The unproven stem cell clinic firm US Stem Cell Inc. is in a world of hurt.
If a federal judge says you can no longer sell your key commercial offering, how do you survive as a company? US Stem probably has been thinking about that possibility for months. Still, it’s not yet clear where the company goes from here now that this has become a reality.
Where do things stand looking ahead?
There’s financial pressure.
The company’s stock ($USRM) has been a penny stock for a while, but lately it’s been sub-one cent and trending downward. I’m not a stockbroker, but even I know that can’t be good.
I’m also not an attorney, but I can figure out that patient lawsuits against the company have also probably taken a toll over the last few years, mostly via confidential settlements.
The federal district judge who imposed the permanent injunction on USRM also indicated all stock of the unapproved fat stem cell drug product the company had been making, called stromal vascular fraction (SVF) must be destroyed. In my view this is another big hit to the company. Many customers appear to have paid USRM to bank and store SVF in cryofreezers for them. Now that a judge has ordered that material destroyed due to the decisions the company made, will USRM have to refund the stem cell banking fees to the customers? It seems like a possibility and if not, then there could be a lot of angry customers.
USRM sent out an email to customers about this specific problem (see at right). My sense is that the email reflects a hope that the court might allow customers to obtain their SVF if enough complain. However, since SVF is a drug that wasn’t made in an FDA-compliant manner, to me this seems like a long shot. The court has to realize that if released to customers, some of them would be likely to have the unapproved drug injected by other physicians. Others might even try self-injection in rare instances. Is a court really going to facilitate that use of an unapproved drug product?
USRM leader Kristin Comella published an opinion piece in the conservative Washington Times a few days ago, arguing USRM’s case about the FDA and the court decision. As a stem cell biologist I disagree with a lot in the piece.
This sentence, for instance, seems to me to have some hype in it, “While no medical procedure is without risk, dozens of peer reviewed papers have demonstrated safety and efficacy. Patients are getting better; they’re getting out of wheelchairs, off pharmaceutical medications and breathing on their own.”
There is also no mention of the patients who went to USRM and apparently lost vision.
I’m wondering if USRM will appeal the court decision and perhaps spend the big money required going down that path. Or might they instead focus on reinventing their offerings? Both?
Overall, it seems that USRM may try to switch over to either bone marrow-related or other types of injections to take the place of the SVF.
Will the switch save the company?