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CardioDynamics Announces Commercial Shipments of BioZ.com -- Result of Fast-Track Development Efforts
Business Wire - June 10, 1998 07:18
%CARDIODYNAMICS CDIC %CALIFORNIA %MEDICINE %PRODUCT V%BW P%BW
SAN DIEGO--(BW HealthWire)--June 10, 1998--
Company Also Announces Outcome of BioZ(TM) Involvement in the Yale University-NASA Everest Extreme Expedition (E3)
CardioDynamics International Corp. (NASDAQ:CDIC), a non-invasive digital cardiac output monitoring manufacturer, announced commencement of shipments of the recently FDA-approved BioZ.com(TM) in late May, ahead of the official June 1, 1998 release date.
The BioZ.com's impressive short development cycle of 11 months was attributed to the continued success of the company's fast-track development programs. The portable, lightweight, and space-efficient design features an integrated battery, blood pressure module, and the ability to interface with the majority of existing hospital monitoring systems.
Since its introduction in March, the BioZ.com has generated excitement from attendees at the American College of Cardiology (ACC) Annual Meeting, the Society of Cardiovascular Anesthesiologists Annual Meeting and the North American Society of Pacing and Electrophysiology (NASPE) Annual Meeting.
Dennis G. Hepp, chief technology officer of CardioDynamics, stated, "The 11-month time span from specification creation to product release, including FDA approval, for the BioZ.com represents a significant achievement for the product development team.
"The company has demonstrated that it can integrate its core technology into the revolutionary BioZ.com platform design with an equipment quality and superior efficiency compared to many world-class medical device manufacturers."
Michael K. Perry, chief executive officer of CardioDynamics, stated, "The rapid development cycle and shipment of BioZ.com units prior to the official product release date is another important milestone achieved by CardioDynamics.
"The BioZ.com's compact design, integrated battery, and clinical interfacability greatly expand the potential customer base benefiting from our non-invasive technology. Momentum is building in several markets, and we are proud of our achievements in the development of the BioZ.com."
The company also announced the success of the BioZ Portable in the Yale-NASA Everest Extreme Expedition (E3), which tested the BioZ at the 18,000 foot base camp on Mount Everest. The E3 provided medical support for the climbers and studied the effects of extreme conditions on the human body.
The E3 team focused on telemedicine, with medical data transmitted from Base Camp to Yale University. In addition to CardioDynamics, AT&T, Sensor Scientific Inc., and Memory Card Technology were among corporate sponsors of the E3. The E3 Internet site is located at www.everest.org.
Dr. Vincent Grasso, medical director and surgeon of the Yale University Everest Base Camp Team, and also the founder of Operation Outreach and Ayudamos Inc., stated, "The BioZ's performance was exemplary under the extreme conditions of Everest, with demonstrated ease of use, durability and dependability.
"The system was instrumental in our telemedicine research and development efforts. With managed care and cost containment pressures driving the emergence of home healthcare, coupled with innumerable remote locations in need of contact with experienced medical centers, telemedicine is one of the most critical and exciting frontiers in medicine today. We will continue to involve the BioZ in our Extreme Expeditions and Operation Outreach programs as we further explore and develop telemedicine."
Perry added, "Telemedicine is an explosive area for medicine, and our non-invasive, safe and cost-efficient products strategically fit in this medical niche. In recent years we have seen home healthcare grow to 136 million home visits annually, and this is anticipated to double within the next five years.
"It is estimated that the $400 billion U.S. annual hospitalization costs could be reduced by $50 billion by expanding home healthcare and that 20% of all home healthcare visits in the U.S. will be delivered via telemedicine by 2001. The BioZ.com has been, and our next generation telemedicine product will be, designed specifically to target the home healthcare markets."
CardioDynamics develops, manufactures, and markets non-invasive digital cardiac output monitoring devices, which provide continuous data on a wide range of hemodynamic parameters (measurements of the heart's ability to deliver oxygen-rich blood throughout the body).
The company's primary products, the BioZ(TM) System, BioZ(TM) Portable, and BioZ.com(TM), use Thoracic Electrical Bioimpedance technology to obtain data, which is typically obtained through a time-consuming, costly, and potentially dangerous invasive Pulmonary Artery Catheterization procedure.
The BioZ(TM) product line use the company's core technology, the proprietary DISQ (Digital Impedance Signal Quantifier) Technology, and Z MARC(TM) (Modulating Aortic Compliance) Algorithm, which 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 to Editors: 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, 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. |