With mental health issues continuing to make headlines as greater importance is placed on its value towards wellbeing, medtech company Medibio (ASX: MEB) is developing a Software Medical Device for early detection of depressive symptoms.
Sleep disorders, their onset, and progression, will be the key depressive symptom being targeted by Medibio’s technology which will be aimed at assisting clinicians target and monitor their patient’s treatment regime.
Discussions between Medibio, which has offices in both Melbourne and Minneapolis, and the United States Food and Drug Administration (FDA) commenced in March 2019 with Medibio’s Sleep Analysis of Depressive Burden study (SADB) approved by the Institutional Review Board in October 2019 for clinical study to commence.
The first clinical study will centre around Medibio’s sleep staging algorithm and overlaying heart rate variability algorithm to provide depressive burden analysis.
Once sufficient data has been collected, Medibio will use the results for their pre-submission meeting with the FDA where they will seek to advance towards a Pivotal Study of 300 patients.
Key to the Pivotal Study will be the integration of Medibio’s STAGER algorithm which uses artificial intelligence and neural network methodology to identify important sleep stages.
STAGER has been tested using close to 1 million epochs (an epoch is a 30-second sleep interval) in more than 1,000 individuals and currently shows 84% accuracy. At the conclusion of STAGER’s current validation phase, it will be submitted for FDA clearance and market acceptance and be incorporated into Medibio’s SADB studies, as well as provide separate commercialisation opportunities.
Over the past few months, Medibio has been undergoing significant corporate changes which concluded with the appointment of Claude Solitario, an original founder of Medibio and its largest shareholder, as its new Managing Director on 9 December 2019.
“In recent times, I have been disappointed by the Company’s many board and management changes, which in my view have unnecessarily impeded the development of our regulated program and that of our corporate wellness product, ilumenTM,” said Solitario in a letter to shareholders last month.
“I am committing that under my leadership, the Company will be more open and transparent than ever before. In addition, as part of our strategic plan, I will also be stepping up our external public relations efforts and promotional activities. It’s time to extend Medibio’s profile beyond the ASX and investment community.”
“The 2020 calendar year will be a significant year for Medibio Limited. After many years as a passive shareholder, I am excited to be leading the Company. The goals and objectives of management and shareholders are now aligned more than ever before.”