Expanded CE Mark Positions Silver Bullet to Improve Patient Care in the EU and Disrupt Established Commercial Trauma Market
Silver Bullet Therapeutics, Inc., a privately-held medical device company, announced today that it has received recommendation for CE Mark approval for the commercial sale of its antimicrobial OrthoFuzIon™ Bone Screw System in the European Union for orthopedic reduction and internal fixation procedures anywhere in the body. Over the next few months, Silver Bullet will be finalizing launch plans with its prospective partners for selected European markets.
The OrthoFuzIon Orthopedic Bone Screw System is the world’s first regulatory-approved antimicrobial bone screw product for orthopedic procedures. The OrthoFuzIon System expands upon the previously approved cannulated screw system and now includes both solid and cannulated titanium bone screws. Bone screws are coated with the Silver Bullet Therapeutics proprietary coating, called AntiBacterIon™, to facilitate sustained silver ion release. The AntiBacterIon coating provides antimicrobial protection to an implanted device. Silver ions are deadly to all forms of bacteria locally, even antibiotic resistant species, yet non-toxic to humans except in extremely high doses. All OrthoFuzIon screws are implanted in the same manner as traditional bone screws to reduce and fixate a fracture. This new OrthoFuzIon CE Mark approval includes screws for use in orthopedic, spinal, dental and maxillofacial procedures.
Paul Chirico, President and CEO of Silver Bullet Therapeutics stated, "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."
"As surgeons we continue to develop more effective skill-based surgical approaches to better patient outcomes. However, device innovation has not kept up," noted Amir Matityahu, MD, an internationally renowned fellowship trained orthopedic trauma surgeon and Professor of Orthopaedic Surgery, University of California, San Francisco, Chairman of Surgery, Chief of Orthopaedics, and Director of Orthopedic Trauma, Regional Medical Center of San Jose, Fellow of the American Academy of Orthopedic Surgery and International Corresponding Member of the German Society for Orthopaedics and Trauma (Deutsche Gesellschaft für Orthopädie und Unfallchirurgie e V.). "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. Every day I have a patient at risk, I wish I had this implant."
Silver Bullet Therapeutics has built an extensive intellectual property portfolio that has allowed the company to develop and validate coating processes for a wide variety of metallic, polymer and electronic medical devices.
About Silver Bullet Therapeutics
Silver Bullet Therapeutics, Inc., located in San Jose, CA, has developed and patented antimicrobial coatings to address surgical-site and hospital-acquired infections by preventing microbial colonization of implanted medical devices. The Company’s first product, the OrthoFuzIon Bone Screw System, utilizes Silver Bullet Therapeutics proprietary blend of platinum and silver technology, called AntiBacterIon, that allows for rapid ionization of the silver and creation of an antimicrobial zone around a bone screw anywhere in the body. Silver Bullet Therapeutics has already developed and validated processes to allow coating of a wide range of devices including both metallic and polymer devices. OrthoFuzIon™ and AntiBacterIon™ are Trademarks of Silver Bullet Therapeutics, Inc. and is pending FDA clearance and is not yet approved for sale in the United States.