The EMPOWER study demonstrated a remarkable level of safety for an implanted medical device, added James W. Freston, M.D., Ph.D., Professor of Medicine and Clinical Pharmacology (emeritus), University of Connecticut Health Center and Chairman of the EMPOWER study Data Safety Monitoring Board.
Results from the two arms of the EMPOWER study as well as from our previous VBLOC Therapy trials were consistent with each other, suggesting a pattern of positive clinical outcome when blocking the vagus nerve, said President and CEO Mark B. Knudson, Ph.D. The apparent control arm effect, while unexpected, may be a scientifically important addition to our understanding of neuromodulation. We are taking steps to discuss the outcome of this study with the FDA to determine the appropriate regulatory path forward for the Maestro System as a treatment for morbid obesity.
The Company will discuss these findings in detail in a conference call and slide presentation today at 8:00 AM Eastern Standard Time.
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