All posts by U.S. Stem Cell, Inc

US Stem Cell Inc Reports Legal Appeal Results and Company Direction

SUNRISE, FL – June. 8th, 2021 – U.S. Stem Cell, Inc. (OTC: USRM), a corporation that has
historically focused on the regenerative medicine / cellular therapy industry specializing in physician
training and certification and stem cell products in both human and veterinary stem cell processes , has
received the results of the Appeal from the United States 11th District Court for the Southern District of
Florida.

Since May 9th, 2018, U.S. Stem Cell, as one of the parties named on a legal action by the FDA, has been
challenged by an injunctive action filed by the U.S. Department of Justice, at the request of the U.S. Food
and Drug Administration (FDA). The suit alleged, among other matters, that the defendants manufactured
“stromal vascular fraction” (SVF) products from patient adipose (fat) tissue without first obtaining what
the government alleged are necessary FDA approvals for a new drug. The Company had always
maintained that stem cell treatments are medical procedures regulated by the respective State medical
boards—and a patients’ own stem cells are not drugs to be regulated by the federal government.
Notwithstanding:

  •  On June 25th, 2019, Florida-based federal court judge Ursula Ungaro ruled in favor of the
    government on summary judgement (a ruling without providing the Company with a trial) and
    ruled that U.S. Stem Cell and the other defendants must stop most product sales, processes and
    procedures.
  •  On August 23rd, 2019, the Company filed an appelate brief challenging Judge Ungaro’s decision
    and respectfully requesting the Company’s due process rights of a trial.
  •  On January 27th, 2020, on a similar case, California-based federal court judge Jesus Bernal
    ruled against the government on summary judgement and ordered the case to proceed to trial.
  • On January 13th, 2021, the 11th District Court of Appeals heard the Company’s oral arguments.
  •  On June 1st, Judge Ungaro retired from the bench after 29 years of distinguished service and
    joined the board of directors of another clinical stage biotechnology company developing cellular
    therapies for chronic, aging-related and life-threatening conditions.
  • On June 2nd, 2021, the Eleventh Circuit Court ruled to affirm Judge Ungaro’s judgement on the
    basis, generally, that neither the same day surgical procedure exception nor the 361 HCT/Ps
    exception applies to the Company’s and the other defendants’ surgical practices.

“The ongoing case has been a long, expensive and arduous fight and although the results of the appeal are
disappointing, the Company will, of course, continue to abide by the court’s decision” states Mike Tomas,
President & CEO. Adding “Nonetheless, we will both examine future legal options on this court case
while looking forward to exploring other avenues of growth for the Company.”

The company will continue to monitor the ongoing trial in California, 5:18-cv-01005 where a federal
judge ruled that a stem cell company involved in a similar stem cell procedure was entitled to a trial and
has yet to rule on whether the stem cell procedures may be regulated by the FDA as a ‘drug.’

As a result of this court case result and taking advantage of the different capabilities housed within U.S.
Stem Cell, the Company will take steps to rebrand, restructure, and relaunch the Company to refocus on
its other divisions.

U.S. Stem Cell, Inc. is a corporation that has historically focused on the regenerative medicine / cellular
therapy industry specializing in physician training and certification and stem cell products in both human
and veterinary stem cell processes. To management’s knowledge, USRM has completed more clinical
treatments than any other stem cell company in the world in the past 20 years, and has certified more than
700 physicians and veterinarians in autologous stem cell therapy worldwide. The company will refocus
on its animal health division while it evaluates its future opportunities for its human division and
subsidiary.

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 and 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, even if new information becomes available in the future. The Company’s historical business and the risks and uncertainties of the business are described in its filings with the Securities and Exchange Commission which can be found at sec.gov.

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Northstar Biotech and USRM BOD Members Reinvest in the Company

SUNRISE, FL – Feb 23, 2021 – U.S. Stem Cell, Inc. (OTC: USRM), a leader in the development of proprietary, physician-based, and novel regenerative medicine solutions, is pleased to announce the efforts of NorthStar Biotech Group and USRM Board Members to reinvest in U.S. Stem Cell, Inc.

On May 9, 2018, the U.S. Department of Justice, at the request of the U.S. Food and Drug Administration (FDA), filed suit against U.S. Stem Cell, Inc. and others to enjoin defendants from utilizing the SVF Surgical Procedure, in which “stromal vascular fraction” (SVF) cells are removed from a patient’s fat tissue and reimplanted in the patient during the same surgical procedure.    The Company has maintained that such cellular therapies are surgical procedures regulated by state law, and that the SVF surgical procedure is excepted from regulation under the Federal Food, Drug, and Cosmetic Act (FDCA). On June 25, 2019, the federal court for the Southern District of Florida ruled in favor of the government, enjoining the Company and the other defendants  from certain product sales and processes. The Company filed an appeal on August 23, 2019 and attended oral argument on January 13th, 2021.  The Court of Appeal has not yet ruled on the Company’s appeal that the injunction should not have been entered.

“While there can be no assurances for a positive outcome of the case, we believe and fully support the mission of U.S. Stem Cell” said Gregory Knutson, Managing Partner of NorthStar Biotech Group and U.S. Stem Cell board director. Further commenting “We believe in the technology and the potential of the Company and now is the time to help support it towards the next goal.”

“The support of our NorthStar Biotech partners and our board of directors is timely, crucial and testament to our company’s potential.” States Mike Tomas, President and CEO of U.S. Stem Cell Inc.

U.S. Stem Cell, Inc. is an emerging leader in the regenerative medicine and cellular therapy industry specializing in physician training and certification, as well as veterinary applications, and management of cellular therapy clinics. To management’s knowledge, the Company historically has completed more clinical treatments than any other cellular therapy company in the world in the past 20 years, and has certified more than 700 physicians and veterinarians in autologous cell therapies worldwide.

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 and 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, even if new information becomes available in the future. The Company’s business and the risks and uncertainties of the business are described in its  past filings with the Securities and Exchange Commission which can be found at sec.gov.

 

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USRM Oral Argument in Appeal from FDA Enforcement Action

SUNRISE, FL – Jan 19, 2021 – U.S. Stem Cell, Inc. (OTC: USRM), a leader in the development of proprietary, physician-based, and novel regenerative medicine solutions, is pleased to announce that oral arguments in the case United States v. U.S. Stem Cell Clinic, LLC, et al., took place on January 13, 2021, before the federal Eleventh Circuit Court of Appeals. The oral argument was held on the Company’s appeal of a judgment denying it the right to present evidence and testimony in support of its position and practices in a trial. The Company continues to maintain it should be afforded the opportunity to support its position in such a trial.

On May 9, 2018, the U.S. Department of Justice, at the request of the U.S. Food and Drug Administration (FDA), filed suit against U.S. Stem Cell, Inc. and others to enjoin defendants from utilizing the SVF Surgical Procedure, in which “stromal vascular fraction” (SVF) cells are removed from a patient’s fat tissue and reimplanted in the patient during the same surgical procedure. The Company has maintained that such cellular therapies are surgical procedures regulated by state law, and that —and that the SVF surgical procedure is excepted from regulation under the federal Food, Drug, and Cosmetic Act (FDCA). On June 25, 2019, the federal court for the Southern District of Florida ruled in favor of the government, enjoining the Company from most product sales, processes and procedures. The Company filed an appeal on August 23, 2019.

During oral argument on January 13, counsel for the Company argued that the SVF Surgical Procedure is not subject to regulation under the FDCA, pursuant to a 2001 FDA regulation that provides an exception for a procedure in which cells are removed from and implanted in the same patient during the “same surgical procedure.” FDA relied upon an interpretation of the “same surgical procedure” exception that precluded its application where the reimplanted cells were derived from fat tissue, arguing that the reimplanted cells were not “in their original form.” The Company’s counsel argued that the FDA’s interpretation, from a 2017 guidance document, should not be given deference, because FDA acknowledged that the 2001 “same surgical procedure” exception was unambiguous. The appellate panel of judges questioned both parties noting the complexity of the subject matter, and also asking about the effect of expert testimony in favor of the Company’s position.

“While the ongoing case has been a long struggle and there can be no assurances for a positive outcome for U.S. Stem Cell Inc, we remain hopeful as we continue to seek a reversal of the June 25th, 2019 ruling,” states Mike Tomas, President and CEO. Tomas further comments, “The regenerative therapies we have pioneered and perfected should be in clinics helping patients, not held hostage by litigation.”

U.S. Stem Cell, Inc. is an emerging leader in the regenerative medicine and cellular therapy industry specializing in physician training and certification, as well as veterinary applications, and management of cellular therapy clinics. To management’s knowledge, the Company has
completed more clinical treatments than any other cellular therapy company in the world in the past 20 years, and has certified more than 700 physicians and veterinarians in autologous cell therapies worldwide.

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 and 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, even if new information becomes available in the future. The Company’s business and the risks and uncertainties of the business are described in its filings with the Securities and Exchange Commission which can be found at sec.gov.

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U.S. Stem Cell Confirms Date for Appeals Court Oral Arguments

SUNRISE, FL – Sep. 30, 2020 – U.S. Stem Cell, Inc. (OTC: USRM), a leader in the development of proprietary, physician-based, and novel regenerative medicine solutions, is pleased to announce that oral arguments for the company’s court case USA v. U.S. Stem Cell Clinic, et al has been set for the docket beginning  January 11, 2021.

Since May 9, 2018, U.S. Stem Cell Inc., as one of the parties named, has been challenged by an injunctive action filed by the U.S. Department of Justice, at the request of the U.S. Food and Drug Administration (FDA). The suit alleges that the defendants manufactured “stromal vascular fraction” (SVF) products from patient adipose tissue without first obtaining what the government alleges are necessary FDA approvals for a new drug. The Company has maintained that cellular treatments are surgical procedures regulated by the respective State medical boards—and that a patient’s own tissues are not drugs to be regulated by the federal government.  Notwithstanding, on June 25, 2019, a Florida-based federal court judge ruled in favor of the government on summary judgment without holding a trial and ordered that U.S. Stem Cell stop most product sales, processes and procedures. The Company filed an appeal on August 23, 2019.

“We welcome the opportunity to defend our cellular technology as the company transitions to a diversified regenerative medicine platform, complying with both the court rulings and the FDA’s guidances,” stated Mike Tomas, President & CEO. “We are cautiously optimistic that, with the court date for oral arguments being set, the Court is considering whether the summary judgment was entered in error, and whether we were entitled to a trial to present evidence supporting our position.”

U.S. Stem Cell, Inc. is an emerging leader in the regenerative medicine and cellular therapy industry specializing in physician training and certification, as well as veterinary applications, and management of cellular therapy clinics.  To management’s knowledge, U.S. Stem Cell has completed more clinical treatments than any other cellular therapy company in the world in the past 20 years, and has certified more than 700 physicians and veterinarians in autologous cell therapies worldwide.

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 and represent our management’s beliefs and assumptions only a of the date hereof. Except as required by law, we assume no obligation to update these forward-looking statements, even if new information becomes available in the future. The Company’s business and the risks and uncertainties of the business are described in its filings with the Securities and Exchange Commission which can be found at sec.gov.

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CEO Blog: A Summary of Recent Events

Dear Shareholders and Friends,

Thank you for your continued interest and support in U.S. Stem Cell, Inc.  In an effort to keep you updated on matters related to the Company, please see our latest summary of recent events below.

Prior to our litigation with the FDA, U.S. Stem Cell had grown remarkably as a company. Since year-end 2015, the Company had experienced 12 quarters of continued growth in revenues (compared each time to the same period the year prior). This performance earned U.S. Stem Cell the honor of being recognized as a Deloitte Technology Fast 500 company, an award that recognizes 500 of the fastest-growing technology, media, telecommunications, life sciences, and energy tech companies in North America based on percentage of fiscal year revenue growth from 2015 to 2018.

During this time (and since May 9, 2018), U.S. Stem Cell, as one of the parties, has been challenged by the FDA’s injunctive action against the Company, alleging, among other matters, that the defendants manufactured “stromal vascular fraction” (SVF) products from patient adipose (fat) tissue without first obtaining what the government alleges are necessary FDA approvals for a new drug. The Company has always maintained that stem cell treatments are medical procedures regulated by the respective State medical boards—and a patients’ own stem cells are not drugs to be regulated by the federal government.  Notwithstanding, on June 25th, 2019, Florida-based federal court judge Ursula Ungaro ruled in favor of the government on summary judgement (and without giving our Company our day in court by holding a trial) and ruled that U.S. Stem Cell must stop most product sales, processes and procedures. The result was a devastating impact on our revenue streams and growth trends. The Company filed an appeal on August 23rd, 2019.

Recently, in a substantially similar case in California (with the same attorneys, Venable LLP, representing the stem cell companies; the other case being “United States v. California Stem Cell Treatment Centers”) the California federal judge in that case, judge Jesus Bernal, denied the FDA’s motion for summary judgement and has designated that the case will proceed to trial. This is positive news for our appeal as two circuit courts have reached an opposite result.

In summary on the legal actions:

1- The FDA filed two lawsuits, one in California and one in Florida, arguing that SVF (stromal vascular fraction) falls under FDA oversight— contrary to the position of our Company and others, branding an individual’s stem cells a “drug” and therefor under the federal jurisdiction of the FDA;

2- Both defendants (U.S. Stem Cell et al and Cell Surgical Network) defended by citing the ‘same day surgical exception,’ which if our position is accepted, would have same-day stem cell therapy fall under the jurisdiction of each respective State’s medical board;

3- In Florida, federal judge Ursula Ungaro ruled that a trial was not necessary and granted the FDA’s requested relief—thus denying U.S. Stem Cell its day in court to present testimony and cross examine the FDA witnesses;

4- In contrast, California federal judge Jesus Bernal, denied the FDA’s same request for summary judgment and ordered the matter to proceed to trial—and declined to follow the Florida court’s ruling;

5- We are gratified that the judge in California took the time to carefully review both the law and science and allowed the matter to proceed to trial.  We respectfully believe that was the correct result.  In the meantime, of course, U.S. Stem Cell et al are adhering to the current Florida court order while our appeal is pending;

6-  As noted, we have filed an appeal with the 11th circuit.

In the meantime, we continue to operate with reduced income and new products to our network. The Company plans to file form 12b-25, requesting a 15-day extension for the 2019 Annual Report on Form 10K deadline.  We are considering possible strategic alliances with other regenerative, integrated, functional and wellness medicine groups.  No assurances can be provided that any alliances will transpire or what impact the COVID-19 preventative measure will have on our business or any potential business transactions.

We truly appreciate your continued support.

Thank you and warm regards,

Mike Tomas

President & CEO
US Stem Cell Inc.

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Corrected: USRM Posts Earnings for Second Quarter 2019

SUNRISE, FL – August 7, 2019 – U.S. Stem Cell, Inc. (OTC: USRM), a leader in the development of proprietary, physician-based stem cell therapies and novel regenerative medicine solutions, today announced earnings for the second quarter that ended June 30, 2019. Correction: U.S. Stem Cell, Inc. posted second-quarter revenues of $1.2M.

While second-quarter earnings lagged, the Company’s results took into account the current regulatory environment. Compared to second quarter of 2018, year-over-year revenue decreased $522k or 29%, from $1.8M to $1.2M. Likewise for the six month period ending June 30, 2019 over six months, the Company’s revenue reduced $926k or 26%.

After 12 quarters of steady growth, the Company saw its first significant dip starting in January 2019.

“While the Company was fortunate to see tremendous growth for nearly four years, pioneering the field of stem cell treatment does not come without obstacles. We have introduced new products and will continue to adjust the business accordingly as we navigate the complexities of an evolving regulatory structure,” said Mike Tomas, President  & CEO of U.S. Stem Cell Inc.

“We are transitioning the clinics to a more diversified regenerative medicine platform, while complying with recent court rulings. While we are considering our appellate options to seek a reversal of those rulings, we are planning to replace the demand for adipose stem cell therapies in the coming years and we expect to see a lag as we shift the business.”

Net decrease in gross profit margin for the second quarter 2019 was 36.8%, or $791k, compared to second quarter 2018. Operating expenses were down 36.1% or $750k, for the second quarter, and also decreased for six-month ending 2019 23.8% from $3.2M to $2.5M.

Working capital deficit is up for the second quarter, $7.1M from $4.4M since December 2018 due to current maturities from Promissory Notes. Net operating income (loss) from operations decreased from ($823k) to ($534k) from the same period last year. Income (loss) from operations decreased from ($933k) in the six-month ending June 30, 2018, to a loss of ($832k) in the six month ending June 30, 2019.

U.S. Stem Cell, Inc. is a leader in the regenerative medicine / cellular therapy industry. To management’s knowledge, USRM has completed more autologous stem cell clinical treatments than any other stem cell company in the world.

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 and 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, even if new information becomes available in the future. The Company’s business and the risks and uncertainties of the business are described in its filings with the Securities and Exchange Commission which can be found at sec.gov.

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USRM Posts Earnings for Second Quarter 2019

SUNRISE, FL – August 7, 2019 – U.S. Stem Cell, Inc. (OTC: USRM), a leader in the development of proprietary, physician-based stem cell therapies and novel regenerative medicine solutions, today announced earnings for the second quarter that ended June 30, 2019. U.S. Stem Cell, Inc posted second-quarter earnings of $1.2M.

While second-quarter earnings lagged, the Company’s results took into account the current regulatory environment. Compared to second quarter of 2018, year-over-year revenue decreased $522k or 29%, from $1.8M to $1.2M.   Likewise for the 2019 over six months, the Company’s revenue reduced $926k or 26%.

After 12 quarters of steady growth, the Company saw its first significant dip starting in January 2019

“While the company was fortunate to see tremendous growth for nearly four years, pioneering the field of stem cell treatment does not come without obstacles. We have introduced new products and will continue to adjust the business accordingly as we navigate the complexities of an evolving regulatory structure,” said Mike Tomas, President & CEO of U.S. Stem Cell Inc.

“We are transitioning the clinics to a more diversified regenerative medicine platform,  while complying with recent court rulings .  While we are considering our appellate options to seek a reversal of those rulings, we are planning to replace the demand for adipose stem cell therapies in the coming years and we expect to see a  lag as we shift the business.”

Net decrease in gross profit margin for the second quarter 2019 was 36.8%, or $791k, compared to second quarter 2018. Operating expenses were down 36.1% or $750k, for the second quarter, and also decreased for six-month ending 2019 23.8% from $3.2M to $2.5M.

Working capital deficit is up for the second quarter, $7.1M from $4.4M since December 2018 due to current maturities from Notes. Net operating income (loss) from operations decreased from ($823k) to ($534k) from the same period last year.  Income (loss) from operations decreased from ($933k) in the six-month ending June 30, 2018, to a loss of ($832k) in the six month ending June 30, 2019.

U.S. Stem Cell, Inc. is a leader in the regenerative medicine / cellular therapy industry.  To management’s knowledge, USRM has completed more autologous stem cell clinical treatments than any other stem cell company in the world.

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 and 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, even if new information becomes available in the future. The Company’s business and the risks and uncertainties of the business are described in its filings with the Securities and Exchange Commission which can be found at sec.gov.

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USRM Posts Financial Results for First Quarter 2019

SUNRISE, FL – May 7, 2019 – U.S. Stem Cell, Inc. (OTC: USRM), a leader in the development of proprietary, physician-based stem cell therapies and novel regenerative medicine solutions, today announced financial results for the first quarter ended March 31, 2019.

For the first time in two years, the Company’s revenue decreased.  The drop was 24%, from $1.7M in the first quarter of 2018 to $1.3M in the current quarter.  

“ We are working to achieve the transition of the autologous stem cell space  from relatively unknown to a recognized, viable option in the marketplace, as more and more people learn about the healing potential from their own stem cells,” said Mike Tomas, President and CEO of U.S. Stem Cell, Inc.  “This quarter we saw a negative shift in our quarterly revenues and earnings. As the benefits of autologous stem cell therapy become more and more relevant, we look forward to continuing to provide leadership and opportunity in the field of regenerative care.”

The Company’s gross profit for the first quarter of 2019 decreased 35% compared to the same period last year, from $1.2M to $0.8M.  Operating expenses were down 3% or $33k, for the first quarter of 2019 compared to last year, but remained at approximately $1.2M, due in large part to the Company’s costs associated with the legal effort to defend, among other matters,  claims challenging autologous stem cell therapy.

“Americans are given the technology inside their own bodies to heal, and we feel strongly the opportunity is here to preserve access to this treatment as an effective, regenerative therapy whose time has come,” said Dr. Kristin Comella.  “We are confident there will be a time when this therapy is part of the standard of care, and we look forward to that day.”

Working capital deficit at the end of the first quarter of 2019 was up 9% to $4.8M, compared to $4.4M at year end 2018. The Company’s operating loss increased from $9k in the first quarter of 2018 to $399k for the first quarter of 2019.  

U.S. Stem Cell, Inc. is a leader in the regenerative medicine / cellular therapy industry specializing in physician training and certification and stem cell products including its leading therapy Adipocell™, as well as veterinary stem cell training, stem cell banking, and the creation and the management of stem cell clinics.  To management’s knowledge, USRM has completed more autologous stem cell clinical treatments than any other stem cell company in the world.

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 and 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, even if new information becomes available in the future. The Company’s business and the risks and uncertainties of the business are described in its filings with the Securities and Exchange Commission which can be found at sec.gov.

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USRM Posts Increase in Revenue and Profit Margin for 2018

SUNRISE, FL – March 13, 2019 – U.S. Stem Cell, Inc. (OTC: USRM), a leader in the development of proprietary, physician-based stem cell therapies and novel regenerative medicine solutions, today announced positive financial results for the year ended December 31, 2018.

Consistent with performance for the past two years, revenue continues to increase, up 21% or $1.2m for year-end, 2018 compared to 2017, from $5.5m to $6.7m.   Likewise, for the three months ended December 31, 2018, the Company reported a $190k or 13% increase in revenue, from $1.5m to $1.7m, compared to the same period last year.

“It is remarkable to watch demand increase for stem cell therapy, as more and more Americans are exploring this option as a solution for chronic pain,” said Mike Tomas, President and CEO of U.S. Stem Cell, Inc.  “We are on the cusp of regenerative medicine becoming a more integral part of patient plan of care,” said Tomas.

Net increase in gross profit margin for year end 2018 compared to 2017 is 26%, or $955k, from $3.6m to $4.6m. Likewise net increase in gross profit margin for the three months ended December 31, 2018, compared to the same period in 2017, is 25%, or $232k, from $936k to $1.2m.  

Operating expenses increased 28%, from $4.4m to $5.7m for the year end, and 55% from $784k to $1.2m for the three months ended Dec. 31, mostly due to stock-based and other employee compensation.  Non-cash compensation for the year and for the three months ended Dec. 31 also increased, from $645k to $1.2m and from $83k to $416k, respectively.

Net operating (loss) was $1.1m for 2018, compared to $805k for 2017. For the three months ended December 31, 2018, net operating (loss) was $47k compared to a profit of $152k for the same period last year.

Currently, Americans have the option to either utilize their own healing stem cells harvested from fat or bone marrow or to use tissue-based products like those from birth tissue or cord blood.  Dr. Kristin Comella, USRM’s Chief Science Officer, is one of the most published scientists in the world on autologous adipose stem cell therapy. She and her colleagues have published several articles in the past few months regarding the benefits of autologous stem cell therapy for chronic conditions, including decubitus ulcers (perpetual sores common in spinal injury patients and the elderly); meniscal tears, and psoriasis.  Chronic conditions can cause chronic pain — the source of a national opioid epidemic which The New York Times reports is the leading cause of death for Americans under the age of 50.

Autologous stem cell therapy involves taking a small sample of a patient’s fat and separating the stem cells from the fat or adipose tissue. Because there are 500 times more stem cells from fat as compared to bone marrow (and much less invasive to retrieve), the protocol has begun to attract more and more patients in the United States, even though the treatment has been available abroad and offshore for many years.  

U.S. Stem Cell, Inc. is a leader in the regenerative medicine / cellular therapy industry specializing in physician training and certification and stem cell products including its leading therapy Adipocell™, as well as veterinary stem cell training, stem cell banking, and the creation and the management of stem cell clinics.  To management’s knowledge, USRM has completed more autologous stem cell clinical treatments than any other stem cell company in the world.

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 and 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, even if new information becomes available in the future. The Company’s business and the risks and uncertainties of the business are described in its filings with the Securities and Exchange Commission which can be found at sec.gov.

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USRM announces U.S. Stem Cell Clinic Expansion of Products and Services

Increasing Market Demand for Regenerative Therapies Drives Diversification

SUNRISE, FL – December 06, 2018 – U.S. Stem Cell Inc, a leader in regenerative medicine products and services, today announced its three partially owned Florida-based clinics have expanded their menu of services to help meet the growing market demand and patient needs for regenerative therapies.

In addition to continuing to offer targeted stem cell therapies of all kinds — bone marrow, adipose, and tissue bank products — U.S. Stem Cell Clinic is also providing regenerative therapies outside the stem cell space, including platelet rich plasma (PRP), IV nutritionals, infrared therapy, electromagnetic pulsed wave therapy, ozone therapy, diet and nutritional counseling and other services designed to promote regeneration and natural healing.

“We are living in a historic time where we are witnessing the emergence of stem cell therapy as a rapidly growing modality that will soon become standard of care in modern medicine,” said Mike Tomas, President and CEO of U.S. Stem Cell, Inc.  “Because we are an industry leader in bringing regenerative medicine therapies to the marketplace in a clinical setting, and because we know cutting-edge therapies can take time to be fully understood and endorsed, it is important for us to maintain a portfolio of proven products and services each patient can choose from based on his or her own needs. It’s good business and it’s good medicine.”

“The opportunity to be a part of history at a time when we are witnessing an incredible paradigm shift in the use of stem cell therapy is monumental,” said Dr. Kristin Comella, Chief Science Officer of U.S. Stem Cell Clinic’s parent company, U.S. Stem Cell, Inc.  “All advancements in science require time. By diversifying our regenerative medicine offerings, we are moving through this very important time in medicine while simultaneously making sure our customers continue to have a variety of safe and effective options for their care that will empower them to choose the product and/or service they feel is right for them.”

U.S. Stem Cell Clinic is a regenerative medicine products and services company founded on the principle belief that quality of life for patients can be improved through stem cell therapy.  The clinic is committed to bringing proven stem cell treatment options to the general public, both in the United States and around the world. The Company’s team of medical researchers and practitioners are top-notch health professionals dedicated to providing safe and effective treatments in its point-of-care facilities.

U.S. Stem Cell, Inc. is a leader in the regenerative medicine / cellular therapy industry specializing in physician training and certification and stem cell products including its lead product Adipocell™, as well as veterinary stem cell training, stem cell banking, and the creation and the management of stem cell clinics.  To management’s knowledge, USRM has completed more clinical treatments than any other stem cell company in the world.

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 and 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, even if new information becomes available in the future. The Company’s business and the risks and uncertainties of the business are described in its filings with the Securities and Exchange Commission which can be found at sec.gov.

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USRM Posts 25% Nine Month Revenue Increase From 3Q 2017

Profit Margins Continue to Increase As Costs And Operating Expenses Decrease

SUNRISE, FL – November 06, 2018 – U.S. Stem Cell, Inc. (OTC: USRM), a leader in the development of proprietary, physician-based stem cell therapies and novel regenerative medicine solutions, today announced third quarter results for this year and comparatively from last year, for the nine months ended Sept. 30, 2018.

As has been the trend for the past several years, revenue continues to rise — almost $1M or 25% for the period compared to the same period last year —  from $4.04M in 3Q 2017 to $5.03M in 3Q 2018. Gross profit margins also increased, $723K or 26.8%, from $2.69M to $3.42M for the same time period. Operating expenses decreased $850K or 42%, from $2.02M to $1.17M.  Net Loss from operations decreased $838K or 79.3%, from $1M to $218K during the same nine months ended this year versus last.

“Our financials directly reflect the success of our ongoing efforts to simultaneously expand and streamline operations to continue to serve the increasing market demand for stem cell therapy and regenerative health services,” said Mike Tomas, President and CEO of U.S. Stem Cell, Inc.  “Driving innovative therapies while helping to define and set industry standards requires a delicate balance. We are working hard to achieve that balance, and I believe our third quarter financials demonstrate that effort.”

For two consecutive years, U.S. Stem Cell, Inc., has continued to sustain substantial revenue growth, which may be attributable to an increased awareness of stem cell therapy, as Americans seek alternatives to pain management and opioids.  The Company has also been instrumental in providing more than ten thousand stem cell procedures in the past 19 years for a variety of indications, including orthopedic, autoimmune, degenerative and neurological diseases.  USRM also trains and certifies physicians in stem cell therapy — to date, more than 700+ physicians worldwide — and has engaged with more than 288 clinics.  

U.S. Stem Cell, Inc. is a leader in the regenerative medicine / cellular therapy industry specializing in physician training and certification and stem cell products including its lead product Adipocell™, as well as veterinary stem cell training, stem cell banking, and the creation and the management of stem cell clinics.  To management’s knowledge, USRM has completed more clinical treatments than any other stem cell company in the world.

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 and 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, even if new information becomes available in the future. The Company’s business and the risks and uncertainties of the business are described in its filings with the Securities and Exchange Commission which can be found at sec.gov.

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USRM Hires Senior VP of US & International Sales

USRM Hires Senior VP of US & International Sales

Former Abbott Pharmaceuticals, Stem Cell Centers Exec Joins Team

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SUNRISE, FL – September 11, 2018 – U.S. Stem Cell, Inc. (OTC: USRM), a leader in the development of proprietary, physician-based stem cell therapies and novel regenerative medicine solutions, today announced Phil Posa has joined its executive management team as Senior Vice President of U.S. & International Sales.

Posa, who brings more than 30 years of experience in the pharmaceutical, medical device and regenerative spaces, most recently served as an Executive and CEO at Stem Cell Centers of Idaho, where he assisted in the launch and management of new and existing clinics — at a rapid growth rate of approximately one clinic per month.

As part of the management process, Posa maintained quality control and efficiency company wide, starting with the successful negotiation of contracts with manufacturers and suppliers to provide the best possible product at the lowest possible cost.  He was also responsible for successfully designing and initiating a shift in training curriculum by emphasizing a focus on marketing, product and protocols for treatment and conditions, which resulted in the incorporation of a seamless program for patient flow thereby allowing the company to track from lead generation to patient satisfaction following treatment.

By focusing on conversion rates, service and best possible outcomes, Posa’s successful approach in design, implementation and execution helped bring sales to an all-time monthly high, resulting in a new benchmark for the company’s profitability. It also launched regenerative medicine into traditional insurance reimbursement medical practices, thereby converting them into ‘white glove’ concierge care cash practices.

“We are ecstatic to have Phil join our team, especially when we are at a pivotal point in expansion and diversification,” said Mike Tomas, Chief Executive Officer of U.S. Stem Cell, Inc.  “The ability to assist in growing our markets both domestically and internationally is one of many skill sets Phil brings to the team. Combined with his expertise in the launch and clinical expansion in the stem cell arena, he is the perfect fit for us at this time.”    

Prior to his tenure at SCC, Posa also served as Senior Vice President U.S. & International Sales for Whale Imaging, Boston, and Skyline Medical, of Minnesota, respectively.  He received his MBA from Rivier College in New Hampshire, and a bachelor’s degree in Biology from Stony Brook University in Stony Brook, NY.  He also was certified as a Public Health Advisor by the State of New York, and as an epidemiologist by the Centers for Disease Control (CDC).

“I am very excited about the potential of U.S. Stem Cell in the U.S. and International markets, and am looking forward to building upon the world-class reputation the Company has built over the past twenty years,” said Posa.  “It is a great opportunity at just the right time in the marketplace. I am looking forward to hitting the ground running to help bring USRM to its next level of success.”

Posa also received 15 All Star awards during his tenure at Abbott Pharmaceuticals as a sales leader and manager.

USRM has been instrumental in providing more than ten thousand stem cell procedures in the past 19 years for a variety of indications, including orthopedic, autoimmune, degenerative and neurological diseases.  USRM also trains and certifies physicians in stem cell therapy — to date, more than 700+ physicians worldwide — and has engaged with more than 288 clinics.  For two consecutive years, USRM has continued to sustain substantial revenue growth, which may be attributable to an increased awareness of stem cell therapy, as Americans seek alternatives to pain management and opioids.

U.S. Stem Cell, Inc. is a leader in the regenerative medicine / cellular therapy industry specializing in physician training and certification and stem cell products including its lead therapy Adipocell™, as well as veterinary stem cell training, stem cell banking, and the creation and the management of stem cell clinics.  To management’s knowledge, USRM has completed more clinical treatments than any other stem cell company in the world.

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 and 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, even if new information becomes available in the future. The Company’s business and the risks and uncertainties of the business are described in its filings with the Securities and Exchange Commission which can be found at sec.gov.

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USRM Posts Profitable Results for Second Quarter 2018

SUNRISE, FL – August 8, 2018 – U.S. Stem Cell, Inc. (OTC: USRM), a leader in the development of proprietary, physician-based stem cell therapies and novel regenerative medicine solutions, today announced results for its second quarter in 2018 — the 10th consecutive quarter where revenue has increased.

For the quarter ending June 30, 2018, the Company posted a revenue increase of 31% to $1.82m, up from $1.39m for the second quarter of last year.  Revenue also increased for the six months ended June 30, 2018, to $3.53m, up 39% from $2.54m for the same period last year.

Profit margin for the second quarter also increased, to 69% from 67% for the same period last year, and profit margin for the first six months of this year increased to 70% from 68% in the first six months of 2017.  Gross profit was also up for both periods, with a 34% increase to $1.25m from $934k for the second quarter, and a 43% increase to $2.46m from $1.73m for the six-month period.

For two consecutive years, USRM has continued to sustain substantial revenue growth, which may be attributable to an increased awareness of stem cell therapy, as Americans seek alternatives to pain management and opioids.

USRM has been instrumental in providing more than ten thousand stem cell procedures in the past 19 years for a variety of indications, including orthopedic, autoimmune, degenerative and neurological diseases.  USRM also trains and certifies physicians in stem cell therapy — to date, more than 700+ physicians worldwide — and has engaged with more than 288 clinics.  

U.S. Stem Cell, Inc. is a leader in the regenerative medicine / cellular therapy industry specializing in physician training and certification and stem cell products including its lead product Adipocell™, as well as veterinary stem cell training, stem cell banking, and the creation and the management of stem cell clinics.  To management’s knowledge, USRM has completed more clinical treatments than any other stem cell company in the world.

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 and 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, even if new information becomes available in the future. The Company’s business and the risks and uncertainties of the business are described in its filings with the Securities and Exchange Commission which can be found at sec.gov.

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‘Renewing Our Heroes’ to Provide USRM Stem Cell Protocol to First Responders

SUNRISE, FL – June 5, 2018 – U.S. Stem Cell, Inc. (OTC: USRM), a leader in the development of proprietary, physician-based stem cell therapies and novel regenerative medicine solutions, today announced Renewing Our Heroes  — a charitable health initiative established to provide first responders and other civil service personnel with access to alternative medical care they would otherwise be unable to obtain — will now offer USRM stem cell procedures and protocols to its recipients following injuries and conditions that occur in the line of duty.

Established by Joseph Radich, Founder and Clinical Director of  RenewU Medical and son of an actively serving New York City firefighter, Renewing Our Heroes was created as a charitable health initiative to help individuals who voluntarily and without hesitation put their bodies, minds, families and lives on the line every day.

“I see the power of regenerative medicine, and because U.S. Stem Cell Clinic and Dr. Kristin Comella are the industry standard for holistic, autologous stem cell therapy, it only makes sense to make this protocol available to the fine men and women who serve our country,” said Radich. “Renewing Our Heroes is a way we as Americans can give back, and help them have access to what they deserve, the very best regenerative medicine has to offer.”

Dr. Kristin Comella, USRM’s Chief Science Officer, is one of the most published scientists in the world for the clinical application of autologous fat derived stem cell therapies. She is also President of the Academy of Regenerative Practices, and is a leading voice in the power of regenerative medicine.

“This is exactly why we do what we do: helping the good people of our nation find the possibility of living healthier, longer lives so that they continue to do what they do best.  For almost 20 years, I have researched, studied, tested, published and provided access to the healing, autologous stem cells in people’s bodies,” said Dr. Kristin Comella, USRM’s Chief Science Officer.  “It is a privilege to be tapping into this holistic form of stem cell therapy and to continue to serve in furthering this mission worldwide.”

“Expansion of our stem cell protocol into the line of service for our first responders means we are starting to reach more and more Americans who otherwise would never have access to this incredible regenerative therapy,” said Mike Tomas, USRM’s President and CEO.  “It is an honor for our organization to know the true heroes of our country can now have access to this standard of care.”

Dr. Comella’s leadership role inspires other organizations and physicians — 700+ clinicians and 287+ clinics worldwide — many of whom train and certify with her and the team at the U.S. Stem Cell Clinic in Sunrise, Florida.

To donate to Renewing Our Heroes, click here.

U.S. Stem Cell, Inc. is a leader in the regenerative medicine / cellular therapy industry specializing in physician training and certification and stem cell products including its lead product AdipocellTM , as well as veterinary stem cell training and stem cell banking and creation and management of stem cell clinics.  To management’s knowledge, USRM has completed more clinical treatments than any other stem cell company in the world in the past 20 years.

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 and 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, even if new information becomes available in the future. The Company’s business and the risks and uncertainties of the business are described in its filings with the Securities and Exchange Commission which can be found at sec.gov.

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USRM Chief Science Officer to Present at Fifth Annual Cell Surgical World Conference

SUNRISE, FL – June 1, 2018 – U.S. Stem Cell, Inc. (OTC: USRM), a leader in the development of proprietary, physician-based stem cell therapies and novel regenerative medicine solutions, today announced its Chief Science Officer, Dr. Kristin Comella, will be presenting at the Fifth Annual Cell Surgical World Conference in Beverly Hills this Saturday, June 2.

Dr. Comella is, to the Company’s best knowledge, one of the most published scientists in the clinical use of fat derived autologous stem cells.  Her work in the application of autologous (a patient’s own) stem cell therapy is unparalleled, and includes autoimmune, neurodegenerative, orthopedic and degenerative conditions.  To date, the company has worked with more than 10,000 patients and trained more than 700+ physicians worldwide.

The conference, which is hosted by the International Cell Surgical Society, features three different tracks to fit interest levels and backgrounds of all types and includes hands-on training and certification in the practice of autologous stem cell therapy. The Science Only, Physician Practicum, and Physician Practicum Plus Mini-Liposuction Certification and Training tracks provides doctors from around the world access to two days of science in lecture format; a Friday night and Saturday night social cocktail and charity dinner gala at the iconic Beverly Hilton Hotel.

To learn more about ICSS, please visit: http://internationalcellsurgicalsociety.org/

“The privilege of presenting at this conference is monumental, because it’s an opportunity to connect with regenerative-minded physicians from all over the world,” said Dr. Comella.  “I look forward to connecting with these leaders in autologous stem cell therapy and having the opportunity to share information about the remarkable results we are seeing on a regular basis.”

U.S. Stem Cell, Inc., and Dr. Kristin Comella, have taken a leadership role worldwide in the development of adipose-derived, autologous stem cell therapy.  In addition to serving as the Chief Science Officer, Dr. Comella is also President of the Academy of Regenerative Practices and is a leading voice in recognizing the power of regenerative medicine.

Along with the 700+ physicians and clinicians she has trained, she and USRM also have a presence with 287+ clinics around the world — many of which feature clinicians that are trained and certified in stem cell therapy by Dr. Comella and her team.

Autologous stem cell treatments are possible because of stem cells harvested from the patient’s own fat. Their application may offer less invasive alternatives to the use of pharmaceuticals and surgery for treating chronic pain and degeneration for a variety of indications including orthopedic, autoimmune, degenerative and neurological diseases.  Chronic pain has been the source of a national opioid epidemic which The New York Times reported in October is the leading cause of death for Americans under 50.

U.S. Stem Cell, Inc. is a leader in the regenerative medicine / cellular therapy industry specializing in physician training and certification and stem cell products including its lead product AdipocellTM , as well as veterinary stem cell training and stem cell banking and creation and management of stem cell clinics.  To management’s knowledge, USRM has completed more clinical treatments than any other stem cell company in the world in the past 20 years.

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 and 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, even if new information becomes available in the future. The Company’s business and the risks and uncertainties of the business are described in its filings with the Securities and Exchange Commission which can be found at sec.gov.

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