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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: 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
USRM News: Statement of Changes in Beneficial Ownership (4) 08/25/2017 04:07:27 PM
PostSubject
#79439  Sticky Note BOARD WARNING: Please Read IH Geek [Dave] 09/14/17 12:53:48 PM
#79194  Sticky Note SO TO RECAP: COMPANY ON THE CUTTING EDGE OF docprep 09/11/17 02:12:05 PM
#78232  Sticky Note Official response to FDA Warning Letter. http://usstemcellclinic.com/fda-respon Deal McMogulson 08/29/17 02:42:32 PM
#75686  Sticky Note US STEM CELL UPDATE 8/8/2017 8:14:40 pm Eastern GoldenMind 08/08/17 08:14:43 PM
#72621  Sticky Note MYOCELL CLINICAL TRIALS, SIX PATIENT DEATHS !! Hornet Driver 06/29/17 10:22:27 AM
#81799   People realizing what is happening here. Insane the GoldenMind 10/22/17 02:41:41 PM
#81798   I agree lots of good things happening behind sorc92 10/22/17 02:18:46 PM
#81797   Should be a $.50-1.00 stock in a year. Tsunamieater 10/22/17 01:02:58 PM
#81796   Lol good to know, love the nickname wild StarGazer777 10/22/17 12:50:50 PM
#81795   Wild Bill is alive and better than ever. GetRichorGetHighTryn 10/22/17 12:46:47 PM
#81794   Just saying. If he is wearing Raybans at StarGazer777 10/22/17 12:35:27 PM
#81793   And we're to take this as a productive post. Jake731 10/22/17 12:33:33 PM
#81792   You think Murphy is still alive? What if StarGazer777 10/22/17 12:05:26 PM
#81791   MORE MISINFORMATION! MyzStreet 10/22/17 12:02:34 PM
#81790   Thanks for all your support. I agree. USRM Zues 10/22/17 11:50:47 AM
#81789   Quote LOL, "I wonder if Murphy had a Hornet Driver 10/22/17 11:21:32 AM
#81788   Lest we forget it's the federal government. GetRichorGetHighTryn 10/22/17 11:04:10 AM
#81787   We haven’t heard from Murphy in awhile. It Ryguy008 10/22/17 10:28:03 AM
#81786   I wonder if Murphy had a few words Greennewlife 10/22/17 10:23:36 AM
#81785   nice recap on ol murphy!! rocketRider 10/22/17 08:55:37 AM
#81784   http://www.referenceforbusiness.com/history2/46/Cordis-Corp.html MyzStreet 10/22/17 08:39:40 AM
#81783   Lmao TYTD! Yup Dollars just a matter of MyzStreet 10/22/17 08:32:07 AM
#81782   What about Johnson and Johnson drug company joyce123 10/22/17 08:15:31 AM
#81781   $1 land here we come! $$IsEverything$$83 10/22/17 05:56:09 AM
#81780   Johnson & Johnson back in the building!!! $$IsEverything$$83 10/22/17 04:06:17 AM
#81779   I'm not saying this is going to $1 TooYoungToDie 10/22/17 01:33:06 AM
#81778   Does anyone think usrm has growth potential ? Cdizz123 10/22/17 12:25:50 AM
#81777   USRM, pop next week. traders in my chat Ryguy008 10/21/17 07:43:00 PM
#81775   Zzzzzzz! Usrm wakes up next week !! FTW! Joeymc77 10/21/17 03:53:43 PM
#81774   Great to hear! Tell us more on exactly a1tellem 10/21/17 10:22:59 AM
#81773   Great to hear about this product making it BillionaireEye 10/21/17 04:24:05 AM
#81772   Really hope these guys make it. Have done Tagprofenrir 10/20/17 10:49:00 PM
#81771   Thanks company and posters win always. Both people 0mn1 10/20/17 09:39:02 PM
#81770   "if" you promote a stock down or up 0mn1 10/20/17 09:23:53 PM
#81767   I could not agree more. The CEO was kaos2k 10/20/17 08:16:11 PM
#81765   I saw that also, now I know what kaos2k 10/20/17 04:24:55 PM
#81764   Drink enough beer and it won't matter!!! GL. GetRichorGetHighTryn 10/20/17 04:18:15 PM
#81763   Have a great weekend all off to play Rinkydink 10/20/17 04:16:40 PM
#81762   HOLD ONTO YOUR KNICKERS. NEXT WEEK OH LORD!!!!! GetRichorGetHighTryn 10/20/17 04:14:47 PM
#81761   I watched that. Good stuff, I appreciate GetRichorGetHighTryn 10/20/17 04:13:54 PM
#81760   Yeah so do I. Have a nice weekend MyzStreet 10/20/17 04:10:18 PM
#81759   I saw that, I foresee a greater week BillionaireEye 10/20/17 04:06:56 PM
#81758   I tried to paint at .037 but they Lonewolf1 10/20/17 04:03:28 PM
#81757   Yup, have a great weekend! BillionaireEye 10/20/17 04:02:12 PM
#81756   Sweet close, that did the trick! thank you. kaos2k 10/20/17 04:01:29 PM
#81754   Went in at .0363 BillionaireEye 10/20/17 03:55:54 PM
#81753   MM favorite trick is to drop the ask Lonewolf1 10/20/17 03:51:32 PM
#81752   Doin' my part smacking that ask all day kaos2k 10/20/17 03:42:39 PM
#81751   Easy enough to flatten these M'Fing MMs. Carl Spackler 10/20/17 03:35:03 PM
#81750   Buying getting more aggressive but still tiny volume. Lonewolf1 10/20/17 03:26:28 PM
#81749   Smack the ask !!!!! Dig deep Moke31 10/20/17 02:52:24 PM
#81748   We need to continue hit that ask and BillionaireEye 10/20/17 02:51:08 PM
#81747   NOT GOOD FOR BUSINESS BUT CALIFORNIA ALWAYS HAS TruthSpeaker12 10/20/17 02:37:28 PM
#81746   THE HILL; "If FDA can't speed up drug TruthSpeaker12 10/20/17 02:31:41 PM
#81745   Walls starting to break...Slap....slap VenOmousInvestor 10/20/17 01:31:50 PM
PostSubject