Sydney, Australia –24 November 2015: Medibio Ltd (MEB or the Company) is pleased to announce that it
has been notified that its study with The Johns Hopkins University School of Medicine (JHM) has received
approval from the JHM Institutional Review Board. The receipt of JHM Institutional Review Board approval
clears the way for the study to start on December 1st, 2015.
The study has been designed to clinically validate the use of MEB’s Circadian Heart Rate (CHR) technology to differentiate between depressed and non-depressed individuals. Another study objective isto provide clinical data to support FDA certification of the company’s proprietary software algorithm for use as an objective method to differentiate between depressed and non-depressed individuals. The study population will comprise approximately 100 subjects, split between participants with Major Depressive Disorder (MDD) and participants without a mental health disorder.
The study will be carried out at The Johns Hopkins University School of Medicine, headquartered in Baltimore, Maryland. JHM is a $7 billion integrated global health enterprise and one of the leading health care systems in the United States with over 124 years of commitment to community care with ground-breaking research, teaching, and medical services to patients worldwide. Johns Hopkins Medicine operates six academic and community hospitals, four suburban health care and surgery centres, and more than 30 primary health care outpatient sites. The Johns Hopkins Hospital, opened in 1889, has been ranked number one in the nation by U.S. News & World Report for 22 years of the survey's 25-year history, most recently in 2013.
The principal Investigator of the study will be Dr Naresh Punjabi, M.D., Ph.D., who is a Professor of Medicine in the Division of Pulmonary and Critical Care division. Professor Punjabi was one of the principal investigators for the multi-centre Sleep Heart Health Study which is an epidemiological study on the longitudinal effects of sleep apnoea on hypertension, cardiovascular disease, and mortality. Dr Punjabi has published well over 100 research papers and is also an active teacher, presenting clinical instruction at The Johns Hopkins University School of Medicine as well as at the Bloomberg School of Public Health.
The study has been designed to clinically validate the use of MEB’s Circadian Heart Rate (CHR) technology to differentiate between depressed and non-depressed individuals. Another study objective isto provide clinical data to support FDA certification of the company’s proprietary software algorithm for use as an objective method to differentiate between depressed and non-depressed individuals. The study population will comprise approximately 100 subjects, split between participants with Major Depressive Disorder (MDD) and participants without a mental health disorder.
The study will be carried out at The Johns Hopkins University School of Medicine, headquartered in Baltimore, Maryland. JHM is a $7 billion integrated global health enterprise and one of the leading health care systems in the United States with over 124 years of commitment to community care with ground-breaking research, teaching, and medical services to patients worldwide. Johns Hopkins Medicine operates six academic and community hospitals, four suburban health care and surgery centres, and more than 30 primary health care outpatient sites. The Johns Hopkins Hospital, opened in 1889, has been ranked number one in the nation by U.S. News & World Report for 22 years of the survey's 25-year history, most recently in 2013.
The principal Investigator of the study will be Dr Naresh Punjabi, M.D., Ph.D., who is a Professor of Medicine in the Division of Pulmonary and Critical Care division. Professor Punjabi was one of the principal investigators for the multi-centre Sleep Heart Health Study which is an epidemiological study on the longitudinal effects of sleep apnoea on hypertension, cardiovascular disease, and mortality. Dr Punjabi has published well over 100 research papers and is also an active teacher, presenting clinical instruction at The Johns Hopkins University School of Medicine as well as at the Bloomberg School of Public Health.
