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FDA guidelines for exemptions
Whenever anyone questions if this procedure needs any type of approval, referencing the FDA guidelines showing that it does not is a good retort.
https://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Tissue/UCM419926.pdf
The exemption that Caverstem and StemSpine and FemCelz will fall under is 21 CFR 1271.15(b)
The reason being is :
The cells are taken from the same person they are put back into
It is all done in one procedure(there are further exemptions for storing and using later in the same person, but this is not applicable to the current treatments we are discussing)
The stem cells remain in their original form
All that is done with the stem cells is a cleaning/filtering process through centrifugation(the Magellan machine). This is articulated in answer A7 as acceptable use.
Another great FDA document is this as well:
https://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/UCM585403.pdf
Yes, Kevin, every single one of their previous filings contains this language, quite standard. If you're on Twitter shoot me a message, my handle is the same as here, JBizzle703.
We are continuing to recruit physicians in the USA and abroad.
Patients are being treated in the USA and abroad.
We are continuing to expand our marketing capabilities.
We are continuing to develop our patent portfolio.
We are cash flowing.
We are continuing to grow the business.
My favorite is continuing to develop the patent portfolio.
https://www.otcdynamics.com/celz-shareholder-update-creative-medical-technology-holdings-inc-3/?utm_campaign=twitter&utm_medium=twitter&utm_source=twitter
I added today as well. This is a solid PR giving some context to our expectations.
This seems to line up with exactly what I said an hour earlier...
Revenue; our revenue has increased in Q3, it was however impacted by delays in training and launch of physicians. The company determined that delays in training some physicians until which time as the Patient Gain technology was implemented and our Generation 2 device technology was secured was of benefit to the company, the physicians and to their patients than booking sales in a given quarter opposed to the following quarter.
FemCelz; as previously announced, we are progressing with the development of the FemCelz procedure for the treatment of female sexual dysfunction using stem cells from the patient's own bone marrow. Following the same model as CaverStem™, we anticipate launching this program in Q1 2019.
FemCelz coming very soon!!!!
CaverStem International: As was announced by publication across social media outlets and our press conference, the company successfully sponsored the treatment of two patients in Moscow by Dr. Dmitri Pushkar, Urology General of Russia using the CaverStem™ procedure.
We also are progressing with the CaverStem™ program in Switzerland and expect to release more information on the treatment of patients in this region soon. Interest in the CaverStem™ procedure remains strong in other EU countries. Setting up such relationships and navigating all legal obligations to conduct business in each country takes a great deal of effort and time on the part of CaverStem™ executives and our counterparts in each medical practice. As we reach milestones as we have in Russia, future disclosure will be made.
CaverStem™ domestic activities: As previously reported, we are continuing marketing to physicians across the United States. There are currently 14 locations at various stages of development, training marketing, recruiting and treating patients. We are recruiting additional marketing representatives to gain increase our exposure to physicians.
CaverStem.com; since implementing Patient Gain on 11-5-18, we have trained physicians and their staff in five locations. The primary training involves use of the CRM for patient recruitment, interaction between the physician and the patient and patient retention. All in HIPAA compliance. The responses to the benefits of this platform and its ease of use has been positive. Training of other physicians is ongoing.
Implementing the Patient Gain platform at this time is of great value as increased proficiency in data management is expected to result in reaching a much larger potential patient market with an ongoing reduction in patient acquisition costs and appointment scheduling and patient follow up directly with each physician's office, which also is expected to increase efficiency and reduce administrative costs. The platform enables the company to quickly replicate and implement our system with each physician joining CaverStem™, resulting in much greater efficiency as we scale the business upward.
https://www.otcdynamics.com/celz-shareholder-update-creative-medical-technology-holdings-inc-3/?utm_campaign=twitter&utm_medium=twitter&utm_source=twitter
"CaverStem™ domestic activities: As previously reported, we are continuing marketing to physicians across the United States. There are currently 14 locations at various stages of development, training marketing, recruiting and treating patients. We are recruiting additional marketing representatives to gain increase our exposure to physicians."
https://www.otcdynamics.com/celz-shareholder-update-creative-medical-technology-holdings-inc-3/?utm_campaign=twitter&utm_medium=twitter&utm_source=twitter
I am optimistic for similar things. From a company perspective, they have only continued to improve from a commercialization standpoint, improved their position with the types of lending they are getting, have revs starting to come in, and are putting the framework in place for an integrated web operation. If numbers like this Q had come out last Q, people would have been pretty happy. So, it got moved a quarter while they were focusing on the international stuff.
This stock ran to .07 on the potential of one conference. Since that time the treatment has been commercialized, doctors are performing it, new doctors are continuing to sign up, and the company has been expanding into international business. This isn't taking into account any of the other patents or the affect the right to try law might have. The last part of the sentence focuses on new trials for the AmnioStem line!
"We commenced marketing stem cell concentration machines and disposable kits for the Caverstem ED treatment in the fourth quarter of 2017. For the next 12 months our plan of operations is to market our stem cell concentration machines and disposable kits, complete the UCLA/LABiomed clinical trial and partner with leading researchers on investigator-initiated trials to advance our neurological programs."
I think that is a smart outlook on it. It's all about risk tolerance. I believe in the fundamentals of the patents and the scientific advisory board.
I agree with that.
Signing up and beginning the process to do to whatever contracts and insurance reviews may be needed is different from making payment to the company and finishing training. I don't know at what point payment is made to the company. Don't forget also, they pivoted slightly to start working through the international stuff as well. We would have loved to have seen the revs from 10 doctors signed up in the Q, but progress is still progress even if it is not the best case.
And from that Sep30, there are two more doctors signed up(since there are 5 doctors in total that you can schedule appointments through).
I could see that, I don't remember at what point the international trip was done. If there was pre-payment from the Austrian clinics then cool, but they are still working through some approval stuff there and haven't begun treatment yet. France is the real wildcard, because I don't know the status of that, even though it was mentioned in the Russian press conference.
I do caveat that though if there was any type of Russia deal pre-payment, which I'm not expecting.
I would be surprised at the high end of that, and comfortable with above 30K for sure. Just based on the 20K pre-payment that was noted in the last 10-K, that was counted as revenue.
I'm sure there will be a little confusion when it comes out(things we are expecting to see based off the current state), as they brought on the institutional investors after the end of the period. They have in the past added some additional financial information for stuff that happened after the end of the period.
What do you think the point will be where we'll move on to other things besides broken windows and strip clubs?
I'm just wondering if there is a number revenue wise or PPS wise. Before May it was there are no doctors, and now that there are doctors revenue will follow. It's just an interesting thought experiment.
I think they will continue to tune things. I believe part of the reason they put this out now is since they are doing the training with the physicians on the new system, it would make sense for the training to be done while the system is up and active.
Would that include building it out for CMS integration, or more on top of that?
All solid points. A lot of folks get caught up in the periphery, and don't acknowledge the business plan here totally revolves around the patents and the licensing of said patents.
My favorite part of the new @CaverStem webpage, the map showing all of the treatment locations. Imagine what this will look like 3 years from now with all the US and International locations!
http://www.caverstem.com/locations-map-caverstem
$CELZ #urology #stemcells #health #erectiledysfunction
Fall promotions, $1000 off treatment, check to see if the doctor in your area is offering a special.
http://www.caverstem.com/ed-procedure-north-florida-specials-promotions
New Website has contact information for all active doctors and allows you to view the schedules and make appointments. Also has the ability to leave reviews!
New Updated Caverstem Website!!!
www.caverstem.com
Integrated with PatientGain CRM.
I found out the Pats are on national CBS here in DC for the 1 PM game. It was like finding a new CMTH patent that had been submitted.
AngioStem, StempSpine, CerebroStem, they do need a name for the AntiAging though...maybe RegenStem.
I want some type of fee if they use RegenStem, lol.
I normally don't post all that much, but what the heck, just getting ready for kickoff time. Why not through some fact based DD out there.
It is pretty strange huh?
Cancer Induced Wasting Treatment
Creative Medical Technology Holdings, Inc. (CELZ) announced today initiation of a program aimed at treating cancer associated wasting, through the in-licensing of patent application #15/814284 entitled "Treatment of Cachexia Using Stem Cells and Products Thereof".
Recently the Company announced data that the AmnioStem™ stem cell was superior to other stem cell types at reducing inflammatory mediators, including TNF-alpha1. It is well known that inflammatory mediators generated by cancer have a pivotal contribution to cancer associated weight loss, formally termed "cachexia". The Company believes that through suppression of inflammatory mediators, as well as direct anticancer effect of amniotic fluid stem cells2,3 that AmnioStemTM may provide value in the treatment of advanced cancer patients.
Cachexia is a very severe complication of cancer: weight loss during treatment is associated with more side effects of chemotherapy, fewer cycles of chemotherapy, a lower response to therapy, and even decreased survival. It is estimated that more than 20% of cancer patients die due to cachexia, and more than 50% of patients die with cachexia4.
"One of the most horrific aspects of having cancer is associated cachexia, which to date is not a major focus of research for the Pharmaceutical and Biotechnology industry. I strongly support the innovative approach that Creative Medical Technology Holdings is taking at dealing with this terrible condition," said Santosh Kesari, MD, PhD Chair and Professor of Department of Translational Neurosciences and Neurotherapeutics at Pacific Neuroscience Institute and John Wayne Cancer Institute at Providence Saint John's Health Center in Santa Monica, CA.
"We are confident that once we have completed Phase I clinical trials to demonstrate human safety of this cell, we will be well positioned to allow access to end stage cancer patients under the Right to Try law," said Thomas Ichim, Ph.D, Chief Scientific Officer and Cofounder of Creative Medical Technology Holdings.
https://finance.yahoo.com/news/creative-medical-technology-holdings-aims-130500118.html
Brain Cancer Treatment
Creative Medical Technology Holdings, Inc. (OTCQB:CELZ), a clinical-stage stem cell company, announced preclinical data showing exosomes harvested from its patented AmnioStem amniotic fluid stem cell, selectively inhibit growth of glioma brain cancer cells. Exosomes are nanoparticles generated by a variety of cells that are critically involved in intercellular communication. The company previously filed patents on the use of AmnioStem-derived exosomes for treatment of stroke.
The AmnioStem technology was originally licensed from the University of California San Diego (UCSD), under an exclusive agreement covering issued US Patent #7,569,385. "Having seen first-hand the devastation and lack of treatment options in glioma patients, I am excited about the prospect of developing a non-toxic biological approach that eventually may provide benefit to this group of patients," said Santosh Kesari, MD, PhD, FANA, FAAN, Chair and Professor, Department of Translational Neurosciences and Neurotherapeutics, John Wayne Cancer Institute, as well as Director of Neuro-Oncology, Providence Saint John's Health Center, and who leads the Pacific Neuroscience Research Center at Pacific Neuroscience Institute.
"The filed patent application contains data showing that while AmnioStem-derived exosomes inhibited proliferation of glioma cells, other stem cell types actually increased proliferation of glioma," said Thomas Ichim, PhD, Chief Scientific Officer of Creative Medical Technology Holdings. "We are currently working under the possibility that AmnioStem stem cells may possess unique biological properties that are different from other types of stem cells." "From a commercialization perspective, exosomes are simpler to manufacture, store, and deliver as compared to living cells. Additionally, because exosomes are not replicating cells, we anticipate a less complicated FDA regulatory pathway as compared to cellular-based products," said Timothy Warbington, President and CEO of Creative Medical Technology Holdings.
http://www.bioquicknews.com/node/4321
If Dr. Gershman is Urologist to the stars because of his work with Frank Sinatra Jr., does that make Dr. Patel the cardiologist to the stars because of his work with Don Ho?
http://www.marketwired.com/press-release/cell-therapy-expert-dr-amit-patel-joins-regen-biopharma-inc-scientific-advisory-board-otcbb-rgbp-1957807.htm
Dr. Amit Patel
I always forget this when tying back CMTH key players to Medistem. Dr. Patel was brought on board to Medistem as well.
Dr. Patel is Director of Clinical Regenerative Medicine and Tissue Engineering at the University of Utah and has been involved in over 17 FDA trials in the area of cellular therapy. Dr. Patel currently holds more than $7 million in research grants for basic and clinical research in the area of regenerative medicine.
Dr. Patel has a Masters of Sciences in Immunology, studied medicine at the Case Western Reserve University, and was a surgical intern, resident and fellow at Baylor University. He was a faculty member at University of Pittsburgh and currently is a faculty member at the University of Utah. In 2002, he led a "breakthrough" study demonstrating that stem cell transplantation could treat congestive heart failure, being the first doctor to inject stem cells into the human heart. Notable patients of his include Hawaiian singer Don Ho; Ho credited Patel's 2005 procedure on him with saving his life and allowing him to return to performing after being forced into retirement for health reasons. Dr. Patel holds numerous industry and governmental grants including from the National Institutes of Health (NIH) and the Department of Defense.
https://sdbn.org/uncategorized/2011/09/22/medistem-receives-fda-approval-to-begin-clinical-trial-in-usa-with-erc-stem-cells-2/
Thank you for brining this all to light, I plan on liquidating all my shares on Monday.
Why would you use Spanish in a way where you are trying to insinuate that I don't understand something? That seems weird....
Interesting, you just posted a link to court proceedings which showed a whole bunch of people associated with West Coast Acquisitions, which had the primary owners on there, but here you are stating that all owners have to sign this form, and only Mr. Warbington did, which makes him the only owner.
So, which is it?
Dr. Said's License is active.
libel
1) n. to publish in print (including pictures), writing or broadcast through radio, television or film, an untruth about another which will do harm to that person or his/her reputation, by tending to bring the target into ridicule, hatred, scorn or contempt of others. Libel is the written or broadcast form of defamation, distinguished from slander, which is oral defamation. It is a tort (civil wrong) making the person or entity (like a newspaper, magazine or political organization) open to a lawsuit for damages by the person who can prove the statement about him/her was a lie.