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Those posts are only to drown out SC8. Tske your pick .
The guy complaining the most about this company and its CEO, still owns shares in this company. Interesting.
Michael K. Korenko, Sc.D.
President • CEO Vivos, Inc.
Mike 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.
He currently is the author of 28 patents and has received many awards, including the National Energy Resources Organization Research and Development Award, the U.S. Steelworkers Award for Excellence in Promoting Safety, and the Westinghouse Total Quality Award for Performance Manager of the Year.
Dr. Korenko served as Vice-President of Westinghouse Hanford, Executive Vice President of Closure at Rocky Flats and Chief Operating Officer for Curtiss-Wright Electro-Mechanical Division producer of the nuclear components for all the United States submarines and aircraft carriers and for commercial nuclear power reactors.
He is currently CEO and President of Vivos Inc. developing yttrium-90 brachytherapy for animals and humans.
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.
Yes he does .
If you’re new here , you’ll figure out in time SC8 posts nonstop FUD .
EVERYONE ignores him . Responding to his posts just generates more nonstop FUD .
The FDA’s Breakthrough Devices program will enhance the
schedule priority for our upcoming IDE submission seeking authorization to begin human clinical trials.
Michael K. Korenko, Sc.D.
President • CEO Vivos, Inc.
Mike 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.
He currently is the author of 28 patents and has received many awards, including the National Energy Resources Organization Research and Development Award, the U.S. Steelworkers Award for Excellence in Promoting Safety, and the Westinghouse Total Quality Award for Performance Manager of the Year.
Dr. Korenko served as Vice-President of Westinghouse Hanford, Executive Vice President of Closure at Rocky Flats and Chief Operating Officer for Curtiss-Wright Electro-Mechanical Division producer of the nuclear components for all the United States submarines and aircraft carriers and for commercial nuclear power reactors.
He is currently CEO and President of Vivos Inc. developing yttrium-90 brachytherapy for animals and humans.
Sure thing MC73,, you and your buddies keep spreading your own "reality"
The FUD is getting pretty weak these days .
Oh well
Especially coming from a very conservative CEO in Dr Korenko
Getting things ready for human trials with the MAYO clinic .
RadioGel™ – compared to current brachytherapy treatment technology
Next-Generation Breakthrough cancer treatment
Based upon its studies and analyses, or general application of experience with current brachytherapy devices and Yttrium-90, Vivos believes that its brachytherapy products are likely to offer the following benefits, among others, for patients and medical professionals:
• Maximizing Therapeutic Index: The short-range beta particles emitted by Y-90 deliver radiation energy within a tight range. This enables radiation to be selectively delivered to target tissues while minimizing radiation dose to nearby normal tissues. High therapeutic indices imply that more radiation energy may be imparted to target tissues, with less radiation reaching adjacent normal tissues.
• Half Life: Y-90 has a half-life of just 2.7 days. Many traditional brachytherapy products use isotopes with longer half-lives such as 9.7 days for cesium-131, and sixty days for iodine-125.
Brachytherapy uses highly localized radiation to destroy cancerous tumors by placing a radioactive isotope directly inside the treatment area. The product 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.
According to Global Industry Analysts, by 2027 the Global brachytherapy market will reach $550 million (USD). It is estimated that the U.S. market represents approximately half of the global market. Vivos believes there are significant opportunities in prostate, breast, liver, pancreatic, head and neck cancers. The 2019 U.S. estimated new cases according to the American Cancer Society are 240,000 prostate cancer, 235,000 breast cancer and 31,000 liver cancer.
Precision Radionuclide Therapy (PRnT)™
The future of brachytherapy cancer treatment – the insertion of our radionuclide device directly into the tumor tissue.
Michael K. Korenko, Sc.D.
President • CEO Vivos, Inc.
Mike 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.
He currently is the author of 28 patents and has received many awards, including the National Energy Resources Organization Research and Development Award, the U.S. Steelworkers Award for Excellence in Promoting Safety, and the Westinghouse Total Quality Award for Performance Manager of the Year.
Dr. Korenko served as Vice-President of Westinghouse Hanford, Executive Vice President of Closure at Rocky Flats and Chief Operating Officer for Curtiss-Wright Electro-Mechanical Division producer of the nuclear components for all the United States submarines and aircraft carriers and for commercial nuclear power reactors.
He is currently CEO and President of Vivos Inc. developing yttrium-90 brachytherapy for animals and humans.
Michael K. Korenko, Sc.D.
President • CEO Vivos, Inc.
Mike 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.
He currently is the author of 28 patents and has received many awards, including the National Energy Resources Organization Research and Development Award, the U.S. Steelworkers Award for Excellence in Promoting Safety, and the Westinghouse Total Quality Award for Performance Manager of the Year.
Dr. Korenko served as Vice-President of Westinghouse Hanford, Executive Vice President of Closure at Rocky Flats and Chief Operating Officer for Curtiss-Wright Electro-Mechanical Division producer of the nuclear components for all the United States submarines and aircraft carriers and for commercial nuclear power reactors.
He is currently CEO and President of Vivos Inc. developing yttrium-90 brachytherapy for animals and humans.
2 new hires , BDD in hand , IDE submission next followed by probable APPROVAL, followed by human trials at the Mayo Clinic . Going to be a fantastic year !
2 new hires , BDD in hand , IDE submission next followed by probable APPROVAL, followed by human trials at the Mayo Clinic . Going to be a fantastic year !
Shows how confident Dr Korenko is about receiving the IDE.
It’s understandable. Those that actually own shares want the same outcome . I appreciate the transparency we have from this last monthly update .
We’ll get there .
I understand that ,, point I’m making is we could have submitted the IDE a while ago only to have it denied . Is it taking longer than I’d like ? Yes . For those who own shares and aren’t happy with the time frame , they’re free to sell their shares .
No need to name call .
Agree ,, we now have a more definitive timeline.
I keep saying what’s important is not the IDE submission but an IDE APPROVAL.
Dr Korenko is giving us the best chance of that IDE APPROVAL
BDD in hand,,, 2 new hires,,, Final training for Mayo this month,,,, looks like things are happening and fast. IDE submission just around the corner imo.
Looking forward to the January monthly update that will be out today. Guess there was much more to report after releasing the Quarterly update?
Moving to monthly updates sounds positive to me . Why else move to more frequent updates ? We are getting close .
If you paid attention to the Twitter posts , you’d know there were 2 phases of testing and one phase of analysis .
We’ll see if tomorrow sheds some light as to where they are with phase 2 .
Let’s see if tomorrow’s January update sheds some light on this second phase of geno testing .
Amen
RadioGel™ is a brachytherapy device comprising highly insoluble yttrium-90 (90Y) particles delivered by needle injection using a water-polymer composite for high-dose treatment of non-resectable solid tumors that cannot be treated effectively by any other means. It is designed for maximum safety: to deliver a high, pure-beta radiation dose to target (tumor) tissue, with comparatively small-to-negligible radiation doses to adjacent normal tissues, and with negligible radiation dose to any major organ or tissue in the body.
The FDA and Mayo.wow just wow
Remember folks, the hard work of Doctor Mike Korenko and his team has now Vivos fast tracked thanks to the 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.
That's right folks, the animal data shows the effectiveness.
BDD baby..DR MK smashing it out of the park time and time again.
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 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.
Michael K. Korenko, Sc.D.
President • CEO Vivos, Inc.
Mike 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.
He currently is the author of 28 patents and has received many awards, including the National Energy Resources Organization Research and Development Award, the U.S. Steelworkers Award for Excellence in Promoting Safety, and the Westinghouse Total Quality Award for Performance Manager of the Year.
Dr. Korenko served as Vice-President of Westinghouse Hanford, Executive Vice President of Closure at Rocky Flats and Chief Operating Officer for Curtiss-Wright Electro-Mechanical Division producer of the nuclear components for all the United States submarines and aircraft carriers and for commercial nuclear power reactors.
He is currently CEO and President of Vivos Inc. developing yttrium-90 brachytherapy for animals and humans.
Main thing is not the submission but the approval and Dr Korenko is doing everything to assure an APPROVAL.
Not sure anyone cares if you're holding your breath or not.
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.
Let this sink in, one of only 20 odd radiology devices to be granted a BDD...ever. ..WOW just WOW
The FDA and the Mayo Clinic know how good Radiogel is.
For those who haven’t heard, this is BIG news for our fourth quarter of 2023, another step closer! #cancertherapy #radiogel #breakthroughstatus #humantrials #nextgeneration #isopet #vivosinc #perserverance $RDGL pic.twitter.com/EcPvlMneAn
— Vivos Inc. (@VivosIncUSA) January 24, 2024
Michael K. Korenko, Sc.D.
President • CEO Vivos, Inc.
Mike 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.
He currently is the author of 28 patents and has received many awards, including the National Energy Resources Organization Research and Development Award, the U.S. Steelworkers Award for Excellence in Promoting Safety, and the Westinghouse Total Quality Award for Performance Manager of the Year.
Dr. Korenko served as Vice-President of Westinghouse Hanford, Executive Vice President of Closure at Rocky Flats and Chief Operating Officer for Curtiss-Wright Electro-Mechanical Division producer of the nuclear components for all the United States submarines and aircraft carriers and for commercial nuclear power reactors.
He is currently CEO and President of Vivos Inc. developing yttrium-90 brachytherapy for animals and humans.
They are following the guidance of the FDA during the process . The hand holding by the FDA increases the likelihood of an IDE approval.
An IDE approval and not just a submission is what matters most .
Nice to see everyone ignoring the constant FUD posts .
Higher probability of an IDE approval. An IDE approval is what matters most .