Histogenics selected ImageIQ to provide imaging analytics for the Phase III IND clinical trial of the former’s NeoCart implant. NeoCart is an autologous bioengineered neocartilage grown outside the body using the patient’s own cells for the regeneration of cartilage lesions.
Through this multiyear partnership, ImageIQ is providing all imaging components of the trial including site training, site compliance, and image management. ImageIQ is developing protocols and ensuring protocol standardization across several sites, each using various types of MRI scanners to acquire images. ImageIQ will aggregate and report on imaging data at specific time points and, at trial conclusion, will assist in developing the imaging portion of Histogenics’ FDA submission and serve as imaging experts when Histogenics presents the results of their trials to the FDA.
“The imaging component of this clinical trial requires an intense focus on data accuracy and smooth workflow,” says Patrick O’Donnell, Histogenics’ president and CEO. “ImageIQ brings a solid reputation of excellence in imaging analysis to the difficult problem of imaging cartilage. We are happy to have ImageIQ as a partner during this important time in the development of NeoCart.”