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."
ImageIQ is an Imaging Contract Research Organization (ICRO) that combines software engineering with biomedical and imaging expertise to provide quantitative visual analysis that enhances R&D and product efficacy/safety testing for research, medical device and pharmaceutical organizations. Incubated within Cleveland Clinic for the better part of a decade, ImageIQ provides customized image analytics and reporting, delivering objective quantitative evidence that speeds time to discovery and market entry, reduces internal overhead and improves grant proposal attractiveness and fundability. By advancing the speed of research, ImageIQ customers can extend their expertise and abilities and complete work quickly, allowing innovative staff members to focus on creative solutions to research. www.Image-IQ.com
Histogenics is a leading regenerative medicine company that combines cell therapy and tissue engineering technologies to develop highly innovative products for tissue repair and regeneration. In May of 2011, Histogenics acquired Israeli cell-therapy company Prochon BioTech. Histogenics' flagship products focus on the treatment of active patients suffering from articular cartilage derived pain and immobility. The Company takes an interdisciplinary approach to engineering neocartilage that looks, acts and lasts like hyaline cartilage. It is developing new treatments for sports injuries and other orthopedic conditions, where demand is growing for long-term alternatives to joint replacement. Histogenics has successfully completed Phase 1 and Phase 2 clinical trials in which the NeoCart autologous tissue implant's effectiveness is compared to that of standard microfracture surgery. Based in Waltham, Massachusetts, the company is privately held. www.histogenics.com.
NeoCart® is an autologous bioengineered neocartilage grown outside the body using the patient's own cells for the regeneration of cartilage lesions. NeoCart recently entered a Phase 3 clinical trial after reporting positive Phase 2 data, in which all primary endpoints were met, and NeoCart was found to be generally well tolerated.