SAN JOSE, Calif.--(BUSINESS WIRE)--Silver Bullet Therapeutics, Inc., a privately-held medical device company, announced today that it has received CE Mark approval for the commercial sale of its antimicrobial OrthoFuzIon™ Cannulated Bone Screw System for orthopedic reduction and internal fixation (ORIF) procedures in the European Union. Over the coming months, the company plans to launch the product to selected European markets.
The OrthoFuzIon Orthopedic Bone Screw System is the Company’s first commercial product and is the world’s first commercially available active antimicrobial device indicated for orthopedic reduction and fixation procedures. The OrthoFuzIon System consists of a platinum plated cannulated titanium bone screw and silver plated nitinol insert that fits into the inner lumen of the screw cannula. Implanted in the same manner as traditional bone screws and positioned to reduce and fixate a lower extremity fracture, the OrthoFuzIon bone screw galvanically produces silver ions, which actively reduce microbial contamination. In vitro testing of the OrthoFuzIon screw demonstrated bactericidal activity against MRSA and other common pathogens.
Post-operative infection remains the most concerning and costly complication following orthopedic fixation procedures, especially with traumatic injuries. A recent UK NHS publication stated, “In open fractures, infection may complicate up to 25% of cases producing an increasing challenge for orthopedic reconstruction services. Poor or delayed care in these cases will result in amputation with lifelong disability.”
Paul Chirico, President and CEO of Silver Bullet Therapeutics stated, “The most complex orthopedic reduction and fixation procedures also tend to be associated with higher incidences of wound contamination and associated infections. Our OrthoFuzIon active antimicrobial cannulated bone screw system is the first of its kind on the market and can reduce and/or eliminate contamination of the implanted fixation devices.”
“As a co-founder of Silver Bullet Therapeutics, we designed the OrthoFuzIon bone screw to meet the more challenging procedures that are associated with higher complications from more complex patient co-morbidities,” noted Bohdan Chopko, Ph.D., M.D., Silver Bullet Therapeutics Co-Founder and Associate Professor of Neurosurgery at Stanford University. “The OrthoFuzIon Cannulated Bone Screw System not only can reduce or eliminate microbial contamination on the inner and outer surface of the device, but the cannula insert increases resistance to pull-out forces relative to standard bone screws. Additionally, it has been tested to be MRI compatible.”
Mr. Chirico added, “Data presented at a recent US scientific meeting highlighted the fact that orthopedic surgical-site infections add an incremental $62k of cost to these cases. Hospital acquired infections are becoming a significant challenge to the healthcare system. MRSA alone has been estimated to cost the US healthcare system $34 billion a year and account for over 8 million additional and unnecessary hospital days. The cost burden of such infections is increasingly being shifted to hospitals, further heightening the awareness of the importance of reducing these complications.”
About Silver Bullet Therapeutics
Silver Bullet Therapeutics, Inc., a privately held company located in San Jose, CA, has developed and patented antimicrobial implants and medical devices to address surgical-site and hospital-acquired infections. The company’s first product, the OrthoFuzIon Cannulated Bone Screw, utilizes an advanced silver ion technology that allows for rapid ionization of the silver and creation of an antimicrobial zone around the screw to prevent microbial colonization of the implanted devices. OrthoFuzIon is a Trademark of Silver Bullet Therapeutics, Inc. and is not yet approved for sale in the United States.
* Presented Feb. 2013 at North American Skull Base Society Meeting, San Diego, CA by Vinod Sahney, Ph.D. (keynote)