Expansion of the CE mark positioning silver bullet to improve patient care in the EU and disrupt the established commercial trauma market

San Jose, California--(BUSINESS WIRE)--Silver Bullet Therapeutics, Inc., a private medical device company, today announced that the commercial sales of its antibacterial OrthoFuzIon™ bone screws have received CE mark approval from the European Union. The system is used for orthopedic reduction and internal fixation procedures of any part of the body. In the next few months, Silver Bullet and its potential partners will finalize a release plan for selected European markets.

The OrthoFuzIon orthopedic bone screw system is the world's first antibacterial bone screw product for orthopedic surgery that has received regulatory approval. The OrthoFuzIon system extends the previously approved hollow screw system and now includes solid and hollow titanium screws. The bone screws are coated with a proprietary Silver Bullet Therapeutics coating called AntiBacterIon™ to promote sustained release of silver ions. AntiBacterIon coating provides antibacterial protection for implanted devices. Silver ions are deadly to all forms of local bacteria, even species resistant to antibiotics, but apart from extremely high doses, they are non-toxic to humans. All OrthoFuzIon screws are implanted in the same way as traditional bone screws to reduce and fix fractures. This new OrthoFuzIon CE mark certification includes screws for orthopedics, spine, dentistry and maxillofacial surgery.

Paul Chirico, President and CEO of Silver Bullet Therapeutics, said: “Silver Bullet is committed to improving patient care. By focusing on controlling our manufacturing process and costs, the OrthoFuzIon bone screw system can be offered at the same price as other manufacturers’ traditional titanium screws This pricing flexibility will allow us to actively penetrate and disrupt the EU trauma market, which is estimated to exceed US$2 billion. In addition, the economic pressures associated with patient readmission fees should further promote interest in OrthoFuzIon’s unique features. Our goal is to eliminate Cost is a key obstacle to rapid adoption and accelerates the replacement of existing bare metal bone screw systems."

“As a surgeon, we continue to develop more effective skills-based surgical methods to improve patient treatment outcomes. However, equipment innovations have not kept up,” noted Amir Matityahu, MD, who was trained by an internationally renowned scholarship Orthopaedic trauma surgeon and professor of orthopedics at the University of California, San Francisco, chair of surgery, director of orthopedics and director of orthopedic trauma, San Jose Regional Medical Center, Fellow of the American Academy of Orthopaedic Surgery, German Orthopedics and Trauma Society (Deutsche Gesellschaft für Orthopädie und Unfallchirurgie e V.) International Correspondence member. "The OrthoFuzIon bone screw system is a revolutionary device that kills bacteria locally. This is an unsolved problem with previously available implants. The safety of low-dose silver and platinum has been fully proven, which will enable The OrthoFuzIon system can be quickly adopted and may result in covering other surgical implants with AntiBacterIon coating. Every day I have a patient at risk and I wish I had this implant."

Silver Bullet Therapeutics has established an extensive intellectual property portfolio that enables the company to develop and validate coating processes for various metals, polymers, and electronic medical devices.

Silver Bullet Therapeutics, Inc., located in San Jose, California, has developed and patented antimicrobial coatings to solve surgical site and hospital-acquired infections by preventing microbial colonization of implanted medical devices. The company's first product, OrthoFuzIon bone screw system, uses Silver Bullet Therapeutics' proprietary platinum and silver technology, called AntiBacterIon, which rapidly ionizes silver and forms an antibacterial area around bone screws in any part of the body. Silver Bullet Therapeutics has developed and validated processes that can coat various equipment including metal and polymer equipment. OrthoFuzIon™ and AntiBacterIon™ are trademarks of Silver Bullet Therapeutics, Inc. and are awaiting FDA approval and have not yet been approved for sale in the United States.

Paul Chirico (408) 436-7500 pchirico@svbtx.com www.svbtx.com

Paul Chirico (408) 436-7500 pchirico@svbtx.com www.svbtx.com