Histogenics Selects ImageIQ to Provide Imaging Analysis for Phase III Clinical Trial
ImageIQ, a Cleveland Clinic-founded contract research organization providing imaging analysis software and services, announces that it has been chosen by Histogenics, a regenerative medicine company, to provide imaging analytics for the Phase III IND clinical trial of the company'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.
CLEVELAND, OHIO – July 26, 2012 – ImageIQ, a Cleveland Clinic-founded contract research organization providing imaging analysis software and services, announces that it has been chosen by Histogenics, a regenerative medicine company, to provide imaging analytics for the Phase 3 IND clinical trial of the company’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 multi-year 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 challenge of the difficult problem of imaging cartilage. We are happy to have ImageIQ as a partner during this important time in the development of NeoCart.”
“We are excited to apply our deep-seated experience in orthopedic imaging analysis to the Histogenics NeoCart trial,” says Tim Kulbago, ImageIQ CEO. “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.”
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