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.
Osteo-Pharma is a Life Sciences company focused on the development of local treatments to improve the healing of bone fracture and defects. It’s proprietary OsteoActivator platform is used to develop biodegradable membranes, microspheres and coatings for implants with sustained release of small molecule drugs that enhance bone formation while simultaneously inhibiting bone resorption. The company is currently in mid-stage pre-clinical development for various projects and will start its first dental clinical trial in mid-2021.