Cambridge Heart Announces Year End 1998 Results.BEDFORD, Mass.--(BW HealthWire)--Feb. 11, 1999-- 1998 Highlighted by Submission of 510(K) for Expansion of Labeling Claims 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 $585,401 for the quarter ended December 31, 1998, compared with revenues of $370,661 a year ago, an increase of 58%. Net loss for the fourth quarter of 1998 was $1,547,899 or $0.14 per share, compared to a loss of $1,610,512 or $0.15 per share for the same period last year. Revenues for the year ended December 31, 1998 were $2,096,853, compared with $1,448,319 for the year 1997, an increase of 45%. U.S. revenues were up 113% during the year, and account for 54% of the total revenue. International revenues were unchanged from the same period last year, due primarily to the Company's change in European distribution partners during the first half of 1998. The net loss for 1998 was $6,537,085 or $0.61 per share, compared with a loss of $6,047,619 or $0.58 per share for 1997. The increase in net loss is primarily attributable to an increase in costs and expenses associated with the Company's clinical trials and 510(K) submission. "1998 has been a very exciting year for Cambridge Heart, highlighted by the achievement of many significant corporate and clinical milestones," stated Jeffrey M. Arnold, Chairman, President, and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Cambridge Heart. "First, we met all study goals in our labeling study and follow-up study for 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. technology. Following these positive clinical results, we submitted a 510(K) to the Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) for expansion of the labeling claims regarding the accuracy of our T-wave alternans technology as a significant predictor of major cardiac events. We have now completed our response to FDA questions, have undergone a pre-approval inspection by the FDA, and believe the process is moving along well. We recognize, however, that future action by the FDA cannot be predicted with certainty." (T-wave alternans is an alternating pattern which, when visible in the electrocardiogram electrocardiogram /elec·tro·car·dio·gram/ (-kahr´de-o-gram?) a graphic tracing of the variations in electrical potential caused by the excitation of the heart muscle and detected at the body surface. (ECG ECG electrocardiogram. ECG abbr. 1. electrocardiogram 2. electrocardiograph ECG Also called an electrocardiogram, it records the electrical activity of the heart. ), has been associated with life-threatening heart rhythm disturbances and sudden cardiac arrest cardiac arrest n. Abbr. CA A sudden cessation of cardiac function, resulting in loss of effective circulation. Cardiac arrest A condition in which the heart stops functioning. .) "Second, pursuant to our corporate strategy, we saw a growing awareness in the medical community of the benefits of T-wave alternans," added Mr. Arnold. "A total of nine abstracts and posters on T-wave alternans was presented at this year's 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. Meeting. The results of a study conducted by Stefan H. Hohnloser, M.D., Professor of Medicine at J.W. Goethe University, Frankfurt, examining T-wave alternans as a predictor of recurrent ventricular tachyarrhythmias in implantable cardioverter/defibrillator (ICD ICD International Classification of Diseases (of the World Health Organization); intrauterine contraceptive device. ICD abbr. ) recipients was also published in the December issue of the Journal of Cardiovascular Electrophysiology(1). "Third, we strengthened our management team with the addition of Andra Thomas as Vice-President, Clinical Affairs, to spearhead the Company's regulatory and reimbursement arenas," continued Mr. Arnold. "Lastly, we are pleased with the Company's revenue growth for the year and the increase in the number of T-wave alternans-capable stress test systems in the U.S., which reflects the effectiveness of our domestic distribution network established during the first quarter of 1998." 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 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. 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. and other filings with 1997 (unaudited) (unaudited) Revenue $ 585,401 $ 370,661 $ 2,096,853 $ 1,448,319 Cost of goods sold Cost of goods sold The total cost of buying raw materials, and paying for all the factors that go into producing finished goods. cost of goods sold 487,532 417,382 1,547,899) $(1,610,512) $(6,537,085) $(6,047,6192 10,585,786 10,748,508 10,451,560 Balance Sheet December 31, December 31, 1998 1997 (Unaudited) Assets Cash & Marketable Securities Marketable Securities Very liquid securities that can be converted into cash quickly at a reasonable price. Notes: Marketable securities are very liquid as they tend to have maturities less than one year, and the rate at which these securities can be bought or sold has $ 6,490,353 $ 12,756,341 Accounts receivable accounts receivable n. the amounts of money due or owed to a business or professional by customers or clients. Generally, accounts receivable refers to the total amount due and is considered in calculating the value of a business or the business' problems in paying , net 555,991 509,918 Inventory 426,489 416,224 Other prepaid assets 190,667 301,127 Total current assets 7,663,500 13,983,610 Fixed assets, net 647,629 574,660 Other assets 403,604 190,167 ----------- ----------- $ 8,714,733 $ 14,748,437 Liabilities and stockholders' equity Accounts payable and accrued expenses $ 901,791 $ 527,137 Stockholders' equity Common stock 10,906 10,606 Additional paid-in-capital 29,603,435 29,405,685 Accumulated deficit (21,700,389) (15,163,304) Deferred compensation (101,010) (31,687) Total stockholders' equity 7,812,942 14,221,300 ----------- ----------- $ 8,714,733 $ 14,748,437 The Company intends to file its annual report on Form 10-K with the Securities and Exchange Commission shortly. Interested parties are encouraged to review this report.
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(1) Hohnloser SH, Klingenheben, T, Li Y-G, Zabel M, Peetermans J,
Cohen, RJ: T- Wave Alternans as a Predictor of Recurrent Ventricular
Tachyarrhythmias in ICD Recipients: Prospective Comparison with
Conventional Risk Markers. Journal of Cardiac Electrophysiology, Vol 9
No 12, December 1998.
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