The FDA has awarded breakthrough device designation to a MYnd Analytics' technology that identifies the medications most likely to work in patients with mental health conditions.
MYnd's technology, PEER 4.0, works by comparing the brain activity of a patient to those of people with similar patterns to zero in on the drugs that have worked in analogous situations in the past.
The breakthrough designation positions MYnd to receive more support from the FDA and a faster review.
MYnd has been through a big 18 months. In July 2017, the provider of decision support tools for physicians treating mental health conditions listed its stock on the small-cap NASDAQ Capital Market, raising $8.8 million. The following month, MYnd bought Arcadian Telepsychiatry Services to move into the remote delivery of psychiatric healthcare. The acquisition gave MYnd access to physicians who may be interested in its core technology, the Psychiatric EEG Evaluation Registry (PEER).
Physicians who sign up to use the registry put patients through electroencephalograms to assess their brainwaves. MYnd then compares the output of the EEG to results from the 11,000 previously-assessed patients in its database. By finding people with similar EEG results and seeing how these previously-treated patients responded to medicines, MYnd thinks it can identify the drugs that are most likely to work in an individual with a mental health condition.
MYnd first registered PEER as a Class I medical device data system in 2011, but early iterations of the technology struggled to gain traction. In the nine months up to the end of June, the neurometric service unit that includes PEER generated sales of just under $200,000. The figure is up on the $94,500 the neurometric unit pulled in over the first three quarters of the previous year but well short of the amount MYnd needs to break even. Operating expenses over the first nine months of this year exceeded $9 million, resulting in MYnd recording a hefty loss.
The pursuit of the breakthrough device designation for the latest iteration of the technology, PEER 4.0, is one way in which MYnd is trying to improve its fortunes. In parallel to the regulatory program, MYnd is working with insurer Horizon Healthcare Services to assess the effectiveness of PEER in 600 patients.
FDA's breakthrough device designation, established as part of the 21st Century Cures Act, enables the agency to fast track review of devices that demonstrate potential to help treat unmet medical needs for life threatening diseases. A FDA spokesperson told MedTech Dive that the agency has granted the breakthrough device designation to 83 devices as of the end of July.