Diagnos Inc. (TSX Venture: ADK) (OTCQB: DGNOF), a leader in early detection of critical health issues, announces today the initiation of a clinical trial study with CommonSpirit Health Research Institute, Chattanooga Center for Neurologic Research LLC and conducted at the CommonSpirit Hospital in Chattanooga, to confirm early Proof-of-Concept results that showed a strong potential in the early detection of stroke through the inspection and analysis of the retina.
The clinical trial will be carried out under the direction of Thomas G Devlin M.D., PhD. The IRB study has been approved by an Institutional Review Board (“IRB”) in compliance with all applicable regulations in the USA.
“DIAGNOS will be providing the necessary hardware and technical support during the first phase of the clinical trial. DIAGNOS will have access to all the results tests performed on patients who are admitted to the hospital following a stroke and who meet the study’s inclusion criteria. The tests performed on these patients will include taking images of the retina using DIAGNOS’ CARA-ST technology. The analysis of the retina by our AI application will be done immediately and all medical staff in the clinical trial will have access to it through our FDA-approved Tele-Medicine platform. The initial goal of the first phase of the study is to demonstrate that the results using CARA-ST correlate with the results of the other clinical results. If successful, the second phase would start shortly thereafter and will be screening over 1,000 patients at the same facility and also a new facility in Canada.
DIAGNOS is seeking to demonstrate that CARA-ST will be able to predict the early signs of the condition leading to stroke, based on the micro circulation analysis of the retina image of the patient.
As per CDC-The Center for Disease Control and Prevention, stroke causes 1 out of every 20 deaths, the management of stroke represents a cost of around USD 34 billion per year in the United States. Hence, early diagnosis and treatment to prevent deaths from stroke is a time sensitive necessity.
According to the World Health Organization, 15 million people suffer a stroke worldwide each year. Of these, 5 million die and another 5 million are permanently disabled. High blood pressure contributes to more than 85% of strokes worldwide. Europe averages approximately 650,000 stroke related deaths each year.
“According to new reports published by Worldwide Research Institutes, the worldwide market size for Stroke Management will hit over $66 Billion dollars by 2023. DIAGNOS intends to be part of the solution by making available an affordable predictive test to the general public’’ said Mr. André Larente, President of DIAGNOS.
“At DIAGNOS we have continued to invest in Research and Development, furthering the creation of our intellectual property by partnering with Quebec government programs and local university (École de Technologie Supérieure) to ensure we stay ahead of our competition worldwide. This year our new stroke management application will be field tested in multiple countries. For our investors this ground-breaking test comes at an ideal time in terms of shareholder value creation as the combination of both CARA-DR and CARA-ST tools will be transformational in helping to monitor the health of existing and future patients with cardiovascular disease,” said Mr. Andre Larente, President of DIAGNOS.
CommonSpirit Health is a non for profit, Catholic health system dedicated to advancing health for all people. It was created in February 2019 through the alignment of Catholic Health initiatives and Dignity Health. With a team of approximately 125,000 physicians and advanced practice clinicians. CommonSpirit Health operates 137 hospitals and more than 1,000 care sites across 21 states. In FY2020, Catholic Health initiatives and Dignity Health had combined revenues of nearly $29.6 billion and provided $4.6 billion in charity care, community benefit and unreimbursed government programs.