Dear Shareholders and Friends,
U.S. Stem Cell, Inc. has seen many exciting accomplishments in April. We have curated new partnerships, finalized investments, and received updates on our RMAT designation from the Food and Drug Administration (FDA).
We have recently partnered with Advanced Stem Cell RX in a strategic alliance to commercialize our proprietary applications and protocols. Advanced Stem Cell RX will aid us in implementing U.S. Stem Cell, Inc. programs into qualified practices and clinics in over 20 different states. They will be utilizing our technology to treat patients suffering from degenerative disorders.
On January 27, 2017, U.S. Stem Cell, Inc. applied for the FDA’s new Regenerative Medicine Advanced Therapy (RMAT) designation for the MyoCell™ product as part of the MARVEL trial. After application, the FDA is given 60 days to review it or request additional information. In late March, the FDA requested additional information in order to reinstate our IND (MARVEL trial)—which has been reinstated to active status. Please note that each time more information is requested, the 60-day timeline resets and the FDA is afforded additional regulatory processing time. Currently, U.S. Stem Cell, Inc. is operating within the regulatory timeline and is actively working with the FDA to quickly and effectively fulfill requests for supplementary materials. We will continue to keep our base informed on any FDA communications that affect this timeline.
Read more here: https://goo.gl/K5pvvt
Recently, we announced a new commitment from private equity firm General American Capital Partners (GACP) to invest up to $5 million in U.S. Stem Cell, Inc. in exchange for up to 63,873,275 shares of common stock. GACP has been an avid supporter of U.S. Stem Cell, Inc. and the regenerative medicine industry. We are working together to open Stem Cell Centers of Excellence and to expand our tissue banking facility. With help from companies like GACP, we get closer to our goal of making regenerative medicine more accessible and available to patients all over the world.
Continue reading: https://goo.gl/EFsmrv
Our Chief Science Officer Kristin Comella was featured in Hartman Media’s podcast, “The Longevity and Biohacking – Using Stem Cells to Give Yourself a Better Life.” Kristin was invited to share insights about stem cell treatments and how they can benefit patients suffering from degenerative conditions.
Listen to the podcast here: https://goo.gl/CGtw2U
U.S. Stem Cell, Inc. is committed to the continued development of regenerative medicine technologies and protocols, with our ultimate goal being to make our therapies as accessible as possible to patients around the world. With a strong focus on new, life-changing treatments, our advancements and innovations continue. Stay tuned below to our latest efforts by following us and our various divisions on social media.
Warmest regards,
Mike Tomás
President & CEO