All posts by U.S. Stem Cell, Inc

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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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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NBA Star John Salley partners with Stem Cell Centers of Excellence

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

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

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

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

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

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

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About U.S. Stem Cell, Inc.

US Stem Cell, Inc. (formerly Bioheart, Inc.) is an emerging enterprise in the regenerative medicine / cellular therapy industry. We are focused on the discovery, development and commercialization of cell based therapeutics that prevent, treat or cure disease by repairing and replacing damaged or aged tissue, cells and organs and restoring their normal function. We believe that regenerative medicine / cellular therapeutics will play a large role in positively changing the natural history of diseases ultimately, we contend, lessening patient burdens as well as reducing the associated economic impact disease imposes upon modern society.

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

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

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

 

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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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CEO Blog: May has been an exciting month

Dear shareholders and friends,

May has been an exciting month with diverse accomplishments for U.S. Stem Cell, Inc. Our revenues continue to trend positive and all financial indicators are moving in the right direction. We have also helped open the first Stem Cell Centers of Excellence and the first patient has successfully been treated.

We are very pleased with the 2017 improvements in operations and balance sheet performance. We are progressing with our principal strategic business initiatives which include growing top line revenues and pursuing new business opportunities for exponential growth.

Here is a summary of the excellent financial figures for Q1 of 2017 recently reported:

  • Revenue up by 62% from $710,000 in Q1 2016 to $1.15M in Q1 2017
  • Gross profit up by 45.6% from $556,000 in Q1 2016 to $810,000 in Q1 2017
  • Cash Flow is positive Q1 2017 at $268,000 compared to Q1 2016 at ($62,000)
  • All debt-to-equity convertible notes have been either fully paid or converted as of March 31, 2017.

The first Stem Cell Centers of Excellence opened its doors and successfully treated its first patient this month in the beautiful city of South Miami, Florida. The center is the first of ten we plan to help open in key metropolitan areas over the next three years. The clinics will deliver patient-specific cellular treatments to patients suffering from degenerative diseases or injury.

Learn more about Stem Cell Centers of Excellence: www.stemcellcoe.com

At the beginning of the year, we applied for the FDA’s new Regenerative Medicine Advanced Therapy (RMAT) designation for our MyoCell™ product. In March 2017, the FDA reinstated our IND (MARVEL trial) to active status. In May, the FDA acknowledged that they received our additional information and are still in the process of reviewing our application for RMAT. Please note the FDA takes up to 60 days to review information submitted.

Read more here: https://goo.gl/K5pvvt

Our Chief Scientific Officer, Kristin Comella, had a chance to speak at the Paleo F(x) Conference in Austin, Texas a few days ago. The conference features speakers on a variety of topics, including holistic wellness, health, nutrition, fitness, sustainability, and self-development. Kristin will also be speaking at the prestigious RAAD Fest in San Diego, as well as the Cell Surgical Network in Los Angeles this weekend.

At U.S. Stem Cell, Inc. our goal is to innovate and develop new therapies and protocols to expand the reach of regenerative medicine and bring our therapies to patients around the world. We are well on track to help meet our goals.

Warmest regards,

Mike Tomas

President and CEO

 

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U.S. Stem Cell, Inc. Reports Continued Positive Results for Q1 2017

Sunrise, FL – May 3, 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 highlight the following results from operations for the quarter ending March 31, 2017:

  • Revenue up by 62% from $710,000 in Q1 2016 to $1.15M in Q1 2017
  • Gross profit up by 45.6% from $556,000 in Q1 2016 to $810,000 in Q1 2017
  • Cash Flow is positive Q1 2017 at $268,000 compared to Q1 2016 at ($62,000)
  • All debt-to-equity convertible notes have been either fully paid or converted as of March 31, 2017.

“We are very pleased with the 2017 improvements in operations and balance sheet performance,” said Mike Tomás, President & CEO of U.S. Stem Cell, Inc. “We are progressing with our principal strategic business initiatives which include growing top line revenues and pursuing new business opportunities for exponential growth.”

U.S. Stem Cell, Inc. continues to make a positive impact on the lives of patients treated using its procedures. This year we hope to continue our accomplishments and value for both patients and shareholders.

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: Exciting Accomplishments in April

Dear Shareholders and Friends,

U.S. Stem Cell, Inc. has seen many exciting accomplishments in April. We have curated new partnerships, finalized investments, and received updates on our RMAT designation from the Food and Drug Administration (FDA).

We have recently partnered with Advanced Stem Cell RX in a strategic alliance to commercialize our proprietary applications and protocols. Advanced Stem Cell RX will aid us in implementing U.S. Stem Cell, Inc. programs into qualified practices and clinics in over 20 different states. They will be utilizing our technology to treat patients suffering from degenerative disorders.

On January 27, 2017, U.S. Stem Cell, Inc. applied for the FDA’s new Regenerative Medicine Advanced Therapy (RMAT) designation for the MyoCell™ product as part of the MARVEL trial. After application, the FDA is given 60 days to review it or request additional information.  In late March, the FDA requested additional information in order to reinstate our IND (MARVEL trial)—which has been reinstated to active status.  Please note that each time more information is requested, the 60-day timeline resets and the FDA is afforded additional regulatory processing time. Currently, U.S. Stem Cell, Inc. is operating within the regulatory timeline and is actively working with the FDA to quickly and effectively fulfill requests for supplementary materials.  We will continue to keep our base informed on any FDA communications that affect this timeline.

Read more here: https://goo.gl/K5pvvt

Recently, we announced a new commitment from private equity firm General American Capital Partners (GACP) to invest up to $5 million in U.S. Stem Cell, Inc. in exchange for up to 63,873,275 shares of common stock.  GACP has been an avid supporter of U.S. Stem Cell, Inc. and the regenerative medicine industry. We are working together to open Stem Cell Centers of Excellence and to expand our tissue banking facility. With help from companies like GACP, we get closer to our goal of making regenerative medicine more accessible and available to patients all over the world.

Continue reading: https://goo.gl/EFsmrv

Our Chief Science Officer Kristin Comella was featured in Hartman Media’s podcast, “The Longevity and Biohacking – Using Stem Cells to Give Yourself a Better Life.” Kristin was invited to share insights about stem cell treatments and how they can benefit patients suffering from degenerative conditions.

Listen to the podcast here: https://goo.gl/CGtw2U

U.S. Stem Cell, Inc. is committed to the continued development of regenerative medicine technologies and protocols, with our ultimate goal being to make our therapies as accessible as possible to patients around the world. With a strong focus on new, life-changing treatments, our advancements and innovations continue. Stay tuned below to our latest efforts by following us and our various divisions on social media.

Warmest regards,

Mike Tomás

President & CEO

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

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

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

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

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

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, Inc. MARVEL Trial Receives Reactivation Status with the FDA

Sunrise, FL – April 10, 2017 – U.S. Stem Cell, Inc. (USCC), a Florida corporation and leader in novel regenerative medicine solutions and physician-based stem cell therapies for human and animal patients, has received reactivation status of the MARVEL phase II/III trial.

Following the passing of the 21st Century Cures Act, U.S. Stem Cell, Inc. has applied to the FDA for Regenerative Medicine Advanced Therapy (RMAT) Designation for the MyoCell product as part of the MARVEL trial.  Our trial had previously been placed on “Inactive Status” as patients were not actively being enrolled.  We placed a request to the FDA to reactivate the protocol and consider the therapy for RMAT designation.  We have recently heard from the FDA who has notified us that the protocol has been placed on “Reactivation Status” after reviewing details on the protocol and data collected on patients to date.  The FDA has also notified us that they are still reviewing our submission for RMAT.  Thanks to the REGROW component of the Cures Act, The FDA will grant RMAT designation for a regenerative medicine therapy that is intended to treat, modify, reverse, or cure a serious or life-threatening disease and demonstrates preliminary clinical evidence that the product has the potential to address unmet medical needs for a disease.  We believe that our MyoCell product meets these requirements as we have demonstrated clinical efficacy in both preclinical and clinical studies including our most recent MARVEL trial publication (review full publication here: https://www.ncbi.nlm.nih.gov/pubmed/21982657).  If RMAT designation is granted, this could expedite the approval process with the FDA.

More information on the FDA’s new RMAT Designation can be found here: https://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ucm537670.htm

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About U.S. Stem Cell, Inc.

US Stem Cell, Inc. (formerly Bioheart, Inc.) is an emerging enterprise in the regenerative medicine / cellular therapy industry. We are focused on the discovery, development and commercialization of cell based therapeutics that prevent, treat or cure disease by repairing and replacing damaged or aged tissue, cells and organs and restoring their normal function. We believe that regenerative medicine / cellular therapeutics will play a large role in positively changing the natural history of diseases ultimately, we contend, lessening patient burdens as well as reducing the associated economic impact disease imposes upon modern society.

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

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

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

 

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

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

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

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

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 RELEASES POSITIVE 2016 FINANCIAL RESULTS

 Sunrise, FL – March 15, 2017 – U.S. Stem Cell, Inc., a Florida corporation and leader in novel regenerative medicine solutions and physician-based stem cell therapies for human and animal patients, is pleased to announce the following results from operations for the year ending December 31, 2016.

“U.S. Stem Cell, Inc. continues to increase revenue, decrease liabilities and decrease operating expenses,” said Mike Tomás, President and CEO of U.S. Stem Cell, Inc. “As a world leader in stem cell research and development for degenerative conditions, we are excited about the industry’s future and dedicated to making a positive impact in our patients’ lives.”

Working with physician partners to offer over 30 protocols to patients, U.S. Stem Cell, Inc. is increasing business opportunities by expanding its services, treatments and therapies both inside and outside the United States.

Financial highlights from 2016 include:

  • Revenue up by 38% from $2.2M in 2015 to $3.03M in 2016
  • Current liabilities down by $1.9M or 23.8% from $8.0M in 2015 to $6.1M in 2016
  • Operating Expenses down 16.5% (or $631,825) from 3.82M in 2015 to $3.19M in 2016
  • Net loss improved 136% from $2.6M (gain) in 2015 to $1.15M in 2016
  • And for the first time in the company’s history, U.S Stem Cell, Inc. ended the year on a cash positive note: $108,596 cash positive as a result of operations in 2016 compared to $844,690 cash negative from operations in 2015

Operating results for the year ending December 31, 2016 are not necessarily indicative of the results that can be expected for the year ending December 31, 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, 2015, and its Quarterly Reports on Form 10-Q.

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CEO Blog: U.S. Stem Cell, Inc. is off to a great start this year!

Dear shareholders and friends,

U.S. Stem Cell, Inc. is off to a great start this year!  We broke ground on our first clinic in the Middle East, presented at several industry conferences and signed several new agreements that will help us expand our business.

Our recent agreement with High Rising Group to open clinics throughout the Middle East, including Kuwait, Dubai, and Qatar is moving forward. Our first new clinic, located in Kuwait City, is currently under construction and we are scheduled to be fully operational before the end of the year. Read more about the launch of U.S. Stem Cell, Inc. in the Middle East here: http://us-stemcell.com/en/u-s-stem-cell-inc-announces-launch-of-us-stem-cell-middle-east/

Demonstrating a progressive step forward, a member of NorthStar Biotech LLC, Greg Knutson, joins the US Stem Cell Inc’s Board of Directors just as the two companies have amicably settled a legal dispute related to NorthStar’s preferred shares. We are extremely pleased to have Mr. Knutson join us as he has been a longtime supporter of U.S. Stem Cell and brings a wealth of entrepreneurial and business acumen to our team. Mr. Knutson will assist us in continuing our recent technological advances and developments alongside our financial accomplishments. Read more here: http://us-stemcell.com/greg-knutson-joins-u-s-stem-cell/

As we recently announced via 8K, we are also working with General American Capital Partners (GACP) to open 10 new clinics in the U.S. called Stem Cell Centers of Excellence. We are excited to help GACP provide stem cell services to new patients in a variety of metropolitan areas over the next three years. In addition, we have entered into an agreement with GACP which will allow for growth of the tissue banking facility.  Read more about the agreement with GACP here:   https://www.sec.gov/Archives/edgar/data/1388319/000118518517000536/usstemcell8k030817.htm

In conference related news, in January, our Chief Scientific Officer and world renowned stem cell expert, Kristin Comella, presented at the Cell and Gene Therapy World 2017 conference. Hosted by Phacilitate, the three-day event featured a variety of topics and sessions covering the world of regenerative medicine.

In February, we participated in the annual Academy of Regenerative Practices conference (www.regenerativeacademy.com).  Scientists and physicians from around the world shared their knowledge and insights in the regenerative medicine field. Ms. Comella presented our latest clinical results and discussed the current regulatory environment.  In addition, Dr. Robert Silbert presented the results from our degenerative disc trial.  Patients in that trial demonstrated significant improvements after injection of adipose stem cells into their backs. Read more here: http://us-stemcell.com/en/cso-kristin-comella-publishes-paper-on-the-implantation-of-stromal-vascular-fraction-in-patients-with-degenerative-disc-disease/

This month, Kristin Comella was also featured on the 30/30 HEALTH podcast to discuss adipose-derived stem cells, including how and when they are used. Her interview with Guillermo Ruiz is available in its entirety here: http://3030health.libsyn.com/podcast/episode-06-an-interview-with-kristin-comella

On regulatory news, following the passing of the 21st Century Cures Act, U.S. Stem Cell, Inc. has applied to the FDA for Regenerative Advanced Therapy or RAT Designation. Thanks to the REGROW component of the Cures Act, The FDA will grant RAT designation for a regenerative medicine therapy that is intended to treat, modify, reverse, or cure a serious or life-threatening disease and demonstrates preliminary clinical evidence that the product has the potential to address unmet medical needs for a disease.  We believe that our MyoCell® product meets these requirements as we have demonstrated clinical efficacy in both preclinical and clinical studies including our most recent MARVEL Phase II/III trial.  If RAT designation is granted, this could expedite the approval process with the FDA. More information on the FDA’s new RAT Designation can be found here: https://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ucm537670.htm

For financial news, refer to the 2016 10K to be filed this month.

As always, we are committed to the development of pioneering regenerative medicine technologies and techniques with our goal being able to reach as many patients around the world as possible.  U.S. Stem Cell, Inc. is committed to new, life-changing treatments.  Please stay tuned to our latest efforts and advancements by following us and our divisions on social media below.

Warmest regards,

Mike Tomás

President & CEO

 

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