Their website states:
The SAGE Clinical Study is currently enrolling patients to assess the safety and efficacy of GelrinC for the treatment of articular cartilage damage in the knee. The SAGE study is a Food and Drug Administration (FDA) Investigational Device Exemption (IDE) clinical study comparing GelrinC to microfracture, the current standard of care treatment for damaged knee cartilage. This multi-center Phase III pivotal study will enroll 120 patients. (NCT03262909)
GelrinC is composed of a synthetic material called polyethylene glycol (PEG) and a structurally modified form of human fibrinogen, a protein which in its native form assists healing processes. PEG and native human fibrinogen have been used individually in medical products for many years with excellent results. This is a non-randomized study, so all patients who meet study requirements and agree to enter the study are provided GelrinC as treatment. Results will be compared to raw level historical microfracture data.
Is it legit or some marketing gimmick?
The SAGE Clinical Study is currently enrolling patients to assess the safety and efficacy of GelrinC for the treatment of articular cartilage damage in the knee. The SAGE study is a Food and Drug Administration (FDA) Investigational Device Exemption (IDE) clinical study comparing GelrinC to microfracture, the current standard of care treatment for damaged knee cartilage. This multi-center Phase III pivotal study will enroll 120 patients. (NCT03262909)
GelrinC is composed of a synthetic material called polyethylene glycol (PEG) and a structurally modified form of human fibrinogen, a protein which in its native form assists healing processes. PEG and native human fibrinogen have been used individually in medical products for many years with excellent results. This is a non-randomized study, so all patients who meet study requirements and agree to enter the study are provided GelrinC as treatment. Results will be compared to raw level historical microfracture data.
Is it legit or some marketing gimmick?