FREQUENTLY
ASKED
QUESTIONS
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The OrthoFuzIon™ Bone Screw System ,with our proprietary coating, is one of the first antimicrobial medical devices specifically designed for orthopedics.
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antiBacterIon® is Silver Bullets proprietary coating which features a blend of platinum and silver. The variable blend allows precise control of silvers elution rate and duration.
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OrthoFuzIon™ is pending approval from the FDA and is not currently for sale in the United States.
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Yes. OrthoFuzIon™ is approved by the SE and is for sale in Europe.
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There is a significant clinical need to prevent bacteria from contaminating medical devices.
Surgical site infections (SSIs) account for 20% of all healthcare-associated infections. While advances have been made in infection control practices, SSIs remain a substantial cause of morbidity, prolonged hospitalization, and mortality.
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Silver ions are highly effective in killing local bacteria, including antibiotic-resistant species, while simultaneously remaining non-toxic to humans (excluding extremely high dosage).
Platinum acts as a catalyst that enables the release of the silver ions.
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Yes. With 20+ dental implant patients to date, Silver Bullets antiBacterIon® coating has outperformed all other antimicrobial coatings in biofilm reduction.
In a clinical study with
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The coating needs to deliver antimicrobial activity immediately.
The coating cannot radically change how surgery is done - the “Fiddle" factor.
The coating needs to be patent protected.
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Yes. OrthoFuzIon™ Bone Screws are 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.
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Silver Bullets multi-step process ensures the coating can withstand abrasive forces and is resistant to flaking, bending, and cracking.
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In todays medical world, expensive products are often ignored. PMAs and De Novos require a new classification and established DRG reimbursements.
Silver Bullets antiBacterIon coating is a 510K and fits established classifications and reimbursed DRGs.
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Yes. Silver Bullet Therapeutics has 30+ patents.