Sernova, CTI ink regulatory deal for Cell Pouch System

Sernova said it inked a regulatory deal with CTI Clinical Trial and Consulting Services to further the clinical development and IND application for its Cell Pouch drug delivery system.

The London, Ontario-based company’s Cell Pouch is an implantable device that acts as an environment within the body to store therapeutic cells for patients with chronic diseases.

Cincinnati-based CTI touted that it’s been a part of more than 100 drug and device approvals since it began in 1999. CTI will support Sernova’s regulatory package submission for the recently announced Juvenile Diabetes Research Foundation-supported clinical trial in patients with insulin-dependent diabetes, according to Sernova.

“We are really enthused to be collaborating with Sernova on filing their Investigational New Drug application with the FDA,” CTI founder & CEO Timothy Schroeder said in prepared remarks. “Sernova is an innovative organization with a regenerative medicine program that could change the standard of care for many chronically ill patients.”

“We are pleased to have CTI supporting Sernova’s clinical trial regulatory processes as they bring proven expertise in medical device and regenerative medicine technologies targeting chronically ill patient populations,” Sernova president & CEO Philip Toleikis added. “We at Sernova see this collaboration as the beginning of a long-term relationship in supporting the clinical development progression of our therapeutic cell and device applications. With their clinical trial experience across 6 continents in bringing research sites, patients, and sponsors together, CTI will be an invaluable member of Sernova’s development team.”