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Silver Bullet Therapeutics has FDA approval to start a premarket 510(k) study of the OrthoFuzIon Orthopedic System.
OrthoFuzIon is a comprehensive antimicrobial coating technology, with an initial application that encompasses bone screws for orthopedic procedures. In the EU, OrthoFuzIon screws are approved for commercialization and indicated for open reduction and internal fixation, and are plated to inhibit microbial colonization and reduce implant-related infection in revision surgery due to implant infection or primary surgery in patients who are at-risk of implant infections.
The FDA-approved premarket study, “Non-Inferiority Study of the Silver-Platinum Coated OrthoFuzIon Bone Screw System Against the Literature Related to Union/Non-Union Incidence on Lateral Malleolus Fractures (AO Classification 44A-44C) on Patients > 55 Years Old with a Co-Morbidity,” is designed to objectively evaluate the impact of silver and OrthoFuzIon on orthopedic healing in support of the company’s 510(k) filing.
Paul Chirico, President and CEO of Silver Bullet Therapeutics stated, “Silver Bullet has worked with the FDA for years to evaluate this technology. This is the first study for a permanent antimicrobial orthopedic implant. This is not only a major milestone for the practice of orthopedics but will provide clinically useful information and products in a relatively short period.” Mr. Chirico added, “We are also pleased with the EU distributors we have evaluated that understand the significant strategic advantage to capturing long-term tenders against larger corporations with the only antimicrobial bone screw system in the world.”
Additionally, the company is pleased to announce a partnership with Merge Medical, a community of physicians passionate about the business of medicine, innovation, and startup investing. Together with Silver Bullet Therapeutics, Merge Medical is collaborating with healthcare startup Pitch Sink (pitchsink.com) to build an ecosystem featuring an on-demand talent-matching marketplace for MedTech innovators, supported by a vibrant network of physician advisors, investors and key opinion leaders.
Source: Silver Bullet Therapeutics
Silver Bullet Therapeutics has FDA approval to start a premarket 510(k) study of the OrthoFuzIon Orthopedic System.
OrthoFuzIon is a comprehensive antimicrobial coating technology, with an initial application that encompasses bone screws for orthopedic procedures. In the EU, OrthoFuzIon screws are approved for commercialization and indicated...
Silver Bullet Therapeutics has FDA approval to start a premarket 510(k) study of the OrthoFuzIon Orthopedic System.
OrthoFuzIon is a comprehensive antimicrobial coating technology, with an initial application that encompasses bone screws for orthopedic procedures. In the EU, OrthoFuzIon screws are approved for commercialization and indicated for open reduction and internal fixation, and are plated to inhibit microbial colonization and reduce implant-related infection in revision surgery due to implant infection or primary surgery in patients who are at-risk of implant infections.
The FDA-approved premarket study, “Non-Inferiority Study of the Silver-Platinum Coated OrthoFuzIon Bone Screw System Against the Literature Related to Union/Non-Union Incidence on Lateral Malleolus Fractures (AO Classification 44A-44C) on Patients > 55 Years Old with a Co-Morbidity,” is designed to objectively evaluate the impact of silver and OrthoFuzIon on orthopedic healing in support of the company’s 510(k) filing.
Paul Chirico, President and CEO of Silver Bullet Therapeutics stated, “Silver Bullet has worked with the FDA for years to evaluate this technology. This is the first study for a permanent antimicrobial orthopedic implant. This is not only a major milestone for the practice of orthopedics but will provide clinically useful information and products in a relatively short period.” Mr. Chirico added, “We are also pleased with the EU distributors we have evaluated that understand the significant strategic advantage to capturing long-term tenders against larger corporations with the only antimicrobial bone screw system in the world.”
Additionally, the company is pleased to announce a partnership with Merge Medical, a community of physicians passionate about the business of medicine, innovation, and startup investing. Together with Silver Bullet Therapeutics, Merge Medical is collaborating with healthcare startup Pitch Sink (pitchsink.com) to build an ecosystem featuring an on-demand talent-matching marketplace for MedTech innovators, supported by a vibrant network of physician advisors, investors and key opinion leaders.
Source: Silver Bullet Therapeutics
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Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.
