Cardima, Inc. Announces First Quarter Results -- Revenues Increase 131%.FREMONT, Calif.--(BW HealthWire)--April 28, 1998--Cardima(TM), 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 :CRDM CRDM Control Rod Drive Mechanism CRDM Centre for Rapid Design and Manufacture (Buckinghamshire Chilterns University) CRDM Cumann Rince Dea Mheasa (Irish dancing organisation) ), today announced financial results for the quarter ended March 31, 1998. Revenues for the quarter increased to $501,000 from $217,000 for the same period a year ago, an increase of 131%. The increases in revenues were due to U.S. sales of the Cardima Pathfinder(TM) line of microcatheters for diagnosis of ventricular tachycardia Ventricular Tachycardia Definition Ventricular tachycardia (V-tach) is a rapid heart beat that originates in one of the lower chambers (the ventricles) of the heart. (VT) and the Revelation(TM) line of microcatheters for diagnosis of atrial fibrillation atrial fibrillation Irregular rhythm (arrhythmia) of contraction of the atria (upper heart chambers). The most common major arrhythmia, it may result as a consequence of increased fibrous tissue in the aging heart, of heart disease, or in association with severe infection. (AF) following 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. clearance in January and November 1997, respectively. Net loss for the first quarter ended March 31, 1998 was $3,849,000, or $0.47 loss per share, compared with a net loss of $2,325,000, or $0.36 loss per share, for the same period in 1997. The increased loss was due primarily to expenses relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc increased spending on new product development, stepped-up clinical and regulatory efforts and increased sales expenses related to the expansion of sales personnel 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. . Phil Radlick, Ph.D., 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 Cardima, said, "We are pleased with our sales growth this quarter. Sales increased 22% over Q4 1997 and this is the fifth consecutive quarter of increasing gross sales Gross Sales A measure of overall sales that isn't adjusted for customer discounts or returns, calculated simply by adding all sales invoices, and not including operating expenses, cost of goods sold, payment of taxes, or any other charge. . The sales growth indicates continuing physician acceptance of our microcatheter systems in the U.S. Our clinical trial for treatment of AF in Europe is proceeding as expected, and we have recently treated our second patient in our U.S. AF trial. The results in both trials to date have shown considerable improvement in each patient's condition with treatment in the right atrium only. The AF trial in Europe is expected to lead to a CE mark application early in the second half of this year, allowing us to market the device for therapeutic applications. The next step in the U.S. will be to submit the results of this 10 patient trial and apply for an IDE (Investigational Device Exemption An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and ) in order to start our pivotal trial." Cardima, Inc. designs, develops, manufactures and markets minimally invasive, single-use microcatheter-based systems for the dual purpose of finding and treating the two most common forms of cardiac arrhythmias cardiac arrhythmia n. See cardiac dysrhythmia. Cardiac arrhythmia An irregular heart rate or rhythm. Mentioned in: Holter Monitoring, Stress Test cardiac arrhythmia : atrial fibrillation, a condition of the heart characterized by the irregular and very rapid beating of the heart's atrial atrial /atri·al/ (a´tre-al) pertaining to an atrium. a·tri·al adj. Of or relating to an atrium. Atrial Having to do with the upper chambers of the heart. chambers, and ventricular tachycardia, a life-threatening condition in which heartbeats are improperly initiated from within the ventricular walls, bypassing the heart's normal conduction system conduction system systema conducens cordis Anatomy A network of specialized nerve fibers innervated by both the sympathetic–SNS and parasympathetic nervous systems–PNS; PNS stimulation, eg, ↑ vagal stimulation, ↓ sinus node automaticity . Cardima is the only company developing unique microcatheters to be used in diagnosing and treating VT from within the wall of the heart. For further information about atrial fibrillation and ventricular tachycardia, contact Cardima's website at www.cardima.com. Except for the historical information contained herein, the matters discussed in this press release are forward-looking statements that involve risks and uncertainties that could cause actual results to differ materially from those in such forward-looking statements. Potential risks and uncertainties include, without limitations, those set forth in the Company's Registration Statement on Form S-1 and the Companies 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 December 31, 1997 filed with the Securities and Exchange Commission, and the Company's ability to conduct successful clinical trials, obtain timely regulatory approvals and gain acceptance from the marketplace for its products. -0-
Cardima, Inc.
Statements of Operations
In thousands, except per share amounts
(Unaudited)
Three months ended
March 31,
1998 1997
Revenues $ 501 $ 217
Cost of goods sold 748 374
Gross margin (247) (157)
Operating expenses:
Research and development 1,663 810
Sales, general and administrative 2,047 1,330
Total operating expenses 3,710 2,140
Operating loss (3,957) (2,297)
Interest and other income 144 25
Interest expense (36) (53)
Net loss $(3,849) $(2,325)
Basic and diluted net loss per share $ (0.47)
Shares used in computing basic and
diluted net loss per share 8,137
Pro forma net loss per share $ (0.36)
Shares used in computing pro forma
net loss per share 6,433
Selected Balance Sheet Data
In thousands
March 31, December 31,
1998 1997(a)
Cash, cash equivalents and
short-term investments $ 9,354 $12,848
Working capital 8,078 11,609
Total assets 14,343 17,674
Total liabilities 3,537 3,230
Stockholders' equity 10,806 14,444
(a) Derived from audited financials
CONTACT: Cardima Inc. Ron Bourquin, 510/354-0162 http://www.cardima.com |
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