MYnd Analytics stock rallies after FDA gives breakthrough status for company device

Shares of MYnd Analytics inc (NASDAQ:MYND) popped on Monday after the US Food and Drug Administration (FDA) granted breakthrough device designation for the company’s next generation database used to predict how a patient will respond to a specific medication.

The Psychiatric EEG Evaluation Registry (PEER) is the company’s clinical phenotype database comprising over 40,000 medication outcomes for 11,000 unique patients. The company’s original product is now in its third generation.  

PEER Online is a registry and reporting platform that allows medical professionals to exchange treatment outcome data for patients referenced to objective neurophysiology data obtained through a standard electroencephalogram (EEG).

READ: MYnd Analytics shares soar after it posts smaller-than-expected fiscal 2Q loss

Shares of MYnd jumped almost 40% to trade at US$2.49 in the premarket. The stock was up 22.5% to US$2.20 at the start of trading.

Under the Breakthrough Devices program, 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.

MYnd is a predictive analytics company that has developed a support tool to help physicians reduce trial and error treatment in mental health and provide more personalized care to patients.

The company is based in Mission Viejo, California.

Story by ProactiveInvestors