Boston Medical Technologies Receives Third 510k Approval From FDA to Incorporate Critical New Device Specific Normal Ranges Into Its Heart Rate Variability Test.

Business/Technology Editors & Health/Medical Writers

WAKEFIELD, Mass.--(BUSINESS WIRE)--May 14, 2001

Company's Anscore System Delivers Industry Precedent-Setting Seven

Percent Coefficient of Variation for Heart Rate Variability 

Measurement

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 the FDA has approved a 510(k) submission to incorporate a device specific normal range measurement standard into its Anscore(TM) Health Management System (see www.anscore.com).

With this regulatory milestone, which represents the Company's third 510(k) approval from the FDA, a future release of Anscore System software will report normal ranges for heart rate variability based on device-specific reference values. This will allow physicians to rely upon the exceptional accuracy and reproducibility of the result when the Anscore test is administered repeatedly to a patient.

The 510(k) submission was based on a multi-site study involving 212 healthy individuals, ages 20-80. Anscore System study participants performed three standard heart rate variability maneuvers: Metronomic Breathing, Valsalva and Stand.

The study, the results of which were just published in Diabetes Technology and Therapeutics, Volume 3, Number 1, found HRV to be the most reliable and available indicator of autonomic function. Of note, the reproducibility portion of the study determined coefficients of variation (CV) under 7 percent for three HRV tests with the Anscore Health Management System--results never before seen in the industry. In compelling contrast, standard blood glucose meter testing usually has a CV in the 20 percent range. This confirms exceptional reliability in the Anscore System's ability to track changes in autonomic nerve function over time.

The normal range study also demonstrated the Anscore System's ability to pinpoint subtle decreases in HRV as a person ages. Autonomic nerves slowly and subtly degrade during a normal person's aging process, but this erosion can dramatically accelerate in a person with a disease such as diabetes. A heart rate variability test is the only non-invasive procedure that can detect these insidious changes. There is currently a clinical consensus on the use of HRV as a recommended component in the routine screening of autonomic dysfunction and for monitoring the progress of autonomic neuropathy.(1)

The six-month study concluded in April, 2000, and was conducted at Rhode Island Hospital, Hebrew Rehabilitation Center for Aged and Toronto General Hospital.

"This Regulatory approval further validates the Anscore System as the most reliable measurement for heart rate variability," said John Schafer, president and CEO of Boston Medical Technologies. "Receiving a third 510(k) represents a tremendous achievement for our engineering staff and proprietary technology, which delivers test data with a degree of accuracy that is unusually high by any medical application standard and has certainly never been seen before with any other heart rate variability test."

The Anscore Health Management System first received 510(k) clearance from the FDA for heart rate variability testing on June 11, 1999. Additionally, on August 11, 2000, the FDA approved a second 510(k) submission for use of the Anscore Health Management System in the assessment of autonomic nervous system dysfunction.

The Anscore Health Management System comprehensively assesses and documents a patient's heart rate variability in response to paced respiration and other controlled exercises. The data is then transmitted through standard phone lines in the physician's office to the Anscore Process Center where trained analysts review each test. Upon receiving patient testing data, Boston Medical Technologies analysts review the data and apply its patented algorithms to calculate standard indices and ratios for heart rate variability. Previous tests performed on the patient, if available, are also trended for a historical view. This careful review of each test provides physicians and patients with an additional level of quality control. Within minutes, comprehensive results are electronically transmitted directly to the physician's office through the printer built into the Anscore unit.

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 also completed in approximately half the time of traditional methods.

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 August 11, 2000, the FDA approved a second 510(k) submission for the use of the Anscore(TM) 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. The entire process takes about 15 minutes. 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.

(1) Consensus Statement: Report and Recommendations of the San

Antonio Conference on Diabetic Neuropathy. Diabetes

1988;37:1000-1004.