US Stem Cell Inc (OTCMKTS:USRM) Receives Investment and FDA Reactivation Status, Shares Could Start Building Momentum Again


US Stem Cell Inc (OTCMKTS:USRM) shares have been up over 4,000% in a three-month period recently, and USRM could continue to build momentum, off of its recent positive catalysts. Prior to this, we examined US Stem Cell Inc and indicated why the stock could continue its meteoric rise. For those of you who haven’t been following us or missed out on USRM’s recent developments, you’ll probably need some background on the company.


US Stem Cell, Inc is an emerging enterprise in the regenerative medicine, as well as cellular therapy industry. The company is focused on the discovery, development, and commercialization of cell-based therapeutics that could potentially prevent, treat, or cure various diseases by repairing and replacing damaged or aged tissue, cells and organs and restoring their normal function. US Stem Cell Inc’s business currently includes three operating divisions: US Stem Cell Training, Vetbiologics, and US Stem Cell Clinic.


Let’s move on to some company news.US Stem Cell Inc (OTCMKTS:USRM) recently received a commitment to invest up to $5M,  from private equity firm General American Capital Partners LLC (GACP). Now, this investment would be in exchange for up to 63.87M shares of common stock.


According to Joseph DaGrosa, Jr., a Principal with General American Capital Partners, “We see exponential growth in the stem cell industry, estimated to grow to $170 billion by 2020…We are very pleased to join forces with U.S. Stem Cell, Inc., a leader in regenerative medicine solutions, to help expand our role in this important market.”


With this commitment, US Stem Cell could benefit significantly, and potentially use those proceeds to invest in R&D. In turn, this could be a key a driver of its stock price and revenue.


According to Mike Tomas, President and CEO of U.S. Stem Cell, Inc. “Patient demand for regenerative medicine procedures as a viable alternative to surgery, as well as the transformative capacity of stem cell therapies, are leading the way to increased acceptance by both the medical and regulatory communities.”


The company also recently announced it received reactivation status of the MARVEL Phase II / III trial with the U.S. Food and Drug Administration (FDA).


Now, after the passing of the 21st Century Cures Act, U.S. Stem Cell applied to the FDA for Regenerative Medicine Advanced Therapy (RMAT) Designation for its MyoCell product, as part of the MARVEL trial.


However, the trial was previously placed on “Inactive Status” since patients were not actively being enrolled. U.S. Stem Cell placed a request to the FDA to reactivate the protocol and consider the therapy for RMAT designation. The company recently heard back from the FDA, and it has notified USRM that the protocol has been placed on “Reactivation Status” after the FDA reviewed details on the protocol and data collected on patients to date. The FDA has also notified us that they are still reviewing our submission for RMAT.


According to U.S. Stem Cell, “Thanks to the REGROW component of the Cures Act, the FDA will grant RMAT 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. U.S. Stem Cell, Inc. believes that our MyoCell product meets these requirements as we have demonstrated clinical efficacy in both preclinical and clinical studies including our most recent MARVEL trial publication.”


These positive catalysts that USRM recently had could continue to cause the stock to build momentum. Don’t worry if you missed this news, because the company could announce more developments in the future. However, if you don’t want to miss any more news on USRM, you could consider signing up to our free newsletter. It’s simple and easy. You just have to provide us with your email address, and we’ll provide you with developments, if any, in USRM.


Disclosure: No one at Street Register has been compensated in any way for the publishing of this article, nor do we hold any position in USRM stock, short or long.