The OSSIOfiber Bone Pin Family received 510(k) market clearance from the U.S. Food and Drug Administration (FDA) in January and the initial product offering is applicable for use in the foot and ankle segment for the treatment of forefoot conditions where hardware removal surgeries are prevalent. Offering a new category of non-permanent fixation material, the OSSIOfiber Intelligent Bone Regeneration Technology features a first of its kind, proprietary bio-integrative material that provides stability and secure bone fixation during the healing process and gradual integration into the native anatomy, ultimately leaving no permanent hardware behind. Combining unparalleled mechanical strength and natural bone healing in a non-permanent implant, OSSIOfiber is designed to fully incorporate into the native anatomy without any adverse biologic response.
“OSSIOfiber brings forward a real paradigm shift in how we approach bone fixation. The new bio-integrative implant is truly unique in that it provides immediate stable fixation that physiologically adapts with the bone during the healing process,” said Dr. Berlet. “I am honored to have performed the inaugural cases in the United States together with Drs. Hyer and Prissel and look forward to adding implants made from this innovative bio-material technology to my treatment arsenal.”
Additional procedures utilizing the OSSIOfiber platform are planned in limited markets in the coming weeks, with full commercialization and availability in all states set to occur in the third quarter of 2019. Over the next year, OSSIO anticipates streamlined adoption of OSSIOfiber among the orthopedic and podiatric surgeon communities, given the implant’s innovative bio-integrative design and overall ease-of-use, requiring no changes to surgeons existing techniques.
“While forefoot disorders are highly treatable, secondary procedures to remove hardware are often warranted, causing a significant cost burden on the patient, physician and healthcare system as a whole,” said Dr. Hyer. “We’ve been waiting for a new option in the orthopedic fixation space for decades and OSSIOfiber shows real promise to become the first credible replacement to permanent implants. Having this new treatment option at the ready will fundamentally impact our approach to treating these patients by avoiding permanent device-related post-operative complications and secondary removal surgeries.”
Since receiving FDA clearance, OSSIO has made significant headway in executing against key commercial related milestones, including:
- Hiring experienced area sales directors and independent sales distributors
- Securing $22 million in financing to accelerate strategic growth
- Completed all manufacturing validations to meet anticipated demand
- Identified the first 25 sites ready to participate in early limited market release
- Completed enrollment in the European Hammertoe Clinical Trial
“The U.S. market anticipation for OSSIOfiber has been overwhelmingly positive to date,” said Brian Verrier, CEO, OSSIO. “We are poised to initiate broader U.S. commercialization of the implant system in the coming weeks, offering surgeons and their patients a new standard of care in orthopedic fixation.”
The proprietary OSSIOfiber technology can address many surgical applications through the manufacturing of endless implant designs, including pins, screws, and plates. The company intends to pursue multiple applications in the distal extremity, trauma, sports, reconstruction, pediatrics, and spine segments.