We are proud to announce that our affiliate partner Biomimetic Innovations Limited(BMI), has announced the execution of an exclusive license and distribution agreement with Sanara MedTech Inc. Sanara agreed to invest in BMI with cash for equity at the same time.
Sanara, a medical technology company based in Fort Worth, Texas, with attention to developing and commercializing cutting-edge technologies to improve clinical outcomes and reduce expenses for healthcare in the chronic wound, surgical and skincare markets.
Sanara now has the exclusive U.S. marketing, sales, and distribution rights to OsStic® Synthetic Injectable Structural Bio-Adhesive Bone Void Filler (“OsStic®”) under the terms of the License and Distribution Agreement, as well as a hardware adaptable supplementary internal fixation technology featuring a newly to promote targeted application of OsStic®, for use in fracture management. The License and Distribution Agreement is for an initial five-year period, with the option to automatically renew for another two years at the discretion of Sanara.
Developed by Biomimetic Innovations Ltd, OsStic®, is a disruptive new bio-adhesive bone void filler technology which was granted a Breakthrough Device Designation by the U.S. Food and Drug Administration (“FDA”) on December 10, 2023.
The proposed indication statement for OsStic® is [a] “structural, mechanically enhanced bioadhesive for reduction, provisional fixation, or void filling of periarticular fractures or defects to enhance structural stability where standard fixation alone cannot provide sufficient support for functional mobilization.”
Breakthrough Device Designation is granted to medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human diseases or conditions.
“We are excited to announce this strategic agreement and investment in Biomimetic Innovations,” said Ron Nixon, Sanara’s Executive Chairman and CEO. “OsStic® offers a truly differentiated solution, designed to enhance the fracture repair process. We believe OsStic® represents a compelling treatment option for the more than 100,000 periarticular fractures that occur in the U.S. annually.”
Dr. Thomas Russell, Chief Medical Officer of PBC Biomed (an affiliate of BMI), stated, “Unlike conventional materials, OsStic® is engineered to optimize fluidic dispersion into bone defects, interdigitate with the surrounding boney structure, and firmly adhere to bone surfaces. These properties provide exceptional structural integrity and mechanically enhanced bioadhesion, making OsStic® uniquely suited for reducing periarticular fractures, achieving provisional fixation, and filling voids. As the first calcium phosphate-based synthetic technology to address all three critical clinical needs, OsStic® offers an unparalleled solution for preserving joint congruency and improving patient outcomes.”
Managing Partner of PBC Biomed Ltd and the acting CEO of Biomimetic Innovations, Paul Burke, stated, “Our goal is to ‘enhance patient wellness’ using disruptive medical innovations. With its market expertise, sales and distribution network, and existing customer relationships, Sanara represents an ideal partner to commercialize our innovative technologies. Together, we look forward to bringing transformative solutions to market that enhance the surgeon’s treatment approach and improve patient outcomes.”
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