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U.S. Stem Cell will expand an additional 12 stem cell treatment centers and clinics in the US.
U.S. Stem Cell (OTCQB:USRM) will expand an additional 12 stem cell treatment centers and clinics in the US.
As quoted in the press release:
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According to the 21st Century Cures Act, within one year of enactment, the FDA must issue draft guidance clarifying how the FDA will evaluate devices used in the recovery, isolation, or delivery of regenerative advanced therapies.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.
Click here to read the full press release.
Source: www.accesswire.com