Paradigm Medical Industries, Inc. (PDMI: OTC Link) | CSO Receives NSE letter From FDA For Paramax

Contact: Stephen L. Davis

President and Chief Executive Officer

801-977-8970

www.paradigm-medical.com

FOR IMMEDIATE RELEASE

FDA Issues Non Significant Equivalence (NSE) Letter

Regarding the Paramax™; New 510(k) Application to Be Resubmitted

SALT LAKE CITY, UTAH, (August 3, 2011) — Paradigm Medical Industries, Inc. (OTC.PK:PDMI) announced that the U.S. Food and Drug Administration (FDA) issued a Non Significant Equivalence (NSE) letter pertaining to the Paramax™. In the letter the FDA stated that in the process of reviewing the 510(k) application for the Paramax™, it had requested by letters dated June 10, 2010 and December 20, 2010 that Costruzione Strumenti Oftalmici (CSO), which manufacturers the Paramax™, provide descriptive and validation information regarding the ability of the Paramax™ to deliver light stimuli, measure electrophysiological signals, and provide reference value information to the user. However, according to the FDA, CSO failed to adequately respond to the requests. The letter contained a detailed list of remaining issues that the FDA deems still open. The FDA then added in the letter that should CSO resubmit a new 510(k), all those issues will need to be properly addressed.

CSO intends to submit a new 510(k) application for the Paramax™ that will address the issues in the NSE letter.

“This news is very disappointing for Paradigm as it has spent over a year positioning this new device in multiple markets,” said Paradigm President and Chief Executive Officer, Stephen Davis. He added: “Although this news is very discouraging, I have been notified by CSO’s management that CSO will submit a new 510(k) application that will address the issues that resulted in the NSE letter from the FDA.” Paradigm has offered its full assistance to CSO in order to expedite the completion of a new application submission for the Retimax™ and Paramax™.

Paradigm also announced that it has entered into an agreement with Total Vision Care, Inc., which is located in Marina del Ray, California, to evaluate Paradigm’s Blood Flow Analyzer™ (BFA) in all of its mobile clinics. Total Vision Care has 18 custom designed mobile diagnostic vehicles with highly skilled ophthalmic technicians who perform glaucoma testing and other ophthalmic diagnostic services for physicians throughout the western United States.

“Paradigm is pleased to offer the BFA for evaluation to Total Vision Care and is confident it will result in improved vision care for their patients and a new partnership opportunity for Paradigm,” stated 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.

Article source: http://www.otcmarkets.com/stock/PDMI/news?id=33876

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