MISSION VIEJO, Calif., Sept. 17, 2018 (GLOBE NEWSWIRE) -- MYnd Analytics, Inc. (NASDAQ: MYND), a market leader in improving the delivery of mental health through the combination of telemedicine and data analytics with augmented intelligence, today announced that the U.S. Food & Drug Administration (FDA) has granted Breakthrough Device designation for the Company’s next generation product PEER 4.0.
PEER (the Psychiatric EEG Evaluation Registry) is the company's proprietary clinical phenotype database comprising over 40,000 medication outcomes for over 11,000 unique patients, which is used to predict how a patient will respond to a specific medication. The Company’s original product, now in its third generation, has been continuously registered as a class 1 MDDS since October 2011.
Under the Breakthrough Devices program, a provision of the 21st Century Cures Act, the FDA works with medical device developers to expedite regulatory review for diagnostic and therapeutic technologies that address a critical unmet need or a serious condition, where preliminary clinical evidence indicates substantial improvement compared to the current standard of care.
George Carpenter, CEO of MYnd stated, “This breakthrough designation highlights the growing evidence from the Company, National Institute of Mental Health (NIMH) and independent researchers of the predictive capacity of EEG data when paired with our unique, proprietary PEER Registry. We appreciate the FDA's determination that PEER meets the requirements for this designation and are eager to work together with the FDA going forward."
MYnd also operates its wholly owned subsidiarity Arcadian Telepsychiatry Services, LLC which manages a suite of services including telepsychiatry, teletherapy, digital patient screening, curbside consultation, on-demand services, and scheduled encounters for all age groups. Arcadian utilizes patient engagement and re-engagement strategies so that care is effectively completed, helping to comfortably move inpatient care to outpatient, assisting patients in readjusting to their life routine, as well as reducing wait times for mental health treatment. Arcadian’s customer base includes major health plans, health systems, and community-based organizations.
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, such as statements regarding market developments, new products and growth strategies, the ability of MYnd’s products to successfully produce objective data and improve efficiency in the treatment of depression and other mental health and psychiatric illnesses, as well as those risks and uncertainties set forth in MYnd'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.