RDGL news Vivos Inc 2018 Highlights GlobeNewswire "Press Releases"
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:
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.
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.
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:
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.
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.
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.
The first canines 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.
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.
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.
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.
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
Initiate the commercial sales of IsoPet.
Secure adequate funding to expand IsoPet therapy in key regional centers.
Begin the pre-clinical testing for human therapy.
File for additional patent(s) to enhance our intellectual property protection.
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 strength our companys 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 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: Michael K. Korenko , President & CEO of Vivos Inc.
MKorenko@RadioGel.com
Source: Vivos Inc.
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:
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.
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.
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:
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.
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.
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.
The first canines 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.
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.
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.
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.
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
Initiate the commercial sales of IsoPet.
Secure adequate funding to expand IsoPet therapy in key regional centers.
Begin the pre-clinical testing for human therapy.
File for additional patent(s) to enhance our intellectual property protection.
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 strength our companys 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 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: Michael K. Korenko , President & CEO of Vivos Inc.
MKorenko@RadioGel.com
Source: Vivos Inc.
