Mental-health technology company Medibio (ASX: MEB) has received European CE Marking certification for its stress-phenotype and sleep-assessing product and platform from independent assessor DQS Med.
Medibio managing director and chief executive officer Jack Cosentino called the accreditation further validation of the company’s technology and product offering.
“Acquiring CE Marking represents the successful completion of a lengthy and thorough evaluation process, and marks an important threshold for the company,” he said of the CE Marking granted yesterday.
“We are pleased to have delivered against this key milestone.”
The chief executive said the Victorian company, which last year bagged a five-year clinical trial agreement with Mayo Clinic in the US, was keen to enter a new phase.
“We are eager to progress to a new phase, and committed across the organisation to deliver exceptional product quality and operational excellence as we work towards transforming mental health care delivery,” he said.
The Mayo partnership includes clinical trials of the technology, which allows caregivers to judge whether a person is experiencing anxiety or depression, based on the Medibio technology measuring their circadian heart-rate waveforms.
Medibio’s app and web-based scientific platforms allow clinicians to assess people’s stress-level phenotypes, while also drawing on an understanding the of a patient’s circadian heart rhythms as they sleep and their physiological biometrics.
The company tipped its system would allow for non-invasive, comprehensive evaluation and monitoring of mental health across the world as it was rolled out globally.
“The successful introduction of rest of world applications in key countries will provide Medibio with the ability to further commercialise its technology and platform in alignment with our strategic plans for additional product releases,” Medibio said in its statement today.
A US Food and Drug Administration approval would be another milestone in the commercialisation of Medibio’s product offering for the clinician and consumer markets.
Corporate mental health
Two days ago, on 1 May 2018, the company confirmed it had launched another product, which targeted the business market.
The corporate mental healthcare initiative aims to improve employee wellness, and starts with a Mental Health Check-In campaign app titled Medibio Inform which is to be launched in the iTunes and Google Play stores by mid-month.
Medibio’s Corporate Health program will be priced between A$15 and A$45 an employee, with the US, Australia and New Zealand to be the first target markets.
Program senior vice-president Peta Slocombe said the platform was a significant advancement in corporate mental health.
The launch of the Corporate Health business arm was made possible with Medibio’s acquisition of Vital Conversations, executed in mid-April 2018, which Curtin University-educated organisation psychologist Ms Slocombe had headed up as managing director.
The company had A$11.6 million cash on 31 March 2018 and tipped in its latest quarterly report it expected its available cash in the next year would be about A$13.5 million.
Medibio drew in A$61,000 from customers in the March 2018 quarter, and burned A$3.56 million in operating activities.
The company’s total receipts from customers in the first three quarters of the 2018 financial year is sitting at A$66,000, with expenditure of A$7.39 million for the nine-month period.
The A$35.23 million company will present its March 2018 quarterly cashflow results to investors during a webcast to be held this Friday, 4 May 2018, at 10am Australian Eastern Standard Time.
Medibio securities had lifted 5.88% to A$0.18 by lunchtime.