US Stem Cell Inc (OTCMKTS:USRM) shares have been up significantly recently, but it has pulled back a little. However, it looks like that recent meteoric rise could still continue. In three months recently, USRM returned over 4,000%, and it could continue higher. This is primarily due to a potential strategic alliance and working with the FDA.
If you haven’t heard of US Stem Cell Inc, it’s a stem cell-related company committed to developing effective cell technologies to potentially treat various injuries and diseases. U.S. Stem Cell Inc believes that humans could potentially reverse damaged tissue to normal function, leveraging the body’s own healing potential. The company’s discoveries include cell therapies in multiple stages of development that aims to repair damaged tissues, which could potentially allow patients to return to a “normal” lifestyle. Some stem cell companies primarily focus on one type of cell, while U.S. Stem Cell uses various cell types in order to treat different diseases.
US Stem Cell Inc (OTCMKTS:USRM) recently announced it was working closely with the FDA in order to obtain regenerative advanced therapy designation. After the passing of the 21st Century Cures Act US Stem Cell Inc applied to the FDA for the Regenerative Advanced Therapy Design (RAT) Designation.
According to US Stem Cell Inc, “e have recently heard from the FDA, who has requested additional information regarding the MARVEL Phase II/III trial. We have provided all requested information to the FDA and are hopeful that the FDA will continue their expeditious review of our MyoCell product. 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 (review full publication here: https://www.ncbi.nlm.nih.gov/pubmed/21982657). If RAT designation is granted, this could expedite the approval process with the FDA.”
Additionally, U.S. Stem Cell Inc and Advanced Stem Cell Rx recently announced they developed a strategic alliance together. Advanced Stem Cell Rx is a U.S.-based provider of regenerative medicine programs, which includes the development of autologous stem cell treatment centers throughout the U.S. According to Managing Director of Advanced Stem Cell Rx Dr. J.S. Landow, “Stem cells are critical to our survival and at the core of our regenerative and healing powers. They will play an immense role in redefining the preferred treatment method for the majority of diseases commonly afflicting mankind. We, at ASC, are proud to form a strong alliance with US Stem Cell Inc., one of the oldest and most respected stem cell research and therapy companies in the world.”
In addition to these company developments, U.S. Stem Cell Inc also released its full year fiscal 2016 financial results recently. The company has been working with its partners in order to offer over 30 protocols to patients. US Stem Cell Inc was able to grow its revenue by 38% year over year, to $3.03M in 2016, from $2.2M in 2015. US Stem Cell Inc was able to end the year cash positive due to its operations in 2016. This was the first time in the company’s history to end on a cash positive note, which may be indicating the company could start spending on R&D and potentially increase its revenues and earnings.
According to President and Chief Executive Officer of U.S. Stem Cell Inc, Mike Tomas, “U.S. Stem Cell, Inc. continues to increase revenue, decrease liabilities, and decrease operating expenses.”
That in mind, US Stem Cell Inc could be poised rise due to these recent developments. The strategic alliance and its announcement that its working closely with the FDA should propel the stock higher, despite pulling back recently. Your going to want to keep up to speed on USRM since it could rebound at anytime. To stay up to date, all you have to do is enter your email to subscribe to our free newsletter, and you will get updates on developments, if any, on USRM.