All posts by U.S. Stem Cell, Inc

CEO Blog: November 2017 Preparing for Year-End and a Productive 2018

Dear Shareholders and Friends,

We are pleased to share with you highlights of our latest key milestones, as we prepare for year-end and the start of a productive 2018.

Our sixth-straight successful period of positive financial results continued in the 3rd quarter of 2017, including a revenue increase of 106 percent from the same quarter last year.  Net increase in gross profit also rose 102 percent, while cash from operations for the nine months ended Sept. 30 increased 1004% from negative $113k in 2016 to more than $1m in 2017.

This quarter, we also announced the opening of a new clinic in West Palm Beach, Florida, bringing the number of clinics using our technology to 287. Our venture at Regenerative Wellness Clinic with Dr. Rosemary Daly, who will be utilizing U.S. Stem Cell’s proprietary technology for pain management and other therapeutics, is evidence of the continued expansion of our clinical distribution platform.

Opportunities in our five revenue centers — clinics, physician training and certification, stem cell processing kits, veterinarian training and kit sales and stem cell banking — continue to expand each year, as we make stem cell treatments available to more and more customers worldwide, with more than 700 USRM certified stem cell physicians globally.

On October 13th, our Chief Science Officer Dr. Kristin Comella presented for a second year at Bulletproof’s 5th Annual Biohacking Conference in Pasadena. Dr. Comella participated in an informational Stem Cell Panel, led by stem cell therapy expert Harry Adelson, ND.   Bulletproof’s founder Dave Asprey, an avid, Stem-Cell advocate, invited Dr. Comella to present at the conference after he received a successful stem cell procedure at a U.S. Stem Cell clinic. Mr. Asprey received stem cell injections for brain health and sexual function.

U.S. Stem Cell Clinic also recently treated top fitness expert Ben Greenfield. You can watch his procedure here: https://www.facebook.com/BGFitness/videos/10156434268379179/

We’re also excited to announce the publication of a new study by Dr. Comella titled “Safety Analysis of Autologous Stem Cell Therapy in a Variety of Degenerative Diseases and Injuries Using the Stromal Vascular Fraction” in the prestigious Journal of Clinical Medical Research.

The study shows the efficacy and safety of autologous stem cell therapy in individuals with degenerative diseases and injuries, and is a treatment that’s helping to change people’s lives.

Dr. Comella will also be presenting this November at the 15th Annual Meeting of the International Federation for Adipose Therapeutics and Science (IFATS) from November 30 to December 3, 2017 in South Beach, Miami. She’ll discuss her paper, “Effects of the Intradiscal Implantation of Stromal Vascular Fraction Plus Platelet Rich Plasma in Patients With Degenerative Disc Disease.”  Patients demonstrated a statistically significant improvement in range of motion, pain reduction and quality of life, with no severe adverse events linked to the therapy. A link to the paper can be found here: http://bit.ly/2yDd33l

Finally, as you may know, we have issued a response to the FDA’s warning letter to US Stem Cell Clinic. We have engaged a large Washington, D.C. law firm who specializes in FDA case law to assist in our communications. We are having open communications with the agency and look forward to their responses.

We are committed to preserving the rights of patients to harness their bodies’ own healing potential. Our dedication to this emerging science is unwavering and we will continue to expand efforts to help patients maximize their health with this amazing technology.

We thank you for your interest and continued support.

Warmest regards,

Mike Tomas,

President and CEO

 

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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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CEO Blog: September 2017 Update on Operations Post Irma, New Clinic Openings and Debt Reduction

Dear Shareholders and Friends,

September is no doubt off to an exciting start—in part due to Hurricane Irma. Although many of our friends and family were not as fortunate and have suffered devastating losses due to the recent storm (and our thoughts and prayers are with them), I am relieved to announce that our 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, reopened on Tuesday, September 12 with regular business hours.

As you know, U.S. Stem Cell, Inc. is an emerging enterprise in the regenerative medicine / cellular therapy industry. Since 1999, we believe that 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. is opening our own network of clinics AND has also partnered with other companies to build a national distribution network of affiliate clinics for stem cell therapies using the U.S. Stem Cell, Inc.-developed technologies—and one such group includes the American Stem Cell Centers of Excellence (“COE”) owned by General American Capital Partners.  

American Stem Cell COE continued to expand in September with the addition of a new clinic in Dallas, TX. The Dallas Center of Excellence, located at 14330 Midway Rd., Suite 121, Dallas, TX, is modeled after the successful Miami center, which opened its doors in May 2017. Dallas COE offers a variety of therapies we believe will enhance the body’s natural healing mechanisms. The clinic is led by Dr. John R. Roland, MD, a certified Stem Cell and Functional Medicine practitioner. The new clinic is part of an aggressive plan to add an additional 10 stem cell treatment centers and clinics in the U.S.

The Dallas clinic opening comes in part thanks to the early adoption of patient rights by the State of Texas.  HB810, which went into effect on September 1, 2017, allows for the use of stem cell treatments to patients with certain severe chronic diseases or terminal illnesses. This bill parallels “Right To Try” laws that have been approved in more than 30 states, including Texas. Bills like these allow patients on borrowed time, that are severely debilitated, or in extreme pain due to an ailment, the access to biological products, devices, or drugs that could preserve or better their current state. Such improvements would have otherwise been missed without the “right to try” due to the lengthy approval process from the Food and Drug Administration. The State of Texas has taken a stance for patients by stating that “the use of available investigational drugs, biological products, and devices is a decision that should be made by a patient with a severe chronic disease in consultation with the patient’s physician and is not a decision to be made by the government.” We stand with the State of Texas and plan to continue to help patients unlock their regenerative potential.

As we have been doing for years, U.S. Stem Cell, Inc. is in the business of helping other affiliate groups enter this exciting field by offering certified physician training (through U.S. Stem Cell Training), selling the required equipment and laboratory kits (through U.S. Stem Cell, Inc.), and treating patients in need (through U.S. Stem Cell Clinic and our network of strategic partners).  Many often ask how U.S. Stem Cell, Inc. benefits from helping others enter the regenerative medicine market and the answer is simple:  U.S. Stem Cell, Inc.  generates revenue for every patient treated by any of the providers using our technologies—including all of our affiliate clinics that are either partially owned by U.S. Stem Cell, Inc. or we sell them equipment and products.. This helps us reach MANY more patients in need—and we believe U.S. Stem Cell, Inc. does well by doing good.

U.S. Stem Cell, Inc. also continued taking steps to clean up the balance sheet and lower the company’s debt. This week we submitted a Form 8-K to the U.S. Securities and Exchange Commission (SEC), reporting a debt restructuring agreement we entered into with Hunton & Williams LLP on August 31, 2017. This agreement is estimated to provide a debt relief of approximately $393,180. 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 us to freeze the interest payments on two notes from 2009 and begin to work towards paying off this long-standing debt. A copy of the SEC Form 8-K filing is available here.

On a final note, we are aware (and it has dawned on many of you) that a select unscrupulous few persons continue to try to manipulate information regarding our company for, we believe, their own benefit.  It is our contention that these online corrupts do not care about the state of our company or the health of our patients as long as they can quickly line their pockets through attempts to improperly influence and manipulate an otherwise orderly market.  We contend that they defame and slander our company with, in our opinion, libelous untruths (behind the veil of their multiple aliases and fake online personas) and then try to benefit by buying and selling our stock during these fabricated periods of fear, uncertainty and lies.  Management has determined that this ends now.  In the past 10 days, we have engaged 3 law firms and 2 investigations companies and have already identified a handful of these truants.  Our ambitious intent is to find them all, press charges, and prosecute to the FULLEST extent of the law in their own jurisdictions.  While there are no guarantees of success, we believe this action is in the best interest of our shareholders, so we will proceed towards full enforcement of the law. We are in the business of helping patients and simultaneously building brand and shareholder value.  We will not allow a handful of unethical, immoral, shameless, and corrupt few to access short-term gains at the expense of our shareholders and our patients in need. Once identified and prosecuted, we look forward to fully exposing them and letting you, FINRA, and any other appropriate regulatory entity know who they are as permitted by law.

Since 1999, we have been helping patients find regenerative medicine solutions to their chronic conditions.  We will not stop now.  For those affected by Irma or Harvey, our best wishes for recovery. Irma notwithstanding, we are thrilled to be on track, open for business and helping patients in need.  

THANK YOU for your support.

Warmest regards,

Mike Tomas

President and CEO

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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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CSO Blog: US Stem Cell Clinic Response to FDA Warning Letter

Dear shareholders and friends,

The U.S. Food and Drug Administration posted a warning letter issued to US Stem Cell Clinic (USCC), a privately-held Florida LLC in which US Stem Cell, Inc. has a 33% Member Interest.  USCC, in our estimation, is a leader in novel regenerative medicine solutions and physician-based stem cell therapies for patients. USCC released the following statement in response to the FDA’s letter:

“The safety and health of our patients are our number one priority and the strict standards that we have in place follow the laws of the Food and Drug Administration. Since November 2014 we have offered the FDA unrestricted access to our facilities and our processes and will continue to work with them as it pertains to clinical and industry improvements. The FDA has stated that they will have specific stem cell guidelines by the 21st Century Cures Act deadline of December 13, 2017 and we intend to follow those standards as well.

We believe that we have helped thousands of patients harness their own healing potential.  It would be a mistake to limit these therapies from patients who need them when we are adhering to top industry standards.”

USCC has issued a response to the FDA (read the full letter here) and we are looking forward to their response.  Management contends that the clinic is completely compliant with medical board requirements of sterility for clinics.  The statements by the FDA regarding the sterility of our facility, in our opinion, are misleading since the requirements for GMP facilities are very different.  It is our sincerest interest to adhere to the FDA’s interpretation of the laws and have several specific questions that we have asked the FDA to kindly provide answers.  We have also specifically requested a meeting with the FDA commissioner to better explain the procedures that have successfully helped thousands of people.

I would like to thank everyone for the huge outpouring of support.  We will continue to fight for the rights of patients to harness their own healing potential.  I am honored to represent this technology and this company and I know that we are on the right side of history.  I have personally witnessed the power of regenerative medicine and as I have said before, I will always stand up for the rights of patients.

The FDA has included a link to ask patients to report concerns.  We would like to encourage patients to come forward using the same link that the FDA has issued to describe their positive experiences.  We know that thousands of patients have had excellent outcomes and the FDA should hear about these outcomes as well.

Warmest regards,

Kristin Comella

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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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CEO Blog: A Historic Quarter for USSC

10 August 2017

Dear Shareholders and Friends,

It has been a historic quarter for us at U.S. Stem Cell Inc.! We achieved many milestones including expanding clinic operations, publishing research as well as sharing our knowledge and findings at world renowned conferences. We have been growing at a tremendous rate with progress in all financial indicators, including increases in revenue, margins and profits–all UP while our working capital deficit decreased. We surpassed projections by almost double and are on our way to exceeding last year’s total revenue, making this our best year in the company’s history.

Our clinic operations are thriving and we are thrilled to bring on more resources to improve the quality of life for more patients in need. We are now underway to be fully operational with US Stem Cell Clinics in Sunrise, West Palm Beach and Chicago—while we help our strategic partners, American Stem Cell Centers of Excellence, open their clinics in Miami, Dallas and Orlando. The simultaneous success of these clinics represents additional revenues for US Stem Cell, Inc.—which is part of the reason for our historic financial results.

During this past month, several academic papers by our CSO Kristin Comella were released, which can be accessed by clicking the links below. We support her active efforts in research and expansion of regenerative medicine.  See her published reports on:

Kristin is also a speaker at this summer’s RAAD Fest and Bulletproof Conference in California. She will also be speaking at IFATs in Miami this Fall.

Our financial progress indicates continued success and this historic year has been a remarkable achievement.

Below is a summary of U.S. Stem Cell Inc.’s most recent figures for Q2:

  • Revenue up by 104% year-over-year: from $678K in Q2 2016 to $1.38M in Q2 2017
  • Margin increased from 65% to 71% quarter-to-quarter
  • Gross profit up by $542K year-over-year for the quarter: from $442K in Q2 2016 to $1.79M in Q2 2017
  • 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 $785K compared to $165K this time last year, a six-month comparison
  • Working Capital Deficit down 6.9% from $5.8M in Q2 2016 to $5.4M in Q2 2017

As a final note, we would like to extend our congratulations to Jason Taylor, a longtime shareholder and an avid supporter of our company, for being enshrined into the NFL’s 2017 Hall of Fame.

The support of our partners and helping our patients is what continues to drive us to excellence. We are committed to expanding regenerative medicine further with research, technology and treatment options for more patients around the world. Our innovative therapies and products are improving lives and continuously advancing medical research.

We invite you to follow us on social media to stay up to date with the latest news about U.S. Stem Cell, Inc. and its divisions.

Warmest Regards,

Mike Tomas
President & CEO
US Stem Cell, Inc.

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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

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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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