Dear shareholders and friends,
U.S. Stem Cell, Inc. is off to a great start this year! We broke ground on our first clinic in the Middle East, presented at several industry conferences and signed several new agreements that will help us expand our business.
Our recent agreement with High Rising Group to open clinics throughout the Middle East, including Kuwait, Dubai, and Qatar is moving forward. Our first new clinic, located in Kuwait City, is currently under construction and we are scheduled to be fully operational before the end of the year. Read more about the launch of U.S. Stem Cell, Inc. in the Middle East here: https://us-stemcell.com/en/u-s-stem-cell-inc-announces-launch-of-us-stem-cell-middle-east/
Demonstrating a progressive step forward, a member of NorthStar Biotech LLC, Greg Knutson, joins the US Stem Cell Inc’s Board of Directors just as the two companies have amicably settled a legal dispute related to NorthStar’s preferred shares. We are extremely pleased to have Mr. Knutson join us as he has been a longtime supporter of U.S. Stem Cell and brings a wealth of entrepreneurial and business acumen to our team. Mr. Knutson will assist us in continuing our recent technological advances and developments alongside our financial accomplishments. Read more here: https://us-stemcell.com/greg-knutson-joins-u-s-stem-cell/
As we recently announced via 8K, we are also working with General American Capital Partners (GACP) to open 10 new clinics in the U.S. called Stem Cell Centers of Excellence. We are excited to help GACP provide stem cell services to new patients in a variety of metropolitan areas over the next three years. In addition, we have entered into an agreement with GACP which will allow for growth of the tissue banking facility. Read more about the agreement with GACP here: https://www.sec.gov/Archives/edgar/data/1388319/000118518517000536/usstemcell8k030817.htm
In conference related news, in January, our Chief Scientific Officer and world renowned stem cell expert, Kristin Comella, presented at the Cell and Gene Therapy World 2017 conference. Hosted by Phacilitate, the three-day event featured a variety of topics and sessions covering the world of regenerative medicine.
In February, we participated in the annual Academy of Regenerative Practices conference (www.regenerativeacademy.com). Scientists and physicians from around the world shared their knowledge and insights in the regenerative medicine field. Ms. Comella presented our latest clinical results and discussed the current regulatory environment. In addition, Dr. Robert Silbert presented the results from our degenerative disc trial. Patients in that trial demonstrated significant improvements after injection of adipose stem cells into their backs. Read more here: https://us-stemcell.com/en/cso-kristin-comella-publishes-paper-on-the-implantation-of-stromal-vascular-fraction-in-patients-with-degenerative-disc-disease/
This month, Kristin Comella was also featured on the 30/30 HEALTH podcast to discuss adipose-derived stem cells, including how and when they are used. Her interview with Guillermo Ruiz is available in its entirety here: http://3030health.libsyn.com/podcast/episode-06-an-interview-with-kristin-comella
On regulatory news, following the passing of the 21st Century Cures Act, U.S. Stem Cell, Inc. has applied to the FDA for Regenerative Advanced Therapy or RAT Designation. 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 Phase II/III trial. If RAT designation is granted, this could expedite the approval process with the FDA. More information on the FDA’s new RAT Designation can be found here: https://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ucm537670.htm
For financial news, refer to the 2016 10K to be filed this month.
As always, we are committed to the development of pioneering regenerative medicine technologies and techniques with our goal being able to reach as many patients around the world as possible. U.S. Stem Cell, Inc. is committed to new, life-changing treatments. Please stay tuned to our latest efforts and advancements by following us and our divisions on social media below.
Warmest regards,
Mike Tomás
President & CEO