US Stem Cell Inc (USRM)

[Dragon Lady]

Quote LOL, "Major insurance company has MyoCell on their website.
"

Yeah, and it says it's labeled in the "INVESTIGATIONAL" category of their policy guidelines, thus is UNPROVEN TO "work", is thus "NOT MEDICALLY NECESSARY" and has NO FDA APPROVAL, and therefor they WILL NOT and DO NOT PAY FOR IT, LOL !!

FANTASTIC ! Oh, and they still call the company "Bioheart" which is NOT the corporate name any longer for U.S. Stem Cell, Inc, since the officially amended and CHANGED their corporate charter documents/filings with the freaking Florida Sec of State in 2015. So how does "Bioheart" do anything, since it's not even a valid name for a corporate entity anymore?

Citing the "insurance company page" (the one being hyped as DIS-INFORMATION):

"MyoCell® (Bioheart, Sunrise, FL) comprises patient autologous skeletal myoblasts that are expanded ex vivo and supplied as a cell suspension in a buffered salt solution for injection into the area of damaged myocardium. MyoCell® SDF-1 (Bioheart) is similar to MyoCell®, but before injection, myoblast cells are genetically modified to release excess stromal-derived factor-1 (SDF-1). Increased SDF-1 levels at the site of myocardial damage may accelerate recruitment of native stem cells to increase tissue repair and neovascularization. For both products, myoblast isolation and expansion occur at a single reference laboratory (Bioheart); both products are therefore subject to FDA approval. Currently, neither product has been cleared by the FDA."

AND:

"

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting."

STRIKE OUT. NO APPROVAL(s), NO KNOWN PROVEN SCIENTIFIC EFFICACY, AND SHAZAM, Blue Cross and Blue Shield say WE NO PAYEEE YOU FOR IT, LOL !! NO MONEY FOR "Myocell", which by the way is NO LONGER UNDER PATENT and now lacks "key licenses" that Bioheart once owned, needed to even make what they call "Myocell", READ THEIR DAMN SEC FILINGS, the ones for the company now named U.S. Stem Cell, Inc. The one with NO FDA APPROVED DRUG PRODUCTS, and their only ever approved "product" the ole "CATHETER", also about to fall off patent protection in Sept of 2017, a few short months from now.

Ole USRM's IP portfolio seems to be dwindling by the day, seems to me. But hey, they got a little "clinic" biz thingy that their SEC filings says they own 33% of, as an "investment" and then those "training" courses and "stuff", so that might get um somewhere, LOL ?????

The Myocell clinical trials, PER THEIR MARCH 2016 SEC 10-K, were "SUSPENDED" for "LACK OF FUNDING", since 2010. Almost SEVEN DAMN YEARS and they couldn't get a large investor or major source of funding to step up to the plate and put down some risk money, to finance the completion of their ole "MYOCELL" clinical trials, now WHY WOULD THAT BE? WHY? "SMART MONEY" finds the best technology IMO, and their's never was able to find any further funding. EVERY "PR" that said they were "close" to finding more funding (NON DILUTIVE, NOT TOXIC CONVERTIBLE DEBT DEALS) every single one of um crumbled and/or just vanished. The cash money never materialized. They've been limping along borrowing TOXIC, FLOORLESS, DILUTIVE, CONVERTIBLE DEBT in increments as tiny as a lousy $25K or $50K at a time now, FOR FREAKING YEARS (See SEC filings Asher, KBM Worldwide, Vis Vires Group, Fourth Man, Daniel James and their new "GOT TO GUY" ole Magna Equities, aka Josh Sason the penny wrecking ball). WHY NO FUNDING? WHY? WHY WOULD THAT BE?

Here's their man "go to" finance guy for about the last 2 years, the one that's kept um barely alive, barely SOLVENT per their own SEC FILINGS, their own GOING CONCERN WARNINGS, their own LACK OF CASH in every SEC 10-K and 10-Q for years:

https://www.bloomberg.com/news/articles/2015-03-12/josh-sason-made-millions-from-penny-stock-financing

https://www.bloomberg.com/view/articles/2015-03-12/death-spiral-convertible-financier-has-a-lot-of-fun