Paradigm Medical Moves Ahead With LD 500 Autoperimeter Upgrade and Update of Paramax(TM) FDA Application
SALT LAKE CITY, UT--(Marketwire - March 28, 2011) -
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Paradigm Medical Industries |
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