November 03, 2016
SAN JOSE, Calif.–(BUSINESS WIRE)–Silver Bullet Therapeutics, Inc., a privately held medical device company that has developed an antimicrobial technology for implantable medical devices such as orthopedic bone screws, reported today the results of a study testing the “Time Kill” and “Adherence” effectiveness of its CE-marked OrthoFuzIon® Antimicrobial Bone Screw against the Top Six CDC Antibiotic-Resistant “Superbugs.”1 The study was performed by Emery Pharma, which is a certified, third party testing laboratory. The study consisted of testing a number of the OrthoFuzIon antimicrobial screws against traditional uncoated titanium screws as a control. The organisms tested in-house and by Emery Pharma form the Top Six antibiotic resistant “superbugs” that include: Carbapenem-resistant Enterobacteriaceae (CRE); Klebsiella pneumoniae; Methicillin-resistant Staphylococcus aureus (MRSA); ESBL-producing Enterobacteriaceae (extended-spectrum β-lactamases); Escherichia coli (E. coli); Vancomycin-resistant Enterococcus (VRE); Enterococcus faecium; Multidrug-resistant Pseudomonas aeruginosa; and Multidrug-resistant Acinetobacter baumannii.
“Our OrthoFuzIon coating creates a galvanic zone of bacterial inhibition surrounding the implanted screw within the body,” said founder, President and CEO Paul Chirico. “This is particularly important as the concern, costs and responsibility related to device-contaminations rise.”
“Medical device infections can be costly, cause increased morbidity and lead to device failure,” said Prity S. Vaidya, M.D., an infectious disease specialist. “These microbiology test results using the OrthoFuzIon device are very encouraging considering the type of organisms tested against.”
“Adherence” testing indicated the ability of an OrthoFuzIon device to penetrate bacterial biofilm. Biofilms are formed by many species of bacteria for cell adherence and protection. By creating biofilms, bacteria can form colonies almost anywhere, including in the human body and on implanted medical devices. Biofilms produced by bacteria render most currently available antibiotics ineffective by creating a “shield” through which antibiotics cannot penetrate. This test demonstrated that the OrthoFuzIon Antimicrobial Bone Screw was able to significantly disrupt the development of biofilm.
“We conduct antimicrobial testing on different devices and technologies,” said Ron Najafi, Ph.D., President and CEO of Emery Pharma Services. “We were most impressed by the ‘adherence’ results for the OrthoFuzIon device against the top six antibiotic resistant pathogens that are commonly implicated in hospital-acquired infections. The results of OrthoFuzlon preventing these pathogens from adhering to them were simply impressive.”
OrthoFuzIon is one of the first antimicrobial implantable medical devices designed specifically for orthopedics. The proprietary Silver Bullet coating applied to OrthoFuzIon causes a “galvanic” reaction wherein the silver component ionizes, creating a localized “cloud” of silver ions that surrounds the implanted device and that acts as a deterrent to bacterial colonization.
About Silver Bullet Therapeutics
Silver Bullet Therapeutics, Inc., a privately held company located in San Jose, Calif., has developed and patented antimicrobial coating processes as well as implants and medical devices to address surgical-site infections (SSIs) and hospital-acquired infections (HAIs). The company’s first commercial product, the OrthoFuzIon Bone Screw System, utilizes an advanced silver ion technology that allows for rapid and sustained 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 currently approved for sale only in the European Union.
About Emery Pharma
Emery Pharma (http://emerypharma.com) is a full-service contract research laboratory, specializing in analytical, bioanalytical, microbiology, cell biology testing and medicinal chemistry support. Emery Pharma supports a wide range of companies from startups consisting of a single scientist, to large multinational and national laboratories. Emery Pharma operates as an extension of its clients’ R&D department. Emery Pharma engages top-level Ph.D. and M.S. scientists to streamline and optimize clients’ projects in Pharma, Biotech, Cleantech, Agrochem and many other industries.
Silver Bullet Therapeutics, Inc.
Ronald Trahan, 508-359-4005, x108