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Thank you for keeping us informed.. $USRM
Dr. Comella explained how the FDA ignored testimonies from adult stem cell practitioners during their 2015 public hearings regarding new guideline proposals. Then they arranged to create new rules behind closed door meetings that included pharmaceutical industry allies and insiders.
http://healthimpactnews.com/2019/fda-wants-to-shut-down-adult-stem-cell-therapy-as-its-healing-powers-are-experienced-around-the-world/
Every hospital, every Dr's office will participate in stem cell therapy.. $USRM
Outstanding Shares 433,903,734 +58,008408
The FDA has allegedly offered to drop the lawsuit if Dr. Comella signed an agreement to stop doing adult stem cell therapy and no longer promote it.
She refused. She said she has witnessed people leave their wheelchairs for good from this therapy. The trial is set for a Federal Court hearing beginning June 2019, in Miami, Florida.
If Dr. Comella loses this court case, adult stem cell therapy in the USA may be forced out of the country and only be available to those who can afford medical tourism
Big Pharma Is Using the FDA to Eliminate “Unregulated” Adult Stem Cell Competition
http://healthimpactnews.com/2019/fda-wants-to-shut-down-adult-stem-cell-therapy-as-its-healing-powers-are-experienced-around-the-world/
FDA Wants to Shut Down Adult Stem Cell Therapy as its Healing Successes are Experienced Around the World
Stem Cell Therapy FDA Approved?
https://www.regenerativeorthopedicinstitute.com/stem-cell-therapy-fda-approved/
Guidelines and Regulations Necessary as Stem Cell Field Advances
http://www.isscr.org/professional-resources/news-publicationsss/isscr-news-articles/article-detail/2019/04/08/guidelines-and-regulations-necessary-as-stem-cell-field-advances
Stem cells will prevail.. Case Dismissed.. $USRM
ISSCR 2019: JUNE 26-29.. LOS ANGELES.. THE GLOBAL STEM CELL EVENT
http://www.isscr.org/meetings-events/annual-meetings/isscr-annual-meeting-2019
Hair Regeneration Success With Stem-Cell Injections
https://www.prnewswire.com/news-releases/liveyons-live-pure-cast-podcast-explores-hair-regeneration-success-with-stem-cell-injections-300827905.html
A doctor injected stem cells below her kneecap—and within 15 minutes, the severe pain was gone.
https://menafn.com/1098365672/Mother-of-Liveyon-CEO-Shares-Heartfelt-Stem-Cell-Success-Story-with-Son-on-PureCast-Podcast
European Commission has granted marketing authorization for the first stem cell-based product in animal health
FDA needs to get on-board. 72% of the public now supports stem cell research... $USRM
https://www.businesswire.com/news/home/20190409005445/en/Boehringer-Ingelheim-Launches-First-Ever-Registered-Stem-Cell-Based/?feedref=JjAwJuNHiystnCoBq_hl-RLXHJgazfQJNuOVHefdHP-D8R-QU5o2AvY8bhI9uvWSD8DYIYv4TIC1g1u0AKcacnnViVjtb72bOP4-4nHK5ieT3WxPE8m_kWI77F87CseT
http://www.premierexhibitions.com/exhibitions/4/4/bodies-exhibition/blog/stem-cell-research-gaining-popularity
Demand Peaks for AAOSCP’s May 2019 “Basic Science to Clinical Practice” Stem Cell Workshop
https://bioinformant.com/aaoscp-may-2019-conference/
https://bioinformant.com/category/press-releases/
Lots of informative info..
Stem cells and regenerative medicine represent the wave of the future.. $USRM
Outstanding Shares 393,315,679 4/05/2019 +3,639,774
Restricted 80,323,939 04/05/2019 (0)
Unrestricted 312,991,740 04/05/2019 (0)
https://www.otcmarkets.com/stock/USRM/security
$USRM will be a pioneer for the industry and push stem cells into the 21st century.. The FDA Is Broken..
Volume 8,230 @ 3:35 ?? $BTCY 0.89
Mesenchymal Stem Cells Market Share, Growth, Statistics, by Application, Production, Revenue & Forecast to 2026
https://www.marketwatch.com/press-release/mesenchymal-stem-cells-market-share-growth-statistics-by-application-production-revenue-forecast-to-2026-2019-04-08
$USRM
Autologous stem cell transplantation in patients with AL amyloidosis with impaired renal function
https://www.nature.com/articles/s41409-019-0524-2
Stem cells will prevail.. Case Dismissed.. $USRM
FDA Mounts Aggressive Push to Regulate Stem-Cell Clinics
(Andrew Harnik/AP)
By Clayton B. Reid | Sunday, 07 April 2019 03:00 PM
The Food and Drug Administration has launched a nationwide crackdown on stem-cell clinics, issuing letters of warning and threatening civil actions that could shut them down if they refuse to comply with FDA regulations.
On Wednesday, the FDA sent correspondence to 20 clinics around the country, putting them on notice that they must seek FDA review and approval for their procedures.
Over the past 12 months, the FDA has sent “regulatory correspondence” to 45 clinics, according to The New York Times, which refers to them as “rogue stem-cell clinics.”
The regulatory crackdown is a paradigm change for more than 700 stem-cell clinics nationwide that have largely gone unregulated by federal authorities for over a decade.
The procedures being scrutinized include those that concentrate a patient’s own stem cells and re-inject them into that patient to treat a wide range of painful, debilitating illnesses such as herniated disks, joint pain, reproductive issues, Parkinson’s disease, multiple sclerosis, and several others.
The FDA has filed civil actions against two clinics, one in Florida and another in California, in a bid to force them to comply with FDA regulatory regimes applied to major drug manufacturers. That would likely be unsustainable for small practices.
Advocates for regenerative stem-cell medicine charge that Big Pharma’s influence is behind the crackdown, suggesting the FDA is being used to clear out potential competitors. They describe stem-cell therapy as a minimally invasive procedure best regulated by local medical boards.
The clinics maintain that because many of the treatments involve harvesting a patient’s own stem cells – known as autologous stem cells – and then re-injecting them into trouble spots in that patient’s own body, they should not be subject to FDA regulation.
Stem cells are undifferentiated, meaning they have the potential to grow into multiple types of bodily tissues. The clinics that use them in treatments maintain they reduce inflammation and promote healing.
Stem cells, they say, have been successfully used to treat thousands of patients, while critics point to cases where patients had adverse reactions – including three Florida seniors with macular generation who reportedly suffered “severe vision loss” after stem-cells were injected into their eyes in a clinical trial, as reported in a March 2017 article in the New England Journal of Medicine.
One factor in the growing controversy: The question of when a procedure involving one’s own tissues comes under the purview of federal regulators. Libertarian-minded medical ethicists argue the government should not be empowered to regulate patients’ decisions about their own medical treatment when it involves materials taken from, and reintroduced into, their own bodies.
Dr. Jeff Singer, a general surgeon in Phoenix who also serves as a senior fellow at the libertarian Cato Institute think tank, tells Newsmax that the FDA refrains from regulation in what’s known as “same surgery,” when a tissue is removed from one part of the body and introduced somewhere else in the same patient. A skin graft would be an example.
But if the tissue is manipulated in some way, it begins to attract the FDA’s attention, in part due to the concern the tissue could be somehow contaminated during the handling process.
“If it’s what they call not the ‘same surgery’ – for example you take it and process it and then later on reinsert it into the patient – they consider that sort of a creation of a drug, and they claim to have regulatory authority over it,” Singer says.
This demarcation is particularly relevant in the case of adipose stem-cell treatments -- that is, stem cells that are derived from fatty deposits in the human body.
The procedure can be performed in just two hours under local anesthesia. An amount of fat approximately equivalent to a stick of butter is removed from the body. Enzymes are added to help the stems cells detach from the fat cells. The fatty material is then spun in a centrifuge to separate out stem cells, which are then collected and re-injected into the treatment areas of the patient.
Singer comments: “The FDA considers that sort of like creating a medicine, and therefore it needs to come under their regulatory jurisdiction before it’s approved – that’s their position on it.”
Singer would like the FDA to limit itself to certifying whether an autologous procedure has been proven to be safe and effective.
“For example,” he says, “if the FDA wanted to say, ‘We haven’t certified that this process is safe, proceed at your own risk,’ I’m ok with that. But I still want to be able to make my own decision.”
Of course patient safety is very important to Singer, but he points out federal regulators are hardly beyond making errors of their own. And he says the principle that the patient, not the government, must ultimately decide his or her own care also must be protected.
As Singer tells Newsmax: “If I want to take my own tissue – my own, not someone else’s – prepare it a certain way, and then put it back in my own body, that’s as sacred as my right to free speech. From a medical ethics standpoint, it’s a patient autonomy question.”
That the FDA sees things differently has become increasingly evident in recent years. Last December, for example, it issued a news release that warned: “Time is running out for firms to come into compliance during our period of enforcement discretion. We’ll be increasing our oversight related to cell-based regenerative medicine as part of our comprehensive plan to promote beneficial innovation while protecting patients.”
Perhaps no one in the stem-cell regenerative medicine business has come under greater scrutiny than Dr. Kristin Comella, chief science officer of U.S. Stem Cell, a firm that operates three clinics in South Florida.
Comella has helped train over 700 practitioners in her company’s adipose stem-cell methodology, and U.S. Stem Cell has been recognized as a leader in its industry. Comella says the FDA’s bid to regulate what patients choose to do with their own tissues is a case of regulatory overreach.
Read Newsmax: FDA Mounts Aggressive Push to Regulate Stem-Cell Clinics | Newsmax.com
Big Pharma is not interested in patients healing themselves, Kristin Comella.. $USRM
Psoriasis, the results from one trip to the clinic is Amazing.. (17 Min mark)
This should be performed as a routine procedure. Very informative.. Thanks for sharing.. $USRM
Analysts expect earnings to be released on May 14th, 2019. The report will be for the fiscal period ending March 31st, 2019. Reported EPS for the same quarter last year was -$0.19. The estimated EPS forecast for the next fiscal year is -$0.79 and is expected to report on March 12th, 2020.
Stem cells to block Zika Virus
http://www.stem-cells-news.com/1/stem-cells-to-block-zika-virus/
Stem cells will prevail.. Case Dismissed.. $USRM
$AXSM CFO Purchases $67,932.00 in Stock
https://www.baseballdailydigest.com/news/2019/04/08/axsome-therapeutics-inc-axsm-cfo-buys-67932-00-in-stock.html
Why Do Americans Take So Many Prescription Drugs?
https://www.oftwominds.com/journal08/Prescription-Drugs.htm
Induced Pluripotent Stem Cell Research Project
http://www.stem-cells-news.com/1/australia-induced-pluripotent-stem-cell-research-project/
Three Heart Disease Patients Improve After Adult Stem Cell Treatment
http://www.stem-cells-news.com/1/three-heart-disease-patients-improve-after-adult-stem-cell-treatment/
An estimated 36 million patients are expected to be equipped with remote monitoring devices by 2020..
“We have secured loyal anchor clients in key industry markets with great customer feedback. This has bolstered our confidence and we believe we are well placed to grow and to kick off the next phase of the Company,” said Mr. Waqaas Al-Siddiq
https://www.biotricity.com/biotricity-achieves-market-expansion-in-two-new-states/
Press coverage about BTCY stock has trended somewhat positive this week, InfoTrie Sentiment Analysis reports. The research firm identifies negative and positive news coverage by analyzing more than six thousand blog and news sources in real-time. The firm ranks coverage of publicly-traded companies on a scale of negative five to positive five, with scores nearest to five being the most favorable. Biotricity earned a media sentiment score of 1.2 on InfoTrie's scale. They also gave media stories about the company a news buzz of 10.0 out of 10, indicating that recent news coverage is extremely likely to have an impact on the company's share price in the near future.
https://www.marketbeat.com/stocks/OTCMKTS/BTCY/
Biotricity is scheduled to release their next quarterly earnings announcement on Wednesday, June 12th 2019
https://www.marketbeat.com/stocks/OTCMKTS/BTCY/
Mutation stands in the way of healthy blood cell maturation
https://www.sciencedaily.com/releases/2019/04/190405101315.htm
Stem cells will cure many types of cancers.. $USRM
Axsome outlined an itinerary for key data readouts for AXS-05, which is being evaluated for indications such as MDD, treatment-resistant depression, Alzheimer's disease-related agitation and smoking cessation.
The company said it anticipates meeting with the FDA in the second quarter of 2019 to discuss the potential regulatory path for developing AXS-05 for MDD.
Implied Volatility Surging for Axsome Therapeutics (AXSM) Stock Options
https://finance.yahoo.com/news/implied-volatility-surging-axsome-therapeutics-125012227.html
HENDERSON, NV / ACCESSWIRE / April 5, 2019 / According to CannaNews, a leading cannabis industry publication, as the industry moves toward large-scale production, "growers' energy consumption continues to explode to almost unimaginable levels." The announcement explains in 2017 that indoor cultivation already used a whopping 1% of the U.S.’s total energy expenditure and that utilities in states where pot growing is now legal have run into struggles with the load and reported cannabis-related power outages. As of March 2017, the cannabis industry was responsible for about 0.5% of total US greenhouse gas emissions. Energy is one of growers’ largest costs, accounting for as much as 50% of total overhead. However, implementing a microgrid can dramatically reduce those costs. Microgrids combine solar, storage, and combined heat and power (CHP). The systems make for a much more environmentally friendly operation while dramatically reducing costs, hence the revolutionary role they will play in this growing industry.
https://finance.yahoo.com/news/microgrid-marijuana-mover-put-radar-130000994.html
CLSK will add the revenue from its acquisition of Pioneer Critical Power' Intellectual property to an already impressive list of accomplishments:
•Closed a $5 million round of funding
•Engaged a firm to navigate the company's up listing
•Announced the near completion of a $900k contract to install a CLSK microgrid at a U.S. Marine Corps Base
•Continued progress on their $18.3 million deal with NYSE company MAC
CLSK has developed a microgrid power solution for the cannabis industry, which can reduce energy costs by up to 82%. This represents a huge potential revenue stream for the company. Due to this fact the company has stated that marketing to cannabis companies is one of their top initiatives for 2019. This could be big... $CLSK
Energy is Cannabis Production's Biggest Cost
https://finance.yahoo.com/news/energy-cannabis-productions-biggest-cost-135500841.html