Silver Bullet Therapeutics received CE Mark approval for the antimicrobial OrthoFuzIon™ Bone Screw System for reduction and internal fixation procedures anywhere in the body.
OrthoFuzIon is reportedly the first regulatory-approved antimicrobial bone screw product for orthopedic procedures. Following its initial CE Mark approval in 2015, the system now includes both solid and cannulated titanium bone screws with proprietary AntiBacterIon™ coating to facilitate sustained silver ion release, which provides antimicrobial protection to an implanted device. All OrthoFuzIon screws are implanted in the same manner as traditional bone screws to reduce and fixate a fracture. This new approval includes screws for use in orthopedic, spinal, dental and maxillofacial procedures.
Paul Chirico, President and CEO of Silver Bullet Therapeutics, said, “Silver Bullet is committed to improved patient care. By focusing on control of our manufacturing processes and costs, the OrthoFuzIon Bone Screw System can be made available at the same price as other manufacturers’ traditional titanium screws. This pricing flexibility will allow us to aggressively penetrate and disrupt the EU trauma market, estimated to be greater than $2 billion. Additionally, economic pressures associated with patient readmission charges should further drive interest in OrthoFuzIon’s unique capabilities. Our goal is to remove cost as a key barrier to rapid adoption and to accelerate the replacement of existing bare metal bone screw systems.”
The company's intellectual property portfolio has allowed for development and validation of coating processes for a wide variety of metallic, polymer and electronic medical devices.
Launch in select European markets will begin within coming months.