All posts by U.S. Stem Cell, Inc

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

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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CEO Blog: Good Summer at USSC

Dear Shareholders and Friends,

This past month has been one of great success here at U.S. Stem Cell Inc., starting with our CSO, Kristin Comella, being published both in the Journal of Translational Medicine and the Journal of Clinical Medicine Research. Comella also presented at the Cell Surgical Network conference in L.A., and is scheduled to present at the RAAD fest on August 9th and at the Bulletproof Nutrition conference on October 13th. In other exciting news,the American Stem Cell Centers of Excellence partnership with John Salley, NBA star and advocate of stem cell treatments brings continued coverage of stem cell therapy on a large scale. We have experienced continued success, growing patient satisfaction and clinic expansion, with June being a record month for number of patients treated and stem cells banked.

We commend our own Kristin Comella for having two of her scientific papers published this month. First on Intra-Articular Injection for Osteoarthritis published in the Journal of Translational Medicine (see full article here: https://goo.gl/NCWvJk

Secondly, for her paper on Chronic Obstructive Pulmonary Disease (COPD) published in the Journal of Clinical Medicine Research. Click here to read the full article: https://goo.gl/SsJT8J

We presented at the Cell Surgical Network conference in Los Angeles this month regarding research and techniques in regenerative medicine. There are also other exciting conferences happening in the next few months where our CSO Kristin Comella is scheduled to present. The first of these is the RAAD fest on August 9th where she will discuss the advancements in stem cell therapy and possibilities they offer. Kristin will also present on October 13th at Bulletproof Nutrition, whose founder, Dave Asprey, has received stem cell treatments with us. To read the CNBC article where Asprey discusses his treatment at our clinic click here: https://goo.gl/n99HAL

The American Stem Cell Centers of Excellence partnership with John Salley started from the NBA player’s personal experience with stem cell treatment. After being set to have surgery on his knees and shoulders Salley decided to use his own cells to heal his body. The wellness expert also banked his cells with us for future use and decided to become an advocate for our innovative stem cell treatments. Gaining key allies like John Salley provides U.S. Stem Cell, Inc continued growing coverage countrywide. Access the full news release here: https://goo.gl/ZyQ3nT

Overall, this summer has been one of great progress and success with many exciting opportunities in the near future. Look for press releases soon on our upcoming clinic openings in Palm Beach and Dallas—and don’t miss company news on our upcoming 10Q filing. We look forward to your continued support as we educate the public about the benefits of stem cells and use the latest technology to unlock the body’s self-healing power.

Warmest Regards,

Mike Tomas
President & CEO
US Stem Cell Inc.

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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.

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 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

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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U.S. Stem Cell to focus on and expand in-clinic therapies

Sunrise, FL – June 19, 2017 – (OTC:USRM) U.S. Stem Cell, Inc., 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, announces an aggressive plan to expand an additional 12 stem cell treatment centers and clinics in the US.  US Stem Cell has been in discussions with the FDA regarding Regenerative Medicine Advanced Therapy (RMAT) Designation for the Myocell product and at this time, the company has decided not to further invest in RMAT Designation and instead invest and focus on our in-clinic therapies for patients.

According to the 21st Century Cures Act, within one year of enactment, the FDA must issue draft guidance clarifying how the FDA will evaluate devices used in the recovery, isolation, or delivery of regenerative advanced therapies. Until this guidance document is published, it is unclear how this regulation will affect the MyoCell program. Until then, U.S. Stem Cell will focus on opening new clinics around the country to better serve patients in need.  In addition to the original Sunrise clinic (that has successfully treated hundreds of patients and generated over $2m in revenues in the past 12 months alone), recent clinic openings include Miami and Palm Beach, Florida.  Upcoming openings include Dallas, Texas (thanks in part to the early adoption of patient rights by the State of Texas), Chicago, Atlanta and Denver—as well as other clinics in the northeast and the west coast.

To be clear, U.S. Stem Cell will focus on our revenue generating programs that are treating patients NOW–which have successfully helped over 7000 patients thus far.  Our company was founded in 1999 and has completed more clinical treatments (for both humans and animals) than any other regenerative medicine company in the world.  In addition to our efforts at US Stem Cell Training and VetBiologics, our focus will be expanding and opening additional clinics throughout the U.S. to offer these cutting edge technologies to more patients.

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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CSO Blog: I will always stand up for patient rights

Dear shareholders and friends,

First, I would like to thank our patients who have put their trust in our medical staff to care for their most precious valuable: their health!  Regenerative medicine is the future of healthcare and now more than ever, we have been getting attention and support from shareholders, practitioners, and patients.  Every morning I remind myself of my personal goal: get stem cell treatments to as many patients as possible.  I then I ask myself if what I’m doing that day is going to accomplish that goal.

As many of you know, we have been working very closely with the FDA to understand the new Regenerative Medicine Advanced Therapy (RMAT) designation.  As with many regulations, the process can be cumbersome and difficult to navigate.  At this time, the FDA has not defined what RMAT designation will mean and as a result, it is unclear how this new regulation will help our company or technology.

For those of you who know me, you know that I have made a career of fighting for the rights of patients and have been to Washington D.C. to communicate this passion.  I stood before a panel of top FDA representatives last September and said, “I am Kristin Comella and I will always stand up for patient rights.”  My resolve and conviction has not changed.  I have seen patients who were wheelchair bound walk again, and I know this technology will one day be known as standard care.

At this time, seeking RMAT designation is not helping achieve the goal of getting regenerative medicine to the general public.  Until the FDA defines these new regulations, our resources are better served focusing on our in-clinic programs that provide treatments to patients every day.  Our phones are ringing off the hook with patients interested in pursuing these potentially life changing therapies.

My commitment to US Stem Cell and to the field of regenerative medicine has never been stronger.  I am excited about the future, and I know that future includes stem cell treatments. I promise I will never stop fighting for the right of patients to harness their bodies own healing potential.  I appreciate the many letters of support I have received as we change the course of medicine.

Warmest regards,

Kristin Comella

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CEO Blog: June is off to an amazing start

Dear shareholders and friends,

June is off to an amazing start for US Stem Cell Inc!  Our team is continuing to grow as we open new clinics—and we will be announcing several new locations in the coming months.  The message about regenerative medicine is beginning to reach a larger and broader audience.  In fact, the State of Texas has already approved legislation providing access to stem cell therapies to patients in need—and many other states are positioned to follow (see http://www.twcnews.com/tx/austin/news/2017/06/14/new-law-opens-door-for-stem-cell-therapy-in-texas.html).  We at U.S. Stem Cell commend the State of Texas for their forward-thinking support of patients in need, as we in turn prepare to open our next clinic in Dallas.

Earlier this month, our Chief Scientific Officer, Kristin Comella, was featured on Dr. Joseph Mercola’s blog with over 1.5 million followers demonstrating additional proof that stem cell options are reaching more folks.  Click here to read/listen: http://articles.mercola.com/sites/articles/archive/2017/06/04/stem-cell-therapy-repair-regenerate-body.aspx.  In addition, Comella has been recognized as one of Miami Today’s Best of Miami Health & Medicine for her work in regenerative medicine and stem cell therapy.  Access the full article here: http://stemcellcoe.com/wp-content/uploads/2016/09/6-1-17-Article-pg23.pdf  On June 5th, Comella also spoke to the Women’s Club at the Michael-Ann Russell JCC about harnessing your body’s healing potential by using adipose (fat) stem cells. She discussed joint issues, inflammation and issues after childbirth.  View here for more: http://www.sun-sentinel.com/business/careers/sofla-ugc-photo-regenerative-expert-kristin-comella-chief-sc-1-2017-06-08-photo.html

And the accolades for our research also continues.  Our scientific paper about intramyocardial implantation co-authored by Comella has recently been recognized as one of the most influential articles of 2016 for the Journal of Translational Medicine according to Altmetric.com.  Read more here: http://us-stemcell.com/kristin-comella-most-influential-scientific-papers-of-2016/

As many of you know, we have been working with the FDA regarding Regenerative Medicine Advanced Therapy (RMAT) designation for our MyoCell™ product. The RMAT process with the FDA has been quite cumbersome, time consuming and interactive as each request for additional information restarts the FDA’s 60-day clock—and the clock again restarting when we provided additional input on the $100,000,000 in clinical research we have invested on Myocell research thus far.  As a small company with limited resources, this process has proven unsustainable until the FDA determines an equitable path for all companies applying—which is apparently not the case today.  Even if approved for RMAT, we are still uncertain as to what the designation would mean for our company nor how we could benefit our patients in need.  U.S. Stem Cell cannot afford to continue this undetermined path so at this time, we have decided not to further invest funds in pursuing RMAT Designation and instead focus on our in-clinic therapies for patients.  According to the 21st Century Cures Act, the FDA has one year to issue draft guidance clarifying how the FDA will evaluate devices used in the recovery, isolation, or delivery of regenerative advanced therapies. Until this guidance document is published, it is unclear how this regulation will affect the MyoCell program.  Due to the uncertainty of this program, we feel that our shareholders and patients will be better served if we focus our efforts on therapies that benefit patients RIGHT NOW.  For this reason, we will instead focus on our revenue generating programs which have successfully helped over 7,000 patients. We at US Stem Cell Inc are very bullish on newly appointed FDA commissioner Scott Gottlieb as he promises to be a transformational leader for both the FDA and the progress of stem cell solutions for patients in need.  See his article on the subject here http://www.aei.org/publication/the-fda-wants-to-regulate-your-cells/

Our company was founded in 1999 and has completed more clinical treatments (for both humans and animals) than any other regenerative medicine company in the world.  We are currently expanding and opening additional clinics throughout the U.S. to offer these cutting-edge technologies to more patients.  We are thrilled to see the excitement about our technologies and will continue to pave the future of medicine.  Our shareholders demand that we focus our resources on helping patients in need TODAY—and we agree.

Warmest regards,

Mike Tomas
President &CEO
US Stem Cell Inc.

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