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CardioDynamics, CDIC, Awarded CE Mark Regulatory Approval for BioZ.com Sales in Europe.


SAN DIEGO--(BW HealthWire)--Dec. 9, 1998--

Vice President of Operations Added to Meet the

Estimated $1 Billion European Market Potential

CardioDynamics International Corporation (Nasdaq: CDIC CDIC Chronic Diseases In Canada (journal)
CDIC Canadian Deposit Insurance Corporation
CDIC Carbon Dioxide Information Center
CDIC Center for Data Intensive Computing (BNL) 
), a noninvasive digital cardiac output cardiac output
n. Abbr. CO
The volume of blood pumped from the right or left ventricle in one minute. It is equal to the stroke volume multiplied by the heart rate.
 monitoring device manufacturer, today announced that it received authorization from TUV (Technischer Überwachungs-Verein) Literally "Technical Watch-Over Association." A German certifying body involved with product safety for the European community.  Rhineland of North America to place the CE Mark on the BioZ.com(TM). The CE Mark is recognized worldwide as an essential European regulatory approval and enables the Company to expand its sales and distribution of the BioZ.com(TM) throughout the European Community. The European Community represents approximately 25 percent of the Company's total estimated worldwide market potential of $4 billion.

The BioZ.com's Thoracic Electrical Bioimpedance (TEB TEB Test & Evaluation Board
TEB Third Eye Blind (band name)
TEB Thread Environment Block
TEB Turkiye Ekonomi Bankasi
TEB Triethylborane
TEB Technical Evaluation Board
TEB Traffic Engineering Bureau (Pakistan) 
) technology provides a safe, cost-effective, and noninvasive alternative to the dangerous, costly and time-consuming invasive Pulmonary Artery Catheterization Pulmonary Artery Catheterization Definition

Pulmonary artery catheterization is a diagnostic procedure in which a small catheter is inserted through a neck, arm, chest, or thigh vein and maneuvered into the right side of the heart, in order to measure
 (PAC) procedure currently being used in Europe to measure cardiac output. Additional advantages of the BioZ.com include its compact design, integrated battery, noninvasive blood pressure module, and ability to interface with a majority of patient monitoring and clinical information systems.

"The award of the CE Mark represents a significant step in the growth of our Company and will expand our presence in the global marketplace," said Michael K. Perry, Chief Executive Officer of CardioDynamics. "This international achievement of quality recognition reflects the tremendous dedication and hard work of our employees and substantiates our commitment to provide the BioZ.com's safe, cost-effective, and innovative technology to the European medical community. During the fourth quarter, we shipped approximately $200,000 in BioZ.com units to European distributors, who were awaiting CE Mark approval."

There is mounting worldwide pressure to provide better and more cost-effective healthcare to an expanding patient population. The BioZ.com's noninvasive TEB technology will contribute significantly in the reduction of healthcare costs by decreasing the length of hospital stays, reducing labor costs, eliminating costs due to invasive procedural complications, and improving efficiency of outpatient care. Among the Europeans who will benefit from the BioZ.com are hypertensive hypertensive /hy·per·ten·sive/ (-ten´siv)
1. characterized by increased tension or pressure.

2. an agent that causes hypertension.

3. a person with hypertension.
, congestive heart failure congestive heart failure, inability of the heart to expel sufficient blood to keep pace with the metabolic demands of the body. In the healthy individual the heart can tolerate large increases of workload for a considerable length of time. , pacemaker, emergency, critically ill, surgical, and fluid management patients.

Richard E. Trayler, Chief Operating Officer Chief Operating Officer (COO)

The officer of a firm responsible for day-to-day management, usually the president or an executive vice-president.
 of CardioDynamics, stated, "In anticipation of receiving CE Mark approval, the Company established a network of European distributors to market the noninvasive BioZ.com throughout the European Community. To date, agreements have been formalized with four distinguished international medical distributors representing 11 European countries. The distributors include HO-MED of Vienna, representing the countries of Hungary, the Czech Republic, Poland, Slovakia, Slovenia, and Austria; Levi Medica medica (māˑ·dē·k  of Rome, representing Italy; Cardiac Services of Dublin, representing Ireland and United Kingdom; and Pilger Medizin Elektronick AG of Spicherstrasse, representing Switzerland and Liechtenstein. In addition to our four European distribution partners, we have recruited seven partners in Asia Pacific, the Middle East and Latin America. We anticipate increasing our number of distributors to more than 20 during 1999."

CardioDynamics also announced the appointment of Russ H. Bergen as Vice President of Operations. Bergen, 51, brings to the Company over 27 years of experience in research and development, manufacturing, technical marketing, and customer assurance. Prior to joining the Company, Bergen held several increasingly responsible management positions within Hewlett-Packard Company's San Diego Printer Division and Thermal Ink Jet Business Unit. Bergen holds Bachelor of Science Noun 1. Bachelor of Science - a bachelor's degree in science
BS, SB

bachelor's degree, baccalaureate - an academic degree conferred on someone who has successfully completed undergraduate studies
 degrees in Aerospace Engineering and Manpower Management from the University of Colorado University of Colorado may refer to:
  • University of Colorado at Boulder (flagship campus)
  • University of Colorado at Colorado Springs
  • University of Colorado at Denver and Health Sciences Center
  • University of Colorado system
, Boulder.

Perry, commenting on Bergen's appointment, stated, "We are delighted to have Russ join our team. Russ brings extensive technical and management expertise which will be instrumental in expanding production capacity to meet the increasing demand for our systems."

CardioDynamics develops, manufactures, and markets noninvasive digital cardiac output monitoring devices which provide continuous data on a wide range of hemodynamic he·mo·dy·nam·ics  
n. (used with a sing. verb)
The study of the forces involved in the circulation of blood.



he
 parameters. The Company's primary products, the BioZ(TM) System, BioZ(TM) Portable, and BioZ.com(TM), use TEB technology to obtain data, which is typically available only through a time-consuming, costly and potentially dangerous invasive PAC procedure. Since TEB monitoring is noninvasive, it decreases costs through elimination of patient risk, reduction of hospital stay, and minimization of hospital expenditures and personnel. The BioZ(TM) product line uses the Company's proprietary DISQ(TM) (Digital Impedance Signal Quantifier (logic) quantifier - An operator in predicate logic specifying for which values of a variable a formula is true. Universally quantified means "for all values" (written with an inverted A, LaTeX \forall) and existentially quantified means "there exists some value" (written with a ) technology and the Z MARC(TM) (Modulating Aortic aortic

pertaining to or emanating from the aorta. See also aortic arch.


aortic aneurysm
occurs most often in dogs, where it is caused by Spirocerca lupi larvae, turkeys and primates, causing dyspnea, cyanosis and coughing.
 Compliance) algorithm, which together provide improved measurements of impedance waveforms and automatic electronic calibration, thereby increasing the repeatability and reliability of TEB technology. For additional information, please refer to the Company's web site at www.cardiodynamics.com.

Note: Except for the historical and factual information contained herein, this press release contains forward-looking statements, the accuracy of which are necessarily subject to uncertainties and risks, which include sole dependence on the BioZ product line, competition from Baxter Healthcare Corp. (manufacturer of the Swan-Ganz(TM) device), further capital requirements Capital requirements

Financing required for the operation of a business, composed of long-term and working capital plus fixed assets.
, and various uncertainties characteristic of companies just emerging from the development stage; as well as other risks detailed in the Company's filings with the SEC, including its 1997 Form 10-KSB. The Company does not undertake to update the disclosures contained in this press release.
COPYRIGHT 1998 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1998, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Dec 9, 1998
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