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I believe in this new treatment and its turn out will be proven.
Just wondering why Vivos can not treat multiple dogs other than one by one?
Please save more time and train many veterinarians to accelerate the application of this product in the pets clinics!!!
WHO can get connected to Dr.Korento
we do need new updated company presentation and conference presentation as well. Please Vivos, do your great job to update with new things and visions to investors
Brachytherapy used exclusively or as adjunct/combination therapy in humans.
Source = Mayo Clinic:
https://www.mayoclinic.org/tests-procedures/brachytherapy/about/pac-20385159
Why it's done
Brachytherapy is used to treat several types of cancer, including:
Bile duct cancer
Brain cancer
Breast cancer
Cervical cancer
Endometrial cancer
Esophageal cancer
Eye cancer
Head and neck cancers
Lung cancer
Pancreatic cancer
Prostate cancer
Rectal cancer
Skin cancer
Soft tissue cancers
Vaginal cancer
Brachytherapy can be used alone or in conjunction with other cancer treatments. For instance, brachytherapy is sometimes used after surgery to destroy any cancer cells that may remain. Brachytherapy can also be used along with external beam radiation.
Isopet (for pets) and Radiogel (for Human) are an innovative tech for delivery of Y-90.
(1) y-90 as radionuclide were proved and used in radiotherapy for human cancers;
(2) The polymer PLGA-PEG was widely used in nanomedicine or bio-carrier for improving drug delivery, is used in the approved drug;
(3) The combination of above has no big regulation hurdles for its usage for fighting human cancers, it is a little over ONE YEAR since the submission of de novo device classification to FDA, the successful cases of treating pets cancer will expedite the FDA approval for human.
Cheers!!! Second dog treatment result will come soon!
BIG NEWS WILL HIT SOON, AND PATIENCE GETS REWARDS
Yttrium-90 (Y-90) Resin Microsphere Therapy for Patients with Unresectable Hepatocellular Carcinoma: a Single-Center Experience.
J Gastrointest Cancer. 2017 Sep;48(3):281.
doi: 10.1007/s12029-017-9968-z.
Ince S1, Karaman B2, Alagoz E3, Karadurmus N4, San H3, Erçin CN5, Arslan N3.
Author information
Abstract
BACKGROUND/AIM:
Selective intraarterial radionuclide therapy (SIRT) with yttrium-90 (Y-90) resin microspheres presently has successful results in primary or metastatic inoperable liver tumors. This procedure, which is also known as radioembolisation, delivers high doses of radiation selectively to hepatic tumors while minimum healthy liver exposure. The aim of this study was to present our clinical experience of radiomicrosphere therapy for the treatment of patients with unresectable hepatocellular carcinoma (HCC).
METHODS:
We performed 40 Y-90 microsphere therapies in 28 patients (5 females, 23 males; mean age ± SD 48 ± 8) with HCC during the period from April 2008 through December 2016. Pretreatment Tc-99m microaggregated albumin (MAA) scintigraphy was performed to all patients in order to detect eligibility for SIRT. All patients had pre- and post-biochemical tests (hemogram and serologic tests) and imaging methods (CT or MRI or PET/CT) at regular intervals to detect any possible complication and determine response rates.
RESULTS:
The mean shunting to the lungs on MAA scan was 6.5% and the mean ± SD administered dose of Y-90 was 1.55 ± 0.32 GBq in all patients. The estimated doses to the target tumors, normal liver parenchyma and lungs were 105.7 ± 55.3, 25.5 ± 8.2 and 5.8 ± 1.7 Gy, respectively. No significant complication was observed during or early after (first week) the treatment procedure and it was well tolerated by all the patients. Only one patient developed a treatment-related gastroduodenal ulcer 3 weeks after the treatment. In control imaging tests (MRI or FDG PET/CT) performed 2.5 months after the treatment, we observed complete response in 2 (7%) patients, partial response in 10 (36%) patients, stable disease in 5 (18%) patients and progressive disease in 11 (39%) patients.
CONCLUSION:
According to our clinical experience, we can conclude that Y-90 microsphere therapy is a safe and effective treatment option for the patients with unresectable HCC without any serious side effects.
Recommendations for SIR-Spheres Y-90 resin microspheres in chemotherapy-refractory/intolerant colorectal liver metastases.
Future Oncol. 2017 Oct;13(23):2065-2082. doi: 10.2217/fon-2017-0220. Epub 2017 Jul 13.
Recommendations for SIR-Spheres Y-90 resin microspheres in chemotherapy-refractory/intolerant colorectal liver metastases.
Aranda E1, Aparicio J2, Bilbao JI3, García-Alfonso P4, Maurel J5, Rodríguez J6, Sangro B7, Vieitez JM8, Feliu J9.
Author information
Abstract
A Spanish expert panel reviewed current evidence for the use of SIR-Spheres Y-90 resin microspheres in patients with chemotherapy refractory/intolerant unresectable colorectal liver metastases. Substantial evidence for its efficacy and safety is available from a randomized controlled study, retrospective comparative studies and several single arm studies. Clinical evidence data obtained from more than 1500 patients have led to the inclusion of selective internal radiation therapy in the 2016 ESMO Clinical Guidelines as third-line treatment. This publication results from an expert panel meeting, where published evidence and author's experiences were shared to position SIR-Spheres Y-90 resin microspheres in Spain for the treatment of chemotherapy refractory/intolerant unresectable colorectal liver metastases, and second, to define the patient subgroup that will benefit the most with this treatment.
using yttrium-90 resin microspheres in patients with unresectable hepatocellular carcinoma
J Gastrointest Oncol. 2017 Oct;8(5):799-807. doi: 10.21037/jgo.2017.08.03.
Selective internal radiation therapy using yttrium-90 resin microspheres in patients with unresectable hepatocellular carcinoma: a retrospective study.
Mantry PS1, Mehta A2, Madani B3, Mejia A1, Shahin I1.
Author information
Abstract
BACKGROUND:
Selective internal radiation therapy (SIRT) with yttrium-90 resin (Y-90 resin) microspheres has been used as a locoregional therapy for patients with unresectable hepatocellular carcinoma (HCC). We examined patient and disease characteristics that might affect survival after Y-90 resin, as well as treatment tolerability.
METHODS:
Data from patients with unresectable HCC treated with Y-90 resin at a single institution were reviewed retrospectively. Survival was assessed with Kaplan-Meier curves and log-rank tests. Response was evaluated with the response evaluation criteria in solid tumors (RECIST) criteria. Adverse events (AEs) were noted, and laboratory values were graded with CTCAE v3.0.
RESULTS:
Data from 111 patients were analyzed. AEs occurred in 23 patients at 1 week after treatment and in 46 at 3 months. At 6 months, 13 patients had a complete response and 13 had a partial response. Factors associated with longer overall survival (OS) included early-stage disease [27.8 months for patients with Barcelona-Clinic Liver Cancer (BCLC) A vs. 9.2 months for BCLC C]; treatment with other locoregional therapies (69.0 vs. 11.4 months); and lack of bilobar disease (23.5 vs. 9.4 months), portal vein thrombosis (16.2 vs. 8.6 months), ascites (16.6 vs. 10.3 months), and treatment with sorafenib (17.2 vs. 10.3 months). In six patients, Y-90 resin was used as a bridge to liver transplantation, which greatly improved survival (69.0 vs. 12.1 months).
CONCLUSIONS:
Several characteristics may prove useful for selecting patients likely to respond well to Y-90 resin. These results should be confirmed in prospective studies.
combination is the key for cancer cure
https://www.amcny.org/radiation-oncology/radiation-therapy-information
Radiation therapy, alone or in combination with surgical excision, is used to shrink or destroy cancers that cannot be safely or completely removed by surgery alone, or cancers that are unaffected by chemotherapy. In some instances, permanent control of the tumor is possible through use of radiation therapy. In other cases, even when cure is not possible, radiation therapy can still bring a measure of relief. Shrinking a large tumor with radiation therapy may improve the quality of life by reducing pressure, bleeding or pain. When used in combination with surgical excision, radiation therapy kills microscopic tumor cells in the surrounding area that would otherwise result in regrowth of the tumor. Radiation therapy may also be used in combination with chemotherapy when the tumor is likely to spread throughout the body.
best hope with other therapies, like target therapies and immunotherapies
HOPE RADIOGEL kills the cancer stem cells (CSCs)
Inactivation of cancer stem cells (CSCs) is of utmost importance for tumor cure after radiotherapy;
high dose of Y-90 internally sitting in the core of tumor mass would be expected in killing CSCs
do not worry, mine is same
radiotherapy has no or very minimum species response rate difference, if for pets it works well, then as human, the great turn out will speed the application of radio gel to human. Y 90 AND polymer in formulation were tested safe for human, why not get quicker approval for human cancers
September Email from inventor of RadioGel Darrell Fisher and feline results -
$RDGL therapeutic ratio higher than anything else approved for human use >1000:1 pic.twitter.com/ah9BVxxnLA
— 🍀LuckiSevens®️ (@LuckiSevens) September 24, 2018
The inventor of Ragiogel!!!
https://versantphysics.com/leadership/drfisher/
Professional Experience
Dr. Fisher is a medical physicist, internal dosimetry specialist, and radiation safety professional with Versant Medical Physics & Radiation Safety. During 35 years at Pacific Northwest National Laboratory, he served as senior research scientist, program manager, and lead for the Laboratory’s isotope sciences program–a national nuclear technology resource.
His background includes work in medical physics, radiological sciences, radiation protection, radiation biology, nuclear engineering sciences, environmental sciences, radioisotope production, and radiochemistry. He specializes in the health effects and dosimetry of exposure to radioactive materials, medically administered radiopharmaceuticals, and uranium compounds. He provides medical internal dosimetry to various cancer research centers and pharmaceutical companies involved in studies on the effectiveness of radiolabeled monoclonal antibodies in cancer diagnosis and therapy. He helped to design therapeutic radiopharmaceuticals, such as alpha-emitter immunoconjugates and beta-emitter radiogels as next-generation cancer treatments. He invented resorbable brachytherapy seeds and injectable radionuclide polymer composites for controlled delivery of yttrium-90 microspheres for treating non-resectable solid tumors.
Darrell Fisher is Research Professor of Pharmaceutical Sciences at the Washington State University College of Pharmacy, Affiliate Associate Professor of Radiology at the University of Washington School of Medicine, and Affiliate Investigator in Clinical Research at the Fred Hutchinson Cancer Research Center. He recently served as president of the Health Physics Society. As a loaned scientist from Pacific Northwest National Laboratory, Fisher previously served as senior technology advisor at U.S. Customs and Border Protection headquarters, in the Department of Homeland Security (2003-2005). And years earlier, he also served as an advisor to the U.S. Department of Energy on a three-year “openness” initiative involving review of the history of nuclear medicine and human radiation experiments.
Darrell Fisher serves as a technical proposal reviewer for various study sections of the National Cancer Institute and for the DOE Office of Science. He is a reviewer for the National Academy of Sciences, for the Centers for Disease Control and Prevention, and for several science and medical journals. Since receiving his formal education, he has completed continuing education in environmental compliance, project management, leadership, and human relations.
6 years aga, this happened and 6 years later we will get the fruit
https://www.seattletimes.com/seattle-news/battelle-scientist-gets-grant-to-test-radiogel-cancer-treatment/
The radiogel is the result of years of research by scientists for Battelle to develop a radioactive isotope product that would be injected into the body, stay in place and deliver a high dose of cancer-killing radiation.
The technology could be used for solid cancers that cannot be removed surgically and require high doses of radiation for treatment to be successful, said Darrell Fisher, a senior scientist at Pacific Northwest National Laboratory, and the recipient of the grant for his research for Battelle.
The radiogel includes a polymer and microspheres of the medical isotope yttrium 90 in a water-based solution. The polymer is in liquid form when it’s injected to the cancer site, but quickly turns into a gel at body temperature and stays in place.
The polymer binds the microspheres in place as the yttrium 90 bombards the cancer with radiation, with little of the radiation reaching nearby healthy tissue. It has applications for cancers of the liver, brain, head and neck, kidney and pancreas, and is showing promise for eye tumors.
Great things will come soon!
https://twitter.com/radiogel?lang=en
Twitter of the company RDGL is showing great confidence or optimistic about the application of isopet and sooner or later for human cancer treatment!
Company twitter saide" One of the Primary reasons we've chosen to develop IsoPet® for animal applications is #ComparativeOncology. The successful results from all our animal patients may be used in data submissions to the FDA for Human use. BTW, if you're a #petlover give the @AnimalCancerFdn a follow.
Once the good news of the second dog patient healing well and recovering, the stock will be shooting high at least 0.02 or 0.10!
great fact of material
nice letter for radiogel introduction, vivos should hire you as manager of public relationship
great, thank you for these sum
GET THE MISSION, SAVE THE PETS THEN SAVE THE HUMAN
Scientifically and clinically Proved
1. Polymers for the Radiogel are biocompatible, biodegradable, and safe and proved wildly used in biomedicines delivery:
2. Y-90 is already being used in radiotherapy FOR CANCERS;
3. Combination of the two gives much-secured delivery of radiotherapy internally and less harm to the normal tissue;
4. More and more success stories and testimonies of isopet would prove its human version of Radiogel, FDA will give green light on it sooner or later
Yes RDGL is getting closer for the partnership in two weeks after huge conferences exposure!!!
They mentioned in the PR after the meeting!It seems like it is considering the proposals by a Major Pharmaceutical Company in the niche of immunotherapy and preparing to be ready for some partners.
Get some shares now when it is still cheap!
https://www.microcapdaily.com/the-sizzle-on-vivos-inc-otcmkts-rdgl/122198/
RadioGel is a hydrogel liquid containing tiny Yttrium-90 phosphate particles to be injected into a tumor. This hydrogel is a liquid at temperatures below body temperature but begins to gel, harden, upon injection as the temperature increases to normal body temperature, thereby locking the particles in place. The particles emit a very high concentrated and contained beta irradiation to kill the tumor. The beta radiation has a short penetration distance so there is minimal collateral damage to healthy tissues outside of the injected area. RadioGelâ?¢ 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 6 weeks or more to deliver a full course of radiation therapy. This is an outpatient treatment much safer to the personnel treating the patient than competing brands and the patient can go home immediately with no risk to family members.
Currently there is nothing on the market like the Y-90 RadioGel device which the Company holds 8 patents on and trademarks in about 40 different countries. The devices design features make it suitable for use in a broad range of solid tumors and the company has highlighted potential opportunities in pancreatic and brain tumors. The Company is engaging the FDA for clearance to market RadioGel [TM] for the treatment of advanced basal and squamous cell skin cancers in humans. Vivos Is also developing IsoPet(R) for treating animals which uses the same technology as RadioGel [TM] for treating humans. The Food and Drug Administration advised using different product names in order to avoid confusion and cross-use.
WHO KNOWS THERE IS NO NEWS ON MONDAY
$RDGL NEWS OUT!!!!!! Vivos Inc. Successfully Administers IsoPet®
https://irdirect.net/prviewer/release/id/3392643
Important points:
1. Vivos Inc reported that the second dog in a five-dog series was successfully treated yesterday with Y-90 IsoPet® at the University of Missouri.
2. Dose was accurately delivered as being said" Our differential between the pre- and post- vial in the dose calibrator was 0.3 mCi, which fits well with our target injected dose. With the bandage on, our patient is already below our release criteria in terms of dose rate."
3. Very convenient outpatient procedure :Dr. Mike Korenko,said "The observational data to be collected over the next few days and during longer term patient follow-up will be made available to the FDA and to veterinarians at regional private clinics that choose to become IsoPet users in the future. The low external radiation dose rate also demonstrates that IsoPet meets the criteria for same day therapy and radiation safety for pet owners and family members.”
4. Helping Vista Veterinary Hospital as a qualified user of isopet is on going! and this will provide a template for other clinics that are interested in becoming licensed to use Y-90 IsoPet. Dr. Michelle Meyer from Vista Veterinary Hospital, our first pilot regional clinic located in the state of Washington, observed the procedure as part of her qualification training to become an authorized user of Y-90 IsoPet. This fulfills a requirement for Vista to obtain their radioactive material handling license from the Washington State Department of Health. Vivos is assisting Vista in applying for, and obtaining their license which will provide a template for other clinics that are interested in becoming licensed to use Y-90 IsoPet.
A
Not really true! but you pointed out a direction on how Vivos do a better job for investor relationship.
We for sure need the release of the conference slides and most recently updated company presentation. The website info is great but company presentation was not updated up to now!!!
with this, it should generate very minimum regulation issues about the safety of using this polymer, which will lead to faster FDA approval for human clinical trials
The polymer for Radiogel, it has good features of biocompatibility, biodegradability, thermosensitivity and easy controlled characters, it is wildly used in biomedical applications
J Control Release. 2013 Dec 28;172(3):715-29. doi: 10.1016/j.jconrel.2013.10.006. Epub 2013 Oct 18.
https://www.ncbi.nlm.nih.gov/pubmed/24144918
Poly(ethylene glycol)-poly(lactic-co-glycolic acid) based thermosensitive injectable hydrogels for biomedical applications.
Alexander A1, Ajazuddin, Khan J, Saraf S, Saraf S.
Author information
Abstract
Stimuli triggered polymers provide a variety of applications related with the biomedical fields. Among various stimuli triggered mechanisms, thermoresponsive mechanisms have been extensively investigated, as they are relatively more convenient and effective stimuli for biomedical applications. In a contemporary approach for achieving the sustained action of proteins, peptides and bioactives, injectable depots and implants have always remained the thrust areas of research. In the same series, Poloxamer based thermogelling copolymers have their own limitations regarding biodegradability. Thus, there is a need to have an alternative biomaterial for the formulation of injectable hydrogel, which must remain biocompatible along with safety and efficacy. In the same context, poly(ethylene glycol) (PEG) based copolymers play a crucial role as a biomedical material for biomedical applications, because of their biocompatibility, biodegradability, thermosensitivity and easy controlled characters. This review stresses on the physicochemical property, stability and composition prospects of smart PEG/poly(lactic-co-glycolic acid) (PLGA) based thermoresponsive injectable hydrogels, recently utilized for biomedical applications. The manuscript also highlights the synthesis scheme and stability characteristics of these copolymers, which will surely help the researchers working in the same area. We have also emphasized the applied use of these smart copolymers along with their formulation problems, which could help in understanding the possible modifications related with these, to overcome their inherent associated limitations.
AGREED NO MORE
RADIOGEL AND RDGL are real!!! It can not be real any more!!!
it is not ethical calling it scam, be human with respectful and thanksgiving hearts
Fact2 of radiogel
it uses insoluble y-90 phosphate microparticles as the source of belta-emitter, very minimum penetration distant, very short half life of 65 hrs, therefore less bilateral damage to normal tissues around the tumor, leading to less side effects! it is applied in clinical radiotherapies, why not the safer delivery approach can not prosper???-no need for testing in clinic trials
Fact 1 about radiogel
Radiogel uses PEGylated PLGA (PEG-PLGA) polymer as delivery matrix, it was safe and less toxic
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5405708/
Drug Delivery Nanoparticles: Toxicity Comparison in Retinal Pigment Epithelium and Retinal Vascular Endothelial Cells
Multiple synthetic polymer nanoparticles (NPs) have been widely used as drug delivery systems. However, their toxicity to the retinal pigment epithelium and retinal endothelium remains unclear. In this study, we analyze the cytotoxic effects of three different kinds of NPs, made of poly lactic-co-glycolic acid (PLGA), polycaprolactone (PCL), and PEGylated PLGA (PEG-PLGA), in a retinal pigment epithelium cell line (ARPE-19) and in primary human retinal vascular endothelial cells (RVEC). PEG-PLGA NPs presented the lowest cytotoxicity on ARPE-19 cells and RVEC as assessed by MTT viability assay. While PLGA and PCL exhibited variable amount of toxicity, no significant toxicity was observed when incubating cells with high PEG-PLGA concentrations (100ug/ml), for up to 6 days. On both transmission electron microscopy and confocal microscopy, Rhodamine 6G-loaded PEG-PLGA NPs were observed intracellularly in multiple subcellular organelles. PEG-PLGA NPs are a potentially viable option for the treatment of eye diseases.
Information of Radiogel and its company
Vivos has exclusively licensed Yttrium-90 (Y-90) polymer composite technology from *Battelle Memorial Institute, developed at Pacific Northwest National Laboratory, a leading research institute for government and commercial customers.
Subject to receipt of all required regulatory approvals from the FDA in the United States and analogous regulators outside of the United States, Vivos plans to introduce a new Y-90-based brachytherapy product line for a range of applications for the delivery of a prescribed dose of radiation to a target site.
BRACHYTHERAPY MARKET:
RELIABLE SOURCES ESTIMATE THAT ANNUAL GLOBAL SALES OF BRACHYTHERAPY PRODUCTS CURRENTLY EXCEED $1 BILLION; ABOUT HALF OF WHICH ARE IN THE UNITED STATES. THE SIZE OF THE U.S. BRACHYTHERAPY MARKET FOR PROSTATE CANCER BRACHYTHERAPY IS SOMEWHERE BETWEEN $90 MILLION AND $130 MILLION PER YEAR. THE MARKET FOR LIVER AND BREAST CANCER COMBINED IS COMPARABLE.
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.
•Optimized Delivery Method: Current brachytherapy devices place permanent metal seeds in the prostate by using up to 30 large needles. By contrast, Vivos’s Y-90 RadioGel™ device is designed to be administered in a minimally invasive procedure with small-gauge needles.
•No Permanent Seeds Remaining: Current brachytherapy devices place permanent metal seeds in the tumor. Vivos’ Y-90 RadioGel™ device utilizes a biodegradable, non-toxic polymer that is ultimately absorbed by the body. This eliminates the possibility of a long-term seed migration or other problems that may sometimes arise when seeds remain in the body.
•Good Safety Profile: Many traditional brachytherapy devices utilize isotopes that emit x-rays (akin to gamma radiation). X-rays or gamma radiation travels within and outside of the body and have long half-lives. Vivos’ brachytherapy products use the Yttrium-90 isotope, which is a beta-emitter. The Yttrium-90 beta-emissions travel only a short distance and has a short half life of 2.7 days.
•Potential Lower Cost: Yttrium-90 supplies are readily accessible and are relatively inexpensive. The elimination of the metal or glass enclosures used in traditional brachytherapy seeds greatly reduces manufacturing costs.
* Battelle is the world's largest independent research and development organization. Headquartered in Columbus, Ohio, Battelle oversees 22,000 employees in more than 130 locations worldwide. Battelle has managed the U.S. Department of Energy's Pacific Northwest National Laboratory in Richland, Wash., since the laboratory's inception in 1965.
Great News!!! Real RDGL does Real GOOD things!!!
Yes, there is a risk of losing huge without holding position!!!, know what we own with patience!
Radiogel will be effectively killing the primary solid cancers, which are inoperable. The strong thing with it is this will kill the cancer stem cells as well, so it will sensitize the combination therapies like chemo or immunotherapies.
do the DD, see the forest
great, skin and prostate cancers are the easiest ones that radiogel can help with, with gaining great experiences, this will treat solid tutors as a routine choice, especially for brain cancer, liver cancer,et cl.
This is right! News soon will hit and we get back to at least 2 cents