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 quantitative image analysis, to generate imaging data that is more quantitative 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."
