MD Systems, Inc. Press Release

For Immediate Release: July 6, 1998

Cardiovascular Fitness Device Receives FDA Clearance

Westerville, Ohio - MD Systems, Inc. received clearance from the Food & Drug Administration (FDA) to market its CardioGrip^(R) hand-held exercise device, providing physicians with a no-drug alternative in the management of cardiovascular fitness. Clinical data indicated the device improved cardiovascular fitness through lowered blood pressures over a four week period, and that continued use maintained lower pressures for more than a year. The clearance allows MD Systems, Inc. to market this new product "for adjunctive use in the overall management of cardiovascular fitness". Additional clinical trials, including a pilot study at the Cleveland Clinic, are in progress & may support more specific indications for use.

CardioGrip^(R) provides users a short, easy-to-do microprocessor guided isometric exercise. The small battery powered device is portable, lightweight, and can be used while watching television or during an airline flight. Each exercise session, done every other day, takes only 7 minutes. In previous clinical studies, it was evaluated as a complement or substitute, under direction of a physician, for drug therapy in treating hypertension.

"FDA clearance allows us to enter the treatment markets with this medical device", said Mike Smyser, president. "This market includes 60 million Americans with elevated blood pressure who may benefit from using our product."

Exercise sessions include measuring right and left handgrip strengths, two isometric exercises with each hand lasting less than a minute, and rest periods between each handgrip effort. The CardioGrip^(R) has a digital display that guides users through exercise sessions. It also records each exercise so that physicians can monitor compliance in addition to its capability to administer unique exercise protocols appropriate for individual patient needs.

Dr. Ronald L. Wiley, a cardiopulmonary physiologist at Miami University in Oxford, Ohio, is credited with the discovery of the exercise protocol used in the CardioGrip^(R). The concept & protocol was issued a patent on March 21, 1995.

For additional product information, call MD Systems, Inc., manufacturer of innovative, electronic products for the health industry, toll free at 888-429-4747, or visit www.mdsystems.com on the web.

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Photo: CardioGrip^(R):
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Small Image JPG (9k)  /   GIF (28k)
Line Drawing JPG (313k)  /   GIF (73k)  /   TIF (71k)

MD Systems, Inc, P.O. Box 1647, Westerville, Ohio 43086
Phone 614-818-3000, Fax 614-818-3182, Web www.mdsystems.com