Biogennix Utilizes ImageIQ for Preclinical Image Analysis for FDA 510(k) Marketing ApprovalJanuary 26, 2016
CLEVELAND, OHIO – January 26, 2016 – ImageIQ, an innovative Imaging Software and Contract Research Organization focused on supporting preclinical research and clinical trials, announced today that it has successfully supported Biogennix in completing its recent long-bone fracture healing and spine fusion preclinical studies. Both of these studies generated data that resulted in 510(k) marketing approvals by the US Food and Drug Administration (FDA).
Biogennix products are indicated for voids or gaps in the extremities, posterolateral spine and pelvis that are not intrinsic to the stability of the bony structure. The product provides bone void filler that resorbs and is replaced with bone during the healing process. Biogennix selected ImageIQ to support these studies because of ImageIQ’s history of leveraging its 2D and 3D imaging expertise, combined with its unique approach to software-based quantiative image analysis, to generate imaging data that is more quantiative and objective than traditional approaches. Specifically, ImageIQ provided histology and micro-computed tomography quantitative imaging and analysis to strengthen the Biogennix 510(k) submissions, and provided data for a more objective and quantitative product efficacy claim.
“Our work with ImageIQ played a major role in receiving our 510k marketing approvals,” said Biogennix CTO, Timothy Bumbalough. “Their knowledge of what was necessary to support our FDA submissions was what first impressed us. They immediately understood how to leverage imaging analysis and data acquisition to demonstrate efficacy of our products to the FDA, and subsequently, to our potential end users.”
“It was a delight to work with the Biogennix team,” said Tim Kulbago, ImageIQ CEO. “Our mission to help our clients deliver clear and concise data that supports their science. We are looking forward to continuing to be a part of the Biogennix success story.”
Biogennix is located in Irvine, California, just 45 miles south of Los Angeles and 90 miles north of San Diego. Irvine is home to over 16,000 businesses and several industry clusters, including medical device manufacturers and bio-medical companies, and is in the heart of Southern California’s “Technology Coast.” Biogennix is a manufacturer of implantable, Class II medical devices, primarily bone graft extenders used in posterolateral spine surgery. The products are used by surgeons as a resorbable, osteoconductive matrix for bone reconstruction, serving as an off the shelf, pre-sterilized bone graft substitute. In 2015, a moldable form of the original osteoSPAN granule product (osteoSPAN Morpheus) was cleared for use by the FDA as a bone graft extender in posterolateral spine. The company also recently introduced its first spinal hardware device, an "ALIF" spacer system that is offered in individually packaged sterile units for added convenience and traceability.