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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.
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 is RADIOGEL, It's what got the Mayo Clinic excited about working with VIVOS.
I'm sure the Mayo Ethics Board took it into consideration when granting Beau T permission to sit on the VIVOS medical advisory board (unheard of in the OTC)
Ignore the FUD
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 is RADIOGEL, It's what got the Mayo Clinic excited about working with VIVOS.
I'm sure the Mayo Ethics Board took it into consideration when granting Beau T permission to sit on the VIVOS medical advisory board (unheard of in the OTC)
Ignore the FUD
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.
You can feel and see the shift in confidence from the Vivos team! They are gearing up for success!
The FDA must love Radiogel to grant it a BDD.
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
The power of a BDD.
Firstly, the BDD fast-tracks RadioGel's journey to market. The FDA prioritizes review for these devices, meaning closer interactions, quicker feedback, and potentially a significantly reduced path to market. This is crucial for RadioGel, as it promises a minimally invasive and potentially curative treatment for difficult-to-reach or radiation-resistant tumors.
Beyond speed, the BDD grants RadioGel access to dedicated FDA experts. This fosters open communication, clearer expectations, and streamlined development. Imagine navigating the regulatory process with a roadmap in hand – that's what the BDD offers. This collaborative approach minimizes uncertainties and saves precious resources, propelling RadioGel closer to patients who need it most.
The BDD also acts as a powerful magnet for investors and payers. It's a stamp of approval, highlighting RadioGel's potential to revolutionize cancer treatment. This can facilitate funding and open doors to earlier reimbursement discussions, ensuring wider patient access to this potentially life-saving technology.
Finally, the BDD distinguishes RadioGel in the crowded medical device landscape. It proclaims it as cutting-edge, innovative, and potentially transformative. This market differentiation is invaluable, giving RadioGel a crucial edge in attracting investment, collaborators, and, most importantly, patients who stand to benefit from its unique approach.
In conclusion, RadioGel's BDD is not just a recognition of its potential; it's a powerful engine propelling it towards making a real difference in the lives of cancer patients. The faster development, closer collaboration, and enhanced visibility it brings pave the way for a future where RadioGel's minimally invasive, targeted therapy becomes a beacon of hope for those battling some of the toughest cancers.
Remember, this is just the beginning of RadioGel's journey. With the BDD wind in its sails, it's poised to make waves in the cancer treatment landscape, offering new hope and potentially brighter tomorrows for patients worldwide.
Isopet - multi functionality treatment. AMAZING
Another tidbit from the Q4 2023 report, to be posted in full on the new website this week, we will be updating regularly in 2024 and eager to see where the equine market heads!#equinehealth #navicularsyndrome #Horses #radiogel #isopet #vivos $RDGL #innovations #NextBigThing pic.twitter.com/ACpOj5gCX4
— RadioGel™ (@RadioGel) January 23, 2024
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
Totally agree, the facts are staking up and years of hard work are starting to pay off.
Isopet - multi functionality treatment. AMAZING
Another tidbit from the Q4 2023 report, to be posted in full on the new website this week, we will be updating regularly in 2024 and eager to see where the equine market heads!#equinehealth #navicularsyndrome #Horses #radiogel #isopet #vivos $RDGL #innovations #NextBigThing pic.twitter.com/ACpOj5gCX4
— RadioGel™ (@RadioGel) January 23, 2024
The Vivos Marketing Team is getting things fired up!
It was a busy day working on our new website https://t.co/kXIvdr5CSv and marketing our Precision Radionuclide Therapy™ (PRnT) to clinics across the USA! Stay tuned for some blog posts soon! #isopet #cancer #radiogel #vivosinc #PRnT $RDGL pic.twitter.com/0kRGdQ6WNz
— IsoPet® (@IsoPet_RadioGel) February 8, 2024
Vivos Inc. has researched and developed patents related to the RadioGel™ device technology for use in high-dose radiation therapy. These patents have established our independence and no longer relying on external sources.
Vivos may have made, use and market RadioGel™ as a medical device. Yttrium-90 is a well-established medical isotope with many applications in cancer treatment. The combination of insoluble yttrium-90 particles and the polymer gel carrier offers physicians an opportunity to deliver a safe, effective treatment option at a reasonable cost.
Sounds like a great program to be part of.
Really does show the faith the FDA has in Doctor Mike Korenko - true fan boys.
The 4th Quarter was great, progress on all fronts.
February 01, 2024
Vivos Inc. Q4 2023 Update | IsoPet® - RadioGel™
Quarterly Progress Report – Q4 2023
Animal Business Sector
Marketing
Vivos Inc participated in seven conferences in 2023. This quarter we had booths in the Veterinary
Cancer Society, the American Association of Equine Practitioners, and the Wild West Vet Show.
Potential New Equine Market
Dr. Bill Bradly, owner of the New England Equine Practice, conducted an experiment to determine if
IsoPet is effective in treating caudal heel pain syndrome, sometimes called navicular syndrome. The
control test showed promise. In Q1, 2024 he will conduct a therapy on an equine patient that is in
pain. If IsoPet is effective this is a potential new and large market.
Medical Business Sector
Breakthrough Designation
The Food and Drug Administration has granted RadioGelTM Precision Radionuclide TherapyTM the
designation as a Breakthrough Device pursuant to the FDA’s Breakthrough Devices Program. Our Risk
Management Report and supporting data concludes that RadioGel™ is intrinsically safe and our animal
therapy data verifies its effectiveness. The FDA’s Breakthrough Devices program will enhance the
schedule priority for our upcoming IDE submission seeking authorization to begin human clinical trials.
Submittal of the IDE - (Q211938/S001)
The key ongoing activities for next IDE application are summarized below:
Mayo Clinic Protocol
We refined the Mayo Clinical Trial Protocol by integrating the previous comments from the FDA, the
comments from the gatekeeper to the Mayo Clinic Institutional Review Board, and from the lessons
learned from the Johns Hopkins VX2 Animal Study, which treated tumors in the same size range.
Next quarter we are planning to complete the final training certification steps for human therapy.
VX-2/Rabbit Animal Study
We completed the testing phase of the study and are now writing the report.
Genotoxicity
We participated in the Pre-Sub meeting with the FDA to gain a consensus on the Genotoxicity
Chemical Characterization Protocol. We have now completed the first phase of the testing.
Quality Management System
Before initiating human clinical trials, the FDA usually conducts a thorough audit of the quality
management system at the production site. Over the last three years we have strengthened our
Quality Management System. This quarter we conducted the required annual Design Review
Meeting to incorporate the 2023 improvements and created or amended 15 additional documents.
Intellectual Property
Intellectual property protection is always a priority and will become increasingly important, for
example, if we pursue international licensing our team with a major medical corporation.
This quarter we filed a utility patent for our Peltier Chiller and the support equipment. This proprietary.
equipment is being used by our regional animal therapy clinics and, in the future, by hospitals for
human therapy.
We previously patented our particles and our hydrogel, as well as potentiall new particles that
administer gamma and alpha radiation. We also have trademark protection for (IsoPet®, RadioGelTM
and Precision Radionuclide TherapyTM.
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
The FDA has only ever granted 26 BDD's to Radiology devices. Radiogel is one of them.
Let that sink in
A Mayo clinic doc is on the VIVOS medical advisory board - unheard of for an OTC company.
Let that also sink in.
Ignore the FUD people.
World’s best investor holds shares when they think the price is going down.
Beau loves Radiogel, he even joins DR MK at the FDA pre sub meetings.
Here he even has to reference his involvement with VIVOS as a conflict of interest.
https://www.mdpi.com/2072-6694/16/3/669
Great to see Beau referencing his involvement with VIVOS only 2 days ago.
For those light of a few brain cells
https://www.mdpi.com/2072-6694/16/3/669
Oh look, he mentions a conflict with VIVOS.
Who would have thought.
Beau..I recognise that name
Ablative #Y90 #radioembolization is now a #BCLC, #AASLD, and #NCCN supported therapy for #HCC.
— Beau Bosko Toskich, MD FSIR (@BeauToskichMD) February 4, 2024
I congratulate our amazing trainees for their efforts in creating a #RADSEG summary designed for #multidisciplinary #tumorboard participants.🧩https://t.co/YjYz76uboT
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