This is fascinating stuff. Bioheart is treating patients in the U.S. and has actually been inspected twice by the FDA, yet they have not issued any warning letters:
US Stem Cell Clinic, LLC, ("SCC"), a partially owned investment of Bioheart, Inc., is a physician run regenerative medicine / cell therapy clinic providing cellular treatments for patients afflicted with neurological, autoimmune, orthopedic and degenerative diseases. SCC is operating in compliance with the FDA 1271s which allow for same day medical procedures to be considered the practice of medicine. We isolate stem cells from bone marrow and adipose tissue and also utilize platelet rich plasma.
So we have Okyanos gong offshore while Bioheart, with a market cap less than 3 million, is operating clinics and training physicians in the U.S. and at the same time running clinical trials. They are also doing a reverse split and changing their name.
Fascinating web of convoluted enforcement and interpretation of what's legal and whats not.Read this
Remember ASTM. They closed down all their so-called phase 2 and 3 trails in peripheral ischemia (limbs, etc.). Their CEO left and they hired a new CEO. The new CEO started the current phase 2 trial in cardio indication. The cash position was very low. But their stock float was high. To generate cash, they did a reverse split to jack up the PPS, so that the stock has become cash to support the clinical trials and corporate relocation to Cambridge. Xoma did the same, but the failure in PPS is due to failed clinical trails (again and again).
Now, how about us ? I think there is a big change in the CYTX turnaround plan. Japan was almost dead, but now a new marketing guru is coming. Business Development was dead and now Hayden is in. Clinical trials in 2 niche areas are doing very well. But, we have very short in cash to do these and many other things.
I see CYTX changing the name and do a reverse split very soon. This is a very workable strategy for a very desperate company, but yet a new beginning (another gamble, but it may work). I think the reason behind all these recent insider buyings is an endorsement of a new business plan (finalized in the latest board meeting and to be announced): new marketing with Asian emphasis (Japan base to work closely with Oxley), EU business development, US clinical trials in niche areas, manufacturing in Deeside, etc.