PMED news:
Friday July 7, 10:18 am Eastern Time
Company Press Release
Paradigm Medical Anticipating FDA
Approval
SALT LAKE CITY--(BUSINESS WIRE)--June 7, 2000--Paradigm Medical Industries, Inc. (NASDAQ:PMED - news) In
response to a press release in the Dow Jones yesterday, from an unknown source, Tracey Best, Director of Paradigm's
Regulatory Affairs Department pointed out that it contained multiple inaccuracies and quotes from unsubstantiated sources.
``The FDA audit at the clinical site in question took place back in March of 2000. The deficiencies pointed out were
addressed in a response to the FDA over a month ago. In addition, the physician mentioned has also already responded to
the letter mentioned in the article,'' Mr. Best explained. ``FDA routinely conducts audits of clinical sites once the sponsor
(in this case Paradigm) submits for final approval. To find no efficiencies among the hundreds or, in this case, thousands
of documents involved would be unusual. In my eighteen years of experience in the regulatory field, to leave an audit with
no deficiencies would be A-typical,'' Mr. Best went on to explain. ``The device application referenced in the release is for
soft cataract removal which accounts for approximately 80% of the 3 million cataract surgical procedures performed in the
U.S. annually. The release negatively implied a lack of efficacy as the physician chose to switch energy modalities
`mid-procedure' on two occasions because the laser modality was not producing `satisfactory results'. This statement is
extremely misleading. The hardness of the cataract was simply misjudged by the physician in these instances. Since the
laser portion of the device is intended for soft cataract removal, the physician chose to use the previously approved (and
more appropriate) ultra-sound energy source within the same device on these harder cataracts, to complete the procedure,
i.e., switching over without starting over,'' Mr. Best added.
``The device is already approved for sale in Europe and is proving to be quite popular because of its more gentle nature
within the eye. To date, over 6,000 successful cases have already been completed worldwide. I intend personally, in
cooperation with the FDA, to perform an audit with an independent third party over the next few weeks. Paradigm's current
submission for Laser Phacolysis remains in effect and we are quite optimistic that we will receive a positive response, once
we have finished this review,'' Mr. Best concluded.
Paradigm Medical Industries, Inc. develops, manufactures and markets diagnostic eye care equipment and surgical systems
for minimally invasive cataract treatment to global markets. The company's corporate offices are located at 2355 South
1070 West, Salt Lake City, Utah 84119. Call 801-977-8970 or visit us at our web site at www.paradigm-medical.com.
This press release contains forward-looking statement that, if not verifiable historical fact, may be viewed as
forward-looking statements that could predict future events or outcomes with respect to Paradigm and its business. The
predictions embodied in these statements will involve risks and uncertainties and accordingly, Paradigm's actual results
may differ significantly from the results discussed or implied in such forward-looking statements.
Contact:
Consulting For Strategic Growth, Ltd.
Public Relations
Corporate Development Consultants
Stanley Wunderlich
Tel: 800/625-2236
Fax: 516/625-4523
Email: cfsg@iname.com
or
Paradigm Medical Industries, Inc.
Shareholder Relations
Kay Boyd
Tel: 800/426-0493 x 128
Fax: 858/550-8067
Web site: www.paradigm-medical.com |
