The objective of this study was to evaluate local tissue response to BleedStop™/StopsBleeding™ hemostatic powder in a chronic rabbit subcutaneous implant model. There were no adverse events, clinical observations, abnormal clinical pathology, or abnormal gross pathology attributed to the test article.
To paraphrase the study, all animals observed after the 4-week period were in the same condition as when they started. The BleedStop™/StopsBleeding™ powder in the animals’ bodies had no adverse effect on any of the animals or in any of the sites.
The in-life assessment for each animal was clinically normal upon entering the study and all animals remained healthy during the in-life portion of the study. There were no adverse events noted during the study. According to the physical examinations, the clinical pathology
results, the daily observations, the procedures, and the in-life assessment all animals in this study demonstrated adequate health to assess the objective of the study.
BleedStop™ and StopsBleeding™ are trade names of CoAg Medical LLC for their hemostatic powder and rigid foam products. In general, BleedStop™ is marketed to consumers, and StopsBleeding™ is marketed to doctors and medical professionals.