The company has secured the US Food and Drug Administration (FDA) approval for OSSIOfiber Suture Anchors in March this year, for fixation of the shoulder, foot/ankle, knee, hand/wrist, and elbow, in different orthopaedic procedures
The OSSIOfiber Suture Anchor. (Credit: Business Wire)
Israeli orthopaedic fixation technology firm OSSIO has announced the first commercial use of its OSSIOfiber Suture Anchors and plans to commercialise the product in the US.
The company secured the US Food and Drug Administration (FDA) approval for OSSIOfiber Suture Anchors in March this year.
The US regulator approved the system for fixation of the shoulder, foot/ankle, knee, hand/wrist, and elbow, in different orthopaedic procedures.
OSSIO intends to initially roll out the 4.75mm implant system into the foot and ankle market, with plans to enter into the sports/shoulder markets later this year.
Orthopedic Foot and Ankle Centre founding partner and OSSIO chief medical officer Gregory Berlet is the first surgeon to use the company’s new implant in clinical practice.
Berlet said: “The new OSSIOfiber Suture Anchors provide amazing strength and biology that I trust to be predictable and safe for my patients.
“Utilising OSSIO’s trusted bio-integrative material, these anchors allow me to maintain my preferred technique for soft tissue fixation procedures while improving my results. This is another big step for OSSIOfiber in becoming a new material standard in orthopaedic fixation.”
OSSIO has designed the implants leveraging its OSSIOfiber Intelligent Bone Regeneration Technology, enabling them to leave no permanent remains behind.
They were made using a unique mineral fibre matrix, held together by a naturally degradable polymer, and with bio-integrative material properties, said the company.
In addition, OSSIO used its DURAlink Coupling Technology for the anchors to increase the stability and prevent suture slippage, creating a single stable unit.
The OSSIOfiber Suture Anchors were designed to provide superior strength and safety, and their US roll-out will expand access to its portfolio of bio-integrative implants, said the company.
OSSIO CEO Brian Verrier said: “Expanding our commercialized portfolio of OSSIOfiber implants, as well as patient access to additional bio-integrative solutions, is mission critical for the company’s continued success, and the launch of our suture anchors mark a significant milestone in that effort.
“Sports and extremity surgeons have been asking for non-permanent suture anchors that deliver improved strength and pull-out resistance, while providing safe, predictable bio-integration.
“OSSIOfiber Suture Anchors have shown strength that is unrivalled and safety that is unmatched in the market, as demonstrated by our bench testing and 30-month in-life studies compared to currently marketed bio-composite anchor controls.”