Core Summary - Biomimetic Innovations Limited, an affiliate of PBC Biomed, has entered into an exclusive license and distribution agreement with Sanara MedTech Inc (NASDAQ:SMTI) for the commercialization of OsStic®, a synthetic injectable structural bio-adhesive bone void filler [1][3] - Sanara MedTech has acquired exclusive US marketing, sales, and distribution rights for OsStic®, along with a hardware-agnostic adjunctive internal fixation technology, under a five-year agreement with automatic renewal options [3] - OsStic® is a disruptive bio-adhesive bone void filler technology that received FDA Breakthrough Device Designation in December 2023, targeting periarticular fractures and defects [4][5] - Sanara MedTech has also made a minority cash investment in Biomimetic Innovations Limited as part of the agreement [1] Company Overview Biomimetic Innovations Limited and PBC Biomed - Biomimetic Innovations Limited is an affiliate of PBC Biomed, a medical device company specializing in design, development, and manufacturing [7] - PBC Biomed partners with innovators in medical devices, biologics, pharmaceuticals, and combination products to accelerate technology through product lifecycle stages [7] - The company provides regulatory, clinical, quality assurance, and commercial support, with ISO 13485 and ISO 9001 certified facilities for clean room manufacturing, packing, and sterilization [7] - PBC Biomed has a history of commercializing new technologies, including N-Force Fixation/iN3 Cement and ReFeel®, a nerve regeneration solution [7][8] Sanara MedTech Inc - Sanara MedTech is a medical technology company focused on developing and commercializing transformative technologies in surgical, chronic wound, and skincare markets [2][9] - The company markets and distributes a range of advanced biologic products for surgical tissue repair and wound care, including CellerateRX®, FORTIFY TRG®, and BIAKŌS® [9] - Sanara MedTech also offers wound care and dermatology virtual consultation services via telemedicine [9] - The company has a pipeline of transformative product candidates targeting wound re-epithelialization, necrotic tissue debridement, and biofilm mitigation [9] Product and Technology - OsStic® is a calcium phosphate-based synthetic technology designed to optimize fluidic dispersion, interdigitate with bone structures, and firmly adhere to bone surfaces, providing exceptional structural integrity [6] - The technology is uniquely suited for reducing periarticular fractures, achieving provisional fixation, and filling voids, addressing three critical clinical needs [6] - OsStic® is indicated for use in periarticular fractures or defects where standard fixation alone cannot provide sufficient support for functional mobilization [5] - The technology has the potential to address over 100,000 periarticular fractures annually in the US [6] Strategic Partnership - The partnership between Biomimetic Innovations and Sanara MedTech aims to commercialize OsStic® and bring transformative solutions to the market [6] - Sanara MedTech's market expertise, sales and distribution network, and existing customer relationships make it an ideal partner for Biomimetic Innovations [6] - The collaboration is expected to enhance the surgeon's treatment approach and improve patient outcomes [6]
Biomimetic Innovations Ltd, an affiliate of PBC Biomed, Announces an Exclusive License and Distribution Agreement and Minority Investment with Sanara MedTech Inc.