ImageIQ, an imaging contract research organization, has entered into a collaboration agreement to provide imaging analytics for Histogenics' Phase 3 IND clinical trial of NeoCart implant.
Histogenics said NeoCart is an autologous bioengineered neocartilage which is grown outside the body using the patient’s own cells for the regeneration of cartilage lesions.
Under the agreement, ImageIQ will provide all imaging components of the trial including site training, site compliance and image management.
ImageIQ will aggregate and report imaging data by making use of its MRI scanners at specific time points, while at trial conclusion, it will develop the image portion of Histogenics’ FDA submission and serve as imaging experts when Histogenics presents the results of their trials to the FDA.
Histogenics president and CEO Patrick O’Donnell said the imaging component of the clinical trial requires an intense focus on data accuracy and smooth workflow.
"ImageIQ brings a solid reputation of excellence in imaging analysis to the challenge of the difficult problem of imaging cartilage," Donnell added.
ImageIQ CEO Tim Kulbago said, "We look forward to supporting the exceptional work of the Histogenics team as they work to bring their NeoCart product to market in the fast-growing and exciting area of regenerative medicine."