US Stem Cell Inc (USRM)

[Dragon Lady]

LOL, "I like the summary table from yesterday's announcement. "

Yeah, that must of taken what, like 5 minutes to make up out of thin air?
NOT ONE DOLLAR value or even ball park DOLLAR estimate in the ole "projection" (aka wild GUESSES IMO) ole table.

Lets see- Myocell (which is NO LONGER UNDER PATENT and for which all key licenses have lapsed by the way, see 10-K SEC filing) and it and Myocell SDF or whatever it's called- have sat parked, gone nowhere in FIVE YEARS essentially (read any 10-Q or 10-K filing).

But one is suddenly to believe that now they're gonna be approved by the FDA in 2019 and what is it- like 2021 on the other one or something? Via a company of 4 people total, who's essentially cash broke at any given time (finished last qtr w/ $46K total cash on hand against just immediate debts like accounts payable of over $2 MILLION and $800K in "bonuses" to just two people that went unpaid for lack of cash- but instead became a debt owed now via issuing those two a "promissory note")- one's supposed to believe one shred of that maybe, might, could happen, if this might maybe, and if appropriate financing and if we can get all the old stuff re-initiated and get back old lapses licences and arrange "internal" stuff and we'll LET YOU KNOW AT SOME LATER DATE?? Bwaah-ha-ha-ha-ha-ha.

Yeah, I'm gonna be holding my breath cause you know- they now made a "table" in a PR. Right on. How'd that ole MIRRROR and ANGEL trial "thingy" work out- the ones now CANCELLED, with MIRROR you know, "FULLY FUNDED BY BIOHEART" but you know, never really funded and never even really happened- that "little" part of the pesky details? And now this vast "table" of supposed "projects" for 5 or whatever things- way more complicate than ONE MIRROR trial- one is to believe they're all gonna happen now, and oh, "WE'LL GIVE SOME DETAILS TO YOU AT A FUTURE DATE"?? MIRROR was just given details at a FUTURE DATE, about 1.5 yrs later- and the dirty details were IT NEVER HAPPENED AS "claimed" in the vast PR originally put out about it. Sorry, just NEVER WAS FULLY FUNDED and in fact NEVER EVEN TOOK PLACE. Oh yea, a "table", super cool. Right on ! I mean if it's in a "table" format now- that pretty much means it must be all true and is gonna happen this time around?

Remember ole Northstar LLC "was" going to raise "$20 MILLION DOLLARS" in a secondary- remember that ole PR, cause I do? NEVER HAPPENED. How bout a $2 MILLION "term sheet" for ole "financing" was signed? What about that one- it also NEVER HAPPENED. Seeing a pattern here with vast, vague, "big claim" ole PR'S? How they just somehow never seem to come true? I sure do, I can list probably 20 of um in under 3 minutes- just vanished and gone and never heard about again. A "table", oh wow. Yeah, super neato.

http://www.marketwired.com/press-release/northstar-launches-20-million-private-placement-round-with-proceeds-fund-bioheart-trials-otcqb-bhrt-1713163.htm

http://www.marketwired.com/press-release/bioheart-receives-2-million-term-sheet-investment-offer-from-vitalmex-global-leader-otcbb-bhrt-1686526.htm

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

All used to try and run the stock- just like now IMO. Same old, same old. They're surviving on Magna and Asher and the rest- they're just covering and making some coin here IMO. They'll notch it back down when ready.

From yr 2013 filed 10-K, various pages, not even Myocell SDF, the supposed "new one" or whatever it is- is even fully patent/license owned by Bioheart according to SEC filing, let alone the older plain Myocell. And Adipocell is licenses under some "term sheet"- which BHRT and "term sheets", well- look at the link above about their history of "term sheet" supposed "agreements"? DO they have a license, exclusive to Adipocell (which was Lipicell until Comella court case involving the license holder of Lipicell, see SEC filing txt which will be posted below)

From SEC filings:

PAGE 14:

"MyoCell SDF-1
Our MyoCell SDF-1 product candidate, which has completed preclinical testing, is intended to be an improvement to MyoCell. In February 2006, we signed a patent licensing agreement with the Cleveland Clinic of Cleveland, Ohio which gave us exclusive license rights to pending patent applications in connection with MyoCell SDF-1. Dr. Marc Penn, the Medical Director of the Cardiac Intensive Care Unit at the Cleveland Clinic and a staff cardiologist in the Departments of Cardiovascular Medicine and Cell Biology, joined our Scientific Advisory Board. The license for SDF-1 was expired and was turned over to a Cleveland Clinic affiliate, Juventas, in July of 2009. We have an oral, non-binding understanding with Juventas pursuant to which the license with Bioheart will be reinstated upon completion of certain financial milestones. Without an agreement from Juventas, we may not be able to commercialize our MyoCell SDF-1 product following regulatory approval. 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."

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."

Notice yesterday's PR, Jan 25th, 2015 had a bunch of vague stuff about (paraphrasing) "We'd need to get a bunch of other people and licenses and re-engage blah, blah and organize internal stuff" BEFORE we could even re-start ole Myocell or Myocell SDF trials, but hey, "We'll LET YOU KNOW IN THE FUTURE AT SOME DATE, SOME FUTURE UNKNOWN DATE". See why now? Licenses have ALL LAPSED. Bioheart didn't "invent" and does not "own" much of anything of their own- they have nothing original really when one read their SEC filings. They just license or in the past bought patent rights to what others had invented- but that all has lapsed for the most part and/or takes a lot of money to keep those things current. Wonder why they haven't attracted any "big money" or "smart money" investors in FIVE plus yrs now- cause those folks do intense due diligence. Maybe they asked, "What am I investing in, or what would this company own- when you don't really own and haven't really invented anything of your own??". Ever think about that? Let alone that Norhtstar LLC holds a "lien" on essentially anything and everything BHRT could own, would own, would ever invent, etc (see 10-K or 10-Q and Northstar word LIEN).

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.
30

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."

Ever wonder why MIRROR never progressed and was an attempt to go outside the FDA bounds, via going to Mexico and similar? But now one is to believe that somehow Marvel or Regen or whatever are going to be "re-started" after sitting for FIVE YEARS and having patients deaths and serious adverse events? Really?

Read the MIRROR PR carefully- the line in it that BHRT never, ever "explained" about how they were "addressing FDA holds" or whatever the exact wording was- here's the quote (never explained as far as I know):

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

"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."

TWO years ago there were "FDA HOLD" issues to be "addressed" and also a "claim" that MARVEL was going to be "re-intitiated". Did MARVEL ever "re-intiated" as claimed, in that nearly 2 yr old PR? Did it? The company as far as I'm aware, never since has explained what "FDA HOLDS" meant or how they've been addressed or were addressed. And now, as of yesterday- MIRROR IS CANCELLED AND GONE, never to be heard of again I guess? Those "holds" and what they meant- will never be explained IMO. Just more vagueness and confusion to me.

PAGE 3, most recent 10-K and the ole "Adipocell" license- you see, BHRT din't "invent" Adipocell, they have a "term sheet" signed, whatever that is? And the "Lipicell license got dropped because Comella and the is being sued in Broward County by the owner of the Lipicell license- Dr. Sharon McQuillan. It's public info- the suit is on the Broward County clerk of the court site. So BHRT just dropped "Lipicell" and just re-named it, via the stroke of a pen, and then signed a "term sheet" for some other company's "cells" and now call it their own, aka "Adipocell"- which makes zero sense to me. What is "Adiopocell" even worth then- BHRT didn't invent it and doesn't own it, so how do they make money on it via clinical trials and all, long term?

PAGE 3, 10-K:

"AdipoCell
Bioheart has successfully completed various trials using adipose stem cells. In August 2013, the Company canceled its license agreement with the Ageless Regenerative Institute for adipose derived stem cells called LipiCell. Bioheart has entered into a term sheet agreement with Invitrx to License their adipose derived stem cell products. Bioheart has changed its adipose derived stem cell product name to AdipoCell.
Bioheart has funded and completed enrollment of 5 patients in the Angel Trial in Mexico utilizing adipose derived cells. Preliminary 3 month follow up data in the study was reported in September 2013. At the 3 month time point, patients are demonstrating an average improvement in exercise capacity or a six minute walk test of 47 meters. In addition, 60% percent or a majority of the patients are walking greater than 65 meters further at 3 months post stem cell injection.
The patients are also reporting an average improvement of 13 points in their Minnesota Living with Heart Failure questionnaire. An improvement of 5 points or greater is considered “clinically meaningful” and 80% of the patients in the trial had a greater than 5 point improvement."

A "term sheet"?? So does Bioheart even have an exclusive actual LICENSE to ole "adipocell"?? Does anyone know??

And now, ole Angel "trial" is also CANCELLED AND GONE as of yesterday's PR, Jan 25th, 2015. But one is now to believe that BioHEART, the supposed "heart experts" are just gonna take those old "Adipocell" cells and now solve ole CLI (chronic limb) problems with um? And supposedly "soon" per some imaginary "chart" in a vague PR?? Really?


https://www.clerk-17th-flcourts.org/Clerkwebsite/BCCOC2/OdysseyPA/CaseSummary.aspx?CaseID=7155410&hidSearchType=party_case&DisplayCitation=no&CaseNumber=CACE13024037&SearchType=

That's the court case that sunk ole "Lipicell" and then they just turned it into "Adipocell"- just like that, via a "term sheet" and a pen, I guess?

How bout the latest 10-Q filing, how is all this "stuff" in the Jan 25th 2015, vague and vast PR going to be funded? How?

PAGE 12, most recent 10-Q filing:

NOTE 2 — GOING CONCERN MATTERS
The accompanying unaudited condensed financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. As shown in the accompanying unaudited condensed financial statements, during nine months ended September 30, 2014, the Company incurred an operating loss of $1,247,199 and used $747,184 in cash for operating activities. As of September 30, 2014, the Company had a working capital deficit (current liabilities in excess of current assets) of approximately $10.0 million. These factors among others may indicate that the Company will be unable to continue as a going concern for a reasonable period of time.
The Company’s existence is dependent upon management’s ability to develop profitable operations and to obtain additional funding sources. There can be no assurance that the Company’s financing efforts will result in profitable operations or the resolution of the Company’s liquidity problems. The accompanying statements do not include any adjustments that might result should the Company be unable to continue as a going concern."

So what's changed in the past 2 weeks or so? What? What exactly has changed because of a bunch of vast and vague "claims" and a "chart" in on PR issued on Jan 25th, 2015? Where's the financial details, not vague " we think and hope to maybe pay for all this someday", but the FINANCIAL DETAILS in that PR? Where, cause I sure didn't find any- let alone answers to the fact their key patents and key licenses have lapsed and expired and about 50 other simple questions one can find in their SEC filings, in every one of them going back 3 yrs.

Makes zero sense to me. Like MIRROR, just another vast, vague PR that I don't ever expect to see little of it, if any of it to come true per my own opinion and experience and thoughts from what they, BHRT has done in the past with similar PR and vast "claims".

My 2 cents.