So, an old "study" (apparently not an actual "trial") from 2010 is being reported in "PR" today, 4 yrs later, that appears to not be the recently reported, "ANGEL" trial in Mexico? But the "old study" done in Mexico on 5 patients, reported, what appears to be far better (at least pretty different results IMO) better results back then, compared to what was released a week or so ago, regarding the "new", most "up to date" ANGEL trial in Mexico?
This is very confusing IMO.
From the 10-K, dated Dec 31st, 2010, PAGE 14:
"On March 23, 2010, the Company announced plans for establishing five Centers of Excellence in Latin America to provide its cell therapy procedures to patients suffering from congestive heart failure (CHF) and peripheral arterial disease (PAD). Bioheart entered into its first agreement with a leading treatment facilitator, Regenerative Medicine Institute of Tijuana, Mexico."
"On April 14, 2010, the Company announced that treatment with stem cell therapy on two congestive heart failure (CHF) patients was performed successfully at the Hospital Angeles Tijuana, Mexico, through Bioheart's Center of Excellence program with Regenerative Medicine Institute.
The center in Mexico has recently completed 6 months follow up on the first 4 heart failure patients (this is 2010 remember, being reported in the 2010, end of yr 10-K). These patients have 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."
It's confusing too, IMO, as it starts by saying (2) patients were treated, then a line later, 6 month data on (4) patients is summarized, and now 4 yrs later, it appears it's being stated that (5) patients were treated and had "6 month follow-ups" done? I can't follow all of this, IMO? It's confusing as heck IMHO? I don't get it?
So, this old data, released a long, long, long time ago (4 yrs approx) is being re-hashed in a "PR" today? Why?
And what's fascinating IMO, was this data from 2010 then, showed better results from the data just released regarding the 5-person, ANGEL trial, done at the exact same center in Mexico, it appears from all that I can "figure out"?
Why is this data from 2010 being re-hashed in a "PR" now? It appears it wasn't even an actual "trial" as in the Phase I, like ANGEL, but was just a "study" at the new, so called "center of excellence" done in Mexico? And it produced BETTER results than what they're doing now, 4 yrs later in the ANGEL trial?
2010, 10-K:
" 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."
ANGEL "trial", 5-person, done at apparently same Mexico facility, this past yr or so, 6 month data just recently presented a week or so ago and released in PR:
"PR dated April 30th, 2014:
" 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"
So in a "study" done at the same facility, 4 yrs ago, in comparison to the ANGEL, phase I trial data just presented recently, 2014- the patients "walk test" improvement declined from 100 meters "improvement" from the original "study" to now 68 meters in the ANGEL trial? And their ejection fraction was 13 percent "improvement" 4 yrs or so ago on a 5-patient "study", but was 10% recently on the official ANGEL "trial" (that would be a difference of about 100-68 = 32/100 = .32 X 100 = 32% difference (worse) in the walk test results and 13-10 = 3/13 = .23 X 100 = 23% (worse) results in the "ejection" measure? This between a 5-patient "study" 4 yrs ago, and their most recent technology and phase I "trial" known as ANGEL done and presented just recently??)
What am I missing here, IMO? Makes zero sense to me? Why is this "PR" and "news" today then, regarding this "study" from 4 yrs ago in 2010? What's it supposed to mean and why is it being brought up again today? I totally don't get it IMO? But hey, maybe that's just me?
Do one's own due diligence for sure. I don't know- maybe I'm just confused by all these different "PR's"? Buy, sell, hold, trade, whatever - only on one's own research and due diligence. Don't listen to me- I'm confused apparently by these multiple "trials" and "studies" and differing (IMO) results and whatnot?
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