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FDA Approves Second Laser Module For Paradigm Medical's Photon Workstation For Multiple Eye Surgery Procedures.


Business Editors

SALT LAKE CITY--(BUSINESS WIRE)--June 7, 2001

Paradigm Medical Industries, Inc. (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
: PMED/PMEDW) disclosed today that the U.S. Food and Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
) has approved a second laser module for the Company's Photon Laser System Workstation.

The laser module--810 nm red diode--will allow the Photon System to perform additional eye surgery procedures.

Last October, Paradigm Medical received FDA approval to market the 532 nm green laser module for multiple eye surgery procedures.

"The ultrasound portion of the Photon Laser System for cataract removal has already been approved by FDA," said Tracy Best, Paradigm Medical's Director of Regulatory Affairs. "By adding laser surgical filtering indications for glaucoma glaucoma (glôkō`mə), ocular disorder characterized by pressure within the eyeball caused by an excessive amount of aqueous humor (the fluid substance filling the eyeball). , the surgical range for the Photon Workstation has been expanded to allow access to almost all the surgical sub-specialties in eye care."

Mr. Best noted that the 810 nm red diode laser will find application for such indications for glaucoma as transcleral cyclophotocoagulation, transcleral endo-cyclophotocoagulation, ablation of the ciliary process ciliary process
n.
Any of the radiating pigmented ridges on the inner surface of the ciliary body that, with the folds in the furrows between them, constitute the anterior portion of the ciliary body.
 for the reduction of the intra-ocular pressure, and retinal photocoagulation photocoagulation /pho·to·co·ag·u·la·tion/ (-ko-ag?u-la´shun) condensation of protein material by the controlled use of an intense beam of light (e.g.  used for diabetic patients.

The 532 nm green laser module approved last year includes indications for retinal photocoagulation, trabeculoplasty, iridotomy, peripheral iridectomy iridectomy /iri·dec·to·my/ (-me) excision of part of the iris.

ir·i·dec·to·my
n.
Surgical removal of part of the iris of the eye.



iridectomy

excision of part of the iris.
, diabetic retinopathy diabetic retinopathy
n.
Retinal changes occurring in long-term diabetes and characterized by punctate hemorrhages, microaneurysms, and sharply defined waxy exudates.
, posterior and anterior procedures, and endo-photocoagulation.

Mr. Best added, "Once we achieve final FDA approval on the integration of our patented 1064 nm laser for cataract removal into the Photon System we will be the logical choice for all the Ophthalmic Outpatient Surgical Centers and hospitals that wish to maintain their competitive edge and at the same time reduce costs. We hope to receive such an approval later this year.

"The Photon now offers two `on-board' wavelengths plus ultrasound capability in addition to irrigation/aspiration and vitectomy. No other ophthalmic device offers greater value covering a wide range of procedures," Mr. Best added.

Paradigm Medical's Chairman and Chief Executive Officer, Thomas F. Motter, commented, "This is in keeping with our workstation approach to problem solving problem solving

Process involved in finding a solution to a problem. Many animals routinely solve problems of locomotion, food finding, and shelter through trial and error.
 and adding value in the cost-sensitive medical environment of the 21st century. We believe that this approval further establishes Paradigm Medical as a leader in the development of breakthrough technologies in the field of health care.

"The Photon Laser Cataract Removal System already has the CE Mark and is currently being placed throughout Europe. This is a first in the eye-care industry, and eliminates the need for the physician or hospital to purchase multiple lasers and ultrasonic surgical devices to perform multiple ocular surgical procedures," Mr. Motter added.

"The physician is able to save time, money, and much needed operating room operating room
n. Abbr. OR
A room equipped for performing surgical operations.
 and exam space with this revolutionary device. This can ultimately translate into substantial savings for patients."

Paradigm Medical Industries, Inc., currently develops, manufactures and markets surgical and diagnostic high-tech "breakthrough" proprietary equipment and consumable products in medicine. The Company's corporate offices are located at 2355 South 1070 West, Salt Lake City, Utah For ships of the United States Navy of the same name, see .
Salt Lake City is the capital and the most populous city of the U.S. state of Utah. The name of the city is often shortened to Salt Lake, or its initials, S.L.C.
 84119. Call 801-977-8970 or visit us at our web site at www.paradigm-medical.com.

This press release contains forward-looking statements 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 risk and uncertainties and accordingly, Paradigm actual results may differ substantially from the results discussed or implied in such forward-looking statements.
COPYRIGHT 2001 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2001, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Jun 7, 2001
Words:548
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