On regulatory news, following the passing of the 21st Century Cures Act, U.S. Stem Cell, Inc. has applied to the FDA for Regenerative Advanced Therapy or RAT Designation. Thanks to the REGROW component of the Cures Act, The FDA will grant RAT designation for a regenerative medicine therapy that is intended to treat, modify, reverse, or cure a serious or life-threatening disease and demonstrates preliminary clinical evidence that the product has the potential to address unmet medical needs for a disease. We believe that our MyoCell® product meets these requirements as we have demonstrated clinical efficacy in both preclinical and clinical studies including our most recent MARVEL Phase II/III trial. If RAT designation is granted, this could expedite the approval process with the FDA. More information on the FDA’s new RAT Designation can be found here: https://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ucm537670.htm
Promising Results from Company’s MARVEL Trials on MyoCell The company recently announced positive clinical results for MyoCell following the first part of its Phase II/III, double-blinded, placebo-controlled clinical trial called MARVEL. Over the 6-month observation period in this trial, the most pronounced changes were seen in the cell-treated groups. The six minute walk distance (6MWD), an established parameter of efficacy utilized in heart failure studies, one of the primary end points in the trial, increased on average by more than 91 meters, or 35%, in cell-treated patients, whereas in the placebo-treated group a decrease of nearly 4 meters was seen. This suggests that patients with heart failure could return to a more active lifestyle after receiving Bioheart’s treatment. No stem cell related safety issues such as arrhythmias, or irregular heartbeat, were observed. An arrhythmia event is disturbing but not serious. In the MARVEL trial pre-treatment with amiodarone enabled patients to avoid arrhythmias.
3 YEAR Clinical TRIAL Approaching Completion Date: estimated March 2017 Official Title: An Open Label, Non-Randomized, Multi-Center Study To Assess The Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered Intra-Discally in Patients With Degenerative Disc Disease https://clinicaltrials.gov/show/NCT02097862
On January 19, 2017, the United States Food and Drug Administration (“FDA”) unveiled a new drug designation process for regenerative advanced therapies, an important first step toward implementation of the regenerative medicine provisions of the 21st Century Cures Act.
A world leader in research and development of stem cell and regenerative medicine treatments for patients with degenerative conditions. Pioneered new applications for diseases and developed more than 30 protocols. http://us-stemcell.com/en/products/
U.S. STEM CELL, INC. provides accredited training programs in regenerative medicine to physicians throughout the world. https://www.usstemcelltraining.com/
Hungry...good post reminding folks about the potential for buyout...however, I am still wary about the fact they had to dilute 4 fold just to get rid of a few thousand $ in convertibles...you or anyone out here have a good explanation for that ? I know the future looks bright, but the future is just that...anything can happen, even bankruptcy (if FDA rejects)...the present and near past is what is hard to explain for me...
$500 M is too much, IMO, for a market valuation in a buyout (I can't guess as to how much, but $500 seems high to me), but I honestly see no way USRM doesn't get bought out soon. Too much evidence to suggest they want to sell, and I think all of the recent filings and releases suggest, to me at least, that they are getting everything in order to proceed with a deal.
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