US-based medical device company Silver Bullet Therapeutics has secured CE Mark approval for the commercial sale of its antimicrobial bone screw system in the European Union (EU).
The OrthoFuzIon bone screw system is used for orthopaedic reduction and internal fixation procedures anywhere in the body.
It system leverages the company’s proprietary blend of platinum and silver technology, AntiBacterIon.
Silver ions are deadly to all forms of bacteria locally, even antibiotic-resistant species, yet non-toxic to humans except in extremely high doses. AntiBacterIon coating offers antimicrobial protection to an implanted device.
The company stated that the product expands upon earlier approved cannulated screw system, now comprising solid and cannulated titanium bone screws.
Silver Bullet Therapeutics added that all OrthoFuzIon screws are implanted in the same manner as traditional bone screws to reduce and fixate a fracture.
Silver Bullet Therapeutics president and CEO Paul Chirico 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 $2bn.
“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.”
OrthoFuzIon CE Mark approval includes screws for use in orthopaedic, spinal, dental and maxillofacial procedures.
University of California Orthopaedic Surgery professor Amir Matityahu said: “The OrthoFuzIon Bone Screw System is a revolutionary device that kills bacteria locally.
“This is a problem that has not been solved with previously available implants. The well-proven safety of silver and platinum in low doses will allow the OrthoFuzIon System to be adopted rapidly and may lead to covering other surgical implants with the AntiBacterIon coating.”
Silver Bullet said that it is in the process of is finalising launch plans with its potential partners for selected European markets.