All Posts in Category: News Releases

Kristin Comella, U.S. Stem Cell’s CSO, co-authors Scientific Paper on Chronic Obstructive Pulmonary Disease (COPD) Published in the Journal of Clinical Medicine Research

Sunrise, FL – July 13, 2017 – (OTC:USRM) A scientific paper about intravenous injection for the treatment of COPD co-authored by Kristin Comella, Chief Science Officer at U.S. Stem Cell, Inc., a Florida corporation and leader in novel regenerative medicine solutions and physician-based stem cell therapies for human and animal patients, was published in the August 2017 issue of the Journal of Clinical Medicine Research.

Comella is a world-renowned expert on regenerative medicine with a focus on adipose derived stem cells. She was named number 24 on Terrapin’s list of the Top 50 Global Stem Cell Influencers and number 1 on the Academy of Regenerative Practices list of Top 10 Stem Cell Innovators. Comella has pioneered stem cell therapies from various sources including cord blood, bone marrow, muscle, and adipose.

Entitled ‘Autologous Stromal Vascular Fraction in the Intravenous Treatment of End-Stage Chronic Obstructive Pulmonary Disease: A Phase I Trial of Safety and Tolerability’, the scientific paper was co-authored by Kristin Comella, Jesus A. Perez Blas, Tom Ichim, Javier Lopez, Jose Limon, and Ruben Corral Moreno. Below is a link and abstract to the paper: http://www.jocmr.org/index.php/JOCMR/article/view/3072/1877.

Background: Chronic obstructive pulmonary disease (COPD) is a consistently progressive, ultimately fatal disease for which no treatment exists capable of either reversing or even interrupting its course. It afflicts more than 5% of the population in many countries, and it accordingly represents the third most frequent cause of death in the US, where it accounts for more than 600 billion in health care costs, morbidity, and mortality. Adipose tissue contains within its stromal compartment a high abundance of adipose stem/stromal cells (ASCs), which can be readily separated from the adipocyte population by methods which require less than 2 h of processing time and yield a concentrated cellular preparation termed the stromal vascular fraction (SVF). The SVF contains all cellular elements of fat, excluding adipocytes. Recent clinical studies have begun to explore the feasibility and safety of the local injection or intravascular delivery of SVF or more purified populations of ASCs derived by culture protocols. Several pre-clinical studies have demonstrated a remarkable ability of ASC to nearly fully ameliorate the progress of emphysema due to cigarette smoke exposure as well as other causes. However, no prior clinical studies have evaluated the safety of administration of either ASC or SVF in subjects with COPD. We hypothesized that harvest, isolation, and immediate intravenous infusion of autologous SVF would be feasible and safe in subjects with COPD; and that such an approach, if ultimately determined to be efficacious as well as safe, would provide a highly practical method for treatment of COPD.

Methods: In this study, an initial phase I trial evaluating the early and delayed safety of SVF infusion was performed. Twelve subjects were enrolled in the study, in which adipose tissue was harvested using standard liposuction techniques, followed by SVF isolation and intravenous infusion of 150 – 300 million cells. Standardized questionnaires were administered to study feasibility as well as immediate and delayed outcomes and adverse events as primary endpoints. Secondary endpoints included subjective wellness and attitudes towards the procedure, as well as willingness to undergo the procedure a second time. The follow-up time ranged from 3 to 12 months, averaging 12 months.

Results: Of the 12 subjects, only one experienced an immediate adverse event, related to bruising from the liposuction. No observed pulmonary or cardiac issues were observed as related to the procedure. There were no deaths over the 12-month study period, and none identified in the subsequent telephonic follow-up. Attitudes toward the procedure were predominantly positive, and 92% of the study subjects expressed a desire to undergo the procedure a second time.

Conclusions: This study is the first to demonstrate safety of SVF infusion in humans with serious pulmonary disease. Specifically, the use of intravenous infusion as a route to achieve pulmonary cellular targeting did not lead to clinical pulmonary compromise. The intravenous administration of SVF should be further explored as a potentially feasible and safe method for delivery leading to possible therapeutic benefit.

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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 business, which includes three operating divisions (US Stem Cell Training, Vetbiologics and US Stem Cell Clinic) includes the development of proprietary cell therapy products as well as revenue generating physician and patient based regenerative medicine / cell therapy training services, cell collection and cell storage services, the sale of cell collection and treatment kits for humans and animals, and the operation of a cell therapy clinic. Management maintains that revenues and their associated cash in-flows generated from our businesses will, over time, provide funds to support our clinical development activities as they do today for our general business operations. We believe the combination of our own therapeutics pipeline combined with our revenue generating capabilities provides the Company with a unique opportunity for growth and a pathway to profitability. 

Forward-Looking Statements: Except for historical matters contained herein, statements made in this press release are forward-looking statements. Without limiting the generality of the foregoing, words such as “may”, “will”, “to”, “plan”, “expect”, “believe”, “anticipate”, “intend”, “could”, “would”, “estimate”, or “continue”, or the negative other variations thereof or comparable terminology are intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Also, forward-looking statements represent our management’s beliefs and assumptions only as of the date hereof. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.

The Company is subject to the risks and uncertainties described in its filings with the Securities and Exchange Commission, including the section entitled “Risk Factors” in its Annual Report on Form 10-K for the year ended December 31, 2016, and its Quarterly Reports on Form 10-Q.

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NBA Star John Salley partners with Stem Cell Centers of Excellence

West Palm Beach – Steve Nudelberg, Principal Thinker of On the Ball Ventures, is pleased to announce the partnership between John Salley and Stem Cell Centers of Excellence.

On June 24, 2017, John Salley had his first stem cell procedure to harvest his own stem cells and create relief in his shoulders and knees. On the Ball, in keeping with our mantra to create ideas and opportunities to grow business, felt that John Salley would be a natural addition to enhance the national roll out of Stem Cell Centers of Excellence treatment clinics. “As a spokesperson for the vegan lifestyle and long-time friend of On the Ball, John has a keen understanding of how the body functions and how stem cell treatment is a natural alternative for the athlete community. John is a perfect conduit” says Steve Nudelberg

John Salley, Entrepreneur, NBA Star, Actor, Philanthropist, and Vegan has suffered years of agonizing pain after a lucrative career in the NBA. He was set to have surgery on his knees and shoulders but, in keeping with his vegan, clean philosophy, Salley partnered with Stem Cell Centers of Excellence to advocate for using your own body’s stem cells to heal itself. “I am excited to be part of the future with the team at Stem Cell Centers of Excellence. Two things jump to mind after my recent treatment: one, I can’t wait for my body to start healing itself and, two, I feel secure in knowing that my stem cells, which are not getting any younger, are now stored and will be ready should I need them for future use at any time” says John Salley.

“Superstar athlete and wellness expert John Salley is the ideal individual to represent Stem Cell Centers of Excellence as we continue educating the public about the benefits of stem cells and the body’s ability to heal itself,” said Mike Tomas, President and CEO of U.S. Stem Cell Inc. “John has seen first-hand how injuries to athletes, and sports enthusiasts alike, can be devastating with long recovery times. Cutting-edge stem cell treatments for individuals with orthopedic as well as neurological conditions are an excellent option for these patients to improve their quality of life.”

With a new clinic in Miami, FL and additional clinics opening soon around the country, Stem Cell COE provides comprehensive stem cell treatments using the U.S. Stem Cell Inc. innovative technologies and the latest USSC regenerative medicine research. After treatment, the body’s own healing potential may naturally repair and regenerate damaged tissue. U.S. Stem Cell’s team of scientists have pioneered in-clinic regenerative medicine protocols and helped thousands of patients to naturally heal. The company is at the forefront of this innovative technology and will continue to create unique solutions for patients in need. For more information or to make an appointment, visit www.stemcellcoe.com.

On the Ball has been in business for over twenty-two years. Starting out as a sports marketing company to a traditional marketing agency to business development resource. Acclaimed for its strategic thinking and sales-focused abilities, On the Ball specializes in all things sales. By investing time and talent in emerging ideas, the agency can specifically help companies grow.

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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 business, which includes three operating divisions (US Stem Cell Training, Vetbiologics and US Stem Cell Clinic) includes the development of proprietary cell therapy products as well as revenue generating physician and patient based regenerative medicine / cell therapy training services, cell collection and cell storage services, the sale of cell collection and treatment kits for humans and animals, and the operation of a cell therapy clinic. Management maintains that revenues and their associated cash in-flows generated from our businesses will, over time, provide funds to support our clinical development activities as they do today for our general business operations. We believe the combination of our own therapeutics pipeline combined with our revenue generating capabilities provides the Company with a unique opportunity for growth and a pathway to profitability.

 Forward-Looking Statements: Except for historical matters contained herein, statements made in this press release are forward-looking statements. Without limiting the generality of the foregoing, words such as “may”, “will”, “to”, “plan”, “expect”, “believe”, “anticipate”, “intend”, “could”, “would”, “estimate”, or “continue”, or the negative other variations thereof or comparable terminology are intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Also, forward-looking statements represent our management’s beliefs and assumptions only as of the date hereof. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.

The Company is subject to the risks and uncertainties described in its filings with the Securities and Exchange Commission, including the section entitled “Risk Factors” in its Annual Report on Form 10-K for the year ended December 31, 2016, and its Quarterly Reports on Form 10-Q.

 

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Kristin Comella, U.S. Stem Cell’s CSO, co-authors scientific paper on Intra-Articular Injection for Osteoarthritis published in the Journal of Translational Medicine

Sunrise, FL – June 21, 2017 – (OTC:USRM) A scientific paper about intra-articular injection for the treatment of osteoarthritis co-authored by Kristin Comella, Chief Science Officer at U.S. Stem Cell, Inc., a Florida corporation and leader in novel regenerative medicine solutions and physician-based stem cell therapies for human and animal patients, was published in the June 20, 2017 issue of the Journal of Translational Medicine.

Comella is a world-renowned expert on regenerative medicine with a focus on adipose derived stem cells. She was named number 24 on Terrapin’s list of the Top 50 Global Stem Cell Influencers and number 1 on the Academy of Regenerative Practices list of Top 10 Stem Cell Innovators. Comella has pioneered stem cell therapies from various sources including cord blood, bone marrow, muscle, and adipose.

Entitled ‘Intra-articular injection in the knee of adipose derived stromal cells (stromal vascular fraction) and platelet rich plasma for osteoarthritis’, the scientific paper was co-authored by Kristin Comella, Himanshu Bansal, Jerry Leon, Poonam Verma, Diwaker Agrawal, Prasad Koka and Thomas Ichim. Below is a link and abstract to the paper: http://bit.ly/2smaM93.

Background:  Stromal vascular fraction (SVF) can easily be obtained from a mini- lipoaspirate procedure of fat tissue and platelet rich plasma (PRP) can be obtained from peripheral blood. We evaluated the safety and preliminary effi-cacy of administering SVF and PRP intra-articularly into patients with osteoarthritis grade 1 and 2.

Methods: A total of ten patients underwent a local tumescent liposuction procedure to remove approximately 100 ml of fat tissue from the abdomen. SVF  was isolated using an enzyme digestion and resuspended in PRP for intra-articular injection in the knee. The estern Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score and six-minute walk distance (6MWD) were used to evaluate clinical effects and included measure of patient’s subjective assessment of pain, joint mobility, and physical disability. WOMAC score, 6MWD and laboratory tests were repeated at 3 and 6 months and 1, 1.5 and 2 years. XRAY and MRI were completed at 1 year.

Results:  The average total WOMAC score was 64 at baseline and significantly reduced to 52 at 3 months, 46 at 6 months, 42 at 1 year, 38 at 1.5 years, and 41 at 2 years. Patients walked an average of 1310 feet at baseline and demonstrated a statistically significant improvement at 3 and 6 months and 1, 1.5, and 2 years post treatment. Cartilage thickness as determined by MRI improved by at least 0.2 mm in six patients, was unchanged in two patients and decreased by at least 0.2 mm in two patients.

Conclusions: Overall, all of the patients were pleased with the treatment results. They reported a reduction in pain levels, especially after 3 months. More importantly, the procedure demonstrated a strong safety profile with no severe adverse events or complications reported.

Trial registration NCT03089762; Name of registry: http://www.clinicaltrials.gov

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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 business, which includes three operating divisions (US Stem Cell Training, Vetbiologics and US Stem Cell Clinic) includes the development of proprietary cell therapy products as well as revenue generating physician and patient based regenerative medicine / cell therapy training services, cell collection and cell storage services, the sale of cell collection and treatment kits for humans and animals, and the operation of a cell therapy clinic. Management maintains that revenues and their associated cash in-flows generated from our businesses will, over time, provide funds to support our clinical development activities as they do today for our general business operations. We believe the combination of our own therapeutics pipeline combined with our revenue generating capabilities provides the Company with a unique opportunity for growth and a pathway to profitability.

Forward-Looking Statements: Except for historical matters contained herein, statements made in this press release are forward-looking statements. Without limiting the generality of the foregoing, words such as “may”, “will”, “to”, “plan”, “expect”, “believe”, “anticipate”, “intend”, “could”, “would”, “estimate”, or “continue”, or the negative other variations thereof or comparable terminology are intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Also, forward-looking statements represent our management’s beliefs and assumptions only as of the date hereof. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.

The Company is subject to the risks and uncertainties described in its filings with the Securities and Exchange Commission, including the section entitled “Risk Factors” in its Annual Report on Form 10-K for the year ended December 31, 2016, and its Quarterly Reports on Form 10-Q

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Kristin Comella’s Co-Authored Paper Recognized As One Of The Most Influential of 2016

Sunrise, FL – June 12, 2017 – (OTC:USRM) A scientific paper about intramyocardial implantation co-authored by Kristin Comella, Chief Science Officer at U.S. Stem Cell, Inc., a Florida corporation and leader in novel regenerative medicine solutions and physician-based stem cell therapies for human and animal patients, has been recognized as one of the most influential articles of 2016 for the Journal of Translational Medicine according to Altmetric.com.

Comella is a world-renowned expert on regenerative medicine with a focus on adipose derived stem cells. She was named number 24 on Terrapin’s list of the Top 50 Global Stem Cell Influencers and number 1 on the Academy of Regenerative Practices list of Top 10 Stem Cell Innovators. Comella has pioneered stem cell therapies from various sources including cord blood, bone marrow, muscle, and adipose. She led the team that gained the first ever FDA approval for a clinical trial using a combined cell and gene therapy product in the heart.

The paper, entitled ‘Effects of the Intramyocardial Implantation of Stromal Vascular Fraction in Patients with Chronic Ischemic Cardiomyopathy’, was co-authored by K. Comella, J. Parcero, H. Bansal, J. Perez, J. Lopez, A. Agrawal and T. Ichim and published in the Journal of Translational Medicine on June 2, 2016. 685 Article Accesses were tracked with an Almetric.com Attention Score of 254.  Below is a link and abstract of the paper: https://www.ncbi.nlm.nih.gov/pubmed/27255774

Background – Stromal vascular fraction (SVF) can easily be obtained from a mini-lipoaspirate procedure of fat tissue. The SVF contains a mixture of cells including ADSCs and growth factors and has been depleted of the adipocyte (fat cell) population. We evaluated the safety and efficacy of administering SVF intra-myocardially into patients with chronic ischemic cardiomyopathy.

Methods – A total of 28 patients underwent a local tumescent liposuction procedure to remove approximately 60 ml of fat tissue. The fat was separated to isolate the SVF and the cells were delivered into the akinetic myocardial scar region using a transendocardial delivery system (MyoCath®) in patients who had experienced a previous myocardial infarct. The subjects were then monitored for adverse events, ejection fraction via echocardiogram and six-minute walk test (6MWT) over a period of 6 months.

Results – The average EF was 29 % at baseline and significantly increased to 35 % at both 3 and 6 months. Patients walked an average of 349 m at baseline and demonstrated a statistically significant improvement at 3 and 6 months’ post treatment of more than 80 m.

Conclusions Overall, patients were pleased with the treatment results. More importantly, the procedure demonstrated a strong safety profile with no severe adverse events or complications linked to the therapy.

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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 business, which includes three operating divisions (US Stem Cell Training, Vetbiologics and US Stem Cell Clinic) includes the development of proprietary cell therapy products as well as revenue generating physician and patient based regenerative medicine / cell therapy training services, cell collection and cell storage services, the sale of cell collection and treatment kits for humans and animals, and the operation of a cell therapy clinic. Management maintains that revenues and their associated cash in-flows generated from our businesses will, over time, provide funds to support our clinical development activities as they do today for our general business operations. We believe the combination of our own therapeutics pipeline combined with our revenue generating capabilities provides the Company with a unique opportunity for growth and a pathway to profitability.

Forward-Looking Statements: Except for historical matters contained herein, statements made in this press release are forward-looking statements. Without limiting the generality of the foregoing, words such as “may”, “will”, “to”, “plan”, “expect”, “believe”, “anticipate”, “intend”, “could”, “would”, “estimate”, or “continue”, or the negative other variations thereof or comparable terminology are intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Also, forward-looking statements represent our management’s beliefs and assumptions only as of the date hereof. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.

The Company is subject to the risks and uncertainties described in its filings with the Securities and Exchange Commission, including the section entitled “Risk Factors” in its Annual Report on Form 10-K for the year ended December 31, 2016, and its Quarterly Reports on Form 10-Q.

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General American Capital Partners invests up to $5 million in U.S. Stem Cell, Inc.

Sunrise, FL – April 13, 2017 – U.S. Stem Cell, Inc., a Florida corporation and leader in novel regenerative medicine solutions and physician-based stem cell therapies for human and animal patients, has received a commitment to invest up to $5,000,000 from private equity firm General American Capital Partners LLC (GACP) in exchange for up to 63,873,275 shares of common stock.

“We see exponential growth in the stem cell industry, estimated to grow to $170 billion by 2020,” said Joseph DaGrosa, Jr., a Principal with General American Capital Partners. “We are very pleased to join forces with U.S. Stem Cell, Inc., a leader in regenerative medicine solutions, to help expand our role in this important market.”

The 21st Century Cures Act, signed into effect in December of 2016, builds on the FDA’s ongoing efforts to advance medical product innovation and ensure that patients get access to treatments as quickly as possible, with continued assurance from high quality evidence that they are safe and effective.

“Patient demand for regenerative medicine procedures as a viable alternative to surgery, as well as the transformative capacity of stem cell therapies, are leading the way to increased acceptance by both the medical and regulatory communities,” said Mike Tomas, President and CEO of U.S. Stem Cell, Inc.

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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 business, which includes three operating divisions (US Stem Cell Training, Vetbiologics and US Stem Cell Clinic) includes the development of proprietary cell therapy products as well as revenue generating physician and patient based regenerative medicine / cell therapy training services, cell collection and cell storage services, the sale of cell collection and treatment kits for humans and animals, and the operation of a cell therapy clinic. Management maintains that revenues and their associated cash in-flows generated from our businesses will, over time, provide funds to support our clinical development activities as they do today for our general business operations. We believe the combination of our own therapeutics pipeline combined with our revenue generating capabilities provides the Company with a unique opportunity for growth and a pathway to profitability.

Forward-Looking Statements: Except for historical matters contained herein, statements made in this press release are forward-looking statements. Without limiting the generality of the foregoing, words such as “may”, “will”, “to”, “plan”, “expect”, “believe”, “anticipate”, “intend”, “could”, “would”, “estimate”, or “continue”, or the negative other variations thereof or comparable terminology are intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Also, forward-looking statements represent our management’s beliefs and assumptions only as of the date hereof. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.

The Company is subject to the risks and uncertainties described in its filings with the Securities and Exchange Commission, including the section entitled “Risk Factors” in its Annual Report on Form 10-K for the year ended December 31, 2016, and its Quarterly Reports on Form 10-Q.

 

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U.S. Stem Cell, Inc. MARVEL Trial Receives Reactivation Status with the FDA

Sunrise, FL – April 10, 2017 – U.S. Stem Cell, Inc. (USCC), 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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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 business, which includes three operating divisions (US Stem Cell Training, Vetbiologics and US Stem Cell Clinic) includes the development of proprietary cell therapy products as well as revenue generating physician and patient based regenerative medicine / cell therapy training services, cell collection and cell storage services, the sale of cell collection and treatment kits for humans and animals, and the operation of a cell therapy clinic. Management maintains that revenues and their associated cash in-flows generated from our businesses will, over time, provide funds to support our clinical development activities as they do today for our general business operations. We believe the combination of our own therapeutics pipeline combined with our revenue generating capabilities provides the Company with a unique opportunity for growth and a pathway to profitability.

 Forward-Looking Statements: Except for historical matters contained herein, statements made in this press release are forward-looking statements. Without limiting the generality of the foregoing, words such as “may”, “will”, “to”, “plan”, “expect”, “believe”, “anticipate”, “intend”, “could”, “would”, “estimate”, or “continue”, or the negative other variations thereof or comparable terminology are intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Also, forward-looking statements represent our management’s beliefs and assumptions only as of the date hereof. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.

The Company is subject to the risks and uncertainties described in its filings with the Securities and Exchange Commission, including the section entitled “Risk Factors” in its Annual Report on Form 10-K for the year ended December 31, 2016, and its Quarterly Reports on Form 10-Q.

 

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U.S. Stem Cell, Inc. and Advanced Stem Cell Rx Develop Strategic Alliance

Sunrise, FL – March 30, 2017 – U.S. Stem Cell, Inc. (USCC), a Florida corporation and leader in novel regenerative medicine solutions and physician-based stem cell therapies for human and animal patients, has developed a strategic alliance with Advanced Stem Cell Rx (ASC), a US based provider of  regenerative medicine programs including the development of autologous stem cell treatment centers throughout the US.

“Stem cells are critical to our survival and at the core of our regenerative and healing powers. They will play an immense role in redefining the preferred treatment method for the majority of diseases commonly afflicting mankind.  We at ASC are proud to form a strong alliance with US Stem Cell Inc, one of the oldest and most respected stem cell research and therapy companies in the world” stated Dr. J.S. Landow, managing director of ASC.

ASC is commercializing many of the proprietary treatments developed by USSC and is currently implementing turnkey programs into qualified practices across the U.S.  ASC has contracted with practices in over 20 states in the US.  The company utilizes treatments which employ over 20 years of US Stem Cell’s international research findings and among the world’s elite cellular scientists and other luminaries in the stem cell field. Patient selection is critical with acceptance for treatment based upon patient’s meeting specific criteria and undergoing a consultation with a member of the clinical team.

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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 business, which includes three operating divisions (US Stem Cell Training, Vetbiologics and US Stem Cell Clinic) includes the development of proprietary cell therapy products as well as revenue generating physician and patient based regenerative medicine / cell therapy training services, cell collection and cell storage services, the sale of cell collection and treatment kits for humans and animals, and the operation of a cell therapy clinic. Management maintains that revenues and their associated cash in-flows generated from our businesses will, over time, provide funds to support our clinical development activities as they do today for our general business operations. We believe the combination of our own therapeutics pipeline combined with our revenue generating capabilities provides the Company with a unique opportunity for growth and a pathway to profitability.

 Forward-Looking Statements: Except for historical matters contained herein, statements made in this press release are forward-looking statements. Without limiting the generality of the foregoing, words such as “may”, “will”, “to”, “plan”, “expect”, “believe”, “anticipate”, “intend”, “could”, “would”, “estimate”, or “continue”, or the negative other variations thereof or comparable terminology are intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Also, forward-looking statements represent our management’s beliefs and assumptions only as of the date hereof. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.

The Company is subject to the risks and uncertainties described in its filings with the Securities and Exchange Commission, including the section entitled “Risk Factors” in its Annual Report on Form 10-K for the year ended December 31, 2016, and its Quarterly Reports on Form 10-Q.

 

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