Soterix Medical Inc. announced today the launch of its U.S. Food and Drug Administration (FDA) 510k cleared electro-detox™ treatment to reduce opiate and opioid withdrawal symptoms. The electro-detox™ is a battery-powered wearable device placed behind the patient’s ear that emits gentle current pulses to stimulate branches of specific cranial nerves. In the study leading to marketing approval, patients reported a symptom reduction of 62% within 20 minutes of using the device and a remarkable 88% transitioned to medication assisted therapy. Patients reported minimal to no side-effects from the treatment. Pharmaceutical medication has been the mainstay for the induction-phase or the initial phase when a patient begins the process of switching from the opioid of abuse to medication, but with varying levels of success and complications. The electro-detox™ system presents a non-drug, non-implantable medical device option with minimal side-effects, and is cost-effective.
Dr. Abhishek Datta, CTO of Soterix Medical commented that, "The launch of electro-detox™ treatment validates our continued commitment to deliver innovative technologies and medical treatments. It is known that discontinuation of opioid use is extremely painful and frightening, and that relapses during the induction phase are common. The electro-detox™ therapy reduces the fear of experiencing unpleasant withdrawal symptoms dramatically, with effects felt as quickly as 20 minutes. Since the declaration of public health crisis, Soterix Medical has been committed to combating the scourge of opioid addiction. We are extremely pleased to now provide a tool to support recovery from addiction".
Mr. Jose Rodriguez, Soterix Medical’s VP Regulatory Affairs, added "The electro-detox™ therapy requires minimal training and can be administered by physician extenders in addition to physicians. The device is available as of today by prescription. We look forward to working with addiction treatment centers and office-based clinics to make electro-detoxTM therapy readily available to patients across United States".
Physicians in the United States interested in providing Soterix Medical electro-detox™ therapy are eligible for the Soterix Medical's Partnership program which includes support on the entire patient treatment pipeline, hands-on training and staff certification, and connection to our network of physician researchers. Interested parties should contact Soterix Medical (at firstname.lastname@example.org) for additional information.