased $12.5 million of preferred stock
• Convertible into common shares at $2.99
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MTWA in Post-MI Patients with Preserved EF (>35%)
• Largest MTWA study to date• 1041 post-MI patients with LVEF ≥ 0.40
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Referral Pattern with Spectral Analytic MTWA in EF > 35%
Creates a Win-Win situation for all parties
CardiologistEF Echo, Nuclear
MTWA
EPEP Studies
Implants ICDs
Patients with EF > 35%
Annual Annual MTWA MTWA TestingTesting
Positive MTWA
Non-positive MTWA
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The Market Opportunity for CAMH
At $70 per test in CAMH disposables:
10% Penetration of 12 million at-risk patients
$84 Million in annual HIGH-MARGIN recurring revenue from sale of sensors
25% Penetration of 12 million at-risk patients
$210 Million in annual HIGH-MARGIN recurring revenue from sale of sensors
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Key Financial Data
$917$1,089
$1,419
$1,765
$2,031$2,223
$2,590
$0
$500
$1,000
$1,500
$2,000
$2,500
($10
00's
)
Q3 05 Q4 05 Q1 06 Q2 06 Q3 06 Q4 06 Q1 07
Alternan Sales Total Revenue21
Key Financial Data
$3,091
$4,199 $6,246
$7,438
($00
0's)
2005 2006
Alternans SalesTotal Revenue
Cash 3/31/07: $18.5 Million 22
Management Team
20 yrs diagnostic sales & marketing experience (Abbott, Bayer, McKesson, Cardiodynamics)
MBA, Northeastern University
Mark FlorenceVP, Sales & Marketing
Scientific founder, Cambridge HeartProfessor of Health Sciences and Technology, Harvard-MIT Division
of Health Sciences and Technology Director, NASA Center for Quantitative Cardiovascular Physiology,
Modeling and Data Analysis
Richard J. Cohen, MD, PhDDirector
10 yrs with Cambridge Heart (R&D, Ops, Reg & Clinical)Inventor, analytical spectral methodDeveloper, HearTwave II systemPhD in Biomedical Engineering, University of Sussex, UK
Ali Haghighi-Mood, PhDEVP, COO & CTO
15 yrs experience as CFO for public life science companiesDirector & Audit Committee member, Endologix and BioLife
SolutionsMBA, University of Oregon
Roderick de GreefVP, Finance & Administration, CFO
Chairman, Belmont CapitalChairman and Co-founder, Provident Corporate FinanceFounder & Chairman, Medical Specialties Group
Robert KhederianChairman, Interim President & CEO
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Key Objectives for Growth
Execute on SJM co-marketing agreement – Build installed base (~700 at Q107)
– Drive sensor utilization at installed sites
– Expand manufacturing capacity
• Current HW II manufacturing capacity: 100 units/month
• Current sensor manufacturing capacity: 40,000 sets/month
Secure additional private payer coverage – 52% of covered lives at YE06
2007 revenue guidance of $14-16 million
60-65% gross margin in 200724
The Cambridge Heart Opportunity
Key components for success in place– $5.5B ICD market ready for MTWA patient identification– Exclusive co-marketing agreement with St. Jude Medical – Reimbursement in place– Significant IP and clinical validation with high barriers to entry
Recurring revenue stream builds shareholder value – Razor/razor-blade model– High-margin disposables
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