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Biotech / Medical : PLSIA (Premier Laser Systems) -- Ignore unavailable to you. Want to Upgrade?


To: Narotham Reddy who wrote (1351)12/4/1997 10:47:00 AM
From: Mama Bear  Respond to of 1773
 
IRVINE, Calif.--(BW HealthWire)--Dec. 4, 1997--Premier Laser Systems (Nasdaq NM:PLSIA) Thursday announced that it has received FDA clearance to market its Vista hand-held corneal topography system.

This device, which is manufactured by the company's EyeSys.Premier unit, is considered a significant development in corneal mapping as it will allow the practitioner a greater degree of flexibility and portability than the large, desktop units currently available.

It is estimated that up to 30,000 optometrists and 15,000 ophthalmologists currently practice in the United States. The hand-held unit alone will be priced below $6,000 and the complete system including an associated computer and printer will cost approximately $9,000. Unit shipments will begin in the quarter ending March 31, 1998.

The Vista hand-held unit, which look similar to a small hand-held video camera, will have the capability of connecting to a laptop computer and operating at remote locations. The Vista system has applications for both optometrists (contact lens fitting) and ophthalmologists (refractive surgery and precision corneal mapping).

The hand held Vista unit will be sold domestically by Marco Technologies Inc. Premier Laser Chairman, President and Chief Executive Officer Colette Cozean Ph.D. commented: "The Vista system, along with the other EyeSys.Premier products, received an extremely positive response at the recent AAO conference.

"This interest among eye care professionals along with the FDA clearance leads us to believe that we will see strong acceptance for the unit."

In addition to the Vista unit, EyeSys.Premier is developing a desktop version of the corneal topography system in association with Japan-based Nidek Inc.

EyeSys.Premier President Ram Rao said: "This next generation of corneal topography devices will have applications both within and outside of the ophthalmologist's office. The unit uses the same proven technology and software of the EyeSys System 2000, while offering a streamlined, portable and affordable platform."

Rao added: "we believe that innovative products such as Vista have a tendency to stimulate growth in their respective markets."

Premier Laser Systems develops, manufactures and markets several lines of proprietary medical lasers, fiber optic delivery systems, corneal topography systems and associated products and services for a variety of dental, ophthalmic and surgical applications. -0-

NOTE: The statements in this news release that relate to future events or performance, statements about growth, levels of sales and market size, future manufacturing capacity and efficiencies, future product shipment rates, current and future FDA submittals and future product introductions are forward-looking statements that involve risks and uncertainties, including risks associated with uncertainties related to the development of markets for and commercial acceptance of the company's products and services, the availability of components, competitors' product introductions, patent or other litigation, and other risks identified in the company's SEC filings. Some of the devices described in this release are not yet cleared for market by the FDA. The company can not offer any guarantee that such clearance will be granted or on what schedule it may be cleared. Actual results may differ from those described in these forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof.

CONTACT:

Allen & Caron Inc.

Matt Clawson (investors)

Owen Daley (media)

714/252-8440



To: Narotham Reddy who wrote (1351)12/4/1997 2:37:00 PM
From: Pancho Villa  Read Replies (1) | Respond to of 1773
 
>>PLSIA gets FDA approval
to market its Vista Topography System (Reuters)<<

This is the link:

biz.yahoo.com

Pancho