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Bio-Gate provided an update on the clinical development status of the HyProtect coating for orthopedic implants. Following the completion of the pilot phase, the comprehensive main clinical trial has now commenced. The project – conducted in collaboration with a project partner and initially announced in December 2024 – is on track to reach the next milestone toward CE approval of HyProtect™-coated revision implants.
The pilot phase of the study (Part A) was initiated as a safety assessment of the HyProtect-coated investigational devices in a small number of patients. In Part B, over 200 additional patients will be enrolled across 10 study centers in Germany, Poland, and Spain.
To the study authors’ knowledge, HIPrevision is the first randomized controlled superiority trial worldwide to investigate the clinical efficacy of a silver-coated versus an uncoated hip revision implant system in the treatment of periprosthetic joint infections (PJI). The primary endpoint is the infection rate 12 months after revision surgery
The assumption underlying the HIPrevision study – namely, a reduction in the reinfection rate – is based, among other things, on existing clinical experience with the HyProtect technology. Over the past decade, more than 170 high-risk patients worldwide have been treated with HyProtect-coated orthopedic and trauma implants – as part of customized special-order devices, therapeutic trials, and compassionate use programs in Europe, North America, and the Asia-Pacific region. The patients treated were predominantly those with multiple prior surgeries due to infection, severe comorbidities, or tumor diseases – patient groups in which reinfection rates are significantly elevated according to scientific studies and which can exceed a 50% reinfection in cases of repeated septic revisions.
The (re)infection rate documented in this high-risk population following HyProtect application was reported to be between 2.6% and 6.4%. Sixteen of the treatments were scientifically analyzed in eight peer-reviewed journal articles.
This real-world data – together with preclinical animal and in vitro studies – are taken into account in the HIPrevision study when deriving the underlying assumption of a reduction in periprosthetic re-infections.
Source: Bio-Gate AG
Bio-Gate provided an update on the clinical development status of the HyProtect coating for orthopedic implants. Following the completion of the pilot phase, the comprehensive main clinical trial has now commenced. The project – conducted in collaboration with a project partner and initially announced in December 2024 – is on track to reach the...
Bio-Gate provided an update on the clinical development status of the HyProtect coating for orthopedic implants. Following the completion of the pilot phase, the comprehensive main clinical trial has now commenced. The project – conducted in collaboration with a project partner and initially announced in December 2024 – is on track to reach the next milestone toward CE approval of HyProtect™-coated revision implants.
The pilot phase of the study (Part A) was initiated as a safety assessment of the HyProtect-coated investigational devices in a small number of patients. In Part B, over 200 additional patients will be enrolled across 10 study centers in Germany, Poland, and Spain.
To the study authors’ knowledge, HIPrevision is the first randomized controlled superiority trial worldwide to investigate the clinical efficacy of a silver-coated versus an uncoated hip revision implant system in the treatment of periprosthetic joint infections (PJI). The primary endpoint is the infection rate 12 months after revision surgery
The assumption underlying the HIPrevision study – namely, a reduction in the reinfection rate – is based, among other things, on existing clinical experience with the HyProtect technology. Over the past decade, more than 170 high-risk patients worldwide have been treated with HyProtect-coated orthopedic and trauma implants – as part of customized special-order devices, therapeutic trials, and compassionate use programs in Europe, North America, and the Asia-Pacific region. The patients treated were predominantly those with multiple prior surgeries due to infection, severe comorbidities, or tumor diseases – patient groups in which reinfection rates are significantly elevated according to scientific studies and which can exceed a 50% reinfection in cases of repeated septic revisions.
The (re)infection rate documented in this high-risk population following HyProtect application was reported to be between 2.6% and 6.4%. Sixteen of the treatments were scientifically analyzed in eight peer-reviewed journal articles.
This real-world data – together with preclinical animal and in vitro studies – are taken into account in the HIPrevision study when deriving the underlying assumption of a reduction in periprosthetic re-infections.
Source: Bio-Gate AG
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JV
Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.
