Saturday, June 25, 2022

US Stem Cell Inc (OTCMKTS:USRM) Explodes Higher Ahead of RMAT Decision

US Stem Cell Inc (OTCMKTS:USRM) is a penny player in the stem cell space that caught a massive jolt of bullish energy to start off this week. We didn’t see any clear new catalyst emerge, but the move likely hooks into the company’s near-term narrative, which is highly entangled with a decision of whether or not to approve the company’s application to the FDA for Regenerative Medicine Advanced Therapy (RMAT) Designation for the MyoCell product as part of its MARVEL trial.

According to a press release last month, “the trial had previously been placed on “Inactive Status” as patients were not actively being enrolled. A request was placed to the FDA to reactivate the protocol and consider the therapy for RMAT designation. We have recently heard from the FDA who has notified us that the protocol has been placed on “Reactivation Status” after reviewing 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.”

US Stem Cell Inc (OTCMKTS:USRM) bills itself as a company committed to the development of effective cell technologies to treat a variety of diseases and injuries. By harnessing the body’s own healing potential, we may be able to reverse damaged tissue to normal function.

U.S. Stem Cell’s discoveries include multiple cell therapies in various stages of development that repair damaged tissues throughout the body due to injury or disease so that patients may return to a normal lifestyle.

USRM is focused on regenerative medicine. While most stem cell companies use one particular cell type to treat a variety of diseases, U.S Stem Cell utilizes various cell types to treat different diseases. It is our belief that the unique qualities within the various cell types make them more advantageous to treat a particular disease.

According to company materials, “US Stem Cell, Inc. (formerly Bioheart, Inc.) is an emerging enterprise in the regenerative medicine / cellular therapy industry. We are focused on the discovery, development and commercialization of cell based therapeutics that prevent, treat or cure disease by repairing and replacing damaged or aged tissue, cells and organs and restoring their normal function. We believe that regenerative medicine / cellular therapeutics will play a large role in positively changing the natural history of diseases ultimately, we contend, lessening patient burdens as well as reducing the associated economic impact disease imposes upon modern society.”

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As noted above, the stock shifted into bull mode to start this week. However, traders are scrambling to uncover the catalyst for the move.

We would say the most likely catalyst has to do with expectations surrounding its application for RMAT status with the FDA. That was apparently expected to hit as a decision sometime in May. Today marks the outset of the new month, and we may have either rumors or speculation fueling the idea that one must not wait any longer if one wants to catch the action into that catalyst – the idea being, approval would seriously juice this stock higher.

Recent action has seen 33% piled on for shareholders of the company during the trailing week. This is emblematic of the stock. USRM has evidenced sudden upward volatility on many prior occasions. What’s more, the listing has benefitted from a jump in recent trading volume to the tune of 16% over what the stock has registered over the longer term.

According to the company, “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 trial publication.”

Earning a current market cap value of $44.2M, USRM has a reported chunk ($271K) of cash on the books, which compares with about $3M in total current liabilities. USRM is pulling in trailing 12-month revenues of $3.1M. In addition, the company is seeing major top line growth, with y/y quarterly revenues growing at 66.6%. We will update the story again soon as developments transpire. For continuing coverage on shares of $USRM stock, as well as our other hot stock picks, sign up for our free newsletter today and get our next hot stock pick!

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