Extremities

OSSIO Launches World’s First and Only Non-Permanent Compression Staple

February 7, 2023

OSSIOfiber® Compression Staple Answers Surgeon, Patient Demand in Fastest Growing Product Category in Extremities

February 7, 2023

WOBURN, Mass.–(BUSINESS WIRE)– OSSIO, Inc., a fast-growing orthopedic fixation technology company, today announced the introduction of the new OSSIOfiber® Compression Staple, the next step towards becoming the gold standard in orthopedic fixation. OSSIO’s fifth product family, OSSIOfiber® Compression Staples, allow surgeons to evolve to stronger, bio-integrative compression.

Combined with OSSIO’s full line of bio-integrative orthopedic fixation products, OSSIOfiber® Compression Staples allow the company to provide solutions for many midfoot and hindfoot procedures including Lapidus fusions, midfoot fusions and procedures associated with flatfoot correction.

Like all OSSIO implants, OSSIOfiber® Compression Staples are made with OSSIOfiber® Intelligent Bone Regeneration Technology, a proprietary bio-integrative mineral fiber matrix, providing surgeons with a biologically friendly way to restore patient stability and mobility while leaving no permanent hardware behind. OSSIOfiber® provides the first credible solution to the shortcomings of permanent metal hardware and conventional resorbable and allograft implants, combining unparalleled mechanical strength and natural bone healing in a non-permanent implant.

Designed for predictable bone in-growth, regeneration, and replacement, OSSIOfiber® Intelligent Bone Regeneration Technology is a first-of-its-kind implant material stronger than cortical bone. OSSIOfiber® is engineered to provide the strength required for functional fixation and allows for full integration into the native anatomy without adverse biological response. OSSIOfiber® implants utilize existing reimbursement and surgical techniques.

OSSIO CEO Brian Verrier explained that at a time when patient education is exploding, the company recently introduced a direct-to-patient campaign that has already resulted in half a million patient visits to OSSIO’s website.

“The benefits of OSSIOfiber® are clear to both surgeons and patients, who prefer the bio-integrative technology and natural repair over metal and are demanding its use,” Verrier said. “OSSIO is excited to offer this additional product family so we can expand patient access to this technology.”

The first and only bio-integrative orthopedic compression staple in the world, OSSIOfiber® Compression Staples, received FDA 510(k) clearance in January 2022 for fixation of arthrodesis, osteotomies and fractures in hand or foot surgery in the presence of appropriate brace and/or immobilization.

OSSIOfiber® Compression Staples provide excellent stability and fixation, are stronger than many nitinol staples, and offer superior compression performance versus many widely used compression staples. With fatigue strength tested to over a million cycles, patients and surgeons can count on reliable strength that will last over time.

OSSIOfiber® Compression Staples leave nothing behind but healthy bone, helping patients to avoid surgical removal and enabling surgeons to see fusion take place with artifact-free imaging. Patients also avoid long-term implant prominence, a problem many people experience with hardware that lies on top of the bone. Unlike nitinol staples, which contain more than 50 percent nickel, OSSIOfiber® Compression Staples provide a nickel-free solution for metal sensitive patients.

Foot and ankle orthopedic surgeons Dr. Samuel Ford with OrthoCarolina and Dr. Selene Parekh of Rothman Orthopaedic Institute were among the first to use OSSIOfiber® Compression Staples commercially.

“OSSIOfiber® Compression Staples offer robust, compressive fixation, potentially improving upon the construct strength and fatigue resistance of nitinol. Unlike current metal staples on the market, OSSIOfiber® Staples do not introduce radiographic/CT scan interference and allow surgeons better postoperative visualization of the fusion site,” explained Dr. Ford, who used OSSIOfiber® Compression Staples while performing talonavicular/calcaneocuboid fusions.

“The introduction of staples made with OSSIO’s bio-integrative material addresses many of the inherent shortcomings of permanent nitinol implants, including the risks associated with secondary hardware removal surgery. This technology has the potential to move the needle even further for patients with degenerative foot and ankle pathology,” added Dr. Ford.

Dr. Parekh, who is renowned for utilizing state-of-the-art implants and techniques, used OSSIOfiber® Compression Staples while performing a metatarsophalangeal joint fusion.

“I used the staple for compression of a first MTP instead of a plate and it was fantastic,” said Dr. Parekh. “I love the fact that there is no metal blocking the view of the fusion site, and the compression and stability achieved just from the one staple was better than what I typically see for metal staples. By using a non-permanent implant, we restore patient mobility and stability through a natural healing process and patients avoid long-term implant prominence.”

About OSSIO

OSSIO is an orthopedic fixation company committed to transforming the orthopedic experience for patients, physicians, providers and payors. Founded in 2014, 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’s development headquarters is located in Caesarea, Israel, and its commercial headquarters is in Woburn, Massachusetts. For more information on the company click here.

Forward-looking statements contained herein are based on estimates and assumptions of OSSIO management and are believed to be reasonable, though they are inherently uncertain and difficult to predict.