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On January 14th, OSSIO announced the U.S. Food and Drug Administration (FDA) 510(k) clearance for its OSSIOfiber™ bone pin line of products. This innovative new technology utilizes a bio-integrative material made from a natural mineral fiber matrix to secure bone fixation during healing. As there is no extraneous hardware post-operative, this product will find its first uses in ankle and foot procedures due to frequent hardware removal surgeries in these domains. However, the OSSIOfiber™ will eventually have a diverse portfolio of applications across the realm of orthopedics.
While metal implants constitute the majority of current orthopedic fixations, this obstructive hardware can create a harsh healing environment, causing an increase in post-operative complications and additional hardware extraction procedures. These trends lead to increased healthcare costs and ultimately a raised rate of patient dissatisfaction. Previously engineered bio-resorbable fixation implants have historically been lacking in structural strength and degradation profiles, which act to avoid sudden releases of acidic by-products of the device, leading to inflammation and a hostile healing environment.
Market data published by iData Research further shows that inadequate physiochemical product strength had been limiting this market segment’s growth, and thus this move for FDA clearance from OSSIO is leading this segment in a more prosperous direction.
“OSSIO has a revolutionary new platform that will change the way we think about orthopedic fixation for both bone and soft tissue,” said Bob Baravarian, DPM, Assistant Clinical Professor, UCLA School of Medicine, and Director, University Foot and Ankle Institute, Santa Monica, CA. “Surgical procedures to treat forefoot conditions are increasing in frequency as the population ages. While these procedures are considered to be effective, they can be associated with secondary implant removal surgeries due to mechanical failure, irritation and pain. OSSIOfiber™ has the potential to be a true game-changer, with pre-clinical studies demonstrating its mechanical strength and bio-integrative nature.”
OSSIOfiber™ boasts a more accurate structural match to real bone and eliminates many physical stressors present in metal fixations, leading to a better promotion of bone growth as stress is gradually transferred to the regenerated bone. It also requires no additional changes to surgeons’ existing techniques, ensuring a secure fixation and ease of insertion. Pre-clinical studies confirmed that full integration occurs at approximately 18-24 months, at which point the device is completely absorbed and only new native bone remains.
“Today’s FDA clearance of the OSSIOfiber™ Bone Pin Family marks a significant milestone for our company, as we bring a new category of orthopedic fixation to the U.S. market,” said Brian Verrier, CEO, OSSIO. “We look forward to partnering with surgeons throughout the United States to integrate the OSSIOfiber™ platform into their surgical treatment options, ultimately changing the current standard-of-care in orthopedic fixation by encouraging natural bone healing that avoids unnecessary hardware removal surgeries and improves the overall healthcare economics of orthopedics. This regulatory achievement supports our overall mission to transform the patient experience.”
OSSIO is set to launch the OSSIOfiber™ line in the United States in the second quarter of 2019. For more information on OSSIOfiber™ please visit www.ossio.io.
For Further Information
More on the orthopedic trauma market in the U.S. can be found in a series of reports published by iData entitled the U.S. Market Report Suite for Orthopedic Trauma Devices 2017 – MedSuite