All Posts in Category: News Releases

U.S. Stem Cell Responds to FDA’s Regenerative Medicine Guidelines

Sunrise, FL Nov. 21, 2017 – U.S. Stem Cell, Inc. (OTC: USRM), a leader in the development of proprietary, physician-based stem cell therapies and novel regenerative medicine solutions, today responded to the recently announced Food and Drug Administration’s comprehensive policy framework for the development and oversight of regenerative medicine products, including stem cell treatments.

The framework is described in a suite of four guidance documents that build upon the FDA’s existing, risk-based regulatory approach, in order to more clearly describe what products are regulated as drugs, devices, and/or biological products. Two of the documents were issued as drafts, and the other two were issued as final.

This new framework also includes more regulatory guidance for off-the-shelf products that, due to their construct, require more complex, lengthy and expensive entries to market. This is partially because they can involve using third-party stem cells that have been modified, including genetically, which can require more intense scrutiny by the FDA. USRM believes that’s it’s in-clinic stem cell procedures should not be subject to the same regulatory process as off-the-shelf drug products.

Likewise, due to the high ramp-up costs with an off-the-shelf gene or cell therapy product, patients can be up against prices of $475,000 per treatment.  USRMs proprietary in-clinic protocols using the patients own tissues/cells are not off-the-shelf gene or cell therapies and can be safely performed in-clinic instead of a hospital, by physicians that are USRM-trained and certified in autologous stem cell therapy practices — procedures that have been and continue to be well documented in the scientific literature with very few complications reported.  The costs to patients typically range from $5000-$12,000.

“As U.S. Stem Cell continues to offer products, education and in-clinic therapeutic services, we are continuing our ongoing communication with the FDA in order to determine more specifically how we best fit into the regulatory model for stem cell therapies,” said Mike Tomas, President & CEO of U.S. Stem Cell, Inc. “Our goal is to provide patients in need with regenerative medicine using the cells inside their own body, and we are hopeful that the FDA is willing to continue to work with us to help define fair regulation for the public regarding these therapies.”

According to the FDA, this modern framework is intended to balance the agency’s commitment to safety with mechanisms to drive further advances in regenerative medicine, so that innovators can bring new, effective therapies to patients as quickly and as safely as possible.

“We’re at the beginning of a paradigm change in medicine with the promise of being able to facilitate regeneration of parts of the human body, where cells and tissues can be engineered to grow healthy, functional organs to replace diseased ones; new genes can be introduced into the body to combat disease; and adult stem cells can generate replacements for cells that are lost to injury or disease. This is no longer the stuff of science fiction. This is the practical promise of modern applications of regenerative medicine,” said FDA Commissioner Scott Gottlieb, MD, who is quoted in the guidelines.

“Just as Dr. Gottlieb has described it, the emerging field of stem cell therapy is dynamic and complex,” said Dr. Kristin Comella, Chief Science Officer of USRM. “That’s one of the reasons why the FDA is taking great consideration, to ensure a comprehensive framework that will simultaneously increase access to these remarkable innovations, while at the same time ensuring public safety. It is also one of the reasons why we here at USRM are so excited to pioneer the holistic approach of using one’s own stem cells in clinic — the sophistication of using autologous stem cell therapies, combined with simplicity of application and use, gives clinics we operate and physicians we train incredible scalability with powerful results. As we continue to grow and expand our business, we are confident that our place in this world of emerging science will be reflected in the FDA’s ongoing regulatory decisions. We look forward to being a part of this dialogue as this historic science unfolds.”

In addition to the final documents, the two draft guidances also provide important information to help spur development and access to innovative regenerative therapies. The first draft guidance, which builds off the regenerative medicine provisions in the 21st Century Cures Act, addresses how the FDA intends to simplify and streamline its application of the regulatory requirements for devices used in the recovery, isolation, and delivery of regenerative medicine advanced therapies (RMATs), including combination products.

The second draft guidance describes the expedited programs that may be available to sponsors of regenerative medicine therapies, including the new Regenerative Medicine Advanced Therapy (RMAT) designation created by the 21st Century Cures Act, Priority Review, and Accelerated Approval. In addition, the guidance describes the regenerative medicine therapies that may be eligible for RMAT designation – including tissue engineering products, human cell and tissue products, and combination products using any such therapies or products, as well as gene therapies that lead to a durable modification of cells or tissues (including genetically modified cells). USRM intends to take full advantage of this RMAT opportunity and join strategic partners to apply for consideration of its MyoCell product for heart failure patients.

Based on these draft guidance documents, the FDA will continue to require a robust clinical trial program for these products which typically costs hundreds of millions of dollars and years of studies. USRM has spent more than $100 million over two decades on both preclinical (animal) and clinical (human) trials using its MyoCell™ product. The trials published to date show culture-expanded autologous stem cells directly injected into the heart can provide benefit to congestive heart failure patients. USRM is actively seeking strategic partners to pursue commercialization of the MyoCell product and finalize RMAT designation based on the draft guidelines published.

At U.S. Stem Cell and our clinical affiliates, we have demonstrated a strong safety profile with our in-clinic physician medical procedures which is completely in line with the risk-based approach that the FDA intends to enforce. We believe that patients have a right to utilize the cells in their own body to help promote natural healing and we have demonstrated the safety of these therapies in our recent publication in a peer reviewed journal. The study describes the use of stromal vascular fraction (SVF) in the clinic for degenerative diseases in orthopedics, neurological and systemic conditions in 676 patients.

U.S. Stem Cell, Inc., is an emerging leader in the regenerative medicine / cellular therapy industry and has, to management’s knowledge, completed more clinical treatments than any other stem cell company in the world in the past 20 years. We look forward to pioneering this space and working closely with regulatory bodies to ensure safety.

 

About U.S. Stem Cell, Inc.

U.S. Stem Cell, Inc. is an emerging enterprise in the regenerative medicine / cellular therapy industry. We are focused on the discovery, development and commercialization of cell-based therapies that prevent or treat 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 (U.S. Stem Cell Training, Vetbiologics and U.S. 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 Reports 3rd Q: Increases Revenue, Reduces Debt

Sunrise, FL – Nov. 7, 2017 – U.S. Stem Cell, Inc. (OTC: USRM), international leader in the development of proprietary, physician-based stem cell therapies and novel regenerative medicine, today announced financial results for the three months ended Sept. 30, 2017.

Revenue increased significantly for the quarter, up 106 percent or $730k from the same quarter last year to $1.5m.  Likewise, for the nine months ended Sept. 30, 2017, revenue also increased 92 percent from $2.1 to $4.04m for the same period last year.

Net increase in gross profits also increased to $1m, a 158 percent increase from the same quarter last year.  Net increase in gross profit also increased 102 percent or $1.4m for the same period in 2016, to $2.8m for 2017.

Cash from operations also increased for the nine months ended, up more than 1004% from negative $113k in 2016 to more than $1m in 2017.  Cash from operations was also up for the three months ended 2017, an increase of more than 368% in 2017, totaling $240k, compared to $52k for the same three months in 2016.

Our operations are continuing to yield successful results for six straight quarters now, including last quarter which was record breaking, and we are still just getting started,” said Mike Tomas, Chief Executive Officer of U.S. Stem Cell, Inc.  “The increase in operational success — which includes certifying 700 physicians and 287 clinics in the use of our proprietary stem cell technology — is being bolstered by more than 30 states that are passing laws to allow regenerative, cutting-edge procedures like ours.  It’s an exciting time to be in the marketplace, and we are looking forward to our continued growth.

On Sept. 1, 2017, the State of Texas joined more than 30 other states by passing HR 810 — a ‘right to try’ law allowing Texans to choose medical procedures like stem cell treatments for certain severe chronic diseases and terminal illnesses that have historically been considered more ‘experimental.’  This legislation paves the way for patients living on borrowed time, that are severely debilitated, or in extreme pain due to an ailment.   As more states join the ranks in approving right-to-try laws, USRM will continue to leverage these legislated opportunities.

 

“Seeing expansion of our proprietary, stem cell therapy process — which empowers a patient to utilize their own, naturally occurring stem cells to treat chronic pain and other systemic conditions — is such a remarkable experience, ” said Dr. Kristin Comella, Chief Science Officer for U.S. Stem Cell, Inc.  “Our ability to teach, train and partner with physicians and clinics, as well as develop our own standalone facilities, gives us a unique opportunity to grow the business in so many ways.”

 

USRM also strengthened its balance sheet this quarter by converting outstanding debt into equity, an indication of debt holders’ increased confidence in the Company’s ability to enhance shareholder value through operations.  In order to facilitate the debt conversion, on Aug. 31 USRM filed an 8-K with the U.S. Securities and Exchange Commission (SEC), executing a debt restructuring agreement with Hunton & Williams LLP.  As a result of the conversion, USRM facilitated a debt reduced of $393k.  The deal freezes interest payments the Company has on two outstanding notes from 2009.  A copy of the SEC Form 8-K filing is available here.

 

Operating expenses rose 47 percent, due to a combination of factors including a 103 percent increase in depreciation and one-time costs association with operations including stock-based compensation as a result of the debt reduction and performance bonuses.  Loss from operations decreased $336k from $1.3m in the nine months ended Sept. 30, 2017, compared to $957k for the nine months ended Sept. 30, 2017.  Likewise, long-term debt made a slight increase, mostly due to terms of the sale-leaseback.

 

About U.S. Stem Cell, Inc.

U.S. Stem Cell, Inc. is an emerging enterprise in the regenerative medicine / cellular therapy industry. We are focused on the discovery, development and commercialization of cell-based therapies that prevent or treat 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 (U.S. Stem Cell Training, Vetbiologics and U.S. 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. Announces Clinical Expansion in U.S. Market

Sunrise, FL – Nov. 1, 2017 – U.S. Stem Cell, Inc. (OTC: USRM), a leader in the development of proprietary, physician-based stem cell therapies and novel regenerative medicine solutions, today announced the opening of another regenerative clinic using its proprietary products and services, bringing the number of clinics using its technology to 287.

Regenerative Wellness Clinic (RWC), located in West Palm Beach, represents another addition to USRM’s global distribution platform for its proprietary, stem cell technology, and is a direct result of USRM’s position as the world’s largest educator in stem cell innovation and physician training, with more than 700 USRM certified stem cell physicians globally.

“We are so pleased to hit this next milestone with Regenerative Wellness, and look forward to working closely with this incredible team of experts,” said Mike Tomas, Chief Executive Officer of U.S. Stem Cell, Inc. “Partnering with RWC provides us the opportunity to expand our strategic goal of market penetration while maintaining scalability. This approach is in direct alignment with our longer-term strategy of establishing and maintaining profitability as we grow globally.”

The minimally invasive, proprietary procedure — which utilizes a patient’s own stem-cell-rich adipose or fat tissue – has, management believes, significantly boosted success rate for patient outcomes in a wide variety of indications including pain management, orthopedic, autoimmune, cardiac and other systemic conditions.

The West Palm Beach clinic is spearheaded by Dr. Rosemary Daly, an interventional spine/pain management physician, board certified in Anesthesiology and Pain Medicine. Dr. Daly graduated from the New York College of Osteopathic Medicine, and completed her Anesthesiology residency at the Montefiore Medical Center at the Albert Einstein College of Medicine.

“Being able to offer U.S. Stem Cell’s proprietary process to our patients means we will be able to make more advanced, successful regenerative treatments available to patients in South Florida,” said Dr. Daly. “Moreover, we contend that the minimally invasive treatments applied in an outpatient procedure can help jumpstart the body’s own healing capabilities and provide long-term relief — an advancement which has endless options in the world of pain management.”

“Dr. Daly’s expertise in reducing chronic and debilitating pain makes her a perfect partner for our expansion,” said Dr. Kristin Comella, Chief Science Officer for U.S. Stem Cell, Inc. “We look forward to collaborating with the excellent researchers and physicians on Dr. Daly’s team, as we continue to deepen our expertise of this ground-breaking, regenerative therapy.”

U.S. Stem Cell’s novel advancements in stem cell therapy, in managements’ opinion, could be a significant alternative to the explosive opioid crisis in America — a direct results of America’s failed attempt at pain management. According to The New York Times, published June 5, 2017, drug overdose is now the leading cause of death in the United States for patients under the age of 50, while the October 15, 2017, edition of 60 Minutes reports that the opioid crisis has claimed 200,000 lives in the United States over the past few decades.

U.S. Stem Cell, Inc. is an emerging leader in the regenerative medicine / cellular therapy industry and has, to management’s knowledge, completed more clinical treatments than any other stem cell company in the world in the past 20 years.

 

About U.S. Stem Cell, Inc.

U.S. Stem Cell, Inc. is an emerging enterprise in the regenerative medicine / cellular therapy industry. We are focused on the discovery, development and commercialization of cell-based therapies that prevent or treat 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 (U.S. Stem Cell Training, Vetbiologics and U.S. 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 CEO Mike Tomas Honored As PACE Center For Girls Miami Pioneer By PACE Center For Girls Miami

Sunrise, FL – October 26, 2017 – U.S. Stem Cell, Inc. (OTC: USRM), a leader in the regenerative medicine, cellular therapy industry providing physician based stem cell therapies to human and animal patients, as well as a developer of novel autologous cell therapies is proud to congratulate its CEO, Mike Tomas, for his committed advocacy and ongoing support of PACE Center for Girls Miami, a philanthropic organization devoted to serving at-risk adolescent girls. Mr. Tomas will be recognized at the 4th Annual BELIEVING IN GIRLS LUNCHEON on October 25th for his continued leadership, vision, and positive involvement in the organization . As a Founding Board Member of PACE Miami, Mr. Tomas has helped paved the way for the at-risk teen girls’ centerorganization to thrive within the South Florida community.

“We are incredibly grateful to Mike Tomas for his vision and leadership in helping launch PACE Miami to become the thriving organization it is, that today serves 60 at-risk teen girls each year with comprehensive programs of education and counseling. Mike helped make PACE Miami a reality and it would not be as strong as it is today without his ongoing support and guidance,” said Sherry Thompson Giordano, Executive Director of PACE Miami. “Mike is and continues to be a guiding force for PACE Miami every day.”

The 4th Annual Believing in Girls PACE Miami Luncheon today will be a dynamic gathering of community leaders, corporate executives and socially-minded donors who will gather to celebrate the PACE Miami girls and help raise funds for the continued growth of the Center.

Community leaders and donors believe in the mission of PACE Miami to serve at-risk teen girls from 11-17 years old in helping them achieve their full potential in a safe and supportive ways, with a strength-based academic and counseling center.

 

About U.S. Stem Cell, Inc.

U.S. Stem Cell, Inc. is an emerging enterprise in the regenerative medicine / cellular therapy industry. We are focused on the discovery, development and commercialization of cell-based therapies that prevent or treat 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 (U.S. Stem Cell Training, Vetbiologics and U.S. 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.

 

About PACE Center for Girls, Inc. Miami

One of the 19 PACE Centers across the state of Florida, PACE Miami opened its doors on its current location at 1400 NW 36th Street, on March 6, 2014. PACE Miami provides girls and young women from the ages of 11-17 an opportunity for a better future through education, counseling, training and advocacy at a full academic and counseling center where girls attend full school day programs. For further information, please visit PACE Center MIAMI.

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U.S. Stem Cell, Inc. New Study Underscores the Safety of Autologous Stem Cell Therapy in Degenerative Diseases and Injuries

Sunrise, FL – October 11, 2017 – (OTC:USRM) 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, today announced the publication of a new study that demonstrates the safety of autologous stem cell therapy in degenerative diseases and injuries.

The study, called “Safety Analysis of Autologous Stem Cell Therapy in a Variety of Degenerative Diseases and Injuries Using the Stromal Vascular Fraction,” is the largest safety trial to date that used stem cells from fat. It was published in the Journal of Clinical Medicine Research and co-authored by U.S. Stem Cell, Inc. Chief Science Officer Kristin Comella, PhD, as well as Michelle Parlo, PA, Rosemary Daly, DO, Vincent Depasquale, DC, Eric Edgerton, DC, Patrick Mallory, DO, Roy Schmidt, MD, Walter P. Drake, PhD.

“Our study demonstrates exceptional patient safety with low complication rates and underscores the safety of autologous stem cell therapy in general,” Dr. Comella said in a statement. “Few adverse events were reported and were overwhelmingly of mild and transient nature, such as the expected soreness at the site of liposuction and occasional headache.”

The study is the first trial to address cells from fat in multiple diseases and with different delivery routes. It describes the use of stromal vascular fraction (SVF) in the clinic for degenerative diseases in orthopedics, neurological and systemic conditions in 676 patients.

Stem cells from adipose tissue offer a novel therapy for patients with damaged tissue. SVF injected into patients may reduce inflammation, promote healing, and repair damaged/scarred tissue. SVF can be isolated from fat (adipose) tissue in a simple outpatient stem cell procedure that takes about 30-90 minutes and can be done under local anesthesia, using a mini-lipoaspirate technique. The stem cells can then be infused or injected after the mini-liposuction.

The new study demonstrates the strong safety profile from a multi-center analysis of SVF injection in treating various diseases. As part of the study, approximately 60 mL of fat tissue was removed from the abdomen or flanks using a local tumescent liposuction procedure. The fat was separated via centrifuge to isolate the SVF and the cells were delivered intraarticularly, intravenously, intrathecally, or intradiscally directly into the same patient. All subjects were monitored for adverse events.

U.S. Stem Cell, Inc. is an emerging enterprise in the regenerative medicine / cellular therapy industry. Since 1999, the company has completed more clinical treatments (for both humans and animals) than any other regenerative company in the world. U.S. Stem Cell, Inc. is focused on the discovery, development and commercialization of cell-based therapies that prevent or treat disease by repairing and replacing damaged or aged tissue, cells and organs and restoring their normal function. U.S. Stem Cell, Inc. has also partnered with other companies to build a national distribution network for stem cell therapies using the U.S. Stem Cell, Inc. developed technologies and is on track to add an additional 10 stem cell treatment centers and clinics in the U.S.

 

About U.S. Stem Cell, Inc.

U.S. Stem Cell, Inc. is an emerging enterprise in the regenerative medicine / cellular therapy industry. We are focused on the discovery, development and commercialization of cell-based therapies that prevent or treat 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 (U.S. Stem Cell Training, Vetbiologics and U.S. 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. Cso to Present at Bulletproof Biohacking Conference on October 13th in Pasadena, Ca

Sunrise, FL – October 10, 2017 – (OTC:USRM) 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, announced today that its Chief Science Officer Kristin Comella, PhD, will present on October 13 th at Bulletproof’s 5 th Annual Biohacking Conference in Pasadena, CA. Dr. Comella’s presentation will be live- streamed, starting at 3:15 p.m. PT via Facebook Live on the U.S. Stem Cell, Inc. Facebook Page at https://www.facebook.com/USStemCellInc/.

Dr. Comella’s participation is part of U.S. Stem Cell, Inc.’s ongoing effort to educate consumers on the power of using their body’s own healing potential through regenerative medicine. At the Biohacking Conference, Dr. Comella will be joining an informational Stem Cell Panel led by Harry Adelson, ND, an expert in stem cell therapy and the founder of Docere Clinics in Park City, Utah. This will be Dr. Comella’s second consecutive appearance at the Biohacking Conference.

Dr. Comella’s invitations to speak at the Bulletproof Conference follow a stem cell treatment Bulletproof Founder Dave Asprey received at U.S. Stem Cell Clinic back in July 2016, when he live-streamed the procedure on Facebook. U.S. Stem Cell Clinic is 33.3% owned by U.S. Stem Cell, Inc. To watch the recoded version of Asprey’s Facebook Live video, click here: https://tinyurl.com/y7vjqwfd.

Dr. 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. Most recently, Dr. Comella made the list of Top 50 Functional and Integrative Medical Doctors in the country by DrAxe.com, one of the most visited natural health websites in the world.

“I am excited and honored to be a part of the Bulletproof Conference that brings together some of the brightest minds in the regenerative industry who are pushing the limits of what the human mind and body can do,” Dr. Comella said in a statement. “Please tune in on Facebook Live at 3:15 pm PT on October 13 th to watch the stem cell panel discussion.”

U.S. Stem Cell, Inc. is an emerging enterprise in the regenerative medicine / cellular therapy industry. Since 1999, the company has completed more clinical treatments (for both humans and animals) than any other regenerative company in the world. U.S. Stem Cell, Inc. is focused on the discovery, development and commercialization of cell-based therapies that prevent or treat disease by repairing and replacing damaged or aged tissue, cells and organs and restoring their normal function. U.S. Stem Cell, Inc. has also partnered with other companies to build a national distribution network for stem cell therapies using the U.S. Stem Cell, Inc. developed technologies and is on track to add an additional 10 stem cell treatment centers and clinics in the U.S.

About U.S. Stem Cell, Inc.

U.S. 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 therapies that prevent or treat 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 (U.S. Stem Cell Training, Vetbiologics and U.S. 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. Reports Debt Restructuring Agreement and Debt Reduction in Form 8-K

Sunrise, FL – September 13, 2017 – (OTC:USRM) 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, today submitted a Form 8-K to the U.S. Securities and Exchange Commission (SEC), reporting a debt restructuring agreement it entered into with Hunton & Williams LLP on August 31, 2017.

The Hunton agreement is part of U.S. Stem Cell, Inc.’s continued effort to clean up the balance sheet and lower the company’s debt. This agreement is estimated to provide a debt relief of approximately $393,180. A copy of the SEC Form 8-K filing is available here.

“Treating patients, generating revenue and restructuring debt has always been a top priority at US Stem Cell Inc,” said the company’s President & CEO Mike Tomas. “Hunton & Williams has been an extraordinary legal partner of the company and we are very grateful for their continued support.  Negotiating the Hunton debt allows the company to freeze the interest payments on two notes from 2009 and begin to work towards paying off this long-standing debt.”

U.S. Stem Cell, Inc. is an emerging enterprise in the regenerative medicine / cellular therapy industry. Since 1999, the company has completed more clinical treatments (for both humans and animals) than any other regenerative company in the world. U.S. Stem Cell, Inc. is focused on the discovery, development and commercialization of cell-based therapies that prevent, treat or cure disease by repairing and replacing damaged or aged tissue, cells and organs and restoring their normal function. U.S. Stem Cell, Inc. has also partnered with other companies to build a national distribution network for stem cell therapies using the U.S. Stem Cell, Inc. developed technologies and is on track to add an additional 10 stem cell treatment centers and clinics in the U.S.

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. Corporate Office, Lab and Clinic Remain Operational Post Hurricane Irma

Sunrise, FL – September 12, 2017 – (OTC:USRM) 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, announced today that its corporate office, lab and clinic have not been affected by Hurricane Irma and remain fully operational. All U.S. Stem Cell, Inc. facilities, including U.S. Stem Cell Clinic, will re-open on Tuesday, September 12 with regular business hours.

“We are pleased to report that there was no damage caused by Hurricane Irma to the U.S. Stem Cell, Inc. facilities in Florida,” said U.S. Stem Cell, Inc. President & CEO Mike Tomas. “Many of our friends and family were not as fortunate, but we are back to work, helping our patients benefit from the power of stem cells and building a national distribution network for stem cell therapies using technologies developed at U.S. Stem Cell, Inc.”

U.S. Stem Cell, Inc. is an emerging enterprise in the regenerative medicine / cellular therapy industry. Since 1999, the company has completed more clinical treatments (for both humans and animals) than any other regenerative company in the world. U.S. Stem Cell, Inc. is focused on the discovery, development and commercialization of cell-based therapies that prevent, treat or cure disease by repairing and replacing damaged or aged tissue, cells and organs and restoring their normal function. U.S. Stem Cell, Inc. has also partnered with other companies to build a national distribution network for stem cell therapies using the U.S. Stem Cell, Inc. developed technologies and is on track to add an additional 10 stem cell treatment centers and clinics in the U.S.

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 Named To The List Of Top 50 Functional And Integrative Medical Doctors By DrAxe.com

Sunrise, FL – August 23, 2017 – (OTC:USRM) Kristin Comella, Chief Science Officer at U.S. Stem Cell, Inc., was named number 45 on the list of Top 50 Functional and Integrative Medical Doctors in the country by DrAxe.com, one of the most visited natural health websites in the world that covers nutrition, natural medicine, and trending health news. The list also features Dr. Mehmet Oz, MD; Dr. Mark Hyman, MD; Dr. Andrew Weil, MD and other doctors and scientists who are truly shaping the functional and integrative medicine fields.

Kristin 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. Learn more here.

“Kristin is lauded as an expert on regenerative medicine, the study of using the body’s own regenerative capabilities to treat diseases and injuries,” according to the Dr.Axe.com article. “She led the team that was the first to gain FDA approval for a clinical trial that used a combination of cell and gene therapy for the heart and pioneered stem cell therapy of adipose tissue, as well as cord blood, bone marrow and muscle, helping people recover from disease and lead normal lives.”

“It’s an honor to be featured on Dr. Axe’s prestigious list of influencers in the integrative medicine field,” Comella said in a statement. “There are some amazing scientists and doctors on this list.” DrAxe.com is one of the top websites in the natural medicine industry with 14 million unique visitors each month.

Comella is the 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. Watch this video as Kristin talks more about stem cell therapy and how it works.

 

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 Paper​ ​On​ ​Irradiation-Induced​ ​Gland Damage​

Sunrise, FL – August 17, 2017 – (OTC:USRM) A scientific paper about intraglandular injection for the treatment of irradiation-induced gland damage post cancer 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 International Medical Case Reports Journal.

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 ‘First-in-man intraglandular implantation of stromal vascular fraction and adipose-derived stem cells plus platelet-rich plasma in irradiation-induced gland damage: a case study’, the scientific paper was co-authored by Kristin Comella and Walter Bell. Below is a link and abstract to the paper: https://www.dovepress.com/articles.php?article_id=34273.

Background: Stromal vascular fraction (SVF) is a mixture of cells which can be isolated from a mini-lipoaspirate of fat tissue. Platelet-rich plasma (PRP) is a mixture of growth factors and other nutrients which can be obtained from peripheral blood. Adipose-derived stem/stromal cells (ADSCs) can be isolated from fat tissue and expanded in culture. The SVF includes a variety of different cells such as ADSCs, pericytes, endothelial/progenitor cells, and a mix of different growth factors. The adipocytes (fat cells) can be removed via centrifugation. Here, we describe the rationale and, to our knowledge, the first clinical implementation of SVF and PRP followed by repeat dosing of culture-expanded ADSCs into a patient with severe xerostomia postirradiation.

Methods: Approximately 120 mLs of adipose tissue was removed via mini-lipoaspirate procedure under local anesthetic. The SVF was prepared from half of the fat and resuspended in PRP. The mixture was delivered via ultrasound directly into the submandibular and parotid glands on both the right and left sides. The remaining 60 mLs of fat was processed to culture-expand ADSCs. The patient received seven follow-up injections of the ADSCs plus PRP at 5, 8, 16, 18, 23, 28, and 31 months postliposuction. The subject was monitored over a period of 31 months for safety (adverse events), glandular size via ultrasound and saliva production.

Results: Throughout the 31-month monitoring period, no safety events such as infection or severe adverse events were reported. The patient demonstrated an increase in gland size as measured by ultrasound which corresponded to increased saliva production.

Conclusion: Overall, the patient reported improved quality of life and willingness to continue treatments. The strong safety profile and preliminary efficacy results warrant larger studies to determine if this is a feasible treatment plan for patients postradiation.

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. Reports Most Successful Financial Performance in the Company’s History

 Sunrise, FL – August 9, 2017 – U.S. Stem Cell, Inc., a Florida corporation, a leader in the regenerative medicine, cellular therapy industry providing physician based stem cell therapies to human and animal patients, as well as a developer of novel autologous cell therapies, is pleased to announce historic results from operations for the quarter ending June 30, 2017.

“We continue to see improvements in operations and balance sheet performance, specifically in the year-over-year increase in both revenue and profit,” said Mike Tomás, President & CEO of U.S. Stem Cell, Inc. “These positive results can be attributed to growing top line revenues through the expansion of our clinics, clinic partnerships, banking patients’ stem cells for future usage, training physicians and pursuing new international business opportunities for growth.”

U.S. Stem Cell, Inc. strives to provide accomplishments and value for both patients and shareholders. Below are highlights of financial results ending June 30, 2017.

  • Revenue up by 104% year-over-year for the quarter:  from $678K in Q2 2016 to 1.38M in Q2 2017
  • Revenue up by 83% YTD: from $1.39M this time last year to $2.54M in Q2 2017
  • Margin increased from 65% to 71% quarter-to-quarter
  • Gross profit up by 122% (or $542K) year-over-year for the quarter: from $442K in Q2 2016 to $985K in Q2 2017
  • Gross profit up by 80% (or $796K) YTD:  from $999K this time last year to $1.79M in Q2 2017
  • Income from operations increased from a loss of ($259K) in Q2 2016 to a gain of $142K in Q2 2017, a three-month comparison
  • Income from operations increased YTD from a loss of ($272K) in Q2 2016 to a gain of $100K in Q2 2017, a six-month comparison
  • Cash Flow is positive YTD at Q2 2017 at $785K compared to YTD Q2 2016 at ($165K), a six-month comparison
  • Working Capital Deficit down 6.9% from $5.8M in Q2 2016 to $5.4M in Q2 2017

VIEW PDF HERE

 

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 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.

VIEW PDF HERE 

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.

VIEW PDF HERE

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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