RDGL news Vivos Inc Sets the Stage for the Introduction of IsoPet (RadioGel) to the Veterinarian Community GlobeNewswire "Press Releases"
Richland, WA , Aug. 02, 2018 (GLOBE NEWSWIRE) -- Vivos Inc (OTC: RDGL) finalizes its plan to introduce IsoPet to the veterinarian community.
IsoPet was designated as a device by the FDA and the Center for Veterinary Medicine has reviewed Vivos labeling and instructions for use for treating feline and canine sarcomas. This means that we have the green light to sell our product commercially for veterinary use. We believe that it is prudent to first complete the clinical study currently underway at the University of Missouri using IsoPet to treat canine sarcomas. We are projecting the IsoPet product debut by October of this year to allow time to collect more data on this indication for use.
The first product introductory step was recently accomplished by Dr. Alice Villalobos , Chair of our Veterinary Medicine Advisory Board . She has just published the 2nd edition of her book entitled, Canine and Feline Geriatric Oncology: Honoring the Human-Animal Bond. It is considered the Bible of Veterinary Oncology and features IsoPet/RadioGel in three separate places.
An important vehicle for engaging thought leaders and early adopters in the veterinary community is through professional society conferences. The two premier conferences are annual meetings of the Veterinary Cancer Society (VCS) and the American College of Veterinary Radiology (ACVR). Attendance at these conferences will allow us to reach hundreds of veterinarians across the country and internationally.
Dr. Charlie Maitz , our principal investigator for canine sarcoma at the University of Missouri , will deliver a key-note presentation on the State of the Art of the Therapeutic use of Nuclear Medicine at the ACVR annual meeting in October 2018 . He is anxious to discuss IsoPet in that important forum.
Vivos Inc is a bronze contributor and will have a booth at the annual VCS conference in October 2018 . The VCS has just confirmed that our paper was accepted. It will summarize our therapies of feline sarcoma at Washington State University and canine soft tissue sarcomas at the University of Missouri . Dr. Janean Fidel from Washington State University , Dr. Charles Maitz from the University of Missouri and Dr. Darrell Fisher are co-authors. As a co-author and a member of the VCS I will be presenting the paper. I am also the introductory speaker for another presentation. This will be the first wide exposure of the veterinarian community to IsoPet.
Dr. Philip Bergman , a Director at VCA, one of our potential private clinic consortium partners, emphasized the importance of publishing in the VCS proceedings.
Mike Korenko , Vivos CEO, said, Our intent is to use the VCS conference to identify a list of initial users of IsoPet. We plan to select the optimum candidates in each of our targeted regions across the United States . We will offer to provide certification training and assist them in obtaining their radioactive material handling licenses. I am excited to be taking this important step. The animal testing has a dual purpose. It is also a key pre-clinical test to support human skin cancer therapy.
About Vivos Inc. (OTC: RDGL)
Currently, the Company has developed an Yttrium-90 based brachytherapy device, for the treatment of tumors in animals and humans. 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.
IsoPet for treating animals uses the same technology as RadioGelTM 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 of RDGL 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. RDGL is positioning itself so that immediately following this demonstration phase, The Company can begin to generate revenues through the sale of IsoPetTM to University animal hospitals and private veterinary clinic consortiums.
The Company is also engaging the FDA for clearance to market RadioGelTM 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 , Aug. 02, 2018 (GLOBE NEWSWIRE) -- Vivos Inc (OTC: RDGL) finalizes its plan to introduce IsoPet to the veterinarian community.
IsoPet was designated as a device by the FDA and the Center for Veterinary Medicine has reviewed Vivos labeling and instructions for use for treating feline and canine sarcomas. This means that we have the green light to sell our product commercially for veterinary use. We believe that it is prudent to first complete the clinical study currently underway at the University of Missouri using IsoPet to treat canine sarcomas. We are projecting the IsoPet product debut by October of this year to allow time to collect more data on this indication for use.
The first product introductory step was recently accomplished by Dr. Alice Villalobos , Chair of our Veterinary Medicine Advisory Board . She has just published the 2nd edition of her book entitled, Canine and Feline Geriatric Oncology: Honoring the Human-Animal Bond. It is considered the Bible of Veterinary Oncology and features IsoPet/RadioGel in three separate places.
An important vehicle for engaging thought leaders and early adopters in the veterinary community is through professional society conferences. The two premier conferences are annual meetings of the Veterinary Cancer Society (VCS) and the American College of Veterinary Radiology (ACVR). Attendance at these conferences will allow us to reach hundreds of veterinarians across the country and internationally.
Dr. Charlie Maitz , our principal investigator for canine sarcoma at the University of Missouri , will deliver a key-note presentation on the State of the Art of the Therapeutic use of Nuclear Medicine at the ACVR annual meeting in October 2018 . He is anxious to discuss IsoPet in that important forum.
Vivos Inc is a bronze contributor and will have a booth at the annual VCS conference in October 2018 . The VCS has just confirmed that our paper was accepted. It will summarize our therapies of feline sarcoma at Washington State University and canine soft tissue sarcomas at the University of Missouri . Dr. Janean Fidel from Washington State University , Dr. Charles Maitz from the University of Missouri and Dr. Darrell Fisher are co-authors. As a co-author and a member of the VCS I will be presenting the paper. I am also the introductory speaker for another presentation. This will be the first wide exposure of the veterinarian community to IsoPet.
Dr. Philip Bergman , a Director at VCA, one of our potential private clinic consortium partners, emphasized the importance of publishing in the VCS proceedings.
Mike Korenko , Vivos CEO, said, Our intent is to use the VCS conference to identify a list of initial users of IsoPet. We plan to select the optimum candidates in each of our targeted regions across the United States . We will offer to provide certification training and assist them in obtaining their radioactive material handling licenses. I am excited to be taking this important step. The animal testing has a dual purpose. It is also a key pre-clinical test to support human skin cancer therapy.
About Vivos Inc. (OTC: RDGL)
Currently, the Company has developed an Yttrium-90 based brachytherapy device, for the treatment of tumors in animals and humans. 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.
IsoPet for treating animals uses the same technology as RadioGelTM 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 of RDGL 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. RDGL is positioning itself so that immediately following this demonstration phase, The Company can begin to generate revenues through the sale of IsoPetTM to University animal hospitals and private veterinary clinic consortiums.
The Company is also engaging the FDA for clearance to market RadioGelTM 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.
