Paradigm Moves Ahead With LD 500 Autoperimeter Upgrade and Update of Paramax(TM) FDA Application
March 28 2011 - 8:00AM
Marketwired
Paradigm Medical Industries, Inc. (PINKSHEETS: PDMI) announced its
new LD 500 autoperimeter has received very positive responses from
many of its existing customers. Work on the LD 500 autoperimeter
was recently completed and the new product has been released both
as a new system, replacing the old LD 400, and as an upgrade for
customers with existing LD 400s. During the past ten years, many LD
400 autoperimeters were sold throughout the world. As a result of
these past sales, there are a large number of systems that can be
upgraded to the new LD 500 level at a reasonable cost. Paradigm has
begun to receive many requests for this LD 500 upgrade. Paradigm
anticipates a rapidly growing number of new upgrade orders in the
upcoming months.
Paradigm recently received new updated information concerning
the Paramax™ from Costruzione Strumenti Oftalmici (CSO), its
Italian partner. The U.S. Food and Drug Administration (FDA) had
requested additional information concerning the Paramax™ pursuant
to a 510(k) application that had been filed. Over 80% of the
additional information has now been provided to the FDA, with the
remaining support materials to be provided soon. The Paramax™ is
designed to perform innovative tests for the early screening and
follow-up for glaucoma, age related macular degeneration vascular
retinal degeneration, and other pathologies related to optic nerve
disease.
Paradigm's management remains confident that the FDA will
approve this important new technology for the early detection of
glaucoma. Paradigm President and Chief Executive Officer Stephen
Davis stated: "There continues to be a strong interest in the
Paramax™. We are hopeful that the Paramax™, when approved by the
FDA for sale in the United States, will have a significant impact
in the Company's sales. Paradigm will continue to monitor the
evaluations of this important new device by key glaucoma
specialists in the United States market while it awaits a decision
from the FDA."
About Paradigm Medical Industries,
Inc.
Paradigm Medical Industries, Inc. is a medical device company
that develops, manufactures and distributes ophthalmic diagnostic
instruments and related products for early detection of glaucoma
and other eye disorders. The Company's primary objective is to
capture a niche market within the glaucoma and ultrasound
microscopy fields. The Company markets its products to
ophthalmologists, optometrists, universities, and clinics
throughout the United States and internationally.
This press release contains statements that, if not verifiable
historic fact, may be viewed as forward-looking statements that
could predict future events and outcomes with respect to Paradigm
and its business. The predictions embodied in these statements will
involve risk and uncertainties and, accordingly, actual results may
differ significantly from the results discussed or implied in such
forward-looking statements.
Contact: Stephen L. Davis President and Chief Executive Officer
801-977-8970 www.paradigm-medical.com
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