Obviously they have FDA approval to do a study in the US. DO you really think they would risk their relationship with the FDA especially at this point.
I would imagine that the commercializing of the MyoCell product itself will be an immense task from sales development with healthcare professionals to integration into insurance coverage, along with production, distribution, etc…
I also believe, as I’m sure do most of us, that this product alone represents a major revenue channel, and may justify the future valuation we one day hope for.
So when I see a company undertake what looks like disparate product development, it too tends to make me worry since I always try to take the most basic approach to human nature. What I’ve seen others do. What I would do in a situation.
My instinct is that the Phase III development has stumbled onto a roadblock, significant enough to get the company to think about plans B, C, & D. It is what I expect coming out, and it at least tempers my thinking so I’m not downside surprised and I can be ready to move as needed.
On the other hand, still assuming this is the case, the leadership at this company undoubtedly believes in the efficacy of their technology and processes. Based on my layman’s knowledge of how stem cells work, it would make sense to me that many of the processes currently in Phase III trials are just as applicable in many other seemingly divergent areas.
Because the basis for the technology itself, stem cells, whether from muscle or fat, is not divergent at all. Depending on how they are cultured, stem cells may provide many of the same benefits we’re reading about in the cardiac trials.
A great example of how malleable or adaptable these cells really are is the article below just released a few days ago…
It demonstrates just how universal stem cells can be in treating ailments and aligns well with the strategy we’re now seeing Bioheart take.
These announcements would lead me to believe that researches at Bioheart are discovering that they can in fact transpose their techniques in the current trials to fit these vastly different ailments, and the common denominator is the stem cell.
I would also guess that safety results in Phase I trials from other efforts may be good indicators of expected early performance for some of the new trials coming out. But again, this is my guess from reading some of the trade rags, press releases and conferences I’ve listened to as an interested observer.
That said, if I’m the CEO of this company, I am definitely looking at these channels if I can afford them, they give us great press and market awareness, initial phases may not require as much human and financial resource allocation, and what ever is needed may be affordable internally.
I’m also looking at these based on expectations of what the FDA may move to approve in the midterm along with a view into how we can commercialize this ourselves, license the technologies domestically and abroad, and what kind of interest this would garner from other biotechs who might see Bioheart as an acquisition target for the intellectual properties they will have developed as this market segment comes closer to mainstream commercialization.
Net, IMO, I see this possibly as a short term strategy due to an imminent challenge or obstacle on the Phase III trial, but I also see an intelligent avenue of pursuit if management believes that the products they are offering truly have value in the market place.
Everything I’ve seen so far tells me that not only do they have the passion for what they’re doing; they also have the skills to get it done...
I hope that in the short-term I am pleasantly surprised and proven wrong, and that the Phase III trials show results are receive approvals well beyond what any of us could have imagined.
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