US Stem Cell Inc (USRM)

[trading.jeff]

$USRM From the CEO's blog:

As many of you know, we have been working with the FDA regarding Regenerative Medicine Advanced Therapy (RMAT) designation for our MyoCell™ product. The RMAT process with the FDA has been quite cumbersome, time consuming and interactive as each request for additional information restarts the FDA’s 60-day clock—and the clock again restarting when we provided additional input on the $100,000,000 in clinical research we have invested on Myocell research thus far. As a small company with limited resources, this process has proven unsustainable until the FDA determines an equitable path for all companies applying—which is apparently not the case today. Even if approved for RMAT, we are still uncertain as to what the designation would mean for our company nor how we could benefit our patients in need. U.S. Stem Cell cannot afford to continue this undetermined path so at this time, we have decided not to further invest funds in pursuing RMAT Designation and instead focus on our in-clinic therapies for patients. According to the 21st Century Cures Act, the FDA has one year to issue draft guidance clarifying how the FDA will evaluate devices used in the recovery, isolation, or delivery of regenerative advanced therapies.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. Due to the uncertainty of this program, we feel that our shareholders and patients will be better served if we focus our efforts on therapies that benefit patients RIGHT NOW. For this reason, we will instead focus on our revenue generating programs which have successfully helped over 7,000 patients. We at US Stem Cell Inc are very bullish on newly appointed FDA commissioner Scott Gottlieb as he promises to be a transformational leader for both the FDA and the progress of stem cell solutions for patients in need. See his article on the subject here http://www.aei.org/publication/the-fda-wants-to-regulate-your-cells/

Our 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. We are currently expanding and opening additional clinics throughout the U.S. to offer these cutting-edge technologies to more patients. We are thrilled to see the excitement about our technologies and will continue to pave the future of medicine. Our shareholders demand that we focus our resources on helping patients in need TODAY—and we agree.

http://us-stemcell.com/en/june-is-off-to-an-amazing-start/