We’ve talked about US Stem Cell Inc (OTCMKTS:USRM) quite a bit here on Street Register in the past, and we wanted to swing back around and catch it again today on the heels of an important press release.
In fact, there have been two notable announcements in just the past week, one of which referring to aggressive clinical expansion plans, and the other, to accolades received by a member of USRM management.
Starting with the new news and working our way back, US Stem Cell Inc (OTCMKTS:USRM) has just announced an aggressive plan to expand an additional 12 stem cell treatment centers and clinics in the US. U.S. Stem Cell has been in discussions with the FDA regarding Regenerative Medicine Advanced Therapy (RMAT) Designation for the Myocell product and at this time, the company has decided not to further invest in RMAT Designation and instead invest and focus on our in-clinic therapies for patients.
According to the 21st Century Cures Act, within one year of enactment, the FDA must issue draft guidance clarifying how the FDA will evaluate devices used in the recovery, isolation, or delivery of regenerative advanced therapies. Until this guidance document is published, it is unclear how this regulation will affect the MyoCell program. Until then, U.S. Stem Cell will focus on opening new clinics around the country to better serve patients in need.
In addition to the original Sunrise clinic (that has successfully treated hundreds of patients and generated over $2m in revenues in the past 12 months alone), recent clinic openings include Miami and Palm Beach, Florida. Upcoming openings include Dallas, Texas (thanks in part to the early adoption of patient rights by the State of Texas), Chicago, Atlanta, and Denver – as well as other clinics in the northeast and the west coast.
To be clear, U.S. Stem Cell will focus on revenue generating programs that are treating patients NOW–which have successfully helped over 7000 patients thus far. The company was founded in 1999 and has completed more clinical treatments (for both humans and animals) than any other regenerative medicine company in the world. In addition to efforts at US Stem Cell Training and VetBiologics, the company’s focus will be expanding and opening additional clinics throughout the U.S. to offer these cutting-edge technologies to more patients. (Source: Accesswire via OTC Disclosure & News Service)
We also mentioned another bit of press concerning a member of the USRM management team. A scientific paper about intramyocardial implantation co-authored by Kristin Comella, Chief Science Officer at USRM, has been recognized as one of the most influential articles of 2016 for the Journal of Translational Medicine, according to Altmetric.com.
Comella is a world-renowned expert on regenerative medicine with a focus on adipose derived stem cells. She was named number 24 on Terrapin’s list of the Top 50 Global Stem Cell Influencers and number 1 on the Academy of Regenerative Practices list of Top 10 Stem Cell Innovators. Comella has pioneered stem cell therapies from various sources including cord blood, bone marrow, muscle, and adipose. She led the team that gained the first ever FDA approval for a clinical trial using a combined cell and gene therapy product in the heart. (Source: Accesswire via OTC Disclosure & News Service)
In terms of USRM stock itself, it has actually gotten hammered recently, and there seems a very good chance of seeing a rebound play at some point so we will want to keep our eyes peeled for that. Want to follow along USRM’s progress with us? Just stay locked to Street Register for updates, and we’ll deliver important developments on USRM as they unfold. In the meantime, if you’ve yet to sign up for our 100% free newsletter, do so now! Just enter your active email address into the box below and submit!
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.