Boston Medical Technologies Granted Patent for Algorithm to Measure Heart Rate Variability; Algorithm Eliminates 98% of the Work Associated with Analyzing a Patient's Heart Rate.

Business Editors and Health/Medical Writers

WAKEFIELD, Mass.--(BW HealthWire)--Oct. 30, 2000

Boston Medical Technologies, the pioneer of office and hospital-based, non-invasive systems for measurement of heart rate variability (HRV), today announced that it has been granted a patent by the U.S. Patent and Trademark Office for its algorithm to reliably and accurately measure a patient's heart rate. The patent, US PAT NO. 5,984,954, titled "The Method and Apparatus for R-Wave Detection," eliminates 98% of the work associated with analyzing a patient's heartbeat, making it easier and more efficient for physicians to include heart rate variability testing as a standard of care in a patient's office visit.

According to extensive published clinical data, heart rate variability can be used as an indicator of autonomic dysfunction--damage to the autonomic nervous system. Autonomic dysfunction is prevalent in patients with chronic diseases such as diabetes and cardiovascular disease, as well as neurodegenerative disorders including Parkinson's disease, multiple system atrophy and peripheral neuropathy(1),(2),(3),(4). In fact, approximately 16 million individuals in the U.S. have diabetes and it is recommended that individuals with Type 1 diabetes should have their heart rate variability tested after five years of the onset of diabetes and every year thereafter, and patients with Type 2 diabetes should have their heart rate variability tested upon diagnosis and every year thereafter(1). Additionally, heart rate variability should be measured whenever a patient's treatment regimen is altered. Despite this clinical utility, heart rate variability testing has existed primarily in research laboratory settings.

The American Heart Association (AHA) and the American Association of Clinical Endocrinologists (AACE) have recently declared heart rate variability to be the recommended test for detecting autonomic dysfunction in diabetes(5). 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(6). With diseases such as diabetes, it is important to identify autonomic dysfunction prior to the onset of symptoms because early intervention may prevent, slow or completely stop the onset or progression of clinical symptoms(2).

"One of the biggest hurdles to make heart rate variability testing an integral part of patient care has been the lengthy time it would traditionally take for testing and analysis. Physicians would need to determine by hand a patient's heart rate, which was a long and often error-prone process," said John Schafer, president and CEO of Boston Medical Technologies. "With our unique algorithm to measure heart rate variability, our Process Center is able to determine a patient's heart rate variability quickly and efficiently, and the results are then automatically forwarded to the physician's office. Remarkably, this entire process only takes 15 minutes."

With Boston Medical Technologies' Anscore Health Management System, a patient can have their heart rate variability assessed and documented in response to paced respiration and other controlled exercises. The data is then transmitted through standard phone lines in the physician's office to Boston Medical Technologies' 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 only takes 15 minutes, enabling physician and patient to immediately discuss its implications for treatment and compliance. This patent-pending process not only ensures that each heartbeat is carefully measured for reliable and accurate analysis, but it is completed in approximately half the time of traditional methods.

About Boston Medical Technologies

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. Founded in 1994, Boston Medical Technologies is headquartered in Wakefield, Mass. For more information, contact Boston Medical Technologies at [phone] or on the Web at http://www.bosmedtech.com.

Under development since 1994, the Anscore Health Management System received 510(k) clearance from the FDA for heart rate variability testing on June 11, 1999. 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. Boston Medical Technologies has also been granted ISO 9001/ EN 46001 certification for their full quality assurance system under the Medical Device Directive.

Anscore(TM) Health Management System is a trademark of Boston Medical Technologies, Inc.

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