Apr 19 2012
Medical
Metrics Inc, (MMI), an experienced provider of medical imaging core
lab services for global clinical trials, has been selected by Exactech,
Inc. to conduct an independent evaluation of medical images from the BiPhasic
Cartilage Repair Implant (BiCRI) IDE Clinical Trial approved by the
Taiwan FDA. This prospective, randomized study will be conducted in
Taiwan to evaluate a novel cartilage repair treatment. The biphasic
implant is a two-phase scaffold that is intended to promote integration
with subchondral bone and regeneration of hyaline-like cartilage. During
the study, MMI will provide comprehensive analysis and management of MR
images.
MMI developed the imaging sequences and assessment panels necessary to
evaluate treatment outcomes, including extent of lesion repair,
bone-implant integration, and overall device integrity. Matt
Christensen, Exactech's Director of Clinical Affairs, said "We chose
Medical Metrics for their extensive expertise in musculoskeletal imaging
and cartilage repair. MMI is a valuable resource for clinical input on
study design, and their commitment to customer services is impressive."
Exactech's BiCRI IDE trial supports the company's corporate
objective to enter the cartilage repair market and commercialize the
new technology in multiple global markets. MMI has supported
osteoarthritis (OA) trials of treatments for cartilage repair and
replacement since 2000. Nick Wharton, MMI's SVP of Technical Services,
commented, "Sponsors benefit from our broad experience in OA clinical
trials and unique clinical and scientific expertise. We are proud to
have been selected by Exactech as the imaging core lab for this
important pivotal trial."
Source: Medical Metrics