When the time comes, you'll be judged for your actions.
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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.
And you won't sell.
Comedy
Same person along with a few others
Look how triggered they get..let's try again. It's like we have them on a bit of string.
MK was brilliant for cleaning house before embarking upon the IDE process. .
Those directly affected by the house cleaning may disagree by the nonstop FUD we see on a daily basis .
Of course not one person will say MK lied in a 10-K. Chickens
JH report will show that Radiogel is safe. The liars will never say anything about the 10K...they are just too scared. Shame they are so gutless.
"Johns Hopkins University Veterinary Clinical Trials Network (“Johns Hopkins”), is now an Isopet® regional clinic. Additionally, Johns Hopkins will also perform new Isopet® animal studies on various specific cancers. They have the required radioactive material license and have completed their training certification for Isopet®. This important relationship will also help meet our objective of obtaining high quality data on a range of cancers that can be published in leading journals. These publications are the optimal way to increase awareness of Isopet®, and to gain broader acceptance from the veterinarian/oncology community. Johns Hopkins just completed the VX2 Tumor therapy animal study in rabbits and is writing a report on the study. The study further demonstrated the safety of RadioGelTM, generating the activity decay curves that show that the hydrogel remains at the injection site. This study also: (1) demonstrated the validity of the Instructions for Use; (2) the validity of the Injection Guidance Table; and (3) provided a basis for refining the techniques for treating small human cancerous lymph nodes."
"I could post total garbage on here all day every day" why change a habit of a lifetime.
"Not selling at a loss" is the definition of a baggy.
Do yourself a favor and get another hobby otherwise you're going to end up broke.
The FDA and VIvos , throw in a sprinkle of Mayo. What a combo
The FDA love Radiogel, which is why they recently granted the BDD.
Ignore the lies that the Doc hasn't delivered anything, the FDA don't dish out BDD's out of the goodness of their hearts.
JH report will show that Radiogel is safe. The liars will never say anything about the 10K...they are just too scared. Shame they are so gutless.
"Johns Hopkins University Veterinary Clinical Trials Network (“Johns Hopkins”), is now an Isopet® regional clinic. Additionally, Johns Hopkins will also perform new Isopet® animal studies on various specific cancers. They have the required radioactive material license and have completed their training certification for Isopet®. This important relationship will also help meet our objective of obtaining high quality data on a range of cancers that can be published in leading journals. These publications are the optimal way to increase awareness of Isopet®, and to gain broader acceptance from the veterinarian/oncology community. Johns Hopkins just completed the VX2 Tumor therapy animal study in rabbits and is writing a report on the study. The study further demonstrated the safety of RadioGelTM, generating the activity decay curves that show that the hydrogel remains at the injection site. This study also: (1) demonstrated the validity of the Instructions for Use; (2) the validity of the Injection Guidance Table; and (3) provided a basis for refining the techniques for treating small human cancerous lymph nodes."
If you truly believe this then unless you are complete moron you wouldn't hold any shares. Grab a calculator and see how many more shares you would get selling at 7 and buying back at 5.
Comedy gold, you must try harder.
They're getting sloppy. Some great AI tools can do wonders with forum posts to see who's who and posting with multiple accounts.
I know IHUB monitor IP's but I'd like to see them clean this up themselves.
You'll go on record 'again' with your first ever post. you login with the wrong account this time?
Comedy gold.
World's best trader holds shares whilst predicting the price will go down.
Can't make this stuff up..pure comedy at this stage.
Battelle's patents predominantly revolve around stimuli-sensitive gels and thermogelling polymers, which exhibit unique properties such as responsiveness to external stimuli and controlled release mechanisms. These patents, represented by patent numbers 6,296,831; 6,869,588; 7,033,571; 6,841,617; 2,327,325; 2,423,488; 6,660,247; and 7,033,571, span a range of applications in medical devices, drug delivery systems, and tissue engineering.
In contrast, Vivos Inc.'s patents showcase a more targeted approach, particularly in the field of medical treatments. Highlighted by patent numbers No.1811.191, US 16309:17/943,311, PCT/US22/4374, Serial Number 63436562, and Serial number 18/152,137, Vivos Inc.'s patents focus on specific innovations tailored to medical treatments. These include proprietary yttrium-90 phosphate particles for targeted therapeutic applications, optimized hydrogel components for medical applications, and innovative improvements in medical devices such as shipping containers and syringe shields.
Vivos Inc.'s have proprietary yttrium-90 phosphate particles, which are crucial for the effectiveness of Radiogel™. Without access to these particles and the corresponding production methods covered by Vivos Inc.'s patents, another company would be unable to replicate Radiogel™ directly from the Battelle patents alone.
Prove me wrong - Battelle licences expired 2 years ago and no one can figure out how to make it.
The FDA granted the BDD for a reason.
Battelle's patents predominantly revolve around stimuli-sensitive gels and thermogelling polymers, which exhibit unique properties such as responsiveness to external stimuli and controlled release mechanisms. These patents, represented by patent numbers 6,296,831; 6,869,588; 7,033,571; 6,841,617; 2,327,325; 2,423,488; 6,660,247; and 7,033,571, span a range of applications in medical devices, drug delivery systems, and tissue engineering.
In contrast, Vivos Inc.'s patents showcase a more targeted approach, particularly in the field of medical treatments. Highlighted by patent numbers No.1811.191, US 16309:17/943,311, PCT/US22/4374, Serial Number 63436562, and Serial number 18/152,137, Vivos Inc.'s patents focus on specific innovations tailored to medical treatments. These include proprietary yttrium-90 phosphate particles for targeted therapeutic applications, optimized hydrogel components for medical applications, and innovative improvements in medical devices such as shipping containers and syringe shields.
Vivos Inc.'s have proprietary yttrium-90 phosphate particles, which are crucial for the effectiveness of Radiogel™. Without access to these particles and the corresponding production methods covered by Vivos Inc.'s patents, another company would be unable to replicate Radiogel™ directly from the Battelle patents alone.
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.
Remember the little pollo's won't say Vivos lied in a 10-K ..they are too scared of the repercussions. Of course they will dance around the subject and say he's a liar, but they will never lay their balls on the line and say it directly about a 10-K.
Can't believe a word the haters write.
Remember the calls for bankruptcy - being happening for years and never transpired.
You can't believe a word the haters spout as none of them ever come true.
Prove me wrong - Battelle licences expired 2 years ago and no one can figure out how to make it.
The FDA granted the BDD for a reason.
Battelle's patents predominantly revolve around stimuli-sensitive gels and thermogelling polymers, which exhibit unique properties such as responsiveness to external stimuli and controlled release mechanisms. These patents, represented by patent numbers 6,296,831; 6,869,588; 7,033,571; 6,841,617; 2,327,325; 2,423,488; 6,660,247; and 7,033,571, span a range of applications in medical devices, drug delivery systems, and tissue engineering.
In contrast, Vivos Inc.'s patents showcase a more targeted approach, particularly in the field of medical treatments. Highlighted by patent numbers No.1811.191, US 16309:17/943,311, PCT/US22/4374, Serial Number 63436562, and Serial number 18/152,137, Vivos Inc.'s patents focus on specific innovations tailored to medical treatments. These include proprietary yttrium-90 phosphate particles for targeted therapeutic applications, optimized hydrogel components for medical applications, and innovative improvements in medical devices such as shipping containers and syringe shields.
Vivos Inc.'s have proprietary yttrium-90 phosphate particles, which are crucial for the effectiveness of Radiogel™. Without access to these particles and the corresponding production methods covered by Vivos Inc.'s patents, another company would be unable to replicate Radiogel™ directly from the Battelle patents alone.
Intellectual Property
Our original license with Battelle National Laboratory (the “Battelle License”) reached its end of life in 2022. During the past several years, we have expanded our proprietary knowledge, as well as our trademark and patent protection, in anticipation of the Battelle License reaching the end of its term.
Our RadioGel trademark protection is in 17 countries. We have expanded our trademark protection from RadioGel to now include IsoPet. We obtained the International Certificate of Registration for ISOPET, which is the first step to file in several countries.
We filed for trademark protection for the term Precision Radionuclide TherapyTM. We believe this term will be increasingly important.
4
The Company received the Patent Cooperation Treaty (“PCT”) International Search Report on our patent application (No.1811.191). Seven of our claims were immediately ruled as having novelty, inventive step and industrial applicability. This gives us the basis to extend for many years the patent protection for our proprietary Yttrium-90 phosphate particles utilized in Isopet® and Radiogel™.
Our patent team filed our particle patent in more than ten patent offices that collectively cover 63 countries throughout the world. We filed a continuation-in-part applications number 1774054 in the United States of America (“USA”, or “U.S.”) to expand the claims on our particle patent. The U.S. Patent office recently gave us the Notice of Allowance for our patent to produce our yttrium phosphate microparticles, U.S. Patent Application Serial No: 16-459,466. We also filed an amendment to correct the wording on our claims at make them consistent with the USE claims. Ref: 4207-0005; European Patent Application NO. 20 834 229.5; VIVOS INC; Our Ref: FS/53791.
We filed a hydrogel utility patent in the USA (16309:17/943,311) and internationally (16389:PCT/US22/4374) based on the last 18 months of development work to optimize our hydrogel component. These include reducing the polymer production time and increasing the output by a factor of three. We have also further reduced the level of trace contaminants to be well below the FDA guidelines.
We filed a provisional patent (Serial Number 63436562) to protect our innovative improvements in our shipping container, our vial shield, our syringe shield, and our Peltier chiller. Our objectives were to reduce shipping costs, decrease radiation exposure, and enhance sterility. These devices will be preferentially used at Mayo Clinics for human clinical studies at and our IsoPet regional treatment centers. We filed a utility patent in our fourth quarter of 2023 for this therapy support equipment.
We anticipate that Precision Radionuclide Therapy will become increasingly important in the future and expand to other isotope and other indications for use. Therefore, we filed an alternate particle utility patent (Serial number 18/152,137). The Company will focus its near-term effort on the Yttrium-90 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.
Intellectual Property
Our original license with Battelle National Laboratory (the “Battelle License”) reached its end of life in 2022. During the past several years, we have expanded our proprietary knowledge, as well as our trademark and patent protection, in anticipation of the Battelle License reaching the end of its term.
Our RadioGel trademark protection is in 17 countries. We have expanded our trademark protection from RadioGel to now include IsoPet. We obtained the International Certificate of Registration for ISOPET, which is the first step to file in several countries.
We filed for trademark protection for the term Precision Radionuclide TherapyTM. We believe this term will be increasingly important.
4
The Company received the Patent Cooperation Treaty (“PCT”) International Search Report on our patent application (No.1811.191). Seven of our claims were immediately ruled as having novelty, inventive step and industrial applicability. This gives us the basis to extend for many years the patent protection for our proprietary Yttrium-90 phosphate particles utilized in Isopet® and Radiogel™.
Our patent team filed our particle patent in more than ten patent offices that collectively cover 63 countries throughout the world. We filed a continuation-in-part applications number 1774054 in the United States of America (“USA”, or “U.S.”) to expand the claims on our particle patent. The U.S. Patent office recently gave us the Notice of Allowance for our patent to produce our yttrium phosphate microparticles, U.S. Patent Application Serial No: 16-459,466. We also filed an amendment to correct the wording on our claims at make them consistent with the USE claims. Ref: 4207-0005; European Patent Application NO. 20 834 229.5; VIVOS INC; Our Ref: FS/53791.
We filed a hydrogel utility patent in the USA (16309:17/943,311) and internationally (16389:PCT/US22/4374) based on the last 18 months of development work to optimize our hydrogel component. These include reducing the polymer production time and increasing the output by a factor of three. We have also further reduced the level of trace contaminants to be well below the FDA guidelines.
We filed a provisional patent (Serial Number 63436562) to protect our innovative improvements in our shipping container, our vial shield, our syringe shield, and our Peltier chiller. Our objectives were to reduce shipping costs, decrease radiation exposure, and enhance sterility. These devices will be preferentially used at Mayo Clinics for human clinical studies at and our IsoPet regional treatment centers. We filed a utility patent in our fourth quarter of 2023 for this therapy support equipment.
We anticipate that Precision Radionuclide Therapy will become increasingly important in the future and expand to other isotope and other indications for use. Therefore, we filed an alternate particle utility patent (Serial number 18/152,137). The Company will focus its near-term effort on the Yttrium-90 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.
When they are too scared to say Vivos lied in a 10-K, you know they don't believe in what they are writing.
Still the doc jumps around in their head.
Onlyfans is the answer
OK thanks for the heads up Gordon Gekko
Haha -who would have thought people would get such a boner bashing a 78 year old working with the FDA/mayo to bring a novel cancer treatment to market, maybe the doc will get a only fans account so they can carry on their fantasies once the IDE has been submitted.
See..they won't say he lied in a 10K..Pollo's
Why are they so scared to say Vivos lied in the 10k??
After providing addition information to the FDA on December 18, 2023, the FDA classified us as a Breakthrough device to our proposed Indication for Use
They will try and twist words but will never say a lie has been written in the 10-K.
24/7
Remember when they tried to say the BDD was a false claim? Why are they so scared to say Vivos lied in the 10k about it?
After providing addition information to the FDA on December 18, 2023, the FDA classified us as a Breakthrough device to our proposed Indication for Use
They will try and twist words but will never say a lie has been written in the 10-K.
24/7
Remember when they tried to say the BDD was a false claim? Why are they so scared to say Vivos lied in the 10k about it?
After providing addition information to the FDA on December 18, 2023, the FDA classified us as a Breakthrough device to our proposed Indication for Use
They will try and twist words but will never say a lie has been written in the 10-K.
Says a lot about the little chickens.
MK is not a serial liar. MK is brilliant for cleaning house years ago before embarking upon the IDE process.
IDE is coming soon and some will be looking for new employment and new stocks to bash.
Remember when they tried to say the BDD was a false claim? Why are they so scared to say Vivos lied in the 10k about it?
After providing addition information to the FDA on December 18, 2023, the FDA classified us as a Breakthrough device to our proposed Indication for Use
They will try and twist words but will never say a lie has been written in the 10-K.
Says a lot about the little chickens.
The doc is best buds with the FDA, unless someone is brave enough to say Vivos are lying in their 10k? The thing is, they can't. Accusing a Ceo of falsifying a 10k especially when it comes to interactions with the FDA could land you in a bit of trouble.
10k
In May of 2022 the Company held another pre-submission meeting with the FDA. They concurred with our dosimetry techniques and requested one more animal test to confirm that the Y-90 stays at the injection site. We will be proposing a pre-submission meeting to discuss this new animal test of VX-2 tumors in rabbits at Johns Hopkins. We have a meeting scheduled with the FDA in October to obtain their feedback on our new animal test plan. In the meantime, the Company is working to complete all the other required pre-clinical testing, such as biocompatibility since they are required for the submittal of the IDE.
We held another pre-submission meeting with the FDA on October 17, 2022 to obtain detailed feedback on the proposed VX-2/Rabbit Animal Test Plan and to submit the Risk Management Report (“RMR”). The RMR analyzed all hypothetical scenarios and concluded that RadioGel is inherently safe.
We participated in pre-submission meetings with the FDA on April 10, 2023, and September 29, 2023, to discuss the preliminary results of the VX2 tumor animal study and to obtain feedback on the genotoxicity protocol.
After providing addition information to the FDA on December 18, 2023, the FDA classified us as a Breakthrough device to our proposed Indication for Use