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And no known additional FDA requests from them.....so far....so good.
Agree. FDA wanted animal data to prove safety, FDA wanted vx2 study, FDA wanted genotoxicity tests and Biocompatibility tests. All passed. I think we are golden here for approval.
Amen. Decent market cap at that level.
$RDGL
Just like to see it up at .50 for a while LOL...
The bullshit should end soon . There won't be anymore selling at 24 and getting back in at 16
Those days are about over
Now we have GTSM on the ASK and BID so if a Slap come in GTSM will give out anything he wants between The Bid price to the ASK.. plus show it in either red of black trade. What BS... When I slap the ASK I expect to get ASK price... Not what ever they want to manipulate and give me.
On board tab on mine is shows the last one on 7-15 for Form 1-A/A... I'll check my Schwab too.. Thanks BBANBOB
It came up this am on schwab news as well by the ticker symbol but can't copy and past it
it is also on the right side of our posting board
Form 1-A/A - Offering Statement [Regulation A]: [Amend]
07/15/2024 06:02:55 AM
Our count down is getting nearer.... Should start to see increasing share price just out of osmosis now in anticipation of projects that are coming
thanks Chereb... Your on top of it...
Great article on clinical trials website! It dates back to Jul 1 (just after submission).
https://www.clinicaltrialsarena.com/news/vivos-eyes-human-trials-for-radiation-treatment-gel-with-ide-submission/
This seems to have been written by a human knowledgable about the facts relevant to someone who is looking for a clinical trial that fits their needs and investors looking for opportunities. This has probably been referenced before here, but it is a great (non-bot generated) read so it can't hurt to see it again.
Ahhh, I had seen this portion of the article referenced before here...must not have read the entire article just this fact
Yup. I reached out to let them know it needed to be updated. Got notice yesterday it had been fixed.
Happy you indicated ASK not bid ....lol
We are 7 business days for automatic approval
Word must be getting out.. Ask Slapping is happening.. up to .184
Can you show a link to that? Thanks Chereb
1-A has been QUALIF
It will be interesting to see how much the doc sells at .15, I'm sure investors are queuing up that price.
The red banner on the radiogel website has been updated!!!
It now reads
"We have submitted the Application for Authority to Initiate Human Clinical Trials"
Not a smart move. Them waiting patiently without engaging in irrational exuberance on their website is preferable and wiser. Countdown is just noise. No real value to it.
Would be kind of cool if Vivos ran a countdown clock on the Radiogel website for IDE approval 😎
Let's have great day tomorrow,good night all.
Many cancers are tough to beat especially colorectal, so far so good we thought was coming back again but so far its not been the case as there is no more discharging and Ivan doesn't pay much attention to that area anymore. This is one more treatment we hope to use in this fight against cancer, maybe to be used with other treatments soon. I think we all know people who this could have helped. Go RDGL!
I think Vivos should not be so squeamish about including before and after shots of butts and other atypical body parts. At least on their website. Its important for owners of potential patients to see for themselves that the treatment can bring about relief from pain and irritation. Thankfully it also resolved Ivan's tumor issue and he continues to live life large. But several of the pets treated enjoyed a higher quality of the life for the time they had left by having their tumor burden decreased, despite the fact their cancers spread and they ultimately passed away from the disease. I think all owners to date have been grateful for being able to give their pets a better time, even if it couldn't be a longer time here.
Nice pic! Your wife and her horse seem to be beaming a feeling of happiness and satisfaction into the camera that it gave me a bit of a pick me up just looking at it. I wouldn't have known a horse could give off that vibe, but he looks incredibly comfortable and content with his face next to hers.
Seeing a before and after of Zippy's treatment area would be nice. It been awhile but I think I recall the before was really scabby. Relief from a constant irritation, even if that irritation is not life threatening is something families want to be able to provide to their pets. I just hope Vivos can get the treatment cost for pets down to the $2 to $4k range to make it more accessible for average pet owners. FYI, my last donation to the center was on 09/09/2023. So the treatment must have been just before that or after. So he would be just coming up on his 1 year mark in a few months. It feels longer than that but email timestamps don't lie.
Share price has doubled since - great call grasshopper.
My dog was treated there ,this is no OTC scam Mr glow. Please glow somewhere else!
Ivan is doing great no sign of slowing down at 12years old, no symptoms or bleeding no chewing back there. We're happy thanks brother.
Of course they are!
$2 billion technology with under 500M shares
I like those numbers...
THE END
Lmao, you are hilarious. You dumbass, posting wrong information as usual
So those 5,426,278 million shares that became unrestricted as of today and filed with the DTC aren't available for trading yet?
How's my favorite husky Ivan doing?
Apples and oranges. One has nothing to do with the other. Swing and a miss.
I don't get to the barn much, but my wife has been volunteering there for like 15 years since she was in middle school. I'll try to get a picture of the area the therpy on. Zippy is reaching upper 20s in age I believe. I wouldn't be surprised if they retire him after this year due to age. He's been a therapy horse his whole life. Very special horse.
They have multiple therapy horses, but unfortunately a couple have recently passed due to colic (most common way horses die) and there's basically nothing you can do about it.
My wife's horse was actually born there. She bought the horse from them after it had lyme disease and received treatment for that. Horse is doing so good you would never know!
I'll have to see how long it's been since Zippy’s treatment and have Vivos post a update on him showing how happy and healthy he's doing. They did like a year or two update on their first horse Summer Solstice.....
Most likely I-Glow and crew saw the the 5,426,278 come off restriction in the last 24 hours
https://www.otcmarkets.com/stock/RDGL/security
Outstanding Shares increased by 522,766 since yesterday
Restricted Shares decreased by 5,426,278 since yesterday
Held at DTC increased by 5,949,044 since yesterday
Outstanding Shares on 07/15/24 were 417,041,285 Today 417,564,051
Restricted Shares on 07/15/24 were 52,333,274 Today 46,906,996
Held at DTC on 07/15/24 were 361,388,202 Today 367,337,246
Interesting details. But the hole must be desperate to try to imply it’s a fake when we had two recent local news networks do stories on the company and its products. Not to mention the local get in Indiana who said on camera that his clinic regular uses the product and he thinks it’s a real game changer. He is just embarrassing himself.
Seriously dude, the only thing that matters is FDA approval. You can bash all you want about any nonsense you can think of, but if you’re not talking about, the only thing that matters, then nobody cares.
Thank goodness!! From the write up about him and how he is in a bunch of the pictures it is obvious that Zippy is a super special horse.
It made me sad to think the kids didn’t have the horses as a resource. I’ll shoot off another donation tonight to do my pet to help a little more going forward. Glad to know I was being paranoid and all is well.
You should see what I mentioned about this posted on ….
a few minutes ago on StockTwits.
Everyone should take a look at that.
Wow, someone is hurting and desperate.
Dude. I’ve respected your DD in the past, but you’re way off on the scam shit. This company and CEO are legit as they come. I’ve been to the company site, know the CEO and some of the BOD. You’re wrong.
The Corporate headquarters is:
"1030 N Center Parkway, Kennewick, WA, 99336"
Virtual office at N. Center Parkway | Kennewick, WA, 99336
Kennewick Virtual Business Address & Live Receptionist Answering Service
1030 N Center Parkway, Kennewick, WA, 99336
That is a huge red flag for a OTC scam.
"Platinum Plan
6 month term
$52 /Mo"
IG
$RDGL
— Stock Scan (@stockscan01) July 17, 2024
🚨 RDGL
💰 0,18365
📈Outstanding Shares Updated:
🔴Old: 417.064.051 (2024-07-16)
🟢New: 417.564.051 (2024-07-17)
Difference: +0.1199% (+500.000)
Graph: https://t.co/ivJ5WgAFn8
You forget the "breakthrough" designation. The trials timeframe is different for these.
Awesome to here about Zippy Cam great news indeed!
I found the following - "Dr. Korenko currently is the author of 28 patents and possesses extensive experience in nuclear applications."
I searched his patents and most were pending - I didn't find any granted by the USPTO.
And there isn't a International patent - that is a myth. And a WIPO (PCT) patents still have to be granted by the USPTO.
10 years of Big Talk but very little has been accomplished.
IG
Awesome good to here, I've shared this with family and friends some have got in others not,like yourself I've shared but my recommendation's have been check it out DD as we say.
Isn't the Radiogel™ Precision Radionuclide Therapy device a Class III Medical Device.
"The cost of clinical trials for medical devices can vary greatly depending on several factors, but estimates range from $6 million to $94 million.
Complexity
The complexity of the device and the regulatory pathway chosen can impact the cost. For example, a Class II medical device of medium complexity can cost between $2 and $5 million for research and development, and around $30 million for FDA approval."
There isn't anything on Clinicaltrials.gov about the Vivos medical advice.
From the 2014 10-K:
"Throughout 2014, the Company focused on the development of its brachytherapy products including the regulatory review of the Y-90 RadioGel™ device by the Food and Drug Administration (“FDA”)."
They have been pumping this for 10 years and still years away from generating any revenue.
IG
Zippy is doing amazing! Treatment worked exactly as it was supposed to. He's a very old horse and his breed/color is very well known for cancer problems. It was on his upper tail and it eventually bursted prior to the treatment. He was rubbing it on the walls and a bad infection resulted from it. Smelled horribbbbble. After they cleaned it up and did the treatment it was all clean, fast, and effective. You would never know it had happened.
The place is somewhat active on their facebook. This is a small family run volunteer nonprofit barn to help people with disabilities. They are still running business as normal. They're not exactly tech savvy people lol. They heavily rely on the volunteers. They make a little money from boarding horses and the "lessons" they give to clients on riding. Most clients are people with disabilities like physical or mental who gain balance or just basic physical activity.
Tough business as horse people are slowly fading away and insurance companies aren't covering thay type of therpy as much as they used to. At least here in southern Maine. All the farm land is turning into houses lol.
Another day passed is another step closer to IDE approval 🙏🤞
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The company is engaging the FDA for permission to use RadioGel™ for the treatment of advanced basal and squamous cell skin cancers. The RadioGel™ Veterinary Solutions division of Vivos is focused on demonstrating the safety and therapeutic effectiveness for different animal cancers in four different university veterinary hospitals. Vivos is positioning itself so that after this demonstration phase, The Company can begin to generate revenues through the sale of RadioGel™ to private animal clinics.
The Company currently is outsourcing material aspects of manufacturing of its product in the United States and intends to enter into licensing arrangements outside of the United States for the manufacturing and distribution of RadioGel™ in other countries.
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 6 weeks or more to deliver a full course of radiation therapy. This is an outpatient treatment much safer to the personnel treating the patient than competing brands and the patient can go home immediately with no risk to family members.
What are the advantages of RadioGel™?
Based upon its studies and analyses, or general application of experience with current brachytherapy devices and Yttrium-90, Vivos believes that its brachytherapy products are likely to offer the following benefits, among others, for patients and medical professionals:
•Maximizing Therapeutic Index: The short-range beta particles emitted by Y-90 deliver radiation energy within a tight range. This enables radiation to be selectively delivered to target tissues while minimizing radiation dose to nearby normal tissues. High therapeutic indices imply that more radiation energy may be imparted to target tissues, with less radiation reaching adjacent normal tissues.
•Half-Life: Y-90 has a half-life of just 2.7 days. Many traditional brachytherapy products use isotopes with longer half-lives such as 9.7 days for cesium-131, and sixty days for iodine-125.
•Optimized Delivery Method: Current brachytherapy devices place permanent metal seeds in the prostate by using up to 30 large needles. By contrast, Vivos’s Y-90 RadioGel™ device is designed to be administered in a minimally invasive procedure with small-gauge needles.
•No Permanent Seeds Remaining: Current brachytherapy devices place permanent metal seeds in the tumor. Vivos’s Y-90 RadioGel™ device utilizes a biodegradable, non-toxic polymer that is ultimately absorbed by the body. This eliminates the possibility of a long-term seed migration or other problems that may sometimes arise when seeds remain in the body.
•Good Safety Profile: Many traditional brachytherapy devices utilize isotopes that emit x-rays (akin to gamma radiation). X-rays or gamma radiation travels within and outside of the body and have long half-lives. Vivos’s brachytherapy products use the Yttrium-90 isotope, which is a beta-emitter. Yttrium-90 beta-emissions travel only a short distance and have a short half-life of 2.7 days.
•Potential Lower Cost: Yttrium-90 supplies are readily accessible and are relatively inexpensive. The elimination of the metal or glass enclosures used in traditional brachytherapy seeds greatly reduces manufacturing costs.
What is the market for RadioGel™?
Reliable sources estimate that annual sales of brachytherapy products exceed $2 billion, about half of which are in the United States. The size of the U.S. brachytherapy market for prostate cancer brachytherapy is somewhere between $90 million and $130 million per year. The market for liver and breast cancer combined is comparable.
What is Brachytherapy?
Brachytherapy is the use of radiation to destroy cancerous tumors by placing a radiation source inside or next to the treatment area. According to Global Industry Analysts, by 2016 the U.S. brachytherapy market will reach $2 billion. It is estimated that the U.S. market represents approximately half of the global market. Vivos believes there are significant opportunities in prostate, breast, liver, pancreatic, head and neck cancers. The 2013 U.S. estimated new cases according to the American Cancer Society are 240,000 prostate cancer, 235,000 breast cancer, and 31,000 liver cancer.
Are there other markets for RadioGel™?
March 15th, 2016, Vivos Inc. announced the formation of a new, wholly-owned subsidiary, IsoPet Solutions Corporation, to focus on the vibrant and expanding veterinary oncology market. In August 2017 the subsidiary was changed and made into a separate operating division inside the Company.
The IsoPet™ Veterinary Solutions division will focus on bringing RadioGel™ yttrium-90 brachytherapy products to veterinary oncologists to treat dogs and cats suffering from tumor cancers.
There are over 150 million pet dogs and cats, with over 1/3 of the households in the US owning at least one dog, and just under 1/3 owning at least one cat. IsoPet Solutions is establishing the infrastructure necessary to provide product to veterinary clinics including regulatory clearances and compliance. The division will also provide product awareness and education to veterinary oncologists. Initial treatments are to be coordinated through the Chair of the Company’s Veterinary Medicine Advisory Board, Dr. Alice Villalobos.
CEO and President Dr. Mike Korenko stated: “IsoPet Solutions allows specific resources to focus on the use of our RadioGel™ Yttrium-90 brachytherapy products in the veterinary space. We believe that RadioGel™ is positioned to build a significant presence in the cancer treatment tool-kit of veterinary oncologists.”
Dr. Alice stated: "I am quite excited at the opportunity to work with RadioGel's™ team to integrate their products into the cancer treatments of companion animals. Cancer affects 50% of dogs over age ten and one in four dogs under age ten. For many years, we have been searching for a useable and effective agent such as RadioGel™ Y-90 brachytherapy devices that can be delivered into tumors on an outpatient basis. I believe that veterinary oncologists around the globe will finally have an ideal product line for the treatment of accessible and inoperable tumors."
What are the steps for FDA clearance?
Vivos met at the FDA offices to discuss next steps, expectations and required testing to progress towards obtaining marketing clearance for the Y-90 RadioGel™ device. The FDA and Vivos management and consulting team are working closely in order to obtain all appropriate data and benchmarks the FDA requires in order to proceed with providing final clearance for marketing the device in the United States.
August 2016, Vivos announced a partnership with IsoTherapeutics Group, a third-party radiopharmaceutical R&D company, to provide commercialization support and conduct additional studies as requested by the FDA for the Y-90 RadioGel™ device. IsoTherapeutics has completed the first stage of the project, comprised of tech transfer, manufacturing and in vitro testing. The next stage, comprised of additional in vitro and in vivo testing. Upon completion of these studies, Vivos anticipates submittal (direct De Novo) for FDA clearance for full commercialization in the U.S. (see company press releases for continual updates on this evolving process).
Press Releases 2018 ( Change in Company name and trading symbol • Jan 2, 2018)
Jan 2, 2018, Advanced Medical Isotope Corporation (ADMD) Announces Corporate Name Change to Vivos Inc., and Ticker Symbol Change to RDGL
Press Releases 2017 ( Change in Management & Directors Dec 2016)
Dec 20, 2016, AMIC's Board of Directors Appoints Dr. Michael Korneko CEO and Dr. Carlton Cadwell Chairman of AMIC
Jan 11, 2017, AMIC's New CEO Issues Letter to Shareholders
Feb 14, 2017, AMIC's CEO Releases Shareholder Letter Outlining New Streamlined Path to FDA Submission
Feb 28, 2017, AMIC's New CEO Releases Shareholder Letter Announcing and Discussing their Cancer Indication Selection to pursue FDA Approval
Mar 7, 2017, AMIC's New CEO Releases Shareholder Letter Detailing Launch of Veterinary Oncology Division with Radiogel
Mar 23, 2017, Update on Feline Cancer Treatment and Improvement to Financial Structure
Jul 6, 2017, AMI Requests Pre-Submission Meeting with FDA
Jul 11, 2017, ADMD Makes Significant Improvement to its RadioGel™ Brachytherapy Product
Jul 27, 2017, ADMD to Host Shareholder Update Webcast with Live Q&A
Aug 2, 2017, Advanced Medical Isotope Corp. Announces Results of Shareholder Meeting, Welcomes Two New Members of the Board of Directors
Sep 14, 2017, Advanced Medical Isotope Corporation has its first discussions with private animal consortiums to utilize RadioGel™
Independent Analyst Research and Price Target
Presentation(s) from CEO & President, Dr. Mike Korenko.
2017 - LINK HERE
STOCK SYMBOL: OTC: RDGL
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