Vivos Inc (QB) News - RDGL

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Current Report Filing (8-k)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C...

Statement of Changes in Beneficial Ownership (4)

FORM 4 [ ] Check this box if no longer subject to Section 16. Form 4 or Form 5 obligations may continue. See Instruction...

Statement of Changes in Beneficial Ownership (4)

FORM 4 [ ] Check this box if no longer subject to Section 16. Form 4 or Form 5 obligations may continue. See Instruction...

Quarterly Report (10-q)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C...

Amended Quarterly Report (10-q/a)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C...

Quarterly Report (10-q)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C...

Quarterly Report (10-q)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C...

Statement of Changes in Beneficial Ownership (4)

FORM 4 [ ] Check this box if no longer subject to Section 16. Form 4 or Form 5 obligations may continue. See Instruction...

Notice of Qualification [regulation A] (qualif)

Post-qualification Amendment to a 1-a Offering Statement (1-a Pos)

Form 1-A Issuer Information FORM 1-A UNITED STATE SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549FORM 1-A REGULATION A OFFERING...

Post-qualification Amendment to a 1-a Offering Statement (1-a Pos)

Form 1-A Issuer Information FORM 1-A UNITED STATE SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549FORM 1-A REGULATION A OFFERING...

Amended Annual Report (10-k/a)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C...

Amended Current Report Filing (8-k/a)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC...

Amended Current Report Filing (8-k/a)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC...

Statement of Changes in Beneficial Ownership (4)

FORM 4 [ ] Check this box if no longer subject to Section 16. Form 4 or Form 5 obligations may continue. See Instruction...

G_rokk 1 hour ago

Why has the stock sold off . We are down 50% . MK bought stock during sprint meetings as to say " we got this " Ive been holding and adding for 7 yrs and believe in Vivos but have questions

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rickstereo3333 3 hours ago

Your attempts to cause a stir and an ensuing selling "stampede" are feebly un-CON-vincing.

Now please explain to us all why you clearly, and IMO intentionally, misrepresented what the company stated???

Are you deficient when coming to reading and comprehending???

Please cite the exact text from Vivos that led to the ARSEumptions you made below.

TIA................

Quote:"Per quarterly report now no human trials in USA in the near future. Human trials will be done overseas in order to provide more data for IDE. Looks like I was right, they need another study to provide more data for IDE."

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rickstereo3333 3 hours ago

The soft bashing Muppet obviously cant read and comprehend.

Quote: "These trials will be initiated prior to trials in the United States, and will be conducted under a protocol consistent with and complimentary to the IDE and human trial roadmap in the United States.”

All the company is simply stating is that they will conduct the foreign trials using a methodology (ROADMAP) that is consistent with FDA standards for IDE/Human Trials in the USA, nothing more, nothing less.

The word "complimentary" is used in the context to indicate that the foreign trials will be conducted in a manner where the data generated would be scientifically acceptable to the FDA and could be used as supporting data to the US trials.

This is certainly not the first, nor will it be the last, time he's misrepresented what the company stated.

I actually got taken in with the lie because I didn't read the quote myself.........shame on me!

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WhAtEvA1 3 hours ago

Nothing is beneath some people; by all means necessary I guess.

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doccjc 3 hours ago

Just leave. You made money. Congrats .
Why stay and soft bash ?

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WhAtEvA1 3 hours ago

Likewise to you! As you wish onto others....

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mc73 3 hours ago

Based on your reply, you are a dem voting beta. I made $3,000 and at this rate only the longs who average below 5 cents will make any money. Good luck to you, may it all be bad

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mc73 4 hours ago

I never said they cancelled anything regarding the IDE.

Glad you posted the quote from the Q report. This part: "and will be conducted under a protocol consistent with and complimentary to the IDE and human trial roadmap in the United States.” tells me that they need information from the overseas trials to feed the IDE. The timeline has shifted in a big way based on this. My interpretation anyway. If the Dr would be specific with an IDE update it would clear things up. I'll be watching and will jump back in here to admit I am wrong if things don't go as I expect.

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Roofus 4 hours ago

It doesn’t say in the Quarterly report that they cancelled getting ready to submit the IDE.

“The Company intends to conduct human trials internationally, initially in Southeast Asia. These trials will be initiated prior to trials in the United States, and will be conducted under a protocol consistent with and complimentary to the IDE and human trial roadmap in the United States.”

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WhAtEvA1 4 hours ago

LOL, here you are after selling the .4/5 shares you purchased 2yrs ago with the $3000 Alaska govt payout? Remember that? Yeah, I can see why you really need this back at same level again.

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doccjc 5 hours ago

One must be working for the glue factory and the other is making some crazy assumptions in the hopes of accumulating cheap shares. Where's the third tenor?

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mc73 5 hours ago

Read the quarterly report, it is mentioned there. That is why there haven't been any further IDE updates. Whether the FDA or RDGL is to blame the outcome is the same...share price will drop back to the 5 cent level. Possibly lower this time as more and more investors see this company as unable to get IDE submitted/approved. The human testing overseas, if approved, will provide additional data for the IDE. Looks like 2027 to submit IDE at the earliest.

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Roofus 6 hours ago

What makes you and others think that IDE submission isn’t coming soon?

They only have 3 more sprint meetings with the FDA, as they’ve already done 5 of them.

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chereb19 6 hours ago

Imagine you have tiny glass marbles inside your body. These marbles don’t break down or disappear—they just stay where they are, even if you live for a really, really long time like 1000 years. The glass is super strong, so unless a doctor decides to take it out, it stays in the same spot forever. It doesn’t turn into anything else or go away, just like if you left a glass cup on the table and it didn’t break!

👋😂

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chereb19 6 hours ago

Betaglue sticky glue can only hold microspheres in place, by design it can't hold dispersed y-90.

Don't embarrass yourself anymore , go hop over to their patents

😂👋

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chereb19 6 hours ago

The radiation emitted by the
glass microspheres diminishes significantly over approximately 2 weeks post treatment; however, the glass
microspheres remain permanently implanted in the liver tissue.

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SC8 6 hours ago

Well back to the apples and oranges comparisons between radioembolization products and Radiogel or YntraDose. That nonsense aside, given the BS product you site is generally for end of life extension for terminal patients, it's accurate for them to say the glass remains in liver. Glass doesn't not remain in vivo long term.

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chereb19 6 hours ago

Glad we agreed it's just a glue to hold microspheres and can't possibly hold y-90 directly. Sometimes it takes a while but you get there.

https://www.bostonscientific.com/en-US/products/cancer-therapies/therasphere-y90-glass-microspheres/therasphere-y90-microspheres-brief-summary.html

POTENTIAL ADVERSE EVENTS
The use of this product leads to irradiation of both tumorous and normal liver tissue. As a result, patients with compromised liver function may be at greater risk of liver function impairment and hence could experience complications.

Clinical side effects usually occur within the first 4 to 6 weeks after treatment. Based on clinical trial data, literature reviews and post market surveillance, adverse events potentially associated with treatment using Y-90 microspheres, including TheraSphere, may include the following:

Complications related to the administration procedure itself may include:

Allergic reaction
Altered liver function, acute or chronic
Anorexia
Anxiety
Ascites
Bile Duct injury
Bleeding/hemorrhage
Chills / rigors
Cholecystitis (inflammatory or infectious)
Colitis
Death
Dehydration
Diarrhea
Dizziness
Dyspnea
Edema (any location)
Electrolyte abnormalities
Elevated BUN/creatinine
Fall
Fatigue
Fever
Gastrointestinal bleeding / hemorrhage
Gastrointestinal ulcer or ulceration
Hepatic encephalopathy
Hepatorenal failure
Hiccups
Hypertension
Hypotension
Infection (any location)
Liver failure, acute or chronic
Lymphopenia
Malaise
Mood alteration
Muscle weakness
Nausea
Neutropenia
Pain (any location)
Pancreatitis
Platelet count abnormalities
Pleural effusion
Portal hypertension
Pre-existing chronic liver disease decompensation
Pulmonary edema
Pulmonary fibrosis
Radiation hepatitis
Radiation induced disease, acute
Radio Embolization Induced Liver Disease (REILD)
Sepsis
Supraventricular arrhythmia
Thrombosis (arterial or venous)
Tumor inflammation (including tumor edema)
Tumor-lysis syndrome
Vomiting
Weight loss

😂👋

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SC8 6 hours ago

Never said otherwise. With YntraDose, the Y90 is encapsulated in the glass microspheres. The microspheres are suspended in the injectable gel. The injectable gel solidifies at body temperature.

Again, due to Betaglue's competent management, YntraDose is already in human trials. Radiogel isn't, all due to MK's gross incompentence going back almost a decade now.

Facts are facts

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chereb19 6 hours ago

Boston scientific got it wrong?

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chereb19 7 hours ago

Yntradose is a glue and it doesn't encapsulate microspheres. It does the opposite..it's hold the microspheres in place and then they are stuck there for eternity.

Betaglue can't possibly hold y-90 directly as its designed to hold things and not encapsulate them.

Microspheres are permanent.

😂👋

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SC8 7 hours ago

Sorry, they're glass. Glass devices don''t stay in body forever.

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SC8 7 hours ago

Again, Betaglue is the company. Their product is YntraDose. If YntraDose with Y90 encapsulated microspheres is just as effective at killing solid tumors vs. dispersed Y90, no doc or patient is going to give a rat's rear regarding the difference. All we know at moment is YntraDose is in clinical trials and Radiogel isn't. We also know there is nothing stopping Betaglue from using dispersed Y90 should there be any advantages to doing so. So far there is no evidence whatsoever of any such advantage to dispersed Y90; that would take clinical trials with dispersed Y90, and to date there have been none.

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chereb19 7 hours ago

The microspheres are not biodegradable, meaning they stay in the tissue even after the radioactive Yttrium-90 decays.

microspheres remain embedded within the tissue indefinitely

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chereb19 7 hours ago

Betaglue is a glue that can't use y-90 unless it's trapped in a microsphere.

I'll dumb it down for you so you understand

Think of BetaGlue like super sticky glue and microspheres like tiny glowing marbles. Right now, BetaGlue's job is to hold the glowing marbles in place so they don’t move around. The glowing comes from the marbles (microspheres), not the glue itself. The glue just keeps everything stuck where the doctor puts it.

If BetaGlue were to work without marbles, it would need to hold the glowing stuff (Y-90) directly and spread it out evenly in the glue. But the glue isn't built to do that—it’s only designed to stick to the marbles and hold them tight. To make BetaGlue work like that, you’d have to redesign it completely to make the glow stay inside the glue evenly, like mixing glitter into slime so the whole slime sparkles. Right now, it’s just not made for that job.

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SC8 7 hours ago

Glass doesn't remain forever in living tissue. That's why glass isn't used in long term implantable medical devices.

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SC8 7 hours ago

May never know if Radiogel never makes it to market. Given the tech is public domain now, I have to believe the Betaglue folks believe the glass encapsulated Y90 microspheres offer advantages vs. dispersed Y90, since there is nothing stopping them from using dispersed Y90. In any case, there is no evidence of any advantages with Radiogel vs. YntraDose, as there is no clinic data with Radiogel.

As far as who invented what, that's a moot point now. Radiogel was invented at Battelle decades ago. All the patents have expired. The tech is public domain now.

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chereb19 7 hours ago

You mean betaglue who invented the glue to hold microspheres in place and then leaving them there for a lifetime.

😂👋

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SC8 7 hours ago

If MK isn't grossly incompetent, then why hasn't he managed to even get Radiogel to human trials in his nearly a decade running RDGL, while competitor Betaglue is already in human trials?

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chereb19 7 hours ago

Yntradose is a glue that holds microspheres in place..and then they stay on your body forever. Betaglue invented a glue, nothing more

Nothing like Radiogel which will be the gold standard.

😂👋

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doccjc 7 hours ago

Far from grossly incompetent. The CEO fired a number of people before embarking upon the IDE process. They're not happy but may have found employment with a glue company.

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SC8 7 hours ago

What patents? They all expired! Radiogel tech is public domain now. RDGL has a single "improved" process patent and has applied for some "improved" application patents, none of which can stop anyone from making Radiogel under a different trademark. Moreover there is no evidence whatsoever of any performance advantages with MK's "improvements".

Again, Betaglue is the company. YntraDose is thier product. Yntradose is in clinical trials killing solid tumors. A dead tumor is a dead tumor. To date, due to MK's gross incompetence, Radiogel hasn't help a single human cancer patient.

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chereb19 10 hours ago

Betaglue is a glue..it holds the microspheres in place so they can emit their radiation. It can't do anything that Radiogel does

You should read their patents

😂👋😂👋

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doccjc 10 hours ago

So glad Dr Korenko cleaned house before starting the IDE process .
Maybe they're working for the Elmer's glue company now ?

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SC8 10 hours ago

YntraDose is killing human tumors, something MK has completely failed at after almost a decade of running RDGL. And there's nothing stopping Betaglue from using dispersed Y90 like RDGL does. They must have a good reason for using the encapsulated Y90. Maybe much easier to get regulatory approval with that approach? Again, Betaglue has competent management and RDGL doesn't. Facts are facts.

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rickstereo3333 10 hours ago

The imbecilic drivel you just posted is what is commonly known as a "Strawman", ie attributing an argument that was never made in order to deflect from the facts presented.

In other words, no one ever made that claim but the fact remains that high levels of Fluoride (ppm levels) are proven to have deleterious effects on ones health.

That's not my opinion, its a claim by the National Institute of Health and many others who've actually done the research, as opposed to some random eejit posting on a stock msg board. hint hint!.

kayak_wench 11 hours ago

OMG, if you drink too much water you die! If you don't believe me sit down and chug several gallons of water in 10 minutes....er, call an ambulance first because you will go into shock and probably die even with medical attention. Excessive amounts of EVERYTHING is harmful if not life threatening. But not drinking any water will also kill you. None of the negative effects you listed result from the amounts of fluoride put into drinking water. Just like a gallon or two of water over the course of a day is good for you.

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chereb19 11 hours ago

Welcome back.

We were worried when you said you'd never post again

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rickstereo3333 11 hours ago

That's great.......now I can purchase even more shares with the equivalent amount of $$.

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mgland 11 hours ago

Saw a bumper sticker........
"FDA go to health"
I have high hopes for RFK in this position

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rickstereo3333 11 hours ago

Yet another example of ignorance on display.

Per the NIH.....are they UN-Scientific also!?!

No worries though, at least they'll have great teeth innit. lololsss

Consuming too much fluoride in water can have a number of side effects, including:

Dental fluorosis
This is the only systemic side effect of fluoride at optimal concentration, and it's usually mild. It can cause white spots, staining, or pitting on tooth enamel.

Skeletal fluorosis
This can lead to bone deformities, calcification of ligaments and tendons, and osteosclerosis.

Neurological problems
High levels of fluoride may be toxic to brain and nerve cells. Exposure to fluoride before birth may lead to poorer cognitive outcomes later in life.

Other health problems

Fluoride can also cause arthritis, osteoporosis, muscular damage, fatigue, joint-related problems, and high blood pressure.

Acne

Regular intake of fluoride may lead to fluoroderma, which can cause acne and painful sores.

The most sensitive period of exposure to fluoride is from birth to age 4, especially from age 1 to 3. After age 8, there's no increased risk of dental fluorosis.

The Environmental Protection Agency (EPA) sets the maximum allowable level of fluoride in water at 4 parts per million (ppm). Levels above 4 ppm could be hazardous.

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mc73 12 hours ago

Per quarterly report now no human trials in USA in the near future. Human trials will be done overseas in order to provide more data for IDE. Looks like I was right, they need another study to provide more data for IDE.

Sorry for all the long who will have to deal with 5 cent share price again...coming soon.

Glad I got out and was able to make a 10% profit. I will keep my eye on this and will jump back in if/when it appears IDE will be submitted and approved.

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dshade 13 hours ago

Not really. I am against the nonsense that has been pushed from more nefarious entities. I am open minded and do not agree with everything RFK espouses. However I, and most with Independent thoughts, witnessed the oppression of scientist and doctors by big media, govt and their mouthpieces, that were later proven to be correct.

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kayak_wench 13 hours ago

Are you against 5G and fluoride in the water?

What is funny about fluoride in the water is that is actually a 'natural' condition and its protective properties were discovered when they figured out residents of a Colorado town's teeth were unusually resistant to decay because their water was naturally high in fluoride..cause in case your don't like science fluoride is a naturally occurring mineral found in rocks and soil. Yet RFK Jr thinks its a man created crime to put it in everyone's water.

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rickstereo3333 13 hours ago

Yes they, including myself, absolutely are!

Reason being the shortcuts, and the blind eye the FDA has gifted the Pharma industry over the past few decades.

A typical vaccine requires at least 5-10 (can be as high as 30 yrs) years to be developed and properly evaluated............not 6 months.

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dshade 13 hours ago

Many are wary of any new vaccines these days.

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rickstereo3333 13 hours ago

That unbelievable statement could only have been made out of your pure ignorance to everything this chap has been saying for years.

He's actually against the ANTI-SCIENCE and unfettered corruption the Medical establishment has been practicing for decades.

He actually wants to return US Medicine to utilizing the "Gold Standard".........do you even know what that is???

Perfect example was the recent lies and deception they all engaged in with the recent so called "Pandemic" where literally everything that emanated from the mouth of those lying charlatans has proved to be 100% false.

Quote: You do realize RFK is anti-science.

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rickstereo3333 13 hours ago

The NEW FDA can then hire more qualified and uncorrupt personnel.

BRAVO!!!!!!!!!!!!!

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AtlasQ 13 hours ago

If you say so, it has to be it then.

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Current Report Filing (8-k)

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Real-time discussions and trading ideas: Trade with confidence with our powerful platform.

RDGL News

Current Report Filing (8-k)

Statement of Changes in Beneficial Ownership (4)

Statement of Changes in Beneficial Ownership (4)

Quarterly Report (10-q)

Amended Quarterly Report (10-q/a)

Quarterly Report (10-q)

Quarterly Report (10-q)

Statement of Changes in Beneficial Ownership (4)

Notice of Qualification [regulation A] (qualif)

Post-qualification Amendment to a 1-a Offering Statement (1-a Pos)

Post-qualification Amendment to a 1-a Offering Statement (1-a Pos)

Amended Annual Report (10-k/a)

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Statement of Changes in Beneficial Ownership (4)

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