QualityStocks News - CNS Response Details Response to FDA Feedback on Investigational Device

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Company plans to design revised protocol and launch a clinical trial with the Walter Reed National Military Medical Center.

QualityStocks would like to highlight CNS Response, a publicly traded company providing reference data and analytic tools for clinicians and researchers in psychiatry. The company offers an online registry, developed by physicians, that enables qualified medical professionals to exchange objective, statistical neurophysiology-based data on individual patient medication response and outcomes.

In the company’s news last week,

CNS Response announced that the U.S. Food and Drug Administration (FDA) has responded to the company’s proposal for a clinical trial of an investigational device, PEER Interactive, designed to help physicians identify the best treatments for certain mental illnesses.

PEER Interactive, a Web service based on a standard electroencephalogram (EEG), records a patient’s brain function much like an electrocardiogram (EKG) does for the heart. The Psychiatric EEG Evaluation Registry (PEER) was developed by physicians as a quality assurance tool to determine which psychiatric medications are effective and which are not.

In its response, the FDA acknowledged that PEER Interactive would require pre-market approval, though the agency indicated that under certain circumstances the product could shift to the 510(k) pathway.

In regards to the FDA’s additional comments and suggestions, CNS said it will revise its protocol to implement the FDA’s suggestions, and that it will launch a clinical trial with Walter Reed National Military Medical Center (WRNMMC) and several other sites to establish partnerships with military physicians to diagnose mental health conditions such as depression, post-traumatic stress disorder (PTSD), mild traumatic brain injury (mTBI), and several other disorders.

The WRNMMC has indicated that it will lead the study upon approval of the final protocol.

The company also highlighted the following studies conducted within the last year:

  • INSURANCE STUDY: An audit of commercial health plan enrollees which found a 71 percent improvement in outcomes for physicians using PEER; an 85 percent reduction in suicidality; and successful prediction of severe adverse events in 55 percent of cases.
  • DEPRESSION STUDY: A 12-week study of treatment-resistant depression, in which physicians achieved a 65 percent success rate in treating patients with depression, compared to a 39 percent success rate in the control group.
  • EATING DISORDERS: A retrospective study of eating disorder patients with comorbid major depression or bipolar disorder. Physicians demonstrated that using PEER data helped reduce trial and error medication selection, and significantly decreased patient symptoms of depression, and reduced overall hospitalization days by 53 percent.
  • ADHD: Recent studies demonstrate a dramatic increase in medication use for ADHD, without corresponding improvements in outcomes. A Michigan State study demonstrated that 1 million children — of the 4.5 million currently diagnosed with ADHD — may be misdiagnosed.

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This release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All forward-looking statements are inherently uncertain as they are based on current expectations and assumptions concerning future events or future performance of the company. Readers are cautioned not to place undue reliance on these forward-looking statements, which are only predictions and speak only as of the date hereof. Risks and uncertainties applicable to the company and its business could cause the company's actual results to differ materially from those indicated in any forward-looking statements.

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