I find that reply vague/weak in my opinion. You go to the BHRT webt site and under the "clinical trials" tab they list 5 trials. Angel, Marvel, Mirror, Myheart and Regen. You then go to clinicaltrials.gov site and what I find under a search of "Bioheart" is Marvel (described as active- not recruiting) and something called Biowhittaker going back to 2006, then what appears to be "REGEN" maybe - it's last update was back in 2007 and then Pulmonary Disease one they created in Jan 2014 (see, they list that but not Mirror, why?) and then the Seismic one with last info/update, again clear back to 2007 and finally the Dry Macular one created in Dec 17th 2013. So they list that "Dry Macular" thing, which isn't even their forte or supposed main focus, but Mirror is not registered?
Makes no sense to me- there is no agreement between the BHRT web site "clinical trials" tab and the clinicaltrials.gov site. Then certain "new/small" trials are registered at .gov while Angel and Mirror don't even appear? Confusing to me to say the least. WHY would you register some, but then give the explanation that others don't need to be registered, cause you know, "It's voluntary and all and helps recruit, but we got plenty of recruits, blah, blah, blah?" I'm not seeing it. Again, why does everything they seem to do have to fall under the vague and inconsistent "umbrella"? Always bothers me- just my opinion.
Then you have this PR from clear back July last yr, which is confusing to me to say the least- it's the one that mentions "one" and "the first" patient being "enrolled" in Mirror, and taking place down in Mexico, but has all this other verbiage about it "might" um "conflict" and some kind of "hold" with the FDA on something else- but Mirror will continue to "enroll" (not necessarily go forward) as these "issues" with the FDA are "worked out"? Again- confusing as all heck to me. Then in the meantime- you get the medical tourism "stuff", you get the ED, erectile "stuff" you go back to a phase one of 5 people called Angel in Mexico when you were all the way to a phase II/III in the same product line? And ALL THIS with what was listed in last 10-Q as 4 full time people I think it was? And we know one of those is the CEO and one other is the sole, "Chief science officer"? It seems just running one, one single major trial would be more than one "Chief science officer" could handle- and she's also listed as the "CEO" of Stemlogix, and as a active managing member, CSO of "Ageless". I mean- come on, there's only so many hours in a 24 hour day.
Here is the last big Pr I saw on Mirror- and it's confusing to me- I don't really think the "we don't need to be on clinicaltrials.gov" is a great explanation- again in my opinion only and the way it "rubs" me- which is not confidence building or positive. You have nothing to lose by being registered on .gov- and every major company conducting major FDA type trials seems to be on there- so why not just put the "trial" on there? What's to lose?
Here is PR with "hold" and "conflict" wording and all the rest (note- we're talking NINE months ago now):
July 02, 2013 15:37 ET
Bioheart Announces Phase III MIRROR Trial for MyoCell Initiated
SUNRISE, FL--(Marketwired - Jul 2, 2013) - Bioheart, Inc. (OTCQB: BHRT) announced today the successful enrollment and randomization of the first patient in the Phase III MIRROR Trial using MyoCell® or muscle derived stem cells.
The MIRROR trial is fully funded by Bioheart and will be conducted at up to 35 centers in North and South America. The trial is designed to enroll up to 126 patients over a 12 month time period. The first patient has been enrolled in Mexico at the Hospital Angeles with the Regenerative Medicine Institute (RMI). This study will complement the data completed in the Phase II/III MARVEL trial on patients with congestive heart failure (CHF). Patients are randomized into either the treatment (2/3) or placebo (1/3) arm. All patients will receive delivery into the damaged areas of the heart using the MyoCath® Catheter. Data endpoints will include safety, exercise capacity, quality of life, and ejection fraction at 3 months and 6 months. Kristin Comella, Bioheart's Chief Science Officer, said, "We are hoping to achieve results similar to those from the MARVEL trial in which patients improved almost 100 meters over placebo in their exercise capacity test. We believe this therapy can address an unmet need for cardiac patients."
The FDA has placed a hold on the request for an Expanded Access protocol using MyoCell in part because the proposed expanded access study would likely interfere with the clinical development of MyoCell and/or interfere with developing market approval. Bioheart intends to continue enrollment in the MIRROR trial while hold items are addressed with the FDA. In addition, Bioheart plans to initiate part 2 of the MARVEL trial using the J&J MyoStar™ Catheter to deliver MyoCell to CHF patients.
Again, my own experience- and that's just me and my opinion perspective- is these guys put out a lot of "PR" and "blogs" and other "stuff" that somehow, just never seems to materialize later or move forward, or be spoken of in detail again later in a 10-Q or similar. I've seen it over and over again. Notice the last line in the PR above- about Marvel being "initiate part 2 with J&J blah, blah"- meantime, they do Angel instead, medical tourism, and 5 or 10 other things and it's almost a yr later- and we haven't heard much about Mirror, let alone some "Marvel part 2 J&J" taking place or advancing? I just find them scattered all over the map (literally geography wise) and spread across so many things- it seems impossible they could ever complete one of them with the staff/money they have? I just don't see the end game or where's it's all going? 4, maybe 5 full time employees- none of who have ever brought a major FDA approved product to market- and they're doing all this stuff from Mexico to Honduras to the Middle East to running multiple FDA "trials" and all? Really? I don't know- I sure got my doubts. I practically have to build a spreadsheet of all the PR releases, what they said they would be doing and where on what date, when, etc and then "try" and see if we've ever gotten any updates later on most of them, any revenues, any progress, etc. It's that complicated to me- to even keep track of.
But that's just me. If others want to get all excited about a PR about every 2 weeks or so- to each his own. I just see it all getting more "scatter shot" and convoluted and "off message" with each passing day? Oh, and that's not even mentioning Stemlogix and all the "animal" stuff they used to mention- what ever happened to all that? Oh well- we'll see what the 10-K says, it's the next "biggest update" coming down the pike. See what it says- and if all this "stuff" is mentioned and described in detail?
