SALT LAKE CITY, May 19, 2011 /PRNewswire/ -- Paradigm Medical
Industries, Inc. (OTC.PK: PDMI) announced today that it had
received notification from its Italian partner, Costruzione
Strumenti Oftalmici (CSO), which manufactures the Paramax™, that it
has provided 26 pages and 24 attachments to the U.S. Food and Drug
Administration (FDA) in order to obtain 510(k) approval for the
Paramax™. This supportive information was submitted to the FDA for
review on Monday, May 16, 2011. The
Paramax™ is the next generation of standard ocular eletrophysiology
utilized for early glaucoma detection. Paradigm will begin
marketing and selling the Paramax™ in the
United States upon receipt of the 510(k) approval.
"Paradigm is confident that CSO has provided the necessary
additional information to the FDA to allow it to move forward with
its decision to approve this valuable early glaucoma diagnostic
device for sale within the United
States within a reasonable amount of time," said
Stephen L. Davis, Paradigm President
and Chief Executive Officer.
"The Paramax™ represents one of the most reliable and durable
early glaucoma diagnostic devices available in the U.S. market. It
will also provide the earliest diagnosis of glaucoma available,
potentially saving the vision for many who would have otherwise
lost it," he added.
Sales for Paradigm's other glaucoma detecting device, the Blood
Flow Analyzer™, have picked up in the
United States as an increased number of physicians are
realizing the dependable information derived from a 15 second test
from the ocular blood flow device can lead to earlier medical
intervention, thereby reducing the risk of further glaucoma-related
vision loss.
"The anticipated pairing of the Paramax™ and the time-tested
Blood Flow Analyzer™ will offer the most current and dynamic
combination of tools available to physicians for the early
detection and treatment of glaucoma," continued Mr. Davis.
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
SOURCE Paradigm Medical Industries, Inc.
