MedTech Awards 2020

GHP / MedTech Awards 2020 7 , Nov20821 Enabling Surgeons to restore, regrow, and renew bone without metal, OSSIO is leading the way with its innovative first-of-its-kind implant. We find out more about this pioneering company. OSSIO OSSIO is an orthopedic fixation company committed to transforming the orthopedic experience for patients, physicians and payors. Its vision is to provide the first credible replacement to metal implants in the multi-billion-dollar global orthopedic fixation market with its OSSIOfiber ® Intelligent Bone Regeneration Technology. OSSIO has sales distribution partners in virtually every US state supporting Podiatrists and Orthopedic Surgeons and their patients. Founded in 2014, OSSIO began as the culmination of years of biomechanical research and a vision for the possibility of better bone healing. OSSIO has created a technology platform that engineers natural mineral fibers (similar in composition to osteoconductive bone void fillers) into a high performing micro-architecture designed for strength and bio-integration. The resulting implants are the first ever non-permanent devices that provide strength greater than cortical bone with gradual bone in-growth until full integration between 18-24 months. OSSIO is the first company to solve age old engineering tradeoffs of strength vs. bio-compatibility, which has eluded the industry until now. Creating a new category in orthopedic fixation, “Bio-Integratives” promises to meet a highly validated need. OSSIOfiber Technology has broad surgical applications throughout orthopedics, including foot and ankle, and hand and wrist procedures. OSSIOfiber implants avoid unnecessary secondary hardware removal surgeries and utilize sterile, disposable instrumentation reducing the time and costs associated with re-sterilizing instrument trays and eliminating unnecessary risks with patient bioburden transmissions. Both are meaningful benefits to patients and providers especially during a pandemic. With its commercial headquarters in Boston, Massachusetts, and development headquarters in Caesarea, Israel, OSSIO has cultivated a passionate and talented team with 50 plus employees to support and grow its mission. Although separated by thousands of miles, the global teams work very well together and stay connected on a daily basis. Israel offers a unique and talented high-tech workforce while the US complements that expertise with broad commercial experience selling into the largest target market. “We strive to be the new gold standard in orthopedic fixation,” explains Marketing Director, Kimberly Baker, of the company’s objectives. “We will do this by enabling natural bone healing that will ultimately eliminate hardware removal procedures, minimize implant-related complications, alleviate pain, and ultimately transform the patients’ orthopedic experience.” Implants that have the mechanical strength for easy insertion and secure fixation, while enabling the body to regrow bone, incorporating and replacing the implant (without the adverse inflammation and weakness often seen in “bio-resorbables” and other “bio-composites”). “OSSIOfiber ® represents a breakthrough material platform for orthopedic surgeons who seek a way to heal bone better, and for the patient - only nature remains. This is possible while also utilizing existing surgical techniques and reimbursement.” Currently available commercially in the US are the OSSIOfiber Trimmable Fixation Nails and OSSIOfiber Hammertoe Fixation System. Recently, OSSIO, Inc. received 510(k) market clearance from the US Food and Drug Administration (FDA) for the OSSIOfiber ® Compression Screw Portfolio. This was the third FDA clearance for the company’s OSSIOfiber ® Intelligent Bone Regeneration Technology. OSSIO plans to introduce the Compression Screws in early 2021 and has an active pipeline of products spanning into other specialities such as trauma, sports medicine, reconstruction, pediatrics, and spine. The company is also thrilled to share the publication of its prospective, multicenter, first- in-human clinical trial in Foot & Ankle Orthopaedics. Twenty-five patients underwent PIPJ fusions with OSSIOfiber ® Hammertoe Fixation Implants in November 2020. All operated joints (100%) were evaluated as clinically stable, with excellent bony fusion rate (88%) at 26 weeks, which is of the highest published fusion rates for hammertoe fixation solutions. The study concluded substantial patient- reported improvements in pain and function and high patient satisfaction; 100% of patients matched or exceeded their expectations for postoperative results and were likely to choose this implant again. Safety and efficacy were demonstrated with no complications, serious adverse events, nor withdrawals from the study. A second, longer- term study is anticipated for publication in 2021. Company: OSSIO Contact: Kimberly Baker Website: www.ossio.io Most Innovative Bio-Integrative Surgical Implant Solution: Bio-Integrative OSSIOfiber ® Trimmable FixationNails