Cambridge Heart Announces Third Quarter Results.BEDFORD, Mass.--(BW HealthWire)--Nov. 5, 1997--Cambridge Heart, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :CAMH CAMH Centre for Addiction and Mental Health CAMH Contemporary Arts Museum Houston (Houston, TX) CAMH Comprehensive Accreditation Manual for Hospitals ) today reported revenues of $340,000 for the quarter ended September 30, 1997, compared with revenue of $235,000 a year ago. Net loss for the third quarter of 1997 was ($1,249,000) or ($0.12) per share, compared to a loss of ($1,061,000) or ($0.11) per share on a proforma basis, for the same period last year. Management noted that revenue for the quarter remains modest reflecting our targeted approach to distribution pending expansion of our labeling claims and the publication of additional clinical data. "Our strategy for commercialization of our CH 2000 system continues to have three key elements, as reflected in our third quarter activities and financial performance," noted Jeffrey M. Arnold, Cambridge Heart Chairman, President, and Chief Executive Officer. "First, we are building a strong foundation of published clinical data to prove the predictive value pre·dic·tive value n. The likelihood that a positive test result indicates disease or that a negative test result excludes disease. predictive value a measure used by clinicians to interpret diagnostic test results. of our T-wave alternans T-wave alternans Cardiology A subtle every-other-beat variation in T waves that is prognostic of Pts at high risk for life-threatening cardiac arrhythmias and sudden cardiac death. See Alternans test. in identifying patients at risk for ventricular arrhythmias ventricular arrhythmia An abnormal, usually rapid, heart rhythm that arises in a ventricle; VAs are often life threatening and 2º to myocardial infarction Examples V tach, V fib . Our clinical study for expanding our labeling claim is on track for completion during the first half of 1998 and we have seen the recent publication of additional scientific papers supporting the clinical efficacy of our technology. "Second, we are building a strong international base of reference sites which we call Centers of Excellence, and then using these reference sites to assist in educating the broader cardiology cardiology Medical specialty dealing with heart diseases and disorders. It began with the 1749 publication by Jean Baptiste de Sénac of contemporary knowledge of the heart. Diagnostic methods improved in the 19th century, and in 1905 the electrocardiograph was invented. community about the benefits of our technology. Through these Centers, we are regularly supporting educational symposia sym·po·si·a n. A plural of symposium. on T-wave alternans such as that recently sponsored by Columbia University Columbia University, mainly in New York City; founded 1754 as King's College by grant of King George II; first college in New York City, fifth oldest in the United States; one of the eight Ivy League institutions. in New York New York, state, United States New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of and others recently held in Europe and Japan. We are supporting the upcoming program, "Recent Advances in T-Wave Alternans," sponsored by Case Western Reserve University School of Medicine and being held as a satellite symposium at the American Heart Association American Heart Association (AHA), n.pr a national voluntary health agency that has the goal of increasing public and medical awareness of cardiovascular diseases and stroke, and thereby reducing the number of associated deaths and disabilities. Annual Scientific Sessions in Orlando this coming weekend. "Third, we are building a worldwide distribution system to enable us to fulfill the market potential for our products once we receive labeling approval and see the publication of additional clinical data. We have established an initial network in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. , Europe, and the Far East, and plan to modify and broaden this capability in the months ahead," Mr. Arnold added. Cambridge Heart is engaged in the research, development, and commercialization of products for the noninvasive diagnosis of cardiac disease. Using innovative technologies, the Company is addressing such key problems in cardiac diagnosis as the identification of those at risk of sudden cardiac death Sudden Cardiac Death Definition Sudden cardiac death (SCD) is an unexpected death due to heart problems, which occurs within one hour from the start of any cardiac-related symptoms. SCD is sometimes called cardiac arrest. , the early detection of coronary artery disease coronary artery disease, condition that results when the coronary arteries are narrowed or occluded, most commonly by atherosclerotic deposits of fibrous and fatty tissue. , and the prompt and accurate diagnosis of heart attack. -0- Statements made in this news release that are not historical facts include forward-looking statements that involve risks and uncertainties. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements are included in Cambridge Heart's Annual Report on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. for the year ending December 31, 1996.
Cambridge Heart, Inc.
Financial Highlights
Three months Nine months
Statement ended ended
of Operations September 30, September 30,
1997 1996 1997 1996
Revenues $340,179 $235,305 $1,077,658 $500,007
Cost of
goods sold 331,528 246,416 969,245 553,747
Expenses
Research and
development 757,814 628,105 2,786,755 1,514,437
Selling,
general and
administrative 742,622 580,023 2,466,643 1,383,610
Loss from
operations (1,491,785) (1,219,239) (5,144,985) (2,951,787)
Interest income 242,525 158,192 707,878 238,506
Net loss ($1,249,260) ($1,061,047) ($4,437,107) ($2,713,281)
Pro forma loss
per share ($0.12) ($0.11) ($0.43) ($.32)
Pro forma
weighted
average
shares 10,495,282 9,300,478 10,406,818 8,501,685
-0-
Condensed
Balance Sheet September 30, December 31,
1997 1996
(unaudited)
Assets
Current assets
Cash and cash
equivalents $7,854,315 $18,588,583
Marketable
securities 6,569,271 --
Accounts
receivable 460,500 420,984
Inventory 274,848 251,788
Prepaid/other
current assets 269,967 384,422
Total current
assets 15,428,901 19,645,777
Fixed assets, net 632,604 423,159
Other assets 107,373 160,523
$16,168,878 $20,229,459
Liabilities and stockholders' equity
Accounts payable/
accrued expenses $474,214 $499,721
Stockholders' equity
Common stock 10,550 10,215
Additional
paid in
capital 29,285,031 29,216,646
Accumulated
deficit (13,552,792) (9,115,685)
Less deferred
compensation (48,125) (381,438)
Total stockholders'
equity 15,694,664 19,729,738
$16,168,878 $20,229,459
The Company intends to file its quarterly report on Form 10-Q
with the Securities and Exchange Commission shortly. Interested
parties are encouraged to review this report.
CONTACT: Cambridge Heart, Inc Evanthia Malliris, 781/271-1200 |
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