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Soterix Medical Announces clinical trial of self-administered transcranial Direct Current Stimulation (tDCS) to reduce craving in cocaine addiction

New York City –Feb 12, 2019

Soterix Medical Inc. has been awarded a Phase I NIH-SBIR contract from the National Institute of Drug Abuse (NIDA) of the National Institutes of Health (NIH) for the development of its portable remote-tDCS platform for the treatment of cocaine addiction. Soterix Medical is the industry leader in transcranial Direct Current Stimulation (tDCS) technologies. The Soterix Medical remote-tDCS platform is the only validated hardware and software system for reliable self-administered tDCS. The Icahn School of Medicine at Mount Sinai (ISMMS) is the partnering clinical center that will oversee a feasibility trial to be run at Samaritan Village, an outpatient rehabilitation center.

Soterix Medical's Phase I contract of approximately $475,000 extends over a period of 8 months supporting the application to Phase II award for a larger efficacy trial culminating in a FDA marketing trial. The focus of the project is to develop and validate the first self-administered electrostimulation system to reduce cocaine craving. The stimulation device and protocols developed in this project are further applicable to other addictive substances like nicotine, alcohol, and marijuana and to opioid misuse. Mr. Denis Arce, Product Development Engineer explains "The reproducible deployment of tDCS into outpatient and home settings requires intelligent hardware, easy-to-use accessories, and stimulation management software that all together make the remote-tDCS platform; the only platform validated for use in deployed settings through multiple rigorous trials. Our unique remote neuromodulation systems continues Soterix Medical's legacy as the technology leader in non-invasive brain stimulation."

"We are pleased to have received this support from NIH-NIDA. This is an important step in developing and commercializing our remote-tDCS platform for cocaine addiction" said Dr. Abhishek Datta, Ph.D., Soterix Medical CTO and the Principal Investigator on the award. "Furthermore, successful development of our unique non-addictive stimulation system potentially presents a solution to address the ongoing opioid epidemic as well. This contract from NIH-NIDA affirms the leadership of Soterix Medical in developing the most advanced deployable non-invasive brain stimulation technologies." Dr. Rita Goldstein, Ph.D. an internationally renowned cocaine addiction researcher is the Co-Investigator. She will spearhead the clinical trial, which will be performed by her team at Samaritan Village.

CAUTION: tDCS is limited by Federal (or United States) law to investigational use only.

Media Contact: Mariana Shuster
Tel: +1-888-990-8327

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