Bio-Gate AG: First Comparative Clinical Data On Hyprotecttm In Trauma Care-Significantly Higher Treatment Success Rate For Infected, Non-Healed Femur Fractures

• Direct clinical comparison of HyProtectTM-coated versus uncoated osteosynthesis implants
• Treatment success at 12 months: 100 percent success in the group coated with Bio-Gate's HyProtectTM technology versus 61 percent in the control group
• Significantly lower inpatient treatment costs, by around 31 percent. Published in the peer-reviewed journal Injury (Elsevier)

• No patient with a HyProtectTM-coated implant suffered a recurrent infection or recurrent pseudarthrosis within twelve months (in no case did bone healing fail).
• The treatment success rate was 100 percent compared to 61.3 percent in the control group.
• In the control group, 20.9 percent of patients had a recurrent infection at twelve months and 12.9 percent showed failure of bony consolidation (bone healing). Over the entire observation period these figures rose to 24.2 and 22.5 percent respectively. Five treatments were ultimately classified as failed.
• The baseline situation in the HyProtectTM coated group was less favorable: All patients had complex fractures (100 percent compared to 54.8 percent in the control group), and multidrug-resistant or difficult-to-treat pathogens were detected in 75 percent of them.
• Patient-reported quality of life (EQ-VAS) improved significantly in the coated group compared to the preoperative baseline.

Context: Why the Severity of Fractures Matters

Fracture-related infections (FRI) are not evenly distributed across all bone fractures. The risk of FRI increases with the severity of the injury and the amount of energy involved: Following simple, closed fractures, the infection rate is in the low single-digit percentage range, whereas following high-energy open fractures of long bones, it reaches up to 42 percent. It is precisely this high-risk profile that characterizes the coated group in the published study: All patients had the most complex type of fracture, half had open fractures, and just under two-thirds had multiple traumata.

An international group of experts led by Metsemakers describes fracture-associated infections in The Lancet Infectious Diseases as a complication with significant clinical and socioeconomic consequences, the global extent of which has not yet been adequately documented. The group calls for giving this condition higher priority in research and clinical care, standardizing treatment protocols, and providing appropriate compensation for the substantial personnel and infrastructure resources required (Metsemakers WJ, Moriarty TF, Morgenstern M, et al. The global burden of fracture-related infection: can we do better? Lancet Infect Dis. 2024;24(6):e386–e393. doi: 10.1016/S1473-3099(23)00503-0). Against this backdrop, the lower complication rate observed in the study and the inpatient treatment costs that are approximately 31 percent lower are also of interest from a health economics perspective.

Economic Outcomes

The cumulative DRG costs for inpatient care in the coated group, at 33,886 euros, were significantly lower than those in the control group, at 48,937 euros-a difference of approximately 31 percent. The publication attributes this to the markedly lower complication rate. Length of stay and the number of surgeries were also lower in the coated group, without reaching statistical significance.

Tolerability

A single HyProtectTM implant contains about half a milligram of silver. The publication puts this at about a thousand times less than in conventional silver-coated megaprostheses for cancer patients. Only very small amounts of silver were detected in the patients' blood, and at the last follow-up examination, all levels had returned to the normal range. The grayish discoloration of the skin (argyria) associated with high silver levels did not occur in any patient.

Note on the study

This release reports the results of a scientific publication produced independently of Bio-Gate. REFECT is an investigator-initiated trial. The sponsor is the treating hospital, not Bio-Gate. Neither the hospital nor the authors of the study were involved in this release or authorized it. Bio-Gate coated the implants used in the study and supplied the characteristics of the coating. The company was not involved in the design, conduct or analysis of the study.

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About Bio-Gate AG

The medical technology company Bio-Gate AG develops and markets applications which use unique silver technology to help prevent infections and thus to improve health. Bio-Gate AG's specialty is using pure silver to treat materials and surfaces that are used in all areas of daily life – thus providing long-term and medically effective protection against bacteria, microorganisms and other pathogens. Bio-Gate AG works in three fields to supply a variety of products that provide antimicrobial protection: material enhancement, surface coating and testing the antimicrobial or anti-adhesive properties of materials. The Nuremberg-based company offers systems that stretch across the entire value-adding chain, from development to approval to production. For more information, please visit.

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