All Posts in Category: CEO’s Blog

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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CEO Blog: September 2018: An Accomplished Summer

Dear Shareholders and Friends,

Thank you for your continued interest and support in U.S. Stem Cell, Inc.’s recent developments and achievements. As we continue to grow, our main focus continues to be our mission of discovering, developing, and commercializing cell-based regenerative therapies.  As a result, we’ve had a summer full of accomplishments and events which we would like to share with you here.

First and foremost, please join us in welcoming our newest Senior Vice President of Sales, Phil Posa. Phil’s most recent role as Executive and CEO at Stem Cell Centers of Idaho, combined with his 30+ years’ extensive experience in the regenerative/medical device & pharmaceutical industries including Abbott Pharmaceuticals, make him the perfect addition to our senior management at a time when we are focused on expansion and diversification company wide. While at Stem Cell Centers of Idaho, Phil restructured patient flow which allowed the company to identify ways to improve conversion rates, service and best possible outcomes. The results helped bring sales to an all-time monthly high, resulting in a new benchmark for the company’s profitability and the launch on average of one clinic per month.  It also launched regenerative medicine into traditional insurance reimbursement medical practices, thereby converting them into ‘white glove’ concierge care cash practices.

We are certain Phil’s proven expertise and background are an incredible asset to our team, and we are looking forward to growth in our domestic and international markets under his leadership and guidance. You can read more about Phil’s background here.  

We are also delighted to announce that during the second quarter of this year we achieved the benchmark of increased revenue for our tenth consecutive quarter, up 31% from the same quarter last year from $1.39m to $1.82m. Our profit margin also increased, from 67% in the second quarter of 2017 to 69% for the second quarter of 2018.  Additionally, our gross profit rose 35% from the second quarter of 2017, increasing from $934k to $1.25m.

This has been a period of continued growth for the last two consecutive years. We believe this may be due in part to the increased awareness of stem cell therapy amongst prospect patients in the US and abroad. Furthermore, an increase in market demand can be attributed in part to patients seeking an alternative to opioids, as well as physicians looking to advance their skill sets.

In June our Chief Science Officer, Dr. Kristin Comella, presented at the Fifth Annual Cell Surgical World Conference in Beverly Hills at the Beverly Hilton Hotel.  Dr. Comella, who is well recognized for her unparalleled dedication and leadership in the development and application of clinical practices in the world of autologous stem cell therapies, presented to an audience of doctors from around the world.  Her enthusiasm was well received as many continue to admire her for her persistence, expertise and vigor in advancing the narrative of autologous stem cell therapy, and attendees at the conference were explicit and open in expressing their admiration.

On the scientific front, we recently made an exciting breakthrough in autologous stem cell therapy from fat tissue by successfully repairing the torn meniscus of a 56-year-old patient.  Meniscal injuries are recognized as the most common knee injury among Americans and without this regenerative therapy are often only repairable by surgery. According to the scientific paper by Dr. Comella published in the Journal of Medical Cases, the patient treated for chronic meniscus injury reported no adverse events in the 12 months following treatment, as well as expressing reduction in pain and an overall improvement in quality of life. Physicians confirmed a complete resolution via arthroscopic evaluation of the tear 9 months after treatment.

We are also pleased to announce we have launched participation in “Renewing our Heroes,” a charitable health initiative for civil service personnel that has been making USRM stem cell therapies and protocols accessible to first responders and those who voluntarily put their well-being on the line every day.  Firefighters, paramedics, military officials, police officers and other civil-service professionals can now have access to medical care that otherwise may have been unattainable. It is an exciting indication that we are able to reach more Americans today than have ever had access to regenerative therapy in the past, and we are delighted that those who serve us now have access to a new standard of care.

Our dedication to making regenerative medicine the new health standard continues to be unwavering. As we progress, we invite you to learn more about the aforementioned events and milestones, as well as staying up-to-date with future announcements, by reading the press releases on our news page which can be found here.

Thank you again for your interest and ongoing support.

Warmest regards,

Mike Tomas,

President and CEO

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CEO Blog: February 2018

Dear Shareholders and Friends,

Thank you all so much for taking the time to learn more about our recent progress.  In this post, we want to take a moment to share key highlights from 2017, as well as update you with new developments for 2018.

A strengthening economy, an increase in marketplace demand as more people learn about stem cell treatments and alternatives to opioids, and an increase in more doctors and physicians advancing their skill sets to include stem cell treatments are all reasons why we are beginning to see steady growth.  

We are pleased to announce that our proprietary AdipocellTM stem cell kit has reached 10,000 units in sales — an indication that the marketplace is starting to demand stem cell therapy more readily.  Although we reached the goal in January of 2018, much of the effort behind attaining that benchmark was done in 2017, and our hard work is paying off.

We are also proud to announce we have completed more than 10,000 stem cell procedures since 1999 for a variety of indications — including orthopedic, autoimmune, degenerative and neurological diseases.  We are pleased to share that, to-date, we have trained more than 700 physicians worldwide on stem cell therapy, and we anticipate that number will only continue to increase.

The FDA’s issuance of guidance documents in November of last year also has also signaled to the marketplace the legitimacy of stem cell therapy as a practice.  Because our science is based on the use of a patient’s own (autologous) stem cells, we are confident that the issuance of these guidance documents moves us closer to a time when there will be clear differentiation between treatments that are autologous, versus those that involve the use of donated, off-the-shelf, third-party stem cells that may or may not have been genetically manipulated and clearly require more regulation.   

USRM is working with one of the best legal teams based in Washington, D.C., to help communicate with the FDA while preserving the rights of patients to harness their bodies’ own healing potential.  We have joined forces with the Academy of Regenerative Practices to ensure that our physicians have a right to practice regenerative medicine with their consenting patients.  We are proud sponsors of the upcoming ARP annual conference March 1st – 3rd where our Chief Science Officer Dr. Kristin Comella will be a keynote speaker.

Demand for stem cell therapy is anticipated to be at an all-time high this year, as more patients seek the growing trend of using their own cells to heal various injuries and diseases.  As a result, we have expanded our clinic locations to include West Palm Beach. This expansion is timely, given the emerging and explosive demand now coming from patients and the marketplace.   We have worked very hard as a team to temper our growth in order to be ready to meet the demands of a growing market at just the right time.  We are confident that timing is now.

USRM technologies are now offered in six continents with interest from various countries throughout the world growing.  We have experienced a few delays with our facilities opening in Kuwait due to unforeseen regulatory hurdles.  These types of challenges are very familiar to us, we know it is part of the landscape and we know how to address them.  We will continue to work with our legal team to neutralize these concerns and move forward with bringing stem cell treatments to the patients in the Middle East.

The recent opioid crisis in America means more patients are seeking alternative therapies to pharmaceuticals and surgery for coping with and managing chronic pain.  Stem cell therapy may offer new solutions for these patients experiencing systemic diseases, orthopedic conditions, neurological symptoms and other therapies for an aging population.  Shape Magazine discusses this subject in their most recent issue, where they mention Dr. Kristin Comella and her work with autologous stem cells.  Shape Magazine is the first of many highly-visible mentions where Dr. Comella has been featured, including “The Healing Miracle: The Truth About Stem Cells,” a docuseries that interviews renowned experts in the field of stem cell medicine and explores in-depth the benefits and application of regenerative stem cell therapy.  Dr. Comella is featured in Episode five of the docuseries; that interview can be viewed in its entirety here.  

Due to the overwhelming response we have had as a result of that docuseries, we were inspired to launch our own live webinar series in order to educate and inform our audience, as well as provide a forum for Q & A on an anonymous platform.   Facts About Stem Cell Therapy,” which had its first live broadcast February 9th, was very well received and had more than 100 participants.  Dr. Comella answered questions live for nearly two hours, which is another demonstration of the growing demand for information about this emerging, holistic, regenerative therapy. If you are interested in joining our mailing list to receive notification for our next stem cell webinar, click here.

In honor of Valentine’s Day and the month of love, our second webinar was broadcast live February 17th and featured Dr. Comella and fitness expert and world renown leading biohacker Ben Greenfield.  The webinar, which is entitled Enhancing Sexual Performance with Stem Cell Therapy,” provides the opportunity to learn more about stem cell therapy and enhancing sexual performance.  Greenfield, who recently underwent penile enhancement with stem cell therapy, documented his journey in the January issue of Men’s Health magazine.  He was successful at increasing both size and rate of performance.  To listen to that webinar in its entirety click here.

Our commitment to this emerging science is unwavering and we will continue to expand efforts to help patients maximize their health with this amazing technology.  We thank you for your interest and continued support and welcome the chance for an ongoing dialogue to answer any questions you may have.

Warmest regards,

Mike Tomas,

President and CEO

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

Dear Shareholders and Friends,

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

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

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

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

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

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

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

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

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

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

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

We thank you for your interest and continued support.

Warmest regards,

Mike Tomas,

President and CEO

 

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

Dear Shareholders and Friends,

September is no doubt off to an exciting start—in part due to Hurricane Irma. Although many of our friends and family were not as fortunate and have suffered devastating losses due to the recent storm (and our thoughts and prayers are with them), I am relieved to announce that our corporate office, lab and clinic have not been affected by Hurricane Irma and remain fully operational.

All U.S. Stem Cell, Inc. facilities, including U.S. Stem Cell Clinic, reopened on Tuesday, September 12 with regular business hours.

As you know, U.S. Stem Cell, Inc. is an emerging enterprise in the regenerative medicine / cellular therapy industry. Since 1999, we believe that the Company has completed more clinical treatments (for both humans and animals) than any other regenerative company in the world. U.S. Stem Cell, Inc. is focused on the discovery, development and commercialization of cell-based therapies that prevent, treat or cure disease by repairing and replacing damaged or aged tissue, cells and organs and restoring their normal function. U.S. Stem Cell, Inc. is opening our own network of clinics AND has also partnered with other companies to build a national distribution network of affiliate clinics for stem cell therapies using the U.S. Stem Cell, Inc.-developed technologies—and one such group includes the American Stem Cell Centers of Excellence (“COE”) owned by General American Capital Partners.  

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

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

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

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

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

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

THANK YOU for your support.

Warmest regards,

Mike Tomas

President and CEO

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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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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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CEO Blog: June is off to an amazing start

Dear shareholders and friends,

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

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

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

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

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

Warmest regards,

Mike Tomas
President &CEO
US Stem Cell Inc.

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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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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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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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CEO Blog: November 2016

Dear shareholders and friends,

November was a very exciting month with various accomplishments and partnerships for U.S. Stem Cell, Inc. Our Chief Scientific Officer was been featured at conferences and interviewed for an eBook. We are also launching new clinics and programs in the Middle East and China that will feature our technologies, therapies, and products.

U.S. Stem Cell, Inc. has just signed a new licensing agreement with High Rising Group to open clinics throughout the Middle East, with locations in Dubai, Kuwait, and Qatar. We will be treating patients suffering from chronic conditions, like COPD and Parkinson’s, with the goal of transforming their lives by helping them with these debilitating conditions. You can read more about our partnership in our Middle East Press Release: http://us-stemcell.com/en/u-s-stem-cell-inc-announces-launch-of-us-stem-cell-middle-east/

Our CSO, Kristin Comella, was invited to speak at Terrapin’s World Precision Medicine Congress on stem cells and regenerative medicine. Kristin spoke on the first day of the conference highlighting our innovative products, methods, and therapies. She was also featured in The World of Precision Medicine Interview eBook, answering questions about precision medicine, what it’s like being a woman in the life sciences industry, and offering an inspiring message for young girls interested in a career in the scientific field. Download the interview eBook here.

Additionally, we have entered into a partnership with Hong Kong Yihe Regeneration Medical Technology, to provide Chinese patients direct access to U.S. Stem Cell, Inc. treatments and regenerative therapies at our Sunrise, Florida clinic. CSO Kristin Comella, attended a conference earlier last month in Changchun, China sponsored by Hong Kong Yihe Regeneration Medical Technology to discuss our technologies and how patients can benefit.

On the business front, our financial indicators continue to trend positive with revenues up and liabilities down. Here is a summary of U.S. Stem Cell’s most recent financial figures for Q3:

  • Current liabilities down $734K or 9.5% from $7.69M in Q3 2015 to $6.96M in Q3 2016
  • Revenue up by 31% to from $557K in Q3 2015 to $729K in Q3 2016
  • Net loss improved 17% from $264K in Q3 2015 to $219K in Q3 2016
  • Cash used in operating activities down $322k or 84% from $384K in Q3 2015 to $62k in Q3 2016

We will continue to develop pioneering regenerative medicine techniques and technologies as we work to bring regenerative therapies to patients around the world. Our focus has always been, and will continue to be, on new life-changing treatments. We invite you to follow us on social media for the latest updates and information about U.S. Stem Cell, Inc. and our divisions.

Warmest regards,

Mike Tomás

President & CEO

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CEO Blog: A Look at U.S. Stem Cell, Inc.’s Clinical, Educational, and Therapeutic Success in 2016

Dear shareholders and friends,

2016 has been a year of great success: U.S. Stem Cell, Inc.’s adipose treatments have been used to treat more than 6000 patients so far, and we continue to research and develop therapies and protocols to benefit others suffering from degenerative diseases that affect their tissues, cells, organs, and bodily functions.

Technology is the best communicator for our scientific advances. On July 8th, Dave Asprey of Bulletproof shared the world’s first live stream of a stem cell procedure, featuring our very own Kristin Comella and Michelle Parlo at U.S. Stem Cell Clinic. You can view the recorded livestream at U.S. Stem Cell Clinic’s Facebook page: https://www.facebook.com/usstemcellclinic/posts/1200333253332375

During August, our stem cell therapies made their way to the Rio Olympics! Dr. Scott Greenberg, a Sports Medicine and Regenerative Orthopedics specialist, took a training course through our U.S. Stem Cell Training division. With the experience and knowledge he gained, Dr. Greenberg was able to use our Platelet Rich Plasma, or “PRP” method to treat Olympic Gymnast Laurie Hernandez at this year’s 2016 Rio Olympics — just seven weeks before she was to perform on the Olympic stage! Dr. Greenberg commented, “[the platelets] forced [her leg] to heal.” Watch Dr. Greenberg discuss PRP: https://youtu.be/gvkqGPkPmiA

Then, in September, Chief Scientific Officer, Kristin Comella, was invited to speak at RAAD (Revolution Against Aging and Death) Fest where life extension enthusiasts come together to learn about the latest scientific advancements and gain vital insight into how to extend health and wellbeing. Kristin spoke about the power and future of stem cells in physician education, animal health, personal medicine, and prescription therapeutics. Her full presentation is available online here: https://youtu.be/H4T6WReGPro

We also continue to make progress in our animal health division, and just last month treated our first victim of an alligator attack at VetBiologics. The canine affected was at severe risk for infection due to a bad gator bite. After surgery and multiple stem cell doses, the patient has healed and made a complete recovery — to the joy of his owners.

At U.S. Stem Cell Clinic, we have had amazing success in our treatments of Traumatic Brain Injury (TBI) and Multiple Sclerosis (MS) this year.

One of our TBI patients, Heather, was given newfound hope from our stem cell treatments.  Two years after her initial injury, she was unable to talk or walk without assistance. Her doctors had told her they were unable to do anything more for her. We began stem cell treatments and her improvements have been miraculous. Her recovery is looking better each day since starting her stem cell treatments with us — so much so, that she even made a video recounting her stem cell journey at U.S. Stem Cell Clinic.

Another one of our patients, Barbara, was diagnosed with Multiple Sclerosis in 1988. Through our stem cell therapies and procedures, she gradually went from being wheelchair-bound to being able to stand up and do 50 squats on her own! As Barbara tells it, the first time her therapist saw her move her left side, she was astounded. Barbara and other MS patients have demonstrated promising improvements utilizing our regenerative medicine treatments.

On the business front, our financial indicators continue to trend positive with revenues up and liabilities down.  Here is a summary of U.S. Stem Cell’s most recent financial figures through Q2 2016:

  • Revenue up by 20% from $565K in Q2 2015 to $678K in Q2 2016.
  • Current liabilities down $2.7 million or 33% from $8.2M in Q2 2015 to $5.7M in Q2 2016.
  • Gross Margin improved from 41% in 2015 to 62% in 2016.
  • Cash used in operating activities decreased ($481K) or 74% from $646K in Q2 2015 to $165K in Q2 2016.
  • Working capital deficit improved by $2.5 million or 31.3% from $8M in Q2 2015 to $5.5M in Q2 2016.
  • Net loss improved 46% from $480K in Q2 2015 to $259K in Q2 2016.

We want to take this opportunity to thank our long-time shareholders and supporters as we develop pioneering regenerative medicine techniques.  We are working to bring regenerative therapies to the patients who need them.  We will continue to focus our efforts on new life-changing treatments. We invite you to follow us on social media for the latest updates and information about U.S. Stem Cell, Inc. and its divisions.

Warmest regards,

Mike Tomás

President & CEO

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CEO’s Blog: April 2016

Dear shareholders and friends,

U.S. Stem Cell Inc. continues to innovate and grow, making our mark in the regenerative medicine field by developing a number of therapies and products for patients suffering from degenerative conditions. Our three main operating divisions (U.S. Stem Cell Training, VetBiologics, and U.S. Stem Cell Clinic), focus on the development and commercialization of cell-based therapies that repair and replace damaged tissues, cells, and organs, restoring them to their normal functions.

Because of our dedication to the field, we have been able to help patients who previously had very few options available to them. We have had success helping patients with degenerative conditions, markedly demonstrated in our Traumatic Brain Injury patients who’ve shown great results.  We have not only been able to treat thousands of patients, but also have been actively involved in training physicians in our field, and have made meaningful contributions to international guidelines for stem cell research.

All of this would not be possible without our shareholders, partners, and dedicated team of practitioners. I would like to personally thank you all for your invaluable contributions and on-going support.

This month, we are pleased to announce a number of new developments.

We have recently launched our brand new website, which we hope will clearly guide you through the work that we do. This is part of our dedication to keeping you fully informed about our business operations and our continuing innovations in the field of stem cell research. Navigate through to learn about our products, board members, company news, financial summaries, and much more.

Our business strives to make its operations as efficient and cost effective as possible. In the most recent quarter, our company has succeeded in reducing its expenditures in operational activities, general and administrative tasks, and marketing strategies. An increase in banking services has meant that our Gross Margin from 2014 and 2015 has decreased. Despite this fact, we have seen a growth in revenue, as well as an improvement in our capital deficit, net loss, and current liabilities.

A summary of U.S. Stem Cell’s most recent financial figures through 4th quarter 2015:

Reductions in expenditure

  • Cash used in Q4 2015 down 85% or $306K.
    • From $361K in Q4 2014 to $55K in Q4 2015
  • Cash used in operating activities down $255k or 24%.
    • From $1.1M in 2014 to $845k in 2015
  • Marketing, general, and administrative expenses down $1.4M or 28.9%
    • From $4.7M in 2014 to $3.3M in 2015

General improvements

  • Current liabilities down by $3.1 million or 28%
    • From $11.1M in 2014 to $8.0M in 2015
  • Working capital deficit improved by $4.4 million or 40%
    • From $10,957,443 in 2014 to $6,583,569 in 2015

Profits and losses

  • Revenue up by 8%
    • From $2.06M in 2014 to $2.2M in 2015
  • Net loss improved 26% from $2.3M in 2014 to $1.7M in 2015
    • Gain on debt in 2014 of $2.5M, compared to gain of debt of $2.6M in 2015
  • Gross Margin down from 58.9% in 2014 to 32.9% in 2015, primarily due to increase in banking service

We invite you to follow us on social media for the latest updates and information about U.S. Stem Cell.

Warm Regards,

Mike Tomas

President & CEO

 

The information provided above is not be relied upon for the purchase or sale of our securities.  Please see our filings with the Securities and Exchange Commission (found at sec.gov).  In addition, this release is for informational purposes only and is not an offer to purchase or sell any of our securities. 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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