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Empi, Inc. Launches New Incontinence Therapeutic Device Combining Surface Electromyography and Pelvic Floor Electrical Stimulation.

SAINT PAUL, Minn.--(BUSINESS WIRE)--Sept. 24, 1997--Empi, Inc., a medical device manufacturer, today announced that the Food and Drug Administration has granted it clearance to market InnoSense(TM), a new device to treat incontinence using pelvic floor muscle reeducation.

InnoSense is being introduced at the American Urogynecologic Society meeting in Tucson this week and will be shown at the International Continence Society meeting this weekend in Yokohama. The product is in limited release and is expected to be available for worldwide distribution in January. This product has been developed to meet the needs of clinicians and patients seeking to combine the benefits of user feedback provided by electromyography with the achievement of a complete nonvolitional pelvic floor contraction using electrical stimulation. The product is priced to make it attractive for office, clinic or home use.

"InnoSense is another step forward in Empi's strategy to provide cost effective, non-invasive therapeutic options to women suffering with stress, urge or mixed incontinence," said Joseph E. Laptewicz, Empi's president and chief executive officer. "By combining electromyography and functional electrical stimulation in a simple-to-use, low cost, battery-powered system, Empi has redemonstrated its technological leadership position in the incontinence therapy market. Behavioral therapies are among the most clinically effective and cost effective options available to the 13 million women and men in America who suffer the often debilitating symptoms of urinary incontinence. Over 2 billion dollars is spent annually to manage this medical problem in the United States alone."

Laptewicz concluded, "Empi remains committed to making these new forms of conservative therapy available to patients suffering with functional disabilities like urinary incontinence. While many private payors, insurance companies, and health maintenance organizations around the country recognize and reimburse for therapy utilizing pelvic floor stimulation (PFS), Empi continues to engage in a dialogue with HCFA to establish a favorable national coverage policy decision for Medicare patients using PFS. Cost savings associated with the use of PFS have been shown to be substantial while achieving a high degree of patient satisfaction."

Certain statements made in this press release relating to the availability of the InnoSense device in January and its ability to meet the needs of clinicians and patients are forward-looking statements and are subject to risks and uncertainties relating to unforeseen development and production delays.

Empi, Inc. develops, manufactures, and markets non-invasive biomedical devices and accessories for use in the physical therapy, sports medicine, and incontinence treatment markets. The company's shares are traded on the Nasdaq Stock Market's National Market under the symbol EMPI.

CONTACT: Empi, Inc., St. Paul

Patrick Spangler, 612/415-7404
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Publication:Business Wire
Date:Sep 24, 1997
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