Osteo-Pharma receives MREC approval for initiation of clinical trial
Osteo-Pharma today 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.
Source: Osteo-Pharma (Press release)