A two-stage clinical trial at 13 sites in the U.S. is currently underway to support CorVista’s development and regulatory filings. The ongoing study, with more than 2,000 patients enrolled so far, will measure the performance of a machine-learned algorithm for CAD detection to gold-standard cardiac catheterization results.
Preliminary results will be presented next month at the Transcatheter Cardiovascular Therapeutics (TCT) conference in Denver. Assuming a positive FDA review, the Company anticipates having CorVista available in the U.S. next year.
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Dr. Aaron Berez Appointed to Board of Directors
Also today, Analytics 4 Life announced the appointment of Aaron Berez, M.D., to its board of directors. Dr. Berez is the founder and CEO of Alembic LLC, an early-stage medical device company, and has been leading and advising medical device companies for more than 20 years.
“Today marks an important milestone for the Company, but also for the 15.5 million Americans living with coronary heart disease,” said Dr. Berez. “I’m excited and honored to join Analytics 4 Life’s Board of esteemed experts as we chart a path toward bringing this potentially transformative way to diagnose cardiovascular disease to patients and physicians.”
Previously, Dr. Berez co-founded and served as CEO of Chestnut Medical, acquired by Ev3 (now Medtronic) in 2009, where he led the development of the Pipeline Embolization Device for the treatment of complex intracranial aneurysms. Dr. Berez is currently an investor, advisor, and director to privately held medical device companies focused on capital-efficient medical device development.
About Coronary Artery Disease
Coronary Artery Disease (CAD) is when the heart becomes weakened from a deficient supply of oxygenated blood due to a buildup of plaque in the coronary arteries, which can lead to blood clots, chest pain, and cardiac arrest. CAD affects approximately 15.5 million Americans and is the number one cause of death in the U.S.
About Analytics 4 Life
Analytics 4 Life is pioneering digital health using artificial intelligence to develop a completely new form of medical imaging. With an initial focus on coronary artery disease (CAD), Analytics 4 Life is advancing a novel, radiation-free, and exercise-free cardiac imaging technology aimed at improving existing care pathways. Analytics 4 Life is based in Toronto with U.S. headquarters in Research Triangle Park, NC.
SOURCE: PR Newswire
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