NFLD – Apart from any regulatory hurdles, I have a concern about the business model if they end up having to recruit paid donors for their blood source.
NFLD The following is from the Denver Health Web site.Denver Health Trauma Center was the first hospital to enroll patients in the current P-3 trial.........We at Denver Health Medical Center were fully informed by the study sponsor, about all earlier clinical studies with PolyHeme. We carefully examined each of those studies, including the ANH trial, prior to our application to the IRB, and subsequently the same material was provided to, and was reviewed and approved by the IRB, prior to starting our Community Consultation and before we were authorized to begin any patient enrollment here in Denver.
The findings suggest to us that: There was no evidence directly linking PolyHeme to the adverse events reported in the ANH trial and in fact, the events which occurred were reported by the investigators involved, to be unrelated to PolyHeme; The trial design between the ANH trial and the current trauma trial are exceptionally different; The patient population and “disease” being studied between the two trials are extraordinarily different. We concluded that the heart attacks were not likely caused by PolyHeme and we assembled our community information accordingly. Further, when we developed our Community Consultation presentation we also considered several years of direct experience with PolyHeme here at Denver Health and the safety profile of PolyHeme we have observed in trauma patients.
Currently, the study remains open for enrollment of eligible injured patients here in Denver and is being conducted with the utmost concern for patient safety, with appropriate FDA and IRB oversight, and in accordance with all applicable regulations. The Independent Data Monitoring Committee reviewing safety data from the current trial, has also reiterated its positive recommendation that the trial go forth without modification to completion, based on four separate reviews of the results from the first 500 patients enrolled in the trial, wherein the committee reviewed all safety data in an “unblinded” fashion, meaning that they are aware of all adverse events, and in which group those events occurred. Therefore the committee is able to make a reasonable evaluation of causality of the study treatment upon a specific event.
The current trial is based upon two potential life-saving benefits. The first and most obvious benefit is based on beginning the infusion of an oxygen-carrying resuscitative fluid at the scene of injury and during transport to the hospital. This offers an important potential life-saving benefit to patients, since donated blood is not available in the pre-hospital setting, and while current therapy may expand circulating volume, it does not meet the critical need of restoring lost oxygen carrying and delivery capabilities.
The second is the potential opportunity to improve outcome associated with the use of donated blood in the early hospital period in critically injured patients. Although blood transfusion is the current standard of care, there is a growing body of scientific evidence suggesting an adverse effect of early blood transfusion in trauma patients. Specifically, the use of donated blood early in the postinjury period is known to cause an increase in the possibility of developing a clinical condition known as multiple organ failure. As well, current data suggests an increased rate of nosocomial (hospital acquired) infections, and intensive care and hospital length of stay, in patients who have received blood transfusions. Thus while it is true that blood is available in the hospital, it may not be optimal, and PolyHeme is being evaluated as a potential better alternative. http://www.denverhealth.org/TraumaCenter/update.aspx
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