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Monday, May 05, 2014 10:09:47 AM
They already had the big aging "conference" and presented the "study results" of "ANGEL" and they released "PR" on that date last week with the "data/results" in it, and also prior to that, that the Angel results were "out", completed, etc
So, what's new in this "PR" and why would it matter, IMO?
It appears to be just another rehash of the Angel, Mexico, 5 person "trial" (that's the only 5-person, Adipose, Mexico, phase I based "trial" that I'm aware of, no?) - and there's nothing new in the "PR", that I can see? Just pushing out "PR" as per SOP, IMO, even when it's now old news now, IMO.
It's about the Phase I? Where's any "news" on the old, Phase II/III trials?
Further, this must be the ANGEL trial IMO, correct (this PR today)? That's the only 5-person, Mexico "trial/treatment" that I'm aware of? But look at this PR and what it states, compared to what Comella just reported last week at that "conference" - they don't seem to match-up IMO?
Don't know what's up with that?
PR dated April 30th, 2014:
" Bioheart, Inc. (OTCQB: BHRT), a biotechnology company focused on the discovery, development and commercialization of autologous cell therapies, presented at the 16th Clinical Applications for Age Management Medicine Group conference and Scientific Seminar in Orlando, Florida April 24-27.
Kristin Comella, Bioheart's Chief Scientific Officer, presented for the first time the Angel 6 month trial data to hundreds of physicians and health care professionals. At the 6 month time point, patients are demonstrating an average improvement in exercise capacity or a six minute walk test of approximately 68 meters (p=.07) as compared to an average improvement of 47 meters at 3 months (p=0.12). Eighty percent of the patients showed an improvement in their exercise capacity from 3 months to 6 months post stem cell injection.
Another end point in the study is ejection fraction (EF) by echocardiogram. At the 3 month time point, 100% of the patients demonstrated either improvement or stayed the same. After 3 months, patients showed an average absolute improvement of 3 percentage points in ejection fraction (p=0.17). The patients continued to improve from 3 months to 6 months with a statistically significant average absolute improvement of 10 percentage points (p=0.01)."
PR dated today- in what appears to also be a rehash, summary IMO, of what must be the ANGEL, 5-person, "ANGEL" trial in Mexico:
" Tijuana, Mexico, five congestive heart failure patients were successfully treated in the initial pilot trial at Hospital Angeles Tijuana. Patients underwent a mini-lipoaspiration procedure where 60ccs of fat were removed. This fat was processed to obtain the stromal vascular fraction (SVF) which contains mesenchymal stem cells, progenitor/endothelial cells, pericytes, hematopoetic stem cells and more. The SVF was injected into the damaged areas of the heart using Bioheart's MyoCath® catheter allowing for a minimally invasive delivery. Patients were followed on protocol for 6 months and demonstrated on average, an absolute improvement of 13 percentage points in ejection fraction and an increase of 100 meters in their 6 minute walk distance."
Doesn't make any sense to me, IMO. What am I missing here- it's two "result" descriptions that don't even match IMO (68 meters versus 100 meters? and 10 percent versus 13 percent? Did the "data" just change in a few days or what?)? Confusing IMO? The two "PR's" as far as I can tell- must be referring to the same, "ANGEL" trial in Mexico, no?
There are not, two different, 5-person "studies/trials" in Mexico that I'm aware of, unless I'm missing something here?
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