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Replies to post #25437 on Paradigm Medical Industries Inc. (PDMI)
07/08/21 2:54 PM
In May 2010, CSO filed a 510(k) application with the FDA for the ParamaxTM. The ParamaxTM is the next generation of standard ocular electrophysiology for early glaucoma diagnosis. The ParamaxTM is to be so ld in North America on an exclusive basis, contingent upon the Company meeting certain sales requirements, and in countries outside North America on a non-exclusive basis. The ParamaxTM performs innovative tests for the early screening and follow up of pathologies such as glaucoma, age related macular degeneration, vascular retinal degeneration, and other o ptic nerve diseases. The Company is unable to market and sell the ParamaxTM in the United States, however, until it obtains 510(k) approval by the Food and Drug Administration (FDA).
By letters dated June 10, 2010 and December 20, 2010, the FDA requested additional information concerning the application. In June 28, 2011, the FD A issued a Non Significance Equivalence (NSE) letter stating that CSO failed to adequately respo nd to requests to provide descriptive and validation information regarding the ability of the ParamaxTM to deliver light stimuli, measure electrophysiological signals, and provide reference value information to the user. The letter contained a detailed list of remaining issues that FDA deemed still open. The FDA then added in the letter that should CSO resubmit a new 510(k) application, all those issues need to be properly addressed. CSO is currently in the process of submitting a new 510(k) application for the ParamaxTM that will address the issues in the NSE letter.
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