Silver Bullet Therapeutics Receives FDA Approval of Pre-Market Study

Silver Bullet Therapeutics, Inc., a privately held medical device company, has received FDA approval to start a pre-market 510k study. 

The OrthoFuzIon Orthopedic System is a comprehensive antimicrobial coating technology. The first application is on a bone screw product line for orthopedic procedures. 

The FDA-approved pre-market study is titled, “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,” and is designed to objectively evaluate the impact of the OrthoFuzIon System on orthopedic healing in support of the Silver Bullet’s 510k filing.

The OrthoFuzIon Bone Screws are approved for commercialization in the EU and is indicated for open reduction and internal fixation (ORIF) fracture surgeries. The screws 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. 

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.”

Silver Bullet Therapeutics has also partnered with Merge Medical, a community of physicians passionate about the business of medicine, innovation, and startup investing. Both co-founders of Merge Medical, Jeffrey Cole, MD, and Jeffrey Brown, DO have joined the Scientific Advisory Board of Silver Bullet Therapeutics.

Silver Bullet Therapeutics and Merge Medical are collaborating with healthcare startup Pitch Sink 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.

“Our partnerships feel like a force multiplier,” said Dr. Cole. “Pitch Sink has captured the attention of some of the largest innovation groups in the U.S., amplifying our reach and allowing us to share incredible stories. Orthopedics hasn’t seen many truly transformative advances in recent decades beyond locking screws. When we encountered Silver Bullet Therapeutics’ breakthrough technology, we knew this was the kind of company we wanted to support.”