Cision PR Newswire
Silver Bullet Therapeutics Announces FDA Approval of Pre-Market Study
Company Provides Update on Operations & EU Commercialization
SAN JOSE, Calif., Jan. 15, 2025 /PRNewswire/ -- Silver Bullet Therapeutics, Inc., a privately-held medical device company, announced today that the Company now has approval to start a pre-market 510k study from the FDA. In addition, Silver Bullet Therapeutics is pleased to have formed a partnership with Merge Medical and will be featured in a podcast scheduled for broadcast March 2nd, 2025. Jeffrey Cole, MD and Jeffrey Brown, DO will also join their Scientific Advisory Board.
The OrthoFuzIon™ Orthopedic System is a comprehensive antimicrobial coating technology. The first application is on a bone screw product line for orthopedic procedures. In the EU, the OrthoFuzIon Bone Screws are now approved for commercialization and indicated for open reduction and internal fixation (ORIF) fracture surgeries 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. Such infections often require reoperation and add significant costs which the hospital must often absorb.
The FDA approved pre-market study 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," is designed to objectively evaluate the impact of silver and OrthoFuzIon on orthopedic healing in support of the Company's 510k 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 (mergemedical.org), 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.
"We are very excited about our partnership with Silver Bullet," states Dr. Jeff Cole. "Their technology has the potential to make a significant global impact in preventing orthopedic implant infections."
Dr. Jeff Brown, co-founder of Merge Medical and host of the Merge Medical Startup Podcast, shared, "We had a great time learning more about Silver Bullet. We look forward to releasing their podcast episode before the orthopedic academy meeting in March and introducing them to physicians and medical device executives within our network."
"Our partnerships feel like a force multiplier," adds 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."
Both co-founders of Merge Medical have joined the Scientific Advisory Board of Silver Bullet Therapeutics. The Merge Medical podcast featuring Paul Chirico and Silver Bullet Therapeutics is scheduled to air on March 2, 2025, and will be available at mergemedical.org and on YouTube (@mergemedical/podcasts).
Silver Bullet Therapeutics was also pleased to announce the in vivo biofilm publication titled, "Biofilm formation on metal alloys and coatings, zirconia, and hydroxyapatite as implant materials in vivo" that was born out of the R&D relationship with Straumann. It stated, "In conclusion, all noble alloys showed benefits concerning plaque accumulation and bacterial viability with AgPt [Silver Bullet Therapeutics AntiBacterIon™] as the most promising alloy followed by AgAuPd and PA."
Silver Bullet Therapeutics has built an extensive intellectual property portfolio that has allowed the company to develop and validate coating processes for a wide variety of metallic, polymer, and electronic medical devices.
About Silver Bullet Therapeutics
Silver Bullet Therapeutics, Inc., located in San Jose, CA, has developed and patented antimicrobial coatings to address surgical-site and hospital-acquired infections by preventing microbial colonization of implanted medical devices. The Company's first product, the OrthoFuzIon Bone Screw System, utilizes Silver Bullet Therapeutics proprietary blend of platinum and silver technology, called AntiBacterIon, that allows for rapid ionization of silver and creation of an antimicrobial zone around a bone screw anywhere in the body. Silver Bullet Therapeutics has already developed and validated processes to allow coating of a wide range of devices including both metallic and polymer devices. OrthoFuzIon™ and AntiBacterIon™ are Trademarks of Silver Bullet Therapeutics, Inc. and is pending FDA clearance and not yet approved for sale in the United States.
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SOURCE Silver Bullet Therapeutics
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