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Great news - unless you're a baggy.
More evidence that those wanting ISOPET progress to be halted are complete morons.
Another horse has been helped with IsoPet® Precision Radionuclide Therapy™ for caudal heel pain. This is very exciting news for many horse owners and is now another use for IsoPet® therapy. #IsoPet #RadioGel #VivosIncUSA #CaudalHeelPain $RDGL pic.twitter.com/ida9JC6kOh
— IsoPet® (@IsoPetForCancer) February 29, 2024
More evidence that those wanting ISOPET progress to be halted are complete morons.
Another horse has been helped with IsoPet® Precision Radionuclide Therapy™ for caudal heel pain. This is very exciting news for many horse owners and is now another use for IsoPet® therapy. #IsoPet #RadioGel #VivosIncUSA #CaudalHeelPain $RDGL pic.twitter.com/ida9JC6kOh
— IsoPet® (@IsoPetForCancer) February 29, 2024
Baggy number 2 seems a little unhinged.
Only the two baggies think isopet is a bad idea.
Says a lot
It's been great update after great update the last few weeks.
Great times ahead.
It's been great update after great update the last few weeks.
Great times ahead.
More evidence that those wanting ISOPET progress to be halted are complete morons.
Another horse has been helped with IsoPet® Precision Radionuclide Therapy™ for caudal heel pain. This is very exciting news for many horse owners and is now another use for IsoPet® therapy. #IsoPet #RadioGel #VivosIncUSA #CaudalHeelPain $RDGL pic.twitter.com/ida9JC6kOh
— IsoPet® (@IsoPetForCancer) February 29, 2024
I can't imagine the mindset of investors who could possibly think ISOPET is a distraction.
Dumb, stupid or parody accounts?
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
ISOPET knocking it out of the park. No wonder the vet clinics are lining up to get this amazing product in their tool kit.
Baggy number 2 doesn't like dealing in facts. They have proven wrong time and time again.
Can't believe a word they say.
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.
ISOPET knocking it out of the park. No wonder the vet clinics are lining up to get this amazing product in their tool kit.
Baggy number 2 doesn't like dealing in facts. They have proven wrong time and time again.
Can't believe a word they say.
Who do you think is telling them certification is required or are you umping on the bandwagon of baggy number 2 that it would be a conditional ide approval?
It is generally recommended to create certification training for a new radiology device after successful completion of clinical trials. Here's why:
Benefits of waiting:
Safety and efficacy: Clinical trials ensure the device is safe and effective for its intended use. Training based on established safety and efficacy data provides users with better guidance and minimizes potential risks.
Standardized procedures: Clinical trials typically involve developing standardized protocols and procedures for using the device. These protocols can then be incorporated into the training, ensuring consistency and optimal use.
Data-driven training: Clinical trial data provides valuable insights into the device's performance and potential challenges. This data can be used to develop more comprehensive and targeted training content.
Regulatory compliance: Some regulatory bodies may require specific training for users of medical devices. By waiting until after clinical trials and regulatory approval, the training can ensure compliance with these requirements.
The guidelines cover radiation devices.
Where do you see certification is required?
The guidelines mention nothing of certification
812.43 Selecting investigators and monitors.
(a) Selecting investigators. A sponsor shall select investigators qualified by training and experience to investigate the device.
Why would companies offer certification to a product that might not make it to market.
There are plenty of examples out there showing clinical trials started without any form of certification.
Training certification isn't required for clinical trials.
You can educate yourself here baggy
https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-812
You can buy mine if you like
5 bucks each
Great news.
Feb update soon and the Mayo Docs have completed sufficient training to start clinical trials. What a great start to the year.
Great news.
Feb update soon and the Mayo Docs have completed sufficient training to start clinical trials. What a great start to the year.
Feb update soon and the Mayo Docs have completed sufficient training to start clinical trials. What a great start to the year.
Another great update today and loved seeing Isopet in action yesterday. it really is an amazing time to be a shareholder.
I didn't expect you to understand baggy
Vivos can manufacture Radiogel to FDA standards. A BDD wouldn't have been granted otherwise.
Not my fault you're short sighted baggy.
breakthrough device designation.
24/7
The FDA knows
https://isopet.com/
can you let me know when you're selling up baggy?
Did I miss the part of the fantasy where the angry disgruntled ex-employee stopped riding 'free' shares ? That was a fun addition.
The ex disgruntled employee is getting a bit angry now. Hopefully they can control their emotions through this difficult times seeing Vivos succeed.