SOURCE: CNS Response, Inc.

CNS Response, Inc.

August 17, 2010 12:15 ET

CNS Response Provides Regulatory Update

ALISO VIEJO, CA--(Marketwire - August 17, 2010) -  CNS Response (OTCBB: CNSO) submitted an application to FDA for obtaining 510k clearance for its Referenced-EEG (rEEG®) service as a Class II device in April 2010. CNS Response CEO George Carpenter commented, "Based on our latest discussions with the FDA, it's clear that 510k clearance will not occur in September, as we had originally hoped. We also thought shareholders should know that our business continues to move forward, with greater focus on pharma bioinformatics and clinical services."

The Company has always considered rEEG to be a reference data service, not a traditional medical device under FDA regulation, since rEEG is a reference database accessed by qualified medical professionals over the web. However, in December 2009, Jeffrey Shuren, MD -- now director of the Center for Devices and Radiological Health -- presented a clear and reasonable route to 510k clearance, citing several packaged software products currently regulated as Class II devices, and which the FDA believed to be similar to rEEG. Based on this clear pathway and the commercial advantages of such approval, the Company filed for 510k clearance in April. In late July, however, reviewers indicated that they now believe rEEG is not substantially equivalent to those software products, but is in fact a new device with a new indication for use requiring a 510k filing with different predicate devices or application for Premarket Approval (PMA). 

Carpenter continued, "This brings us back to our original position, which was never waived. The growth of the internet and medical informatics have led to an explosion of similar services which offer physicians objective information about patient treatment options. rEEG was developed by physicians to solve a critical information gap in medicine, and it is now the largest reference database correlating electrophysiology (EEG) with standard pharmacotherapy. We will continue to grow our non-device business, and we will also continue our dialog with the FDA toward a mutual understanding of its regulatory relationship to rEEG services."

About CNS Response
Today, most physicians are able to base treatment on objective test data, such as EKGs, MRIs, blood tests, etc. Broadly speaking, such advances have not yet come to those physicians practicing psychiatry.

Referenced-EEG was developed by physicians to provide objective, personalized, statistical data on patient neurophysiology. In clinical trials, physicians using rEEG data have consistently achieved superior clinical results compared to physicians using trial and error pharmacotherapy.

The Company announced publication last week of results from its most recent clinical trial in The Journal of Psychiatric Research, in which physicians using Referenced-EEG (rEEG®) had success rates reaching 65 percent for patients with treatment-resistant depression.

To read more about the benefits this patented technology provides physicians, patients and insurers, please visit the CNS Response website, www.cnsresponse.com.

Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995
Except for the historical information contained herein, the matters discussed are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. These forward-looking statements involve risks and uncertainties as set forth in the Company's filings with the Securities and Exchange Commission. These risks and uncertainties could cause actual results to differ materially from any forward-looking statements made herein.

Contact Information

  • Investors:
    Marty Tullio
    Managing Partner
    McCloud Communications, LLC
    949.553.9748
    Email Contact