The companies announced the collaboration on regulatory matters respecting Sernova’s implantable medical device, Cell Pouch System, yesterday.
As per the agreement, CTI will support Sernova's clinical trial regulatory processes, including submission of Sernova's regulatory package with the FDA for the company’s recently announced clinical trial in patients with insulin-dependent diabetes.
Dr. Philip Toleikis, Sernova President and CEO said the collaboration is the beginning of a long-term relationship in supporting the clinical development of the company’s therapeutic cell and device applications.
"With their clinical trial experience across six continents in bringing research sites, patients, and sponsors together, CTI will be an invaluable member of Sernova's development team," he explained.