Boston Medical Technologies Receives Extended Clearance From the FDA for Its Heart Rate Variability Test.

Business Editors and Health/Medical Writers

WAKEFIELD, Mass.--(BW HealthWire)--October 10, 2000

Leading Medical Associations now Recommend Heart Rate Variability 

Testing for Detecting Autonomic Dysfunction in Diabetes

Boston Medical Technologies, the pioneer of office and hospital-based, non-invasive systems for measurement of heart rate variability, today announced that the United States Food & Drug Administration (FDA) has given the Company extended clearance to market its heart rate variability test, called the Anscore Health Management System.

Extensive published clinical data reports that heart rate variability can be used as an indicator of autonomic nervous system dysfunction -- damage to the autonomic nervous system -- which is prevalent in patients with chronic diseases such as diabetes. (1)(2)(3)(4) 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.(7)

Heart rate variability testing has traditionally been limited to research settings. Designed to be provided by the treating physician, the Anscore Health Management System assesses and documents a patient's heart rate variability in response to paced respiration and other controlled exercises. The session data is then transmitted through standard phone lines in the physician's office to the Anscore Processing Center where trained analysts review each test.

"We are delighted by this recently expanded clearance by the FDA which, when combined with extensive published clinical findings and vigorous advocacy by leading medical associations, is building momentum that is driving heart rate variability testing into the mainstream of care for diabetes and other medical conditions," said John Schafer, CEO and president of Boston Medical Technologies.

"Patients rightfully want to be fully informed so that they can make the most appropriate decisions regarding their treatment and lifestyle," said Peter Mlynarczyk, M.D., Trinitas Hospital, Elizabeth, NJ. "The problem, however, is that the treating physician's standard `tool chest' does not provide an accurate picture of the autonomic nervous system, which is a critical omission that prevents us from detecting and monitoring the dangerous complications of conditions such as diabetes. An office-based heart rate variability test fills this critical information gap for both physician and patient."

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 autonomic nervous system function. Boston Medical Technologies has also been granted ISO 9001/ EN 46001 certification for their full quality assurance system under the Medical Device Directive.

Anscore Health Management System is a trademark of Boston Medical Technologies, Inc. All other Company and product names are the property of their respective owners.

(1) Vinik, Al, MD, PhD, and Suwanwalaikorn, S, MD: Autonomic Neuropathy, In deFronzo, R.M. (ed). Current Therapy of Diabetes Mellitus. Yearbook Inc. 1997; 165-176.

(2) Robertson, D; Beck, C; Gary, T; Picklo, M: Classification of Autonomic Disorders. Int Angiol. 12 (2): 1993; 93-1002.

(3) Low, PA. Autonomic Neuropathy. Semin Neurol 1987 Mar; 7 (1): 49-57.

(4) Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Heart Rate Variability: Standards of Measurement, Physiological Interpretation and Clinical Use. Circulation: Vol. 93, No. 5, 1996.

(5) The American Association of Clinical Endocrinologists Medical Guidelines for the Management of Diabetes Mellitus: The AACE System of Intensive Diabetes Self-management 2000 Update, Endocrine Practice 2000; 6(1): 43-84; American Heart Association, 1999. AHA Scientific Statement; Diabetes and cardiovascular disease. Circulation 100:1134-1146.

(6) Ewing, DJ; Campbell, IW; Clarke, BF: The Natural History of Diabetic Neuropathy. Quarterly Journal of Medicine 1980; 49 (193): 95-108).

(7) The effects of Intensive Diabetes Therapy on measures of Autonomic Nervous System Function in the Diabetes Control and Complication Trial. (DCCT) Diabetologia. 1998; 41(4): 416-423.