OSSIO Inc.’s Distribution Deal With OrthoPediatrics Corp. Brings Bio-Integrative, Metal-Free OSSIOfiber® Implants to U.S. Children’s Hospitals Nationwide

Pediatric patients with bone fractures and skeletal deformities represent ideal use case for revolutionary orthopedic fixation technology by obviating need for secondary procedures to remove hardware

Solving for skeletal immaturity

TAMPA, Fla.--(BUSINESS WIRE)--In striking an exclusive distribution agreement with OrthoPediatrics Corp. announced today, OSSIO Inc. expands access to its revolutionary orthopedic fixation technology — bio-integrative, metal-free OSSIOfiber^® implants — to the approximately 400 U.S. children’s hospitals and care facilities whose orthopedic surgeons treat most pediatric patients admitted with bone fractures and skeletal deformities.

"It’s not often that kids need implants for broken bones, since most pediatric fractures can be treated without surgery,” said Dr. Jue Cao, M.D., a Denver-based orthopedic surgeon with specialty fellowship training in pediatric orthopedics, including hand surgery, and an Assistant Professor in the Department of Orthopedics at the University of Colorado School of Medicine and Children’s Hospital Colorado. “But when a child does need surgery, I sit down with them and their parents to explain the options.”

“We have two options for fixing your fracture: metal or no metal, I tell them. When a fracture is appropriate for a metal-free implant, that’s my preference. OSSIOfiber implants provide the stability the broken bone needs to heal while gradually being replaced by the child’s own new bone. One of the biggest advantages of these bio-integrative implants is what doesn’t have to happen during recovery. Because there’s no metal involved, many children can avoid a second surgery to remove hardware. The implant is gradually incorporated into the healing bone, allowing kids to focus on getting back to being kids instead of another operation.”

Conservative estimates of annual hospitalizations for pediatric patients requiring surgical treatment of bone fractures coalesce at upwards of 150,000 cases.

Based on a revolution in biomaterial science, OSSIOfiber implants are gradually incorporated into the patient’s bone after performing their fixation function, leaving nothing permanent behind after about two years post-implantation. This advance in orthopedic fixation technology obviates the need for the hardware removal surgeries that pediatric patients who initially receive metal implants usually require due to their skeletal immaturity.

“Partnering with OrthoPediatrics — the gold standard in pediatric orthopedics — is a natural fit for us,” said Brennan Marilla, OSSIO Chief Commercial & Operating Officer. “The deep relationships they have with the country’s leading children’s hospitals and pediatric-focused orthopedic surgeons will accelerate adoption of OSSIOfiber implants, a fixation technology ideally suited to kids that offers obvious benefits to patients of all ages, adults included. Our FDA-cleared technology has already demonstrated remarkable results across a variety of orthopedic surgeries, including pediatric trauma and reconstructive cases.”

Unlike traditional metal implants that remain in the body permanently, OSSIOfiber implants are made from a proprietary blend of natural mineral fibers that integrate with newly formed bone surrounding the fracture. They provide initial fixation strength comparable to traditional metal implants while safely and completely integrating into the patient’s own bone tissue within 18–24 months, leaving no foreign material behind. More specifically, OSSIOfiber implants transform orthopedic fixation because they are designed to:

• Eliminate second surgeries. Traditional metal fixation implants sometimes require removal in a second surgery, adding risk, cost, pain and anxiety to patients and caregivers alike. (For pediatric patients, these hardware removal surgeries are common.) By contrast, OSSIOfiber implants don’t need to be removed because their proprietary mineral fiber matrix enables rapid bone in-growth, regeneration and replacement — a new way to restore patients’ stability and mobility without metal.
• Support natural osteogenesis. Following fixation, the body naturally forms new bone tissue around the surgical site. Absent metal, OSSIOfiber implants accommodate natural bone healing, an ideal solution (especially for skeletally immature patients whose bones are still developing).
• Reduce long-term complications. Permanent metal implants create a variety of risks, including allergic reactions, stress shielding and ion toxicity, as well as hardware corrosion, incarceration and overgrowth. OSSIOfiber implants avoid these risks by design.
• Afford peace of mind. Metal hardware understandably worries many patients, as well as their families and physicians because of the inherent drawbacks associated with them. (This concern is common among pediatric patients and their parents.) By contrast, OSSIOfiber implants inspire comfort and confidence by allowing for natural healing.

The OSSIOfiber portfolio includes compression screws, nails, anchors and other fixation devices cleared by the U.S. Food and Drug Administration (FDA) for use in patients as young as two years old for alignment and fixation of fractures, osteotomies, arthrodesis and bone grafts, as well as soft tissue fixation to bone. Through June 2026, nearly 100,000 OSSIOfiber implants have been used since their debut in 2019.

Focused exclusively on advancing the field of pediatric orthopedics, OrthoPediatrics Corp. offers the most comprehensive product offering to improve the lives of children with orthopedic conditions. Founded in 2006, the company currently markets nearly 90 systems that serve three of the largest categories within the pediatric orthopedic market, including trauma and deformity, scoliosis and sports medicine.

About OSSIO

OSSIO Inc. is an orthopedic medical technology platform company committed to transforming the surgical experience for patients, physicians, providers and payors. Founded in 2014, the company’s vision is to provide the first credible replacement for metal implants in the multibillion-dollar global orthopedic fixation market with OSSIOfiber Intelligent Bone Regeneration Technology. OSSIO conducts product development in Caesarea, Israel, and commercial operations from Palmetto, Fla. and Woburn, Mass. For more information about the company and OSSIOfiber implants, visit www.ossio.io.

Disclaimer: Forward-looking statements in this news release are based on estimates and assumptions of OSSIO management and are believed to be reasonable, though they are inherently uncertain and difficult to predict.