Executive Officers and Directors
Set forth below is information regarding our executive officers and directors as of December 31, 2013
|Mike Tomas ||48 ||Director, President and Chief Executive Officer, Chief Financial Officer |
|William P. Murphy, Jr., M.D. ||90 ||Director, Chairman of the Board |
|Mark P. Borman ||59 ||Director |
|Gregory Knutson ||59 ||Director |
|Kristen Comella ||37 ||DirectorChief Scientific Officer |
|Sheldon T. Anderson ||63 ||Director |
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About U.S. Stem Cell, Inc.
US Stem Cell, Inc. (formerly Bioheart, Inc.) is an emerging enterprise in the regenerative medicine / cellular therapy industry. We are focused on the discovery, development and commercialization of cell based therapeutics that prevent, treat or cure disease by repairing and replacing damaged or aged tissue, cells and organs and restoring their normal function. We believe that regenerative medicine / cellular therapeutics will play a large role in positively changing the natural history of diseases ultimately, we contend, lessening patient burdens as well as reducing the associated economic impact disease imposes upon modern society.
Our principal objective is to become a leading regenerative medicine company that discovers, develops and commercializes novel, autologous cell therapies, and related devices, for the treatment and improved care of patients suffering from chronic and acute heart damage as well as lower limb ischemia. Our secondary objective is the discovery, development and commercialization of autologous cell therapies for the treatment of degenerative diseases. The number of heart failure patients is expected to increase from 25 million worldwide today to over 50 million in five years. Our focus is on serving these patients. To achieve our primary objective, we plan to pursue the following strategies:
- - Obtain initial regulatory approval of MyoCell and/or MyoCell SDF-1 by targeting patients with severe heart damage.
- Continue existing studies with adipose derived stem cells and endothelial progenitor cells.
- Continue to develop our pipeline of cell-based therapies and related devices for the treatment of chronic and acute heart damage.
- Develop our sales and marketing capabilities.
- Continue to refine our MyoCell and MyoCell SDF-1 cell culturing processes.
- Expand and enhance our intellectual property rights.
- License, acquire and/or develop complementary products and technologies.
Sunrise, FL – April 10, 2017 – U.S. Stem Cell, Inc. (USRM), a Florida corporation and leader in novel regenerative medicine solutions and physician-based stem cell therapies for human and animal patients, has received reactivation status of the MARVEL phase II/III trial.
Following the passing of the 21st Century Cures Act, U.S. Stem Cell, Inc. has applied to the FDA for Regenerative Medicine Advanced Therapy (RMAT) Designation for the MyoCell product as part of the MARVEL trial. Our trial had previously been placed on “Inactive Status” as patients were not actively being enrolled. We placed a request to the FDA to reactivate the protocol and consider the therapy for RMAT designation. We have recently heard from the FDA who has notified us that the protocol has been placed on “Reactivation Status” after reviewing details on the protocol and data collected on patients to date. The FDA has also notified us that they are still reviewing our submission for RMAT. Thanks to the REGROW component of the Cures Act, The FDA will grant RMAT 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 trial publication (review full publication here: https://www.ncbi.nlm.nih.gov/pubmed/21982657). If RMAT designation is granted, this could expedite the approval process with the FDA.
More information on the FDA’s new RMAT Designation can be found here: https://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ucm537670.htm
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