Boston Medical Technologies to Showcase Non-Invasive Heart Rate Variability Testing System At American Association of Diabetes Educators Annual Meeting.

Business/Technology Editors & Health/Medical Writers

AADE Annual Meeting 2001

Booth #1254

LOUISVILLE, Ky.--(BUSINESS WIRE)--Aug. 15, 2001

American Association of Diabetes Educators (Booth #1254)--Boston Medical Technologies (www.bosmedtech.com), the pioneer of office and hospital-based, non-invasive systems for measurement of heart rate variability (HRV), today announced that its Anscore(TM) Health Management System, an easy-to-use heart rate variability test, will be demonstrated at the 28th annual meeting of the American Association of Diabetes Educators in August. Conference attendees can view a complete demonstration of the Anscore System at the Company's booth #1254.

The Anscore Health Management System enables treating physicians to measure a patient's heart rate variability during a routine office visit. Extensive published clinical data reports that heart rate variability testing can be used as an indicator of autonomic nervous system dysfunction1, 2, 3, 4--a deadly but initially asymptomatic condition prevalent in people with diabetes. This condition can cause the gradual breakdown of nearly every organ in the human body.

There is currently a clinical consensus from the American Diabetes Association and the American Academy of Neurology on the use of HRV as a recommended component in the routine testing of autonomic dysfunction and for monitoring the progress of autonomic neuropathy.5 Regardless of age, health or type of diabetes, people with diabetes could have autonomic nerve damage even if they don't have symptoms. In fact, a shocking statistic reveals that one out of three people with diabetes may have autonomic neuropathy. 6

"In rapidly growing numbers, medical institutions and office-based clinical practices throughout the country are now incorporating heart rate variability testing as part of their patients' routine office visits to assess autonomic nervous system function," said John Schafer, president and CEO of Boston Medical Technologies. "We are thrilled that the highly accurate and reproducible test results achieved with the Anscore System have established it as the standard for heart rate variability testing among so many physicians. At AADE, diabetes educators can see first hand how seamlessly this non-invasive testing system can be incorporated into a patient's visit."

In diseases such as diabetes, identifying autonomic neuropathy when the patient is asymptomatic is significant because early intervention may prevent, slow or completely stop the onset or progression of clinical symptoms.7 According to published research, loss of heart rate variability in diabetic autonomic neuropathy is associated with up to a 50 percent mortality rate within five years of the onset of clinical symptoms.8

About the Anscore Health Management System

The Anscore Health Management System is a non-invasive, easy to perform heart rate variability test designed for office-based use. Until now, heart rate variability testing systems have existed primarily in research laboratory settings. With the Anscore Health Management System, patients can have their heart rate variability easily assessed and documented in response to paced respiration and other controlled exercises. The Company's 510(k) approval from the FDA allows the Anscore System to report normal ranges for heart rate variability based on device-specific reference values, a milestone not achieved by any other heart rate variability test on the market. The data is then transmitted through standard phone lines in the physician's office to Boston Medical Technologies' state-of-the-art Process Center where trained analysts review each test and apply the patented algorithm to calculate standard indices and ratios for heart rate variability. Within minutes, comprehensive results are electronically transmitted directly to the physician's office. From taking the test to receiving the results, heart rate variability testing with the Anscore Health Management System takes only 15 minutes, enabling physician and patient to immediately discuss its implications for treatment and compliance.

About Boston Medical Technologies

Founded in 1994, Boston Medical Technologies is pioneering the development and worldwide deployment of office and hospital-based, non-invasive heart rate variability testing systems to improve the quality and cost-effectiveness of clinical care. On April 26, 2001, the FDA approved a third 510(k) submission for Boston Medical Technologies to incorporate a critical new device specific normal range measurement standard into its Anscore(TM) Health Management System. On August 11, 2000, the FDA approved a second 510(k) submission for the use of the Anscore Health Management System in the assessment of heart rate variability. The company received an initial 510(k) clearance from the FDA to market the Anscore Health Management System on June 11, 1999. Boston Medical Technologies has also been granted ISO 9001/ EN 46001 certification for their full quality assurance system under the Medical Device Directive.

Under development since 1994, the Anscore Health Management System is the first full-service, office-based heart rate variability testing system that can be efficiently and cost-effectively integrated into patient care. The system also features the Anscore Process Center, an advanced facility where trained analysts receive data from each test via telephone lines. Upon review and analysis, the results are immediately transmitted back to the physician to share with the patient. For additional information about diabetic autonomic neuropathy and the Anscore Health Management System, visit www.anscore.com. For more information on the company itself, contact Boston Medical Technologies at [phone] or on the Web at http://www.bosmedtech.com.

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