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AMERICAN MEDICAL ELECTRONICS GAINS FDA APPROVAL TO REDUCE SPINAL-STIM(R) TREATMENT TIME; LAUNCHES GUARANTEE PROGRAM

    DALLAS, Aug. 5 /PRNewswire/ -- American Medical Electronics, Inc. (NASDAQ: AMEI), a manufacturer and distributor of advanced devices for orthopedics and neurosurgery, announced today that the Food and Drug Administration has approved AME's premarket approval application supplement for a minimum two-hour treatment time -- compared with eight hours previously -- for the company's Spinal-Stim(R) System.
    Spinal-Stim(R) is a portable, noninvasive device that utilizes pulsed electromagnetic field (PEMF) technology.  It is prescribed by surgeons as an adjunct to lumbar spinal fusion surgery, as well as a nonoperative treatment for failed fusions.  Adjunctive use of Spinal- Stim(R) increases the probability of spinal fusion success by 37 percent.
    "The FDA's approval of the shorter daily treatment time comes only three days after we initiated a program to guarantee radiographic fusion success for patients wearing a Spinal-Stim(R) System as an adjunct to their lumbar fusion surgery," said Joseph Mooibroek, president and chief executive officer of AME.
    "Under terms of the Limited Guarantee Program, AME will reimburse the full amount of Spinal-Stim(R) rental fees for those patients who have complied with the prescribed guidelines but are diagnosed by their doctors as having a radiographic fusion failure," said Mooibroek.  "The company had previously instituted in mid-June a similar money-back guarantee for its Physio-Stim(R) units for use in the treatment of non- union bone fractures.  That program has been received very favorably by physicians, contributing to in a 28 percent first-month increase in prescriptions written over the previous month.
    "The combination of the significantly lower daily treatment time and money-back guarantee provides a much stronger argument for surgeons to prescribe Spinal-Stim(R) units to help increase the potential heal rate for their patients," Mooibroek noted.  "We also believe that providing a money-back guarantee is a very strong statement to insurance companies and other third-party payers that AME is very confident of the efficacy and cost-effectiveness of both its Spinal-Stim(R) and Physio-Stim(R) devices."
    AME produces and distributes medical devices used primarily by orthopedic and neurosurgical professionals.  The company's product lines include: the Spinal-Stim(R) System to enhance the healing of spinal fusions, Physio-Stim(R) bone growth stimulators for the healing of non- union fractures, the AME(R) Universal Bone Plate, the Halifax(R) Clamp cervical spine fixation system, the Ogden bone anchor and the Carbon- One(TM) Halo System for patients suffering trauma or deteriorating cervical spine conditions.
    -0-             08/05/93
    CONTACT:  Joseph Mooibroek, president and CEO, 214-918-8383, or Wesley Johnson, vice president-finance and CFO, 214-918-8477, both of American Medical Electronics, Inc.
    (AMEI) CO:  AMERICAN MEDICAL ELECTRONICS, INC. IN:  MTC ST:  TX


-- NY067 -- X262 08/05/93
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Publication:PR Newswire
Date:Aug 5, 1993
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