OSSIOfiberTM Intelligent Bone Regeneration Technology
A True Breakthrough in Orthopedic Fixation
Designed for rapid bone in-growth, regeneration and replacement, OSSIOfiber™ is a first-of-its-kind implant material stronger than cortical bone that leaves nothing permanent behind.
OSSIO aims to provide the first credible replacement to permanent implants. Metal implants can cause unwanted removal surgeries, associated complications, and an unnatural healing environment for patients, and, until now, the industry has fallen short on developing a fixation material that is both strong and bio-friendly. There have been many attempts to fabricate implants from various bioresorbable polymers, but those devices have not provided the required mechanical strength or optimal degradation profiles avoiding burst releases of acidic by-products and inflammation. OSSIOfiber™ Intelligent Bone Regeneration Technology is engineered to provide the strength required for functional fixation and allows for full integration into the native anatomy without adverse inflammation. This proprietary technology can address many surgical applications through manufacturing of endless implant designs. In addition, OSSIOfiber™ implants utilize existing reimbursement and surgical techniques.
“…a first-of-its-kind implant material stronger than cortical bone that leaves nothing permanent behind.”
Proven Materials Engineered into a Unique, Bio-Integrative Platform
A unique combination of natural mineral fibers and bioresorbable polymer
Fibers are composed of minerals naturally found in bones. These mineral fibers (also referred to as bioactive glass) have been in clinical use for over 30 years, most commonly as osteoconductive bone void fillers.
Engineered into a proprietary high performing matrix, the reinforcing fibers contribute to excellent, customized mechanical properties. Each fiber is approximately 2-3x thinner than one human hair. Thousands of continuous fibers are combined in each OSSIOfiber™ implant.
The bioabsorbable polymer resin (PLDLA) binds the fiber matrix together into a cohesive material. PLDLA has over 30 years of clinical success and can be gradually and naturally cleared by the body. The polymer in OSSIOfiber™ is virtually eliminated by 78 weeks post-implantation, as shown in pre-clinical studies.
Unprecedented Combination of Strength & Bio-Friendliness
Metal-like strength with bio-integrative material
OSSIOfiber™ is bio-integrative, by fully incorporating into native anatomy without adverse inflammation, and strong, by providing the needed load-bearing fixation strength like metal.
OSSIOfiber™ provides the necessary load-bearing fixation strength like metal. At the time of surgery, OSSIOfiber™ implants provide secure fixation without requiring any changes to surgeons’ existing techniques. Initially, the mechanical strength of OSSIOfiber™ is 1.5x that of cortical bone, and its performance supports the bone throughout the healing process. OSSIOfiber™ then gradually transfers load to the native bone after the critical rehabilitation phase. Unlike metal, the stiffness of OSSIOfiber™ is a better match to cortical bone and this improved bone compliance can prevent stress risers and weakening of the bone around the implant. OSSIOfiber™ outperforms other implant materials, such as PEEK, with 3x greater flexural strength. Integration into the surrounding anatomy takes place within ~18-24 months, leaving only native bone behind with no residual hardware or associated permanent implant complications.
OSSIOfiber™ provides necessary load-bearing strength throughout healing process
Data on File at OSSIO.
OSSIOfiber™ fully incorporates into the native anatomy without adverse inflammation, local osteolysis, cyst formation, or fibrotic encapsulation, as proven in pre-clinical studies. OSSIOfiber™ does not require secondary implant removal operations for patients after the rehabilitation process. Only nature remains.
Pre-clinical animal study performance: OSSIOfiber™ Pin v Bioresorbable Pin (Control)
Histology images from pre-clinical animal studies (in-bone implantation in rabbit femurs).Data on File at OSSIO.
Behind the Magic of OSSIOfiber™
OSSIOfiber™ is built on 4 critical elements providing advantages over other implant materials
regeneration and replacement
Who We Are
OSSIO is an orthopedic fixation company committed to transforming the orthopedic experience for patients, physicians, and payors. Our vision is to provide the first credible replacement to metal implants in the $10B+ orthopedic fixation market (screws, pins, plates) with an Intelligent Bone Regeneration Technology. OSSIOfiber™ represents a breakthrough material platform for orthopedic and podiatric surgeons who seek a more biologically friendly way to restore patient stability and mobility with nothing permanent left behind.
Founded in 2014, OSSIO began as the culmination of years of biomechanical research and a vision for the possibility of better bone healing. The technological basis of OSSIOfiber™ was developed and would lay the groundwork for ushering in a new breakthrough category of non-permanent fixation, “Bio-Integratives” hardware that has both desired strength AND bio-friendliness. Hardware that has the mechanical strength for easy insertion and secure fixation, while enabling the body to regrow bone, incorporating and replacing the implant (without the adverse inflammation and weakness often seen in “bio-resorbables” and other “bio-composites”), has remained elusive to the industry until now.
OSSIO strives to become THE gold standard in orthopedic fixation by encouraging natural bone healing that will ultimately eliminate hardware removal procedures, minimize implant-related complications, alleviate pain, and dramatically improve the healthcare economics of orthopedics.
OSSIO has its development headquarters in Caesarea, Israel and its commercial headquarters in Boston, Massachusetts.
Leadership, Innovation, and Experience
Moshe Shneor, CPA, MBA
Taly Lindner, PhD
Ronit Merchav-Feuermann, DVM
Board of Directors
Sanket S. Parekh
Kerry Assil, MD
Click below to explore OSSIO press releases and recent news articles written about OSSIOfiber™ Intelligent Bone Regeneration Technology.
OSSIO, an orthopedic fixation company, today announced that its OSSIOfiberTM Bone Pin Family has received 510(k) market clearance from the U.S. Food and Drug Administration (FDA).
In the News
A new class of bio-integrative implants’: Dr. Stuart Miller on orthobiologics and implant selection.
FDA CLEARS OSSIO’S BIO-INTEGRATIVE BONE FIXATION IMPLANT
Ortho dev Ossio wins FDA nod for bio-integrative bone pins
FDA clears absorbable foot and ankle implant
Biointegrative orthopedic fixation material receives FDA clearance: 5 things to know
FDA clears Ossio’s integrative mineral bone pins for orthopedic surgeries
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