Osteo-Pharma announced that it has successfully obtained MREC approval for testing their lead product, OsteoActivator-P, in patients. OsteoActivator-P is a novel coated porcine collagen barrier membrane that will be placed on a dental defect to improve early bone formation. The study is a randomized prospective clinical trial, comparing OsteoActivator-P coated membranes vs Collagen Membrane-P uncoated for accelerated localized alveolar ridge preservation and will investigate the efficacy and safety of OsteoActivator-P. The study is expected to enroll a total of 16 patients at 2 clinical centers in The Netherlands.
“OsteoActivator-P is a new and promising innovative product for the dental market for all applications requiring guided bone regeneration. Preclinical data have provided a strong rationale for this first clinical trial and a robust study protocol is now available to address the efficacy and safety profile of OsteoActivator-P” said Jan Gossen, CEO of Osteo-Pharma.
Osteo-Pharma is a Dutch Life Sciences company developing novel medical devices and pharmaceuticals to improve the local healing of bone defects and fractures. Its proprietary OsteoActivator platform is currently used to develop products for both dental and orthopedic applications.