FDA CLEARS CELLULITE CLAIMS FOR DYNATRONICS' SYNERGIE DEVICE
SALT LAKE CITY, March 25 /PRNewswire/ -- Dynatronics Corporation (Nasdaq: DYNT) today announced that the United States Food and Drug Administration (FDA) has given formal clearance to expand labeling claims for the company's Synergie AMS device to include the claim of "temporary reduction in the appearance of cellulite."
"After working with the FDA for seven months," said Kelvyn H. Cullimore, Jr., President of Dynatronics, "we can now actively promote the Synergie AMS device for one of its most effective uses: reducing the appearance of cellulite. This claim is strongly supported by our research study, which revealed that 91 percent of the participants reported a favorable reduction in the appearance of cellulite."
The Synergie Lifestyle System utilizes non-invasive vacuum technology to massage the skin and subcutaneous tissues in common cellulite problem areas such as thighs, hips, and buttocks. Since the product's introduction to the market in July 1998, hundreds of Synergie units have been sold domestically and internationally.
According to Larry K. Beardall, Executive Vice President of Sales and Marketing at Dynatronics, thousands of patients have already enjoyed the benefits of the Synergie treatments, and many have reported losing six, eight, and even twelve inches off their thighs, hips, and waist combined.
"With the clearance of this additional claim, our ability to more effectively promote this product and generate enthusiasm for its potential in the marketplace will be greatly enhanced," Beardall explained.
Sales for the third quarter ending March 31, 1999 are expected to increase 11 percent over the same period a year ago. Changes in Medicare reimbursement (effective January 1, 1999) slowed overall sales, dampening the previously anticipated sales growth for the quarter. Consequently, third-quarter earnings are predicted to trail second-quarter results.
Dynatronics manufactures, markets, and distributes advanced-technology
medical devices, orthopedic soft goods and supplies, nutritional
supplements, treatment tables, and rehabilitation equipment for the
physical therapy, sports medicine, chiropractic, podiatry, plastic
surgery, dermatology, and other related medical, cosmetic, and
aesthetic markets.
SOURCE Dynatronics Corporation
-0- 03/25/99 /CONTACT: Bob Cardon, Corporate Secretary of Dynatronics, 800-874-6251 or 801-568-7000/
/Web site: http://www.dynatronics.com/ (DYNT) CO: Dynatronics Corporation; U.S. Food and Drug Administration ST: Utah IN: MTC HEA SU: EXE PDT