Sanara MedTech secures Exclusive License and Invests in Biomimetic Innovations

Based in Fort Worth, Texas, Sanara MedTech Inc., a medical technology company focused on developing and commercializing transformative technologies to improve clinical outcomes and reduce healthcare expenditures in the surgical, chronic wound and skincare markets, announced the execution of an exclusive license and distribution agreement (the “License and Distribution Agreement”) with Biomimetic Innovations Ltd (“Biomimetic Innovations” or “BMI”), a privately-held medical device company headquartered in Shannon, Ireland. In tandem, Sanara agreed to contribute up to €8.0 million in cash to BMI in exchange for approximately 12.5% of BMI’s outstanding equity. Sanara made an initial cash investment totaling €4.0 million, including €1.0 million of converting debt. The remaining €4.0 million contribution is due upon the achievement of certain development, clinical and regulatory milestones.

Under the terms of the License and Distribution Agreement, Sanara has acquired the exclusive U.S. marketing, sales, and distribution rights to OsStic^® Synthetic Injectable Structural Bio-Adhesive Bone Void Filler (“OsStic”), as well as a hardware agnostic adjunctive internal fixation technology featuring novel delivery 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 successive two-year periods at Sanara’s discretion.

OsStic was granted a Breakthrough Device Designation by the U.S. Food and Drug Administration (“FDA” or the “Agency”) on December 10, 2023, with proposed indications for use as 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 disease 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.”

Mr. Nixon continued: “Leveraging the receipt of FDA Breakthrough Device Designation for OsStic, BMI is engaging with the Agency in pursuit of U.S. regulatory clearance. We look forward to introducing this innovative surgical solution to the U.S. market, which we anticipate in the first quarter of 2027. Importantly, we expect OsStic and related delivery technologies to complement our existing surgical product portfolio, as we continue our focus on enhancing patient outcomes, improving healthcare providers’ surgical experience, and reducing the total cost of care.”

Dr. Thomas Russell, Chief Medical Officer of PBC Biomed (an affiliate of BMI), stated, “While traditional calcium phosphate bone substitute materials offer basic bone void filling properties, they are limited in their ability to fully integrate with the bone and ultimately do not provide the adequate mechanical support to assist fracture repair. OsStic sets a new standard with its innovative formulation. 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.”

Paul Burke, Managing Partner of PBC Biomed Ltd and acting CEO of Biomimetic Innovations 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.”