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24/7
Introducing our CEO Mike Korenko to our loyal followers. Dr. Korenko has a Doctor of Science from MIT, was a NATO Postdoctoral Fellow at Oxford University, and was selected as a White House Fellow for the Department of Defence. #VivosIncUSA $RDGL pic.twitter.com/6JyaKcJyWv
— RadioGel™ (@RadioGel) March 6, 2024
Some bed time reading - if you can read
https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program
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Some bed time reading - if you can read
Go do your homework..
https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program
Our ISOPET hero, getting it done with the FDA and Mayo.
Introducing our CEO Mike Korenko to our loyal followers. Dr. Korenko has a Doctor of Science from MIT, was a NATO Postdoctoral Fellow at Oxford University, and was selected as a White House Fellow for the Department of Defence. #VivosIncUSA $RDGL pic.twitter.com/6JyaKcJyWv
— RadioGel™ (@RadioGel) March 6, 2024
The FDA granted a breakthrough device designation for a reason.
They wouldn't do it on a whim, VIVOS have presented enough data to show that Radiogel is safe and effective.
“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.
This is why Radiogel is one of only 20 odd Radiology devices EVER to be granted a BDD.
That is quite the obsession.
A virtual stalker - hopefully that is the limit of the obsession.
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Introducing our CEO Mike Korenko to our loyal followers. Dr. Korenko has a Doctor of Science from MIT, was a NATO Postdoctoral Fellow at Oxford University, and was selected as a White House Fellow for the Department of Defence. #VivosIncUSA $RDGL pic.twitter.com/6JyaKcJyWv
— RadioGel™ (@RadioGel) March 6, 2024
It's why Doctor Mike Korenko is the shrewdest CEO in the business.
We have a lot to be thankful for.
The companies prospects were going nowhere under the prior team.
Imagine being so dumb you didn't think ISOPET was important.
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.
Great post on twitter about the Doc today. He is the MAN
5's..some were calling for 4's. All the time why holding shares, AKA BAGGY #1,#2 and #3
I'm actually disappointed, as the posters are becoming more unhinged and lack any sort of narrative.
I wonder when they will lash out again and show their true colours.
The pic of the Doc must have triggered some today.
Dr. Toskich job is treating people with the best therapy that is currently available and doing research with new therapies... he’s the best in Y-90 dosimetry so he just using what’s available to treat humans.. it is not his job to promote company’s, his doing science!
Here look for yourself
https://www.mayoclinic.org/biographies/toskich-beau-m-d/publications/pbc-20309025
They want to me my BF too..most DM's I've had since I was 18
Something the old management team couldn't get delivered.
Thank you Doctor Mike Korenko
They are clutching at straws and there are no straws left.
The FDA, MAYO and VETS love ISOPET.
The old management team didn't, probably why MK kicked them out.
Isopet is leading the way for Radiogel.
If VIVOS had parked Isopet then Radiogel would be months behind where it is.
There is also a new market in Caudal Heal Pain for Isopet. The morons who said stop ISOPET would have stopped this new market.
It is what it is..
You keep saying the share price is going down but aren't selling
AKA - Baggy #1
“Trading for Dummies”
Section 1a - How to be a baggy
---
the fact you're getting defensive proves my point
You're right..Baggy #3 has run out of ideas to stay relevant.
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: MKorenko@RadioGel.com
Follow Vivos Inc @VivosIncUSA., Radiogel™ @RadioGel and Isopet® on X (fka Twitter):
*When all they've got is you've lied, you know you've won*
Vivos Inc Files a New Patent on Alternate Particles for Precision Radionuclide Therapy
January 11, 2023 09:30 ET
| Source: Vivos Inc.
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Richland WA, Jan. 11, 2023 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL), Vivos Inc announced today that the company filed a utility patent application on a range of particles for precision radionuclide therapy as a follow-up to its provisional patent filed on 1/15/2022. This patent was filed in the USA and internationally via the Patent Cooperation Treaty, PCT. This includes Canada, the European Union, Japan, Australia, Brazil, China, India, South Korea, and the Russian Eurasian (Russia, Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Tajikistan, and Turkmenistan).
Dr. Mike Korenko stated, “We are convinced precision radionuclide therapy will become increasingly important for future cancer therapy in animals and humans. We will remain focused on IsoPet/RadioGel Yttrium-90 beta therapy, which we believe is the best beta emitter; however, we leveraged our hydrogel utility patent to incorporate other promising isotopes and compounds for a range of future applications. This includes gamma and alpha particle emitters. This will place us in a strong future intellectual property position.”
About Vivos Inc. (OTCQB: RDGL)
Vivos Inc. has developed a 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.
In 2018 the Company 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
MKorenko@VivosInc.co
Vivos Inc Files a New Patent on Precision Radionuclide Therapy Support System Equipment
January 03, 2023 09:30 ET
| Source: Vivos Inc.
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Richland WA, Jan. 03, 2023 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL), Vivos Inc announced today that they filed a provisional patent application on the system equipment to support precision radionuclide therapy.
This includes the shipping containers, the shielded vial holder, the Peltier chiller, and the syringe shields. These device designs are integrated into our production standardization effort. They can be used for treating a range of tumor sizes from 0.5-gram human lymph nodes to half-pound equine tumors. This equipment was just tested at our recent equine therapy in NY.
SHIPPING CONTAINER
Eliminated the can and the lead pig containers and designed the shielding of the new plastic container to improve the ease of unpackaging and to ensure that we can ship to White 1 label (UN2910) standards to reduce the Fed Ex shipping costs and logistics.
SHIELED VIAL HOLDER
Incorporated stability in securing the vials while filing the syringes and maximized the vial holder wall thickness to further reduce the relatively low radiation.
PELTIER CHILLER
Designed to chill the vial holders and the syringes with a plug-in system.
Avoids the potential contamination from ice baths, which was a Mayo Clinic concern for human clinical trials.
Contains an imbedded magnetic stirrer to keep the IsoPet solution particles in suspension.
Each syringe port can be dedicated to a specific human lymph node, a specific VX-2 tumor in the animal testing, or as a staging center for treating larger animal tumors.
SYRINGE SHIELD
Maximized the diameter of the syringe shield to reduce radiation while designing the finger position to maintain the optimum ergonomics.
Received very positive feedback from the therapists about the ergonomics. This flexibility is important to ensure the accuracy in precision injections.
Dr. Mike Korenko stated “This development occurred over the entire year while incorporating practical experience and feedback from our therapists. We will make this equipment available to the Mayo Clinic for human clinical trials and to the therapists in all our current and future regional clinics.”
About Vivos Inc. (OTCQB: RDGL)
Vivos Inc. has developed an Yttrium-90 based injectable Precision Radionuclide Therapy brachytherapy device, for the treatment of tumors in animals (IsoPet®) and in humans (RadioGel™). Brachytherapy uses highly localized radiation to destroy cancerous tumors by placing a radioactive isotope directly inside the treatment area using the company’s proprietary hydrogel technology. 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 safe delivery of higher doses needed for treating both 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 an 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 out-patient procedure and the patient may return home without subsequent concern for radiation dose to family members.
The Isopet® Solutions division is used university veterinary hospitals to demonstrate the safety and therapeutic effectiveness for different animal cancers. Testing on feline sarcoma at the Washington State University was completed in 2018 and testing on canine soft tissue sarcomas at the University of Missouri was completed in 2019.
In 2018 the Company 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 in order 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
MKorenko@RadioGel.com
Radiogel™ Precision Radionuclide Therapy™ Receives FDA Breakthrough Device Designation
December 20, 2023 10:08 ET
| Source: Vivos Inc.
Share
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: MKorenko@RadioGel.com
Follow Vivos Inc @VivosIncUSA., Radiogel™ @RadioGel and Isopet® on X (fka Twitter):
So you hold no shares?
Really got her baggy knickers in a twist.
A one page executive summary and she's not happy with the order of the bullet points.
Fantastic monthly update
Market loved it too - up 20%
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Imagine thinking something is bottom of the list because it's written at the bottom of a literal list.
Are we in high school?
Lol - funny to see the baggies fall apart in front of our eyes.
24/7
Enjoy your weekend baggy number 2
Imagine thinking something is bottom of the list because it's written at the bottom of a literal list.
Are we in high school?
Lol - funny to see the baggies fall apart in front of our eyes.
Great Feb update
When the two baggies run out of things to say you know their games up.
World's best trader / baggy hold shares when they think the share price is going down.
Things that never happen
Who's betting a march IDE submission.
I am
Any baggies want to take the bet?
Goes up when you sell baggy