Cardio Technologies, Inc. Earns Recommendation for ISO 9002 Certification for Proprietary CardioSupport System.

PINE BROOK, N.J.--(BW HealthWire)--October 29, 1998--Cardio Technologies, Inc., a private medical device company, has earned a recommendation for ISO 9002 certification - a key quality assurance benchmark - for its proprietary CardioSupport SystemTM, it was announced today by Thomas E. Wood, the company's president and chief executive officer.

Cardio Technologies, Inc. (CTI) was founded in 1996 to develop new, medical devices and companion products designed to improve survival, increase the quality of life and reduce costs for patients with life threatening diseases. Development of the CardioSupport SystemTM -- an innovative, less invasive, therapeutic device for short-term use in patients with severely compromised heart function - is currently the main focus of CTI's efforts.

The ISO 9000 series Standards are internationally recognized quality management system requirements developed by the Geneva-based International Organization for Standardization (ISO). ISO 9002 registration focuses on quality system requirements for a company's production and installation processes. More than 90 countries have adopted ISO 9000 worldwide, and the standard is rapidly becoming a key requirement for doing business in the U.S. and international markets.

"Earning ISO certification allows us to move forward with a series of clinical studies of the CardioSupport System in Europe later this year," said Mr. Wood. "More broadly, ISO certification represents significant third-party validation of the operational excellence supporting production and launch of the CardioSupport System across the entire CTI organization."

CTI earned its recommendation for ISO certification following a three-and-a-half month internal process designed to review and where necessary amend the company's operational practices and procedures in order to meet the ISO criteria. The process to earn ISO certification was directed by Myles Kramer, CTI manager of quality systems.

CTI's bid for ISO certification was assessed by TUV Product Service, San Diego, which is regarded by many compliance professionals in the medical device industry as one of the most rigorous assessment firms for ISO applications, Mr. Kramer said.

"Third party auditors generally agree that companies who have ISO certification from TUV have the best quality systems in the medical device industry," he said.

CTI Market Opportunity

CTI's CardioSupport SystemTM (CSS) fills a significant need in the rapidly growing, worldwide congestive heart failure (CHF) market for a reversible, minimally invasive, cost-effective alternative to traditional approaches and therapies. Chronic CHF afflicts about 5 million people in the U.S., and is the only form of heart disease still increasing in frequency, with an estimated 400,000 new cases annually.

The key element of CSS is a cuff-like device, placed around the outside of the heart, that powers a failing or arrested heart by applying external pressure to enhance bloodflow. CSS can support patients until either their native heart function recovers or their clinical condition is deemed appropriate for more long-term or permanent support.

CTI currently is readying the CardioSupport System for feasibility and clinical trials in Europe and the U.S., with the goal of launching European sales in late 1999 and U.S. sales in early 2001.