US Stem Cell Inc (USRM)

[Dragon Lady]

Bid now collapsed to .0125, free falling on high volume.

Myocell is not even under patent, so I can't fathom what possible "myocell news" there would possibly be about it that matters really in the end (or MyoCell SDF-1 for that matter)?

From Bioheart's own, past 10-K SEC filings, their words verbatim:

BHRT 10-K:

PAGE 17:

"MyoCell SDF-1 Patents
To develop our MyoCell SDF-1 product candidate, we have relied primarily on certain patents which we had previously licensed but with respect to which our license has lapsed. These patents relate to methods of repairing damaged heart tissue by transplanting myoblasts that express SDF-1 and other therapeutic proteins capable of recruiting other stem cells within a patient’s own body to the cell transplant area. We believe we will also need to, among other things, license some additional intellectual property to commercialize MyoCell SDF-1 in the form we believe may prove to be the most safe and/or effective.
In February 2006, we signed a patent licensing agreement with the Cleveland Clinic which provided us with the worldwide, exclusive rights to three pending U.S. patent applications and certain corresponding foreign filings in the following jurisdictions: Australia, Brazil, Canada, China, Europe and Japan, or, collectively, the Cleveland Clinic IP, related to methods of repairing damaged heart tissue by transplanting myoblasts that express SDF-1 and other therapeutic proteins capable of recruiting other stem cells within a patient’s own body to the cell transplant area.
The term of our agreement with the Cleveland Clinic expired in July of 2009, when the license to the patents was turned over to a Cleveland Clinic affiliate, Juventas. We have an understanding with Juventas to restore the license to the patents once certain milestones have been achieved by us.
In 2007, we signed a Letter of Intent with Ono Pharmaceutical which provided rights to conduct clinical development and testing of SDF-1 to determine the effectiveness of SDF-1 for the treatment of damaged myocardium and tissues following acute myocardial infarction, coronary arterial diseases or heart failure. If the results of this testing is deemed successful then we and Ono Pharmaceuticals have agreed to enter into good faith negotiations in an effort to reach a definitive license agreement that will allow us to commercialize our SDF-1 product candidate in all territories of the world except Japan. The Letter of Intent is still in effect.
"

PAGE 16:
"Our MyoCell product candidate is no longer protected by patents, which means that competitors will be free to sell products that incorporate the same or similar technologies that are used in MyoCell without infringing our patent rights. As a result, MyoCell, if approved for use, may be vulnerable to competition in the form of products that use the same or similar technologies. We have previously licenses certain patents and patent applications relating to our MyoCell product candidate. These licenses have all lapsed as of the date of this report, although we have had discussions with the relevant licensor regarding a potential reinstatement of our rights in such licenses."

PAGE 30:

"Our product candidates may never be commercialized due to unacceptable side effects and increased mortality that may be associated with such product candidates.
Possible side effects of our product candidates may be serious and life-threatening. A number of participants in our clinical trials of MyoCell have experienced serious adverse events potentially attributable to MyoCell, including six patient deaths and 18 patients experiencing irregular heartbeats. A serious adverse event is generally an event that results in significant medical consequences, such as hospitalization, disability or death, and must be reported to the FDA. The occurrence of any unacceptable serious adverse events during or after preclinical and clinical testing of our product candidates could temporarily delay or negate the possibility of regulatory approval of our product candidates and adversely affect our business. Both our trials and independent trials have reported the occurrence of irregular heartbeats in treated patients, a significant risk to patient safety. We and our competitors have also, at times, suspended trials studying the effects of myoblasts, at least temporarily, to assess the risk of irregular heartbeats, and it has been reported that one of our competitors studying the effect of myoblast implantation prematurely discontinued a study because of the high incidence of irregular heartbeats. While we believe irregular heartbeats may be manageable with the use of certain prophylactic measures including an ICD, and antiarrhythmic drug therapy, these risk management techniques may not prove to sufficiently reduce the risk of unacceptable side effects.

Although our early results suggest that patients treated with MyoCell do not face materially different health risks than heart failure patients with similar levels of damage to the heart who have not been treated with MyoCell, we are still in the process of seeking to demonstrate that our product candidates do not pose unacceptable health risks. We have not yet treated a sufficient number of patients to allow us to make a determination that serious unintended consequences will not occur."

With patents no longer in effect and all these lapsed licenses and what not- what's really there with MyoCell of any real value? Bioheart didn't really even invent or create anything original with MyoCell as far as I can tell- they'd just licensed a bunch of stuff and had rights to use patents of others it seems, all of which have now expired.

So how would MyoCell supposedly ever be monetized in the future- and that's not even beginning to discuss how a cash poor company like Bioheart would ever fund a large FDA quality phase 3 trial and get it to approval and all the rest. Hey, remember the MIRROR phase 3 big "trial" that was per their PR, "FULLY FUNDED BY BIOHEART" and had "ENROLLED ONE PATIENT"- how'd that all turn out in the end? Remember that one?

Original "MIRROR" ole "phase 3 trial" PR. Sounded pretty darn good, eh? I mean is "sounded" real, real good IMO. But what was the reality?

http://www.marketwired.com/press-release/bioheart-announces-phase-iii-mirror-trial-for-myocell-initiated-otcqb-bhrt-1807938.htm

From BHRT most recent 10-Q filing:

PAGE 29:

"We are seeking to secure sufficient funds to reinitiate enrollment in the MARVEL and REGEN trials. If we successfully secure such funds, we intend to re-engage a contract research organization, or CRO, investigators and certain suppliers to advance such trials. We have initiated and enrolled our first patient in the MIRROR trial in 2013. The trial is very similar to the MARVEL trial but focusses on sites outside the US. We will continue enrollment in the MIRROR trial once we have secured sufficient funds.
We have completed the Phase 1 Angel Trial for AdipoCell (adipose derived stem cells). Five patients were enrolled and treated in the second quarter of 2013. At the twelve (12) month time point, patients demonstrated a statistically significant average improvement in ejection fraction (EF) by echocardiogram."

That ole "ANGEL" ole "trial" info sounded pretty darn good too, eh? A lot of PR's about the ole ANGEL trials. Yeah baby.

http://finance.yahoo.com/news/bioheart-announces-phase-angel-trial-110823792.html

http://pipelinereview.com/index.php/2014030453581/DNA-RNA-and-Cells/Bioheart-Announces-Positive-6-Month-Data-From-Angel-Phase-I-Trial.html

http://www.pipelinereview.com/index.php/2014101355700/DNA-RNA-and-Cells/Bioheart-Announces-Positive-12-Month-Preliminary-Data-From-Phase-I-Angel-Trial.html

But, but wait? Suddenly Jan 25th, 2015 comes along - and the "big" latest PR and what happened to the ole MIRROR PHASE 3, you know, "FULLY FUNDED BY BIOHEART" and then that much PR'd ole "ANGEL" trial? What happened to um?

https://finance.yahoo.com/news/bioheart-updates-diversifies-clinical-development-150000986.html

Quote from the Jan 25th, 2015 PR:

"The Company has no further plans to advance its ANGEL and MIRROR clinical development programs."

So, BAMM, just like that- the ole "MIRROR PHASE 3 FULLY FUNDED BY BIOHEART", the "big trial" that well, seems to me just never really was- is just cancelled. Gone. Over when it never really even started.

But now, now one is to believe that some 5 yr old "Marvel" trial that's been in the parking spot since like 2009/2010 and for which they have no real patents and all key licenses appeared "lapsed" per their own SEC filings- one is to believe now, now that's the "big thing" that's gonna lead to what? What is the MARVEL (if it actually ever restarts in any serious way) - how's it gonna be funded, how's it ever gonna lead to FDA approval or ever be commercialized- and what's the point to commercializing it anyway if they no longer hold patent on it via their own SEC filings??

None of it makes any sense to me. Also, how does MIRROR just "vanish" for all intents and purposes- when it never really happened in the first place? How does that all "work"? A lot of PR hype about it- but it really was never true in the first place IMO? Cause MIRROR really never even happened, let alone was FULLY FUNDED BY BIOHEART now was it?

My 2 cents. I don't get it?