Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
yes, that is why RDGL is much undervalued.
nice finding, love it, vivos will not be ignored anymore
great post and a little salt added
Vivos owned patented technology which makes the production of Y-90 particle more cost-effective, lesser time and much tinier, all these make PNNL(Battelle) having no choice to continue licensing the original patents to Vivos. This is good and great because of Vivos leading the way to commercialize it in more effective ways.
RICHLAND, WA / ACCESSWIRE / July 11, 2017 / Advanced Medical Isotope Corporation ("AMI") (OTC PINK: ADMD), a late stage radiation oncology focused medical device company today announced that a new proprietary process has been developed that significantly improves originally licensed technology on the company's Y-90 RadioGel™ device.
After five months of effort, the AMI team have finalized an improved manufacturing process for our yttrium phosphate particles. We conducted more than thirty process development runs to achieve the most cost-effective process to reproducibly give us the small particles that we desire.
Small particles perfuse further into the tumor and reduce the number of injections required for dose coverage in large tumors. In parallel, we concentrated on reducing the time and cost required for manufacturing and increasing the batch yield. As an example, one production step was reduced from 20 hours to just an hour. Product yield increased from 80% to 99.99%. The process is elegantly simple, but based on fundamental understanding of the underlying chemistry involved.
IsoTherapeutics, a key manufacturing and testing contractor, did a very professional job working with our team to explore all of the key manufacturing variables.
AMI Interim CEO and President Dr. Mike Korenko stated, "This is a significant improvement over the technology that was originally licensed to AMI from the Pacific Northwest National Laboratory. This new proprietary process is an important part of our intellectual property and will reduce our manufacturing costs to position AMI to make a profit on future sales.
The manufacturing process has now been institutionalized in a formal Standard Operating Procedure, which is needed to ensure a safe reproducible product for animal and human therapy and it is the protocol required by the Food and Drug Administration."
Dr. Korenko added, "This accomplishment required a great deal of effort and is a major step in executing our business plan, which I outlined in my first letter to Shareholders January 2017."
AMI previously created the Standard Operating Procedures for the hydrogel (RadioGel™). We are now working on the Quality Assurance and Quality Control Plans and to convert all process activities to GMP (Good Manufacturing Processes) which is a FDA requirement. This will complete the entire disciplined manufacturing process requirements.
I saw it there
the third dog is scheduled to receive the treatment this week
Y-90 for liver cancer
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6230849/
Hepatobiliary Surg Nutr. 2018 Oct;7(5):382-385.
doi: 10.21037/hbsn.2018.06.09.
The role of selective internal radiotherapy with Y-90 resin microsphere in first-line therapy for hepatic colorectal metastases.
Yttrium-90 is a high-energy, pure ß-emitter with a half-life of 64 hours and maximum tissue penetration of 11 mm, which makes it very suitable for treatment of liver tumours. Yttrium-90 is relatively straightforward to use, with limited issues relating to radioprotection for the patient, family or attending staff.
Thank you and give link is much better
https://www.otcmarkets.com/stock/RDGL/security
Market Cap 7.43 million
7.43 M/0.0056=1326M shares
Shares Outstanding 1.3 billion
GREAT finding
this is Huge deal
we never know, there are many subsidiaries of China biotech pharm here in USA, they can help with this process
Great summary of important points but missed the potential of China licensing partnership.
Read the News 100 times and do your own DD, No need to pump and bash!!!
Richland WA, Jan. 09, 2019 (GLOBE NEWSWIRE) -- Vivos, Inc. (OTC PINK: RDGL)
The Board of Directors Reports:
In spite of being handcuffed by legacy debt financing, Vivos Inc made considerable progress in 2018. This was largely possible due to the breakthrough nature of the IsoPet® technology. Major accomplishments this past year include the following:
1. Completed planned testing at Washington State University for the treatment of feline sarcoma. Most importantly this study confirmed the effectiveness of IsoPet for killing cancer. It further allowed us to refine techniques for safe and efficient use in future animal and human therapies.
2. Utilized professional society conferences to communicate the potential of our product to veterinary and medical professionals:
For animal therapy we had strong reception to IsoPet® at the Veterinary Cancer Society Conference setting the stage for commercializing IsoPet in the veterinary community. This is a key conference that is attended by veterinarians from across the USA and internationally.
3. For human therapy we had outstanding response to our poster presentation at the Society of Nuclear Medicine and Medical Imaging (SNMMI) Conference in Philadelphia. We were invited to submit a paper on new innovative technology to their technical journal and also had strong interest from the president of the China Society of Nuclear Medicine.
Intellectual property protection is a high priority:
4. We updated our trademark protection of RadioGel, which is currently registered in 17 countries.
We renegotiated our license agreement with Battelle to obtain a significant reduction in fees.
The U.S. Patent and Trademark Office issued the Certificate of Registration for the marks RadioGelTM and IsoPet®.
5. The FDA reviewed our Label and confirmed the classification of IsoPet® as a device for animal sarcoma cancer therapy. There are no remaining regulatory obstacles to commercialize IsoPet® for those cancers.
6. We strengthened the Veterinary Medicine Advisory Board by adding Tariq Shah with strong commercial expertise to work with Dr. Alice Villalobos, the internationally recognized Chair of our Board.
We established a test plan with the University of Missouri for treatment of canine soft tissue sarcoma and administered IsoPet in the first two patients. It takes about three months to assess the safety and effectiveness of the therapy.
7. The first canine’s tumor was classified as CR, Complete Response. This was unprecedented compared to the standard therapies, in which the tumors tend to reoccur.
The latest examination of the second patient, treated in late October, also looks promising with response similar to the first canine patient.
8. We retained well-known analyst and consultant, George Sharp, as an Advisor. He is widely respected as a watchdog for ethical behavior in the small cap markets and has outstanding business sense.
9. We strengthened our management team by bringing on Michael Pollack as our new CFO. Michael has extensive experience guiding public companies.
Completed common stock equity financing to halt toxic selling and eliminate the secured toxic debt. This was necessary to curb the death spiral of our share price.
10. Our commercialization plan is to first pilot with a local clinic and then to partner with several regional clinics across the United States:
Signed a Memorandum of Understanding with Vista Veterinary Hospital to become the pilot clinic for commercial IsoPet® therapy. We are currently working with them on certification training and to obtain their Radioactive Material Handling license.
11. Identified several interested veterinary clinics at the VCS conference that are candidates for regional clinics.
We are looking forward to another productive year in 2019. Our strategic objectives are:
1. Initiate the commercial sales of IsoPet.
2. Secure adequate funding to expand IsoPet therapy in key regional centers.
3. Begin the pre-clinical testing for human therapy.
4. File for additional patent(s) to enhance our intellectual property protection.
5. Continue to reduce production costs to make IsoPet more affordable for the average pet owner.
We realize that our loyal shareholders have gone through many emotional peaks and valleys with respect to our share price. We believe that with the elimination of our toxic debt and our progress in the development of IsoPet™ and our pending human trial testing that these trying times are at an end. We will be taking further steps to strengthen our company’s position while maximizing shareholder value in the near future. The Board of Directors appreciates the patience of our shareholders as we develop a legacy of advanced treatments for cancerous tumors.
About Vivos Inc. (OTC: RDGL)
Vivos, Inc. is a pharmaceutical company researching and developing minimally invasive treatments to combat cancer in humans and animals. It has developed an Yttrium-90 based brachytherapy injectable device, for the treatment of tumors in animals (IsoPet®) and in humans (Radiogel™). Brachytherapy uses highly localized radiation to destroy cancerous tumors by placing a radioactive isotope directly inside the treatment area using the company’s proprietary hydrogel formulation. 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 safe delivery of higher doses needed for treating both non-resectable and radiation-resistant cancers.
IsoPet® for treating animals uses the same technology as RadioGel™ for treating humans. The Food and Drug Administration advised using different product names in order to avoid confusion and cross-use.
IsoPet® is a hydrogel liquid containing tiny yttrium-90 phosphate particles that may be administered directly into a tumor. This hydrogel is an yttrium-90 carrier at room temperature that gels within the tumor interstitial space after injection to keep the radiation source 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.
IsoPet® 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 out-patient procedure and the patient may return home without subsequent concern for radiation dose to the family.
The IsoPet® Solutions division is using university veterinary hospitals to demonstrate the safety and therapeutic effectiveness for different animal cancers. The testing on feline sarcoma at the Washington State University is completed and the testing on canine soft tissue sarcomas at University of Missouri will begin in the near future.
The Company recently obtained confirmation from the FDA Center for Veterinary Medicine that IsoPet® is classified as a device for skin cancer therapy in cats and dogs. The FDA also reviewed and approved the product labeling. FDA does not require pre-market approval for veterinary devices so no additional approval is required for treating skin cancer, which is the largest market sector. Following this demonstration phase, Vivos can begin to generate revenues through the sale of IsoPet® to University animal hospitals and private veterinary clinic consortiums.
The Company is also engaging the FDA for clearance to market RadioGel™ for the treatment of advanced basal and squamous cell skin cancers in humans.
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:
Michael K. Korenko, President & CEO of Vivos Inc.
MKorenko@RadioGel.com
News powered by iR Direct — Copyright © 2019 Issuer Direct Corporation.
All Rights Reserved.
Amazing, this gonna to be Huge
https://irdirect.net/prviewer/release/id/3558128
All the highlights for 2018 and expectations for 2019 are great and meant a lot.
Especially the following is HUGE
For human therapy we had outstanding response to our poster presentation at the Society of Nuclear Medicine and Medical Imaging (SNMMI) Conference in Philadelphia. We were invited to submit a paper on new innovative technology to their technical journal and also had strong interest from the president of the China Society of Nuclear Medicine.
China has lots of investors with huge funds, they are hungry for new tech, especially in the field of cancer treatments. Considering large population of cancer patients and high incidences of some cancers, like lung, breast, liver and prostate cancers, licensing news of radiogel and isopet, and its techs will be huge in terms of market in China.
Richland, WA, Dec. 04, 2018 (GLOBE NEWSWIRE) -- Vivos, Inc. (OTC PINK: RDGL) a pharmaceutical company in the process of researching and developing minimally invasive treatments to combat cancer in humans and animals, has agreed to supply IsoPet® to treat a dog with advanced cancer at the University of Missouri. The procedure is scheduled to take place on December 6, 2018. The animal has a large tumor that weighs approximately one-half pound, which is well outside the parameters of our study plan for treatment of canine sarcomas. In addition, the patient has a growth in one lung indicating the cancer may have metastasized.
The dog’s owner was passionate about obtaining the treatment. We ultimately agreed on humanitarian grounds that the potential benefits of treatment with IsoPet® would outweigh the risks, even though the patient is likely to eventually succumb to metastatic disease. It will be the largest tumor treated with IsoPet to date, and offers the opportunity to evaluate the practical aspects of treating large tumors and help determine the parameters of effectiveness of the therapy. Additionally, there is evidence that a dying tumor can stimulate an animal’s immune system to recognize and destroy the cancerous cells, providing some encouragement for an outside chance that the metastatic cancer cells could be attacked well outside the tumor boundary. Effectively then, this treatment is being provided both for the hopeful benefit of the dog, as well as research.
Dr. Mike Korenko, Vivos Inc CEO stated “We deliberated carefully prior to making this decision since losing an animal, as is likely the case here, can draw substantial scrutiny by the FDA. We are being careful to identify this case as being outside the study plan criteria. In the end, the humanitarian aspect was the overriding factor in making this determination. A secondary benefit is the potential to learn from this therapy. We are confident that IsoPet® will be effective in treating the primary tumor, but there are uncertainties on how the patient’s system will react to a large necrosis volume and whether a synergistic effect against the metastatic disease will in fact be observed.”
hope this becomes real next week. As the images of moose showed, the treated part got healed nicely and hairs has grown back, indicating it did treat the cancer part with minimum dagame to the adjacent normal tissue like skin.
honestly, I lost money in paper in this stock but I hold hope for it gaining back much.
thank you for the information! As isopet is being proven to be successful in treating pets cancer, Radiogel will be approved for human clinical trials, which will be a great effective choices for treating solid cancers, even powerful in combination with other treatments like immunotherapies. The huge potential value is there but just need time and patience to wait for it. Eventually, longs will be laughing over shorts
haha, that is right. In the long-term, this is much undervalued, who knows when the news hits but when it hits, it flashes the dumpers and flippers.
Happy New Year! although the SP is down treading, the future of this RDGL is getting brighter. The company is much undervalued now, even the OS will be doubled, but the MC of it should be 10 times of the value now, so we surely will see it soon.
great post
Sounds logic and promising! hold my shares tight and will add more when having funds.
Thank you for putting all the images together, Clearly it is much improved and hopefully, medical check-ups shows good results. Hope Moose is cancer free.
Nice post! thank you for the sincere heart for making things clear
Haha, let the storm coming stronger and wash off the greedy money.
Scare the shorts off and keep the longs for supporting the good treatment of Radiogel and isopet
Very aggressive and brave decision, hope it is truly based on the solid understanding of the isopet!
Richland, WA, Dec. 04, 2018 (GLOBE NEWSWIRE) -- Vivos, Inc. (OTC PINK: RDGL) a pharmaceutical company in the process of researching and developing minimally invasive treatments to combat cancer in humans and animals, has agreed to supply IsoPet® to treat a dog with advanced cancer at the University of Missouri. The procedure is scheduled to take place on December 6, 2018. The animal has a large tumor that weighs approximately one-half pound, which is well outside the parameters of our study plan for treatment of canine sarcomas. In addition, the patient has a growth in one lung indicating the cancer may have metastasized.
The dog’s owner was passionate about obtaining the treatment. We ultimately agreed on humanitarian grounds that the potential benefits of treatment with IsoPet® would outweigh the risks, even though the patient is likely to eventually succumb to metastatic disease. It will be the largest tumor treated with IsoPet to date, and offers the opportunity to evaluate the practical aspects of treating large tumors and help determine the parameters of effectiveness of the therapy. Additionally, there is evidence that a dying tumor can stimulate an animal’s immune system to recognize and destroy the cancerous cells, providing some encouragement for an outside chance that the metastatic cancer cells could be attacked well outside the tumor boundary. Effectively then, this treatment is being provided both for the hopeful benefit of the dog, as well as research.
Dr. Mike Korenko, Vivos Inc CEO stated “We deliberated carefully prior to making this decision since losing an animal, as is likely the case here, can draw substantial scrutiny by the FDA. We are being careful to identify this case as being outside the study plan criteria. In the end, the humanitarian aspect was the overriding factor in making this determination. A secondary benefit is the potential to learn from this therapy. We are confident that IsoPet® will be effective in treating the primary tumor, but there are uncertainties on how the patient’s system will react to a large necrosis volume and whether a synergistic effect against the metastatic disease will in fact be observed.”
Thank you for your kindness, yes I am now in loss on paper, but holding long for the good things coming! This company is much undervalued in the market.
I am holding tight too. we see the light through the dark tunnel
thank you for sharing. though the RDGL is dropping in last two weeks while I was traveling, just taking the chance to accumulate more today! This trend will be turn around soon!
yes, hope radiogel prospers with bright future not only in pets cancer treatment but also in human as well.
EXACTLY
we are almost there.good news comes imminently
good warning!wise people listens
yes,that is the confidence we have. It is not affected by daily up and downs at all. cheer up and we walk along with great people
please have real DD discussed here!
that is 75% of small population cancer patients, radiogel applies to almost all solid cancer types
thank you for what you have done for us. hope Natalie have radiogel as the choice to fight cancer
it is only good for certain gene fusion type, so it is for the limited population not for all.
Good sum about RDGL and its potential, well-done job!
patience is the key;PR is imminent
check up the website there
www.radiogel.com
yes, here the RDGL is much undervalued