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SCHEDULING ORDER FOR PRETRIAL CONFERENCE AND TRIAL: Pretrial Conference set for 5/17/2019 10:00 AM in Miami Division before Judge Ursula Ungaro. Jury Trial set for 6/10/2019 09:00 AM before Judge Ursula Ungaro. Calendar Call set for 6/5/2019 01:00 PM before Judge Ursula Ungaro.
That’s right a JURY TRIAL. This isn’t up to a judge, It’s up to a jury of our peers. IMO there is no way a jury of human beings who are not influenced by political contributions is going to side against Kristen Comella. IMO they will see through all the noise and see that she is a woman and mother who has dedicated her life to help people. IMO The trend in this country is less govt regulation especially when it comes to a person’s right to their own body/cells. Slam dunk for USRM IMO.
Your wrong...this is about a random senator who came out of nowhere in attempt to force the FDA/DOJ’s hand to take action against a company with record growing revenues which clearly is seen as a threat to Big Pharma. Drugs for pain or Stem Cells?all this comes years after the experimental eye procedure, furthermore it is no longer performed. You really think the senator cares about the 3 blind ladies? That is what started all of this.
Right regenexx has a method to “concentrate” the cells rather then “separate/isolate” with centrifuge. Otherwise it seems pretty darn similar and the FDA gives them the green light and hassles USRM. Something doesn’t add up
The other kicker here is even if by small chance they are forced to stop the procedure as is...which all comes down to the “minimal manipulation” of cells....I am sure they can tweak the process of how they isolate the cells. Over $100 million in research here, not to mention a lifetime of work on the line, and hundreds of clinics who have a vested interest in this therapy. IMO USRM has a strong case and also a backup plan.
IMO After this trial a lot more people will know...
-USRM has been instrumental in proving more than 10,000 stem cell procedures over the last 19 years including orthopedic, autoimmune, degenerative, and neurological
-USRM has trained more than 700 physicians and engaged with 288+ clinics
-USRM has completed more clinical treatments than any other stem cell company in the world
-More and more Americans are seeking alternatives to pain management and opiods(example Tarek El Mousa)
-USRM has a great track record for safety when looking at SAE’s and the amount of procedures performed
-The FDA for many years didn’t have a clear path for approving these treatments
-The FDA’s most recent guidance is in fact “guidance”and only guidance not law
-Other countries are more open to advancing these therapies
-Big Pharma May have a lot to loose if more people look at Stem Cell therapy as an alternative to drugs
-USRM has many cases of positive outcomes and testimonials documented
-FDA’s Gottlieb said there will be a paradigm shift in modern medicine with stem cells
-Stem cells can not be patented which may be why trying to regulate them and cause companies in this space to spend millions and millions to go through the “approval” process is not realistic.
-Some Senators receive a lot of money from Big Pharma in political donations
-FDA has approved drugs which have had many harmful side effects and even deaths
-The blind ladies signed a waiver for an experimental procedure
-It is common to get sued in medical/clinical practices
-Kristin Comella is well respected in the stem cell community
-Kristen Comella is a human being trying to help people based on her life research
-Stem cell therapies from adipose tissue can help people
IMO Never go cheap on your lawyers or employees. Money well spent. While we are at it another piece of free advice...never go cheap on your butter. Always buy a good quality Irish or European style. U$RM gold
My oh my! Must be some good news coming IMO
SEC investigation is either a dead end or nothing substantial IMO. If Tomas thought the SEC investigation was going to be problematic I am sure they wouldn’t be fighting the DOJ with such confidence and instead folded. I bet this revelation is the next good news we hear which may be what’s driving the price up now. IMO First they come out of the SEC investigation clean and then the DOJ backs off or makes a concession/deal. Imagine what the upside on this will be with one or two of these coming to fruition. This is just what my crystal ball is telling me make your own opinions.
So long story short have faith!
Something here with the number 11......
On the latest Instagram For a split second the clock his 8:21 = 11
Today’s date is 08/03 = 11
The battery is at 92%. = 11
Yesterday’s post clock at 9:20 = 11
Previous insta post 11:11 on the clock
The year 2018 = 11
Anyone got the puzzle figured out?
https://ig.me/apb8qS7DE0JMbw
New Instagram post. Phone looks legit and expect a video clip on second phone soon!
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm613026.htm?utm_campaign=07112018_Statement_FDA’s%20efforts%20to%20advance%20development%20of%20gene%20therapies&utm_medium=email&utm_source=Eloqua
Link to latest statement from FDA. It seems they are becoming more and more encouraged by advancements and potential in this space!
How many times does someone need to tell you what An FDA guidance document is? Guidance is simply guidance and not enforced law! I will Keep this 3rd level, all you got is a slightly dirty vent in the lab. BFD! Go look at your air conditioner. This articles don’t approval is great! One small step for adipose one giant leap for the industry. The industry includes USRM btw. One of the leaders like it or not!
https://www.regenexx.com/lipogems-review-fat-stem-cell-procedure/
Is this a stem cell procedure? IMO clearly yes but it doesn’t get FDA approval being listed as a “stem cell” procedure. Question is why? It was approved and has compelling evidence of potential. So why so much effort to not label it as a “stem cell” therapy!? Someone doesn’t want “stem cells” having any credibility or given any credit for some reason. This is Adipose!!! Clearly it’s stem cell derived! Unbelievable effort to hold back the stem cell revolution. No regulator has such motivation to approve something but be careful how it’s labeled only big business or Big Pharma would put so much effort IMO.
Nice!!!very nice!!!
Experimental trial procedure not performed any longer....Period. Trials are how we learn efficacy and unfortunately sometimes there are adverse effects. IMO Saying that all injections of SVF’s in other parts of the body need to be stopped because of the issues experienced with the cornea injection is like saying we should ban sunglasses since they don’t seem to be effective and may even cause harm if worn on other parts of the body other than over the eyes.
Did I mention it was a trial? It’s not like they have a Statue of Liberty on the street corner waving a SVF filled syringe saying 2 for 1 eye injections!
Safety record impeccable!
“Stem cells from adipose tissue offer a novel therapy for patients with damaged tissue. Stromal vascular fraction (SVF) injected into patients may reduce inflammation, promote healing, and repair damaged/scarred tissue. Here we describe the use of SVF in the clinic for degenerative diseases in orthopedics, neurological conditions and systemic conditions in 676 patients. The procedure demonstrates exceptional patient safety, and the study underscores the safety of autologous stem cell therapy in general.”
http://usstemcellclinic.com/safety-data/
Maybe you missed the part the this so called “establishment of a drug” was written up in what is called a guidance document.
“FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe FDA’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word “should” in FDA’s guidances means that something is suggested or recommended, but not required.”
https://www.fda.gov/downloads/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/guidances/cellularandgenetherapy/ucm585403.pdf
Now I understand people hating on Ben Greenfield’s improvement with his erection which he discussed in Men’s Health Magazine...lol
But for God’s sake let the Rats improve their hard-ons people!
“in a study of erectile function in a rat model of cavernous nerve injury, SVF treatment showed superior statistically significant results”
Let’s stand up for SVF rights! (No pun intended folks)
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5472998/
Read a good article today! Link at bottom...
“the U.S. holds the most stringent regulations for SVF”
“Exemption from the drug pathway occurs when the harvesting of the adipose tissue is processed during the “same surgical procedure.”
“In Japan, “The Act on the Safety of Regenerative Medicine” which regulates medical professionals' practices and clinical studies related to regenerative medicine classifies SVF as a low risk or medium risk depending upon the level of risk associated with the medical treatment.”
“In Europe, MSCs are classified as advanced therapy medicine products (ATMPs) guided through the European Medicines Agency (EMA). According to Directive 2004/23/EC and 1394/2007, in procedures in which SVF is autologous, cell administration is conducted in the same surgical procedure, and the essential function of cells is considered to be the same as in the donor's fat tissue, the cellular therapy treatment is not considered an ATMP.”
“In Australia, legislative framework for the regulation of human cell and tissue products by the “Therapeutic Good Administration” (TGA) allows products that are derived from human tissue and cells during medical procedures that are considered a part of medical practice to be excluded from regulation provided they are collected from a patient who is under the clinical care and treatment of a licensed medical provider and manufactured by that medical provider for the therapeutic application in the treatment of a single indication and in a single course of treatment of that patient by the same medical provider, or by a person or persons under the professional supervision of the same medical provider. Thus, SVF is exempt from regulation in Australia based on the criteria discussed previously (https://www.tga.gov.au).”
“Conclusion...
Given its abundance and mixture of potentially therapeutic cells, the treatment of various diseases and conditions with SVF-derived cell therapies holds great clinical promise.”
https://stemcellsjournals.onlinelibrary.wiley.com/doi/full/10.1002/sctm.16-0337
Can’t wait for the good old US of A to get up to speed with other countries! Just a matter of time!
Maybe some good news on the way huh?! Lol
I repeat...FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities only guidelines for what they would prefer! IMO BIG PHARMA must be in panic mode with new stem cell clinics opening, more doctors recommending, more patients demanding, more success stories, not to mention record revenues quarter after quarter and social media and mass media attention. This is just so amazing the paradigm shift which is happening in modern medicine. When a select few are is trying to hold this type of treatment back from you or discredit the success stories of countless people, one must ask why? Please name the reason an adult should not be able to make a choice to
Let their own cells attempt to heal? Again its a choice...no one is holding a gun to anyone’s head saying they have to try this. Often times it has been a last resort and it turns out it has worked wonders for many! Good for them!
I repeat...FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. This list is banishing folks from “drug” applications. Last I checked my own cells reintroduced to my own body is not a drug. It is great that there is a list like this helping protect people from unsafe harmful DRUGS...Nice work FDA!!! Please Educate me on any procedures that were harmful in the 10,000 plus performed other than the golden girls! Safety first here folks is impeccable!
Furthermore, This adipose tissue isolation is widely used worldwide and becoming more well known that attempting to single out a pioneering Female in this space would open up a can of worms for the FDA. Rosa parks had to go to the front of the bus and IMO Kristen is going to go down in American History for human rights to their own cells. Don’t underestimate the FDA? I would argue don’t estimate KC and your rights to your own body and its cells.
To play devils advocate, if there was all this compelling evidence of these treatments being harmful I too would want them regulated, but I don’t see any evidence of rejection or harm other than the 4 Golden Girls which was experimental and not performed a note. It makes me think that those who want this regulated have hidden agendas other than safety of patients. those who argue this shouldn’t be allowed I urge you to reach out to folks who have had their lives changed by this. Tarek El Moussa the most recent we’ll known case. He was on large amounts of opioid pain management and is now 80% better after one adipose SVF treatment. Ask yourself this... should the FDA decide that He doesn’t deserve to be drug free and out of pain? Or should he be required to travel out of the country to get help? Very selfish IMO of anyone who thinks this way.
Is this a drug???
Minimal manipulation...that is the question. FDA “guidelines”state that adipose is connective tissue for cushioning and support. It has been discovered that simply isolating cells from this tissue and reintroducing to their own body can have many applications with little to no rejection.
Is Isolating cells from this tissue more than “minimal manipulation”? Many would argue isolating through centrifuge is not manipulating. The FDA’s “guidelines” imply that isolation is manipulation. IMO isolating something is not Manipulation which is why I don’t think this falls under the FDA’s regulation.
Furthermore....”FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe FDA’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word “should” in FDA’s guidances means that something is suggested or recommended, but not required.”
https://www.fda.gov/downloads/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/guidances/cellularandgenetherapy/ucm585403.pdf
FDA violation? What was the violation again? a vent that wasn’t as clean as they wanted? Lol
Lol...KC will Never work in research again? “She was named number 24 on Terrapin’s list of the Top 50 Global Stem Cell Influencers and number 1 on the Academy of Regenerative Practices list of Top 10 Stem Cell Innovators. Most recently, Dr. Comella made the list of Top 50 Functional and Integrative Medical Doctors/Scientists in the country by DrAxe.com, one of the most visited natural health websites in the world.
Dr. Comella has pioneered stem cell therapies from various sources including cord blood, bone marrow, muscle, and adipose. She led the team that gained the first ever FDA approval for a clinical trial using a combined cell and gene therapy product in the heart. In addition to advanced cell culturing experience, Dr. Comella has managed the development, manufacturing, and quality systems of a variety of cellular products. She has developed a wide range of regenerative techniques and products that have now been successfully implemented into the clinic setting. Her professional experience includes positions in several companies including US Stem Cell, VetBiologics, Tulane University and Osiris Therapeutics. Dr. Comella progressed from research engineer at Osiris Therapeutics developing stem cell therapies for osteoarthritis to building and managing the stem cell laboratory at Tulane University’s Center for Gene Therapy. She was the co-founder and Chief Executive Officer of Stemlogix, a regenerative medicine company focusing on veterinary medicine.”
Hopefully USRM can get a partnership
Like they have in the Euro Union. Education will foster understanding, acceptance, and partnerships IMO
https://www.eurostemcell.org/about-eurostemcell
Let me guess all the success stories are just placebo effect! Lmao
If you have been around here as long as some of us and done your due diligence, maybe you would see the big picture. Read that article I posted and trial info as well as testimonials from people like Tarek El Moussa. Why on earth would they not want to explore something so promising(adipose versus bone marrow)? Over TEN Thousand procedures and no problem cases other then the experimental procedure to help 3 ladies who were already going blind. Water under the bridge until some random senator in Ohio who gets major funding from Big Pharma reaches out to FDA/DOJ. Why on earth would he do that my friend? Random?I think not and why on earth did the DOJ PR come out in concurrence with another record setting quarterly financial report. This was just random as well I guess? They are buying time IMO. And if you think that money doesn’t buy people/politicians then your naive.
Lol, ya god forbid anyone test anything or study the efficacy of treatments before they jump to conclusions and threaten to shut them down! Lol. IMO reason is they know what this will do to Big Pharma, they also know they can’t stop it, but to save face with their major $$$ donators they have to look like they are trying to stop them. Good weekend to all!
“First, a recent stem cell research article by Jang and Koh titled Characterization of Adipose Tissue-Derived Stromal Vascular Fraction for Clinical Application to Cartilage Regeneration highly supports the premise that adipose derived cells are a far better source of stem cells than bone marrow concentrate (BMC) for a point of care (same day) cartilage regeneration stem cell procedure. This article did an excellent multi-part analysis comparing bone marrow concentrate to stromal vascular fraction (SVF) and cleared some stem cell misconceptions.
It demonstrated that SVF contained 10 times more MSC’s and 5 times more adherent cells than BMC, perhaps the most crucial components for these types of procedures .
It also showed that SVF had 200 times more stromal cells and 18 times more pericytes, both also very important in a regenerative procedure for joints and soft tissue. Also of importance, the BMC contained 6 times more leukocytes, or white blood cells which can impede healing by furthering the inflammatory reaction at the site of the injury.”
Read the whole article and study for yourselves. Get educated folks!
https://thrivemdvail.com/achieving-cartilage-regeneration-fat-derived-stem-cells-vs-bone-marrow/
https://www.ncbi.nlm.nih.gov/m/pubmed/25361717/
Demand and awareness are trending up while Govt regulation is trending down. Sure It stings a bit for the share price to take a hit but we have gone down this path before and it happens fast both directions. The silver lining is that this DOJ garbage his lit a fire under USRM and other clinics who are now working overtime to educate and create awareness! IMO the news going forward will be positive and doors will open!
Disrupting the current healthcare industry! Plain and simple. The fact the Senator/DOJ are focused on the blind ladies case several years old(on a procedure which isn’t even performed anymore)is evident they have no legs to stand on in regards to efficacy and safety in regards to the other tens of thousands of procedures performed. Now In the old days the Powers that be could overpower and prevent Americans from accessing these therapies through bad press, regulation and suppression...however Social media and globalization are changing this! IMO this will be a landmark case which will change the stem cell therapy world as we know it.
HUGE! Another 278k followers of HGTV star Tarek can see stem cell treatment worked for him when nothing else did! Could barely walk and was on huge doses of prescribed Vicodin and Percocet. He said he was skeptical going into the surgery!
https://www.instagram.com/p/BjIwimDAwi4/?utm_source=ig_embed
HUGER!!!!And on top of stem cells working for him...it looks like he just recently was on DR. OZ, yes Oprah’s Dr OZ, discussing his health struggles! Maybe an update on his back being 80% better and improving each day on DR OZ’s show might be in order.
https://instagram.com/p/BhrdZu9AyEZ/
The stars are aligning here folks and once these types of positive testimonials get mass media’s attention... it’s over for the FDA’s selfish attempt to hold these kinds of life changing therapies back from adults who make a choice to try! All it would take is Dr Oz, Kristen Comella, Tarek El Moussa, Ben Greenfield, and John Sally in a round table discussion on national television to put all the cards on the table and let grownups make their own decisions on how they want to heal!
All just my opinion!
HUGE! Another 278k followers of HGTV star Tarek can see stem cell treatment worked for him when nothing else did! Could barely walk and was on huge doses of prescribed Vicodin and Percocet. He said he was skeptical going into the surgery!
https://www.instagram.com/p/BjIwimDAwi4/?utm_source=ig_embed
HUGER!!!!And on top of stem cells working for him...it looks like he just recently was on DR. OZ, yes Oprah’s Dr OZ, discussing his health struggles! Maybe an update on his back being 80% better and improving each day on DR OZ’s show might be in order.
https://instagram.com/p/BhrdZu9AyEZ/
The stars are aligning here folks and once these types of positive testimonials get mass media’s attention... it’s over for the FDA’s selfish attempt to hold these kinds of life changing therapies back from adults who make a choice to try! All it would take is Dr Oz, Kristen Comella, Tarek El Moussa, Ben Greenfield, and John Sally in a round table discussion on national television to put all the cards on the table and let grownups make their own decisions on how they want to heal!
All just my opinion!
171,000 subscribers are able to view the recent podcast KC did with the health/muscle fitness guru. That’s some great exposure!
125 million in R&D... don’t think they will go away with all that’s been invested here. Lots of support for this revolution and people’s rights. Not to mention increasing demand for the therapies. All this B/S about safety is ridiculous, extremely safe from a numbers standpoint. I think a major dark horse here is the psoriasis therapy. If this can be consistently be shown to have efficacy it will be a game changer.
No changes to daily business! Great quarter and a battle between the FDA and people’s own rights when it comes to their cells should create a lot of awareness. Big pharma just buying time here but it may backfire as this should get some serious attention. Last I checked people feel they have a sense of ownership and freedom of choice with their own bodies. Wait in till some of the major news outlets run this story.
Great reminder that anyone hanging onto some idea Dr Comella isn’t fully capable of being a leading innovator in this space because of where her PHD is from is foolish, she already is world renowned!!
“Dr. Comella, who has more than 20+ years' experience and is a world renowned expert in the development and clinical practice of stem cell products and therapies, is extensively published in the scientific literature in the practical application of autologous (a patient's own) stem cell therapy. Last month, Dr. Comella and her team were the first in the world to publish in the scientific literature in-human results of adipose stem cell therapy significantly reducing psoriasis — a condition that affects more than 7 million Americans annually. Her leadership continues to inspire other physicians who can train and certify in stem cell therapy with Dr. Comella and her team.”
Should we stop the production of assembly line cars because Henry Ford wasn’t a graduate of Harvard nor had any degree!?!?