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My guess is yes. It would definitely be a material event and subject to dissemination.
Just made my last buy of the year at .07125. Here's to a prosperous 2024.
I'm just happy that we are trading over .064, the last adjusted filing price update.
Bring on 2024!!
More updates means more progress and closer to IDE submission hopefully.
Excellent.....ready to rock and roll.
Going crazy after hours. Last trade 0.43. Huge volume.
Kind of quiet on the western front today.
Must be a bad hair day!
Year end rally!!!!
Or more news??
Nice dream!!!
Monday is Christmas. I think the markets will be closed.
Finally the amended price of .064 looks good compared to current price of .0729. It's a deal for someone.
That's what I am thinking too!! Great minds think alike.
No apology neccessary. Sometimes reading and comprehension come in handy even when you get old.....like me!
Never mind my .064 to .08 post. The .08 offering is/was still open but they just amended the price to .064. This is not a new offering. The doctor must need the money a little quicker than before. Wonder why?
The doctor is giving someone one a heck of a deal??!!
I wonder if this one at .064 cancels the remaining one that is still open at .08?
Must be getting very close to IDE submission.
Price a tad lower so as to get them sold. Let's see how quick they are bought.
Looking for a slow move to the upside for Friday before the long Christmas weekend. Not a bad week at all.
Buying this dip too.
That's why I had to add a few more!!
Just added on this chili dipper.
Did that too. Keeps sticking my old post. Think IHUB is having a problem.
I did that.
I tried but it won't let me as a mod?
NEWS -- Radiogel™ Precision Radionuclide Therapy™ Receives FDA Breakthrough Device Designation
[Suppressed Image]
Richland WA, Dec. 20, 2023 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL), Vivos Inc is pleased to announce that the Food and Drug Administration has granted RadioGel Precision Radionuclide Therapy the designation as a Breakthrough Device pursuant to the FDA’s Breakthrough Devices Program.
Dr. Mike Korenko stated “We are pleased with the FDA’s decision to grant Breakthrough Device Designation following our recent data submissions. The FDA did a very thorough review. The analysis in our Risk Management Report concluded that RadioGel™ is intrinsically safe and our animal therapy data verified its effectiveness. We are currently working closely with Mayo Clinic for our initial indication for use of Radiogel for delivering “therapeutic radiation to solid metastatic tumors in lymph nodes associated with papillary thyroid cancer, accessible by percutaneous direct needle injection, in patients who are not surgical candidates or have declined surgery, had non-radioiodine avid disease and had limited burden regional nodal disease.” The Breakthrough Device classification will enhance the schedule priority for our upcoming IDE submission seeking authorization to begin human clinical trials.
The FDA’s Breakthrough Devices program facilitates accelerated development and expedites the review of breakthrough technologies to help patients potentially gain timely access to technologies that can provide more effective treatment options.
Contact for journalists:
Mike Korenko
Email: mailto://MKorenko@RadioGel.com
Follow Vivos Inc @VivosIncUSA., Radiogel™ @RadioGel and Isopet® on X (fka Twitter):
About Vivos Inc. (OTCQB: RDGL)
Vivos Inc. has developed an Yttrium-90-based injectable Precision Radionuclide Therapy brachytherapy device to treat tumors in animals (IsoPet®) and humans (RadioGel™). Using the company's proprietary hydrogel technology, Brachytherapy uses highly localized radiation to destroy cancerous tumors by placing a radioactive isotope directly inside the treatment area. The injection delivers therapeutic radiation from within the tumor without the entrance skin dose and associated side effects of treatment that characterize external-beam radiation therapy. This feature allows the safe delivery of higher doses needed for treating non-resectable and radiation-resistant cancers.
RadioGel™ is a hydrogel liquid containing tiny yttrium-90 phosphate microparticles that may be administered directly into a tumor. The hydrogel is a yttrium-90 carrier at room temperature that gels within the tumor interstitial spaces after injection to keep the radiation sources safely in place. The short-range beta radiation from yttrium-90 localizes the dose within the treatment area so that normal organs and tissues are not adversely affected.
RadioGel™ also has a short half-life – delivering more than 90% of its therapeutic radiation within 10 days. This compares favorably to other available treatment options requiring up to six weeks or more to deliver a full course of radiation therapy. Therapy can be safely administered as an outpatient procedure, and the patient may return home without subsequent concern for radiation dose to family members.
University veterinary hospitals use the IsoPet® Solutions division to demonstrate animal cancers' safety and therapeutic effectiveness. Testing on feline sarcoma at Washington State University was completed in 2018, and testing on canine soft tissue sarcomas at the University of Missouri was completed in 2019. The Company has obtained confirmation from the FDA Center for Veterinary Medicine that IsoPet® is classified as a medical device according to its intended use and means by which it achieves its intended purpose. The FDA also reviewed the product labeling, which included canine and feline sarcomas as the initial indications for use. The FDA does not require pre-market approval for veterinary devices, so no additional approval was required to generate revenue through the sale of IsoPet® to University animal hospitals and private veterinary clinics.
IsoPet® for treating animals uses the same technology as RadioGel™ for treating humans. The Food and Drug Administration advised using different product names to avoid confusion and cross-use.
Safe Harbor Statement
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. You can identify these statements by the use of the words "may," "will," "should," "plans," "expects," "anticipates," "continue," "estimates," "projects," "intends," and similar expressions. Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those projected or anticipated. These risks and uncertainties include, but are not limited to, the Company's ability to successfully execute its expanded business strategy, including by entering into definitive agreements with suppliers, commercial partners, and customers; general economic and business conditions, effects of continued geopolitical unrest and regional conflicts, competition, changes in technology and methods of marketing, delays in completing various engineering and manufacturing programs, changes in customer order patterns, changes in product mix, continued success in technical advances and delivering technological innovations, shortages in components, production delays due to performance quality issues with outsourced components, regulatory requirements and the ability to meet them, government agency rules and changes, and various other factors beyond the Company's control.
CONTACT:
Vivos Inc.
Michael K. Korenko, Sc.D.
President & CEO
mailto://MKorenko@VivosInc.co
Bullish
BULLISH
Every dip seems to be bought today. Maybe a dime by Friday is not such a far fetched dream.
Just hit .06.
Huge volume coming in. Merry Christmas.
Amazing...we have news justed posted.
Usually my bait dies before a hit!!
Why hold a web call an hour before opening on Monday unless you have something really good to say? That's just crazy to put out and average web call on a Monday before the open with a nothing burger. They are doing this on purpose and want the whole trading day before them to react..
I was lucky enough to get part of it at .05.
Light volume but the bid sizes have been increasing quietly.
Idiot. It's not new. Learn to read.
He does need to be better keeping us informed as to what is going on, I agree.
Might be nice if we get a small Christmas present from the good DR>
Get bored??
I think that Biden moves faster....when he is not falling down.
Looks like the DR. still has the balance sheets under control.