ADM Tronics' Receives FDA Clearance for Tinnitus Device
Released_By: USANews Press Release Network
Date: 8/11/98
Time: 4:18:10 PM
For_Immediate_Release
Northvale, NJ - A new medical device for use in the treatment and control of
tinnitus has been cleared for marketing by the U.S. Food and Drug
Administration. The non-invasive, electronic therapy device, called the
Aurex-3(TM) is designed for home use by tinnitus patients. ADM Tronics
Unlimited, Inc. (NASDAQ-ADMT) will manufacture the device for both national and
international distribution.
Tinnitus is the medical term for perception of sound when no external sound
is present, often described as "ringing in the ears." Time Magazine reported in
its July 27, 1998 cover story that "...roughly one person in 10 is affected by
tinnitus. For about 15% of sufferers, the noises inside their heads are
disturbing enough to shatter their peace of mind..." ADM Tronics estimates the
potential US market for tinnitus therapies to be in excess of $6 billion.
Dr. Alfonso DiMino, President and founder of ADM Tronics was delighted over
the FDA clearance, "This is one of the most important events in our company's
history. We now have an FDA cleared product that can help millions of people
suffering from this terrible condition." Dr. DiMino, who hold numerous patents,
suffered from tinnitus for several years. Research into solving his own
condition led him to discover the technology behind Aurex-3. ADM Tronics plans
to launch distribution of Aurex-3 in late fall of this year and is assembling
distribution outlets and related infrastructure. "Based upon the high interest
we have seen so far, we want to be ready to satisfy the strong demand we are
expecting for Aurex-3," stated Andre' DiMino, COO of ADM Tronics.
Commenting on the FDA clearance of the 510K Notification for Aurex-3 filed
this past May, ADM Tronics' FDA attorney, James E. Lenick, said "The rapid
approval from the FDA was, in large part, due to the quality of the data
supporting the device's safety and efficacy."
ADM Tronics is a technology based developer and manufacturer of a diversified
line of products categorized into three distinct market segments - therapeutic,
non-invasive electronic medical devices, environmentally safe chemical products
and innovative topical dermatological products.
Contact: Andre' Di Mino 24-S Pegasus Avenue Northvale, New Jersey 07647
Phone: 201-767-6040 Fax: 201-784-0620 E-mail: andre@admtronics.com Website: http://www.admtronics.com