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Don't be fooled by the uneducated. ISOPET is the real deal.
The Mayo Clinic have backed Radiogel , probably due the tight patents it has.
Richland WA, Jan. 03, 2023 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL), Vivos Inc announced today that they filed a provisional patent application on the system equipment to support precision radionuclide therapy.
This includes the shipping containers, the shielded vial holder, the Peltier chiller, and the syringe shields. These device designs are integrated into our production standardization effort. They can be used for treating a range of tumor sizes from 0.5-gram human lymph nodes to half-pound equine tumors. This equipment was just tested at our recent equine therapy in NY.
SHIPPING CONTAINER
Eliminated the can and the lead pig containers and designed the shielding of the new plastic container to improve the ease of unpackaging and to ensure that we can ship to White 1 label (UN2910) standards to reduce the Fed Ex shipping costs and logistics.
SHIELED VIAL HOLDER
Incorporated stability in securing the vials while filing the syringes and maximized the vial holder wall thickness to further reduce the relatively low radiation.
PELTIER CHILLER
Designed to chill the vial holders and the syringes with a plug-in system.
Avoids the potential contamination from ice baths, which was a Mayo Clinic concern for human clinical trials.
Contains an imbedded magnetic stirrer to keep the IsoPet solution particles in suspension.
Each syringe port can be dedicated to a specific human lymph node, a specific VX-2 tumor in the animal testing, or as a staging center for treating larger animal tumors.
SYRINGE SHIELD
Maximized the diameter of the syringe shield to reduce radiation while designing the finger position to maintain the optimum ergonomics.
Received very positive feedback from the therapists about the ergonomics. This flexibility is important to ensure the accuracy in precision injections.
Dr. Mike Korenko stated “This development occurred over the entire year while incorporating practical experience and feedback from our therapists. We will make this equipment available to the Mayo Clinic for human clinical trials and to the therapists in all our current and future regional clinics.”
Richland WA, Jan. 03, 2023 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL), Vivos Inc announced today that they filed a provisional patent application on the system equipment to support precision radionuclide therapy.
This includes the shipping containers, the shielded vial holder, the Peltier chiller, and the syringe shields. These device designs are integrated into our production standardization effort. They can be used for treating a range of tumor sizes from 0.5-gram human lymph nodes to half-pound equine tumors. This equipment was just tested at our recent equine therapy in NY.
SHIPPING CONTAINER
Eliminated the can and the lead pig containers and designed the shielding of the new plastic container to improve the ease of unpackaging and to ensure that we can ship to White 1 label (UN2910) standards to reduce the Fed Ex shipping costs and logistics.
SHIELED VIAL HOLDER
Incorporated stability in securing the vials while filing the syringes and maximized the vial holder wall thickness to further reduce the relatively low radiation.
PELTIER CHILLER
Designed to chill the vial holders and the syringes with a plug-in system.
Avoids the potential contamination from ice baths, which was a Mayo Clinic concern for human clinical trials.
Contains an imbedded magnetic stirrer to keep the IsoPet solution particles in suspension.
Each syringe port can be dedicated to a specific human lymph node, a specific VX-2 tumor in the animal testing, or as a staging center for treating larger animal tumors.
SYRINGE SHIELD
Maximized the diameter of the syringe shield to reduce radiation while designing the finger position to maintain the optimum ergonomics.
Received very positive feedback from the therapists about the ergonomics. This flexibility is important to ensure the accuracy in precision injections.
Dr. Mike Korenko stated “This development occurred over the entire year while incorporating practical experience and feedback from our therapists. We will make this equipment available to the Mayo Clinic for human clinical trials and to the therapists in all our current and future regional clinics.”
The Mayo Clinic have been using these for their training and will also need them for clinical trials.
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Mayo Love Isopet , it's what got them interested in Radiogel.
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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 last three Isopet sites opened up (Myhre Equine Clinic, Hopkinton Animal Hospital and Indian Creek Veterinary Hospital) are all Synovetin/Exubrion Clinics.
Dr Nigel R Stevenson is the link from Vivos to Exubrion.
There might be other clinics on the way outside of the Synoventin Network but I would imagine a fair few are coming from their sites.
They have 50 or 60 already and have the right clients coming through the door already so a good match for Vivos and Isopet.
If all they've got is 'you're lying' you know you've won.
They lost when the BDD was granted. There is no come back.
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Simple fact, you don't get a BDD unless there is enough safety and effectiveness data available for your device.
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Clinical trials soon
The FDA's words not mine.
"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. "
The FDA must love Radiogel.
Really powerful from the FDA.
The FDA's words not mine.
"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. "
The FDA must love Radiogel.
The FDA's words not mine.
"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. "
This 70 odd year old who is trying to get a medical device that will help save cancer patients with the support of the Mayo Clinic can only trigger a certain type of person to spend their days trying to discredit him. That person(s) is most likely someone that was kicked out of the company when Doctor Mike Korenko saved the company by getting rid of the dead wood bleeding the company dry.
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The FDA words
The device provides for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions
Facts hurt the narrative but Radiogel is what is is. A life saver.
For my fans, you can’t not reply.
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.
REMEMBER
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.
That's good to hear.
Stockholm syndrome?
Try blocking me.
REMEMBER
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.
Whatever you might read today, remember this.
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.
I care what happened years ago . Dr Korenko cleaned house before embarking upon the IDE process . Imagine the disgruntled employee complaining every step of the way in the process . Instead we get to hear the daily complaints.
Remember folks, it was the good Doc Mike Korenko that came in and cleared house at Vivos. The old management and team had run the company into the ground and it was on the verge of collapse.
When you read critical comments it's easy to see who would be annoyed at the current situation.
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