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U.S. Stem Cell Inc. (USRM)

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http://us-stemcell.com/en/home-2/
http://stemcellcoe.com
http://usstemcellclinic.com/en/home/
https://www.usstemcelltraining.com
http://www.vetbiologics.com



A COMMITMENT TO EXCELLENCE

US. Stem Cell, Inc. is committed to the discovery and development of autologous cellular therapies to treat a variety of degenerative diseases, as well as the continuation of our ongoing research for the treatment of heart failure, cardiovascular and perioheral vascular disease. 

 


The US. Stem Cell Inc. Vision
Our vision is to improve the quality of patients’ lives, while reducing hospitalizations and healthcare costs. 
Bioheart is and will continue to be recognized by physicians and patients as the world’s leader in providing 
innovative treatment and management of patients with severe cardiovascular and peripheral vascular 
disease. We are also focused on the discovery, development and commercialization of autologous cell therapies 
for the treatment of degenerative diseases.

 

.

Management:

Mike Tomás

President & CEO

Mike Tomas. Mr. Mike Tomas was appointed President and Chief Executive Officer and a member of our Board of Directors on June 19, 2010. Mike Tomas was appointed as the Company’s President and Chief Executive Officer, and as a director on June 19, 2010. Mr. Tomas has been President for the past nine years of The ASTRI Group, an early stage private equity investment company in Florida with an investment in Bioheart since 2001. In 2003, he joined Bioheart’s Board of Directors as the independent representative of The ASTRI Group. ASTRI provides capital, business development and strategic marketing support to emerging private companies. Mr. Tomas will continue to serve as President of The ASTRI Group. Previously from 1983 to 2001, Mr. Tomas held ascending executive positions including Chief Marketing Officer at Avantel, a $1 billion dollar joint venture with MCI. Upon retiring from MCI and WorldCom, Tomas joined other ex-MCI executives and helped raise $40M in venture capital to form Ineto, an integrated customer communications software solution that was successfully sold in 2001.
 
Mr. Tomas sits on the boards of Avisena (revenue cycle management company for medical practices), SilverSky (fka Perimeter Internetworking) (SaaS/managed security services provider for medical practices and financial institutions), Rokk3r Labs (a digital and mobile products developer and portfolio), Bioheart (adult stem cell development for heart muscle tissue repair) and is the current chairman of Florida International University’s Global Entrepreneurship Center. He is an inductee into the Miami-Dade College and WACE Halls of Fame for business, an FIU Torch Award winner — and winner of top communications, medical innovations, education and entrepreneurial awards. Mr. Tomas holds a Masters of Business Administration from the University of Miami and a Bachelor’s degree from Florida International University.
 

Kristin Comella

Chief Scientific Officer

Kristin Comella. Ms. Comella was appointed Chief Scientific Officer in September 2010. Ms. Comella has served as our Vice President of R&D and Corporate Development since December 2008 and has played a major role in managing our product development, manufacturing and quality systems since joining Bioheart in 2004. Ms. Comella has 15 years of industry experience with expertise in regenerative medicine, training and education, research and product development, and currently serves on multiple advisory boards in the stem cell arena. Ms. Comella has many years of cell culturing experience including building and managing the stem cell laboratory at Tulane University's Center for Gene Therapy and developing stem cell therapies for osteoarthritis at Osiris Therapeutics. Ms. Comella holds an M.S. in Chemical Engineering from The Ohio State University and a B.S. in Chemical Engineering from the University of South Florida.  On March 12, 2013, Kristin Comella was appointed to serve as a member of our Board of Directors.
 

Dr. William P. Murphy, Jr.

William P. Murphy, Jr., M.D. Dr. Murphy has served as a member of our Board of Directors since June 2003. Dr. Murphy founded Small Parts, Inc., a supplier of high quality mechanical components for design engineers, in 1964 and served as its Chairman until his retirement in April 2005. Small Parts, Inc. was acquired by Amazon.com, Inc. in March 2005. From October 1999 until October 2004, Dr. Murphy served as the Chairman and Chief Executive Officer of Hyperion, Inc., a medical diagnosis company which had an involuntary bankruptcy filed against it in December 2003. Dr. Murphy is the founder of Cordis Corporation (now Cordis Johnson & Johnson) which he led as President, Chairman and Chief Executive Officer at various times during his 28 years at Cordis until his retirement in October 1985. Cordis Johnson & Johnson is a leading firm in cardiovascular instrumentation. Dr. Murphy received an M.D. in 1947 from the University of Illinois and a B.S in pre-medicine from Harvard College in 1946. He also studied physiologic instrumentation at Massachusetts Institute of Technology, or MIT. After a two year rotating internship at St. Francis Hospital in Honolulu, he became a Research Fellow in Medicine at the Peter Bent Brigham Hospital in Boston where he was the dialysis engineer on the first clinical dialysis team in the United States. He continued as an Instructor in Medicine and then a research associate in Medicine at Harvard Medical School. Dr. Murphy is the author of numerous papers and owns 17 patents. He is the recipient of a number of honors, including the prestigious Lemelson-MIT Lifetime Achievement Award, the MIT Corporate Leadership Award, the Distinguished Service Award from North American Society of Pacing and Electrophysiology, and the Jay Malina Award from the Beacon Council of Miami, Florida. He is also a member of the Inventors Hall of Fame
 

 

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
     
     

 

 

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.


Business Strategy

 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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USRM News: Quarterly Report (10-q) 11/07/2017 04:04:52 PM
USRM News: Current Report Filing (8-k) 09/13/2017 09:01:32 AM
USRM News: Initial Statement of Beneficial Ownership (3) 09/01/2017 04:06:18 PM
USRM News: Statement of Changes in Beneficial Ownership (4) 09/01/2017 04:04:29 PM
USRM News: Statement of Changes in Beneficial Ownership (4) 09/01/2017 04:02:44 PM
PostSubject
#85904  Sticky Note Stem Cell Testimonials and info: http://usstemcellclinic.com/testimonials/ Form MyzStreet 12/17/17 08:45:11 AM
#85293  Sticky Note $USRM in 1 year has ~X3 Profits,~X2 revenues,~X4 GoldenMind 12/04/17 04:27:33 PM
#84213  Sticky Note MUST READ: After some heavy research I came StemCellJunkie 11/22/17 07:13:38 PM
#79439  Sticky Note BOARD WARNING: Please Read IH Geek [Dave] 09/14/17 12:53:48 PM
#78232  Sticky Note Official response to FDA Warning Letter. http://usstemcellclinic.com/fda-respon Deal McMogulson 08/29/17 02:42:32 PM
#87320   RMAT FDA Approval here we come! $USRM $$IsEverything$$83 01/19/18 04:19:06 AM
#87319   $USRM https://www.prnewswire.com/news-releases/usrm-reaches-key-sales-milestone- $Pistol Pete$ 01/19/18 12:44:06 AM
#87318   Just in case anyone missed it Afterhoursearnings3 01/19/18 12:40:11 AM
#87317   I always love reading that article, thanks again GoldenMind 01/19/18 12:17:31 AM
#87316   What the FDA Crackdown on Stem Cells Means KRex0969 01/18/18 11:02:04 PM
#87315   NEW FLORIDA LAW...WILL "CRACK DOWN" on STEM CLINICS... Hornet Driver 01/18/18 10:42:20 PM
#87314   FDA STARTS 2018 w/ "SVF" WARNING LTR... Hornet Driver 01/18/18 10:36:20 PM
#87313   Outrage of the Month: Illegal Stem Cell Treatments.. Hornet Driver 01/18/18 10:32:07 PM
#87312   Comella BEGS FOR "LEGAL DEFENSE FUNDS"...WTH...???? Hornet Driver 01/18/18 10:30:38 PM
#87311   FDA.."SVF" from fat is a "DRUG" CASE CLOSED.. Hornet Driver 01/18/18 10:29:08 PM
#87310   Love it, after hours! Bam! TruthSpeaker12 01/18/18 10:11:17 PM
#87309   Do your own DD. NoMoDo 01/18/18 09:31:26 PM
#87308   Ichimoku cross in the cloud- bullish Afterhoursearnings3 01/18/18 09:27:45 PM
#87306   $1 on the way looks like, and it's GoldenMind 01/18/18 08:05:23 PM
#87305   Invest or dont. In the days and weeks Afterhoursearnings3 01/18/18 04:38:22 PM
#87304   Look man...so do all of us. Stem cells Afterhoursearnings3 01/18/18 04:25:30 PM
#87303   Because I have a life and responsibilities. I tqipres 01/18/18 04:23:24 PM
#87302   It was after the FDA letter. He stated JPL1868 01/18/18 04:08:19 PM
#87301   Why? Because he is dealing with the issue Afterhoursearnings3 01/18/18 04:07:46 PM
#87300   Fomo is a terrible thing to have Rinkydink 01/18/18 04:06:12 PM
#87299   Here is the bottom line here. Whatever the Afterhoursearnings3 01/18/18 04:03:51 PM
#87297   Buy em up. MyzStreet 01/18/18 03:55:54 PM
#87295   Look, I’ve lost trust in the guy. He tqipres 01/18/18 03:48:28 PM
#87294   Boom? lol. Boom where? fourcloze 01/18/18 03:45:57 PM
#87293   Stem cells on joe rogan today!! Gonna be Afterhoursearnings3 01/18/18 03:44:50 PM
#87292   That was before the fda letter. My point tqipres 01/18/18 03:44:43 PM
#87291   The CEO blog and PRs have mentioned that JPL1868 01/18/18 03:29:09 PM
#87290   BOOM! TruthSpeaker12 01/18/18 03:26:11 PM
#87289   Dude...email mike and ASK! Afterhoursearnings3 01/18/18 03:22:26 PM
#87288   Nice bid. I don't think that one Atom Smasher 01/18/18 03:22:07 PM
#87287   What proof do you have? tqipres 01/18/18 03:19:28 PM
#87286   Hour of power is upon us...lets get over Afterhoursearnings3 01/18/18 03:17:45 PM
#87285   Thi$ Train is about to leave the station MCMarketShare 01/18/18 03:08:33 PM
#87284   Big money coming in now. It's about to $$IsEverything$$83 01/18/18 03:07:00 PM
#87283   RMAT is definitely still in the works. $$IsEverything$$83 01/18/18 03:05:15 PM
#87282   So, is rmat not a possibility any longer? tqipres 01/18/18 02:58:58 PM
#87281   Money being made here 4toSchool 01/18/18 02:52:26 PM
#87280   The swings today phew getting whipsawed Rinkydink 01/18/18 02:48:12 PM
#87279   Well 2... or 6. The next report NoMoDo 01/18/18 02:17:53 PM
#87278   Just hold your shares! In about 2 weeks Neco batmaz 01/18/18 02:12:14 PM
#87276   Well said Carl. NoMoDo 01/18/18 01:38:07 PM
#87274   Market makers looking to trade back through .039 Afterhoursearnings3 01/18/18 01:16:14 PM
#87273   IMO the sp has been rising the last Atom Smasher 01/18/18 01:14:54 PM
#87270   Yea I wont be selling until fair value Afterhoursearnings3 01/18/18 01:10:23 PM
#87269   Oh no. It wasn't me. I'll Atom Smasher 01/18/18 01:08:54 PM
#87266   Bid COLLAPSE .0380, looks like mini PUMP OVER.... Hornet Driver 01/18/18 01:04:54 PM
#87265   There will just be another wall waiting Atom Smasher 01/18/18 01:02:56 PM
#87264   Less than a 20k slap gets us past Afterhoursearnings3 01/18/18 12:57:33 PM
#87263   Gap filled...time to break .045 folks...last few shares Afterhoursearnings3 01/18/18 12:54:01 PM
#87262   Just a quick question board - Stemcell treatment HeadHunter 01/18/18 12:50:02 PM
PostSubject