RDGL nice news out Vivos Inc. Successfully Administers IsoPet to a Second Dog for Canine Sarcoma at the University of Missouri GlobeNewswire "Press Releases"
Richland WA , Oct. 26, 2018 (GLOBE NEWSWIRE) -- Vivos, Inc . (OTC PINK: RDGL) 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 .
Dr. Charlie Maitz , the University of Missouri veterinarian reported The procedure today went really well. Because the tumor was oddly shaped, I ended up administering the remaining 0.02 ml in what looked to be the most underdosed region. I was happy with how the injections went. 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. He recovered well from anesthesia and will likely be discharging on Monday.
Dr. Mike Korenko , Vivos Inc CEO stated We anticipated this to go well based on our past experience with the procedures described in the product labeling coupled with Dr. Maitzs high level of competence and expertise. 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.
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.
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 companys 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:
Vivos Inc. Michael K. Korenko , President & CEO
MKorenko@RadioGel.com
Source: Vivos Inc.
Richland WA , Oct. 26, 2018 (GLOBE NEWSWIRE) -- Vivos, Inc . (OTC PINK: RDGL) 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 .
Dr. Charlie Maitz , the University of Missouri veterinarian reported The procedure today went really well. Because the tumor was oddly shaped, I ended up administering the remaining 0.02 ml in what looked to be the most underdosed region. I was happy with how the injections went. 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. He recovered well from anesthesia and will likely be discharging on Monday.
Dr. Mike Korenko , Vivos Inc CEO stated We anticipated this to go well based on our past experience with the procedures described in the product labeling coupled with Dr. Maitzs high level of competence and expertise. 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.
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.
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 companys 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:
Vivos Inc. Michael K. Korenko , President & CEO
MKorenko@RadioGel.com
Source: Vivos Inc.
