https://www.otcmarkets.com/stock/RDGL/security
Vivos Inc Signs Memorandum of Understanding with Private Veterinary Hospital as Pilot Clinic for Commercial IsoPet® Therapy https://www.otcmarkets.com/stock/RDGL/news/story?e&id=1184491 Richland, WA, Oct. 02, 2018 (GLOBE NEWSWIRE) -- Vivos Inc (OTC: RDGL) selected its first clinic for commercial sales of IsoPet
Vivos Inc., a pharmaceutical company in the process of researching and developing minimally invasive treatments to combat cancer in humans and animals, announced today that the Vista Veterinary Hospital in Kennewick WA, located near Vivos’ headquarters, has been selected for the commercial launch of IsoPet® therapy. After several meetings with the clinic’s veterinarian owners, a Memorandum of Understanding has been signed.
Vivos’ strategy is to partner with several regional clinics across the country using this pilot program to provide practical experience to be shared with other potential regional clinic partners. Having selected a local clinic as the pilot provider of IsoPet™ therapy will make for cost-effective frequent site visits for the assistance of facility set-up, certification training, and radioactive material handling licensing. Certification training and the process of acquiring a Radioactive Material License for the clinic from the Washington State Department of Health has begun.
It is expected that as the successful results of the therapies become known, pet owners from as far as Spokane, Seattle and Portland will seek to have their affected animals treated at the Vista Clinic. It is estimated that more than 9 million people live within 250 miles of Kennewick.
Dr. Mike Korenko, Vivos CEO stated “Best management practice dictates that we pilot partnering with a private clinic prior to expanding to other regional clinics across the county. We will gain practical experience, such as the effectiveness of our certification training and the time and effort required to obtain the Radioactive Material License. This will optimize the process of engaging with other treatment centers”.
As noted in a previous press release, the company will introduce IsoPet® to the larger veterinarian community at the annual Veterinary Cancer Society Conference to be held in Louisville, KY October 17-20, 2018.
About Vivos Inc. (OTC: RDGL)
Vivos, Inc. 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 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 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.
© 2018 GlobeNewswire, Inc.
First Successful Treatment of Canine Sarcoma using IsoPet® to be Presented at Veterinary Cancer Society Conference https://www.otcmarkets.com/stock/RDGL/news/story?e&id=1180102 Richland, WA, Sept. 26, 2018 (GLOBE NEWSWIRE) -- Vivos Inc (OTC PINK: RDGL) first therapy to canine treat soft tissue sarcoma is successful
Vivos Inc, a pharmaceutical company in the process of researching and developing minimally invasive treatments to combat cancer in humans and animals, is pleased to report several significant outcomes after its signature product, IsoPet®, was used to treat a hind-leg soft-tissue sarcoma in a Sheltie at the University of Missouri Veterinary Health Center in Columbia, Missouri.
Veterinary oncologist, Dr. Charles Maitz, reported that the treatment of the sarcoma resulted in a “complete response,” meaning tumor destruction and disappearance, together with a healthy recovery. Results will be presented in at the Veterinary Cancer Society’s annual conference in Louisville, Kentucky, October 17 – 20, 2018.
After therapy the pet owner commented that the dog had more energy than she can remember for a long time. “The owner is delighted!” said Dr. Maitz.
Study investigators were also pleased that IsoPet® met all RadioGel™ design performance criteria. Post-treatment imaging and dosimetry provided confirmatory data addressing the principal questions previously raised by an FDA review panel, including:
Near-uniform placement by injection and interstitial perfusion within the tumor without vascular clearance to normal organs and tissues
Very high therapeutic ratios (radiation dose to the tumor relative to normal organs)
Effective, highly localized, high-dose radiotherapy, and complete absence of adverse side-effects in critical normal tissues
The University of Missouri is now advertising availability of IsoPet® treatment for dogs and other species, including treatment of equine (horse) sarcoids.
Mike Korenko, Vivos Inc CEO stated “The successful treatment of the cat and dog subjects thus far increases the likelihood of IsoPet® becoming a practical solution in the treatment of animal cancer. Additionally, the data obtained at the University of Missouri will support the pre-clinical investigations required by the FDA to provide evidence that RadioGel™ can be safe and effective for treating various human cancers.”
About Vivos Inc. (OTC: RDGL)
Vivos, Inc. has developed an yttrium-90-based brachytherapy injectable device for treating tumors in animals (IsoPet®) and in humans (Radiogel™). Brachytherapy employs highly localized minimally invasive radiation to destroy cancerous tumors by placing a radioactive isotope directly inside the treatment area using the company’s proprietary hydrogel formulation. The injections deliver 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 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 continue.
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.
© 2018 GlobeNewswire, Inc.
Amending and Replacing the Initial Press Release on George Sharp; Disregard the first release: https://www.otcmarkets.com/stock/RDGL/news/story?e&id=1179493 Richland, WA, Sept. 25, 2018 (GLOBE NEWSWIRE) -- Vivos Inc. (OTC: RDGL), a pharmaceutical company in the process of researching and developing minimally invasive treatments to combat cancer in humans and animals, today announced that it has retained well-known microcap analyst and consultant, George Sharp, as an advisor to the company. Mr. Sharp will advise Vivos on its business strategy, financing endeavors and its commitment to investor interests.
Vivos Inc. President, Mike Korenko, stated, “As we discovered from an unsolicited July 17, 2018 article written by George and posted on his blog, George is very supportive of our efforts towards developing cancer treatments, and to date, Vivos remains the only microcap issuer that he has ever endorsed.”
Mr. Korenko went on to say, “George's experience as an advocate for individual investors in the microcap space, has garnered him a significant following, and his respect is a commodity valued by Vivos. We look forward to George’s continued contribution as we endeavor to execute on the agreements outlined in our previous press release to eliminate the toxic debt and provide critical funding for product development.”
"I am thrilled for the opportunity to work with Vivos’ management and I am encouraged by their dedication to create a valuable company that can improve therapeutic results and quality of life for those needing treatment and reward investors for their support of this important effort. This is a genuine commitment rarely found within the OTC Markets”, stated George Sharp. "I look forward to making my small contribution towards finding less invasive treatments for cancer through my continued support of the company."
About Vivos Inc. (OTC: RDGL)
Vivos, Inc. 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 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 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.
About George Sharp
Drawing from his experiences as a litigant, investigator and forensic researcher, George Sharp consults with attorneys and publicly-traded companies seeking to protect investors. He has appeared on television and referenced in the print media for his efforts to combat microcap fraud. To learn more about George Sharp's services, visit www.clippercp.com.
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.
© 2018 GlobeNewswire, Inc.
Vivos Inc Retains Well-Known Analyst, George Sharp, as Advisor - Updated https://www.otcmarkets.com/stock/RDGL/news/story?e&id=1179363 Richland, WA, Sept. 25, 2018 (GLOBE NEWSWIRE) -- Vivos Inc. (OTC: RDGL), a pharmaceutical company in the process of researching and developing minimally invasive treatments to combat cancer in humans and animals, today announced that it has retained well-known microcap analyst and consultant, George Sharp, as an advisor to the company. Mr. Sharp will advise Vivos on its business strategy, financing endeavors and its commitment to investor interests.
Vivos Inc. President, Mike Korenko, stated, “As we discovered from an unsolicited July 17, 2018 article written by George and posted on his blog, George is very supportive of our efforts towards developing cancer treatments, and to date, Vivos remains the only microcap issuer that he has ever endorsed.”
Mr. Korenko went on to say, “George's experience as an advocate for individual investors in the microcap space, has garnered him a significant following, and his respect is a commodity valued by Vivos. We look forward to George’s continued contribution as we endeavor to execute on the agreements outlined in our previous press release to eliminate the toxic debt and provide critical funding for product development.”
"I am thrilled for the opportunity to work with Vivos’ management and I am encouraged by their dedication to create a valuable company that can improve therapeutic results and quality of life for those needing treatment and reward investors for their support of this important effort. This is a genuine commitment rarely found within the OTC Markets”, stated George Sharp. "I look forward to making my small contribution towards finding less invasive treatments for cancer through my continued support of the company."
About Vivos Inc. (OTC: RDGL)
Vivos, Inc. 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 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 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.
About George Sharp
Drawing from his experiences as a litigant, investigator and forensic researcher, George Sharp consults with attorneys and publicly-traded companies seeking to protect investors. He has appeared on television and referenced in the print media for his efforts to combat microcap fraud. To learn more about George Sharp's services, visit www.clippercp.com.
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.
© 2018 GlobeNewswire, Inc.
Vivos Inc Signs a Standstill Agreement with Debt Holders Designed to Halt the Toxic Selling and Eliminate the Secured Toxic Debt https://www.otcmarkets.com/stock/RDGL/news/story?e&id=1177528 Richland WA , Sept. 24, 2018 (GLOBE NEWSWIRE) -- Vivos, Inc. (OTC PINK: RDGL)
Vivos Inc is pleased to announce that all the debtholders of Vivos’ secured convertible debt have agreed to a ten trading day market standstill, during which time they agree to refrain from any conversions or to trade in our security. The market standstill will be in effect from Wednesday September 26th through Wednesday October 10. Pursuant to the terms of the agreement, and subject to completion of a capital raise with proceeds of at least $500,000, the remaining outstanding balance on these secured debentures, which totals approximately $2,500,000 of principal and accrued interest, will automatically convert into common stock (or convertible preferred stock for conversions that would result in ownership in excess of 4.99% of the company’s common shares) at a fixed conversion price of $.004. These shares will be subject to a restriction on any sales below $.02 through December 31, 2018 and will have volume limitations on any sales below $.01 for the first six months of 2019.
Mike Korenko, Vivos Inc CEO, stated “It is our goal for the new capital to come in the form of common stock and warrants. In addition, we may consider additional financing in the form of convertible debt that automatically converts into a larger equity financing or converts at a fixed conversion price. Upon the successful completion of these transactions we plan to have a company free of convertible toxic debt moving forward. We are confident that we will be successful, but there is no guarantee that we will complete the transactions described above. We look forward to providing an update related to the financing in the next couple of weeks and we will continue to communicate developments related to Isopet® and Radiogel™.”
About Vivos Inc. (OTC: RDGL)
Vivos, Inc. 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 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 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.
© 2018 GlobeNewswire, Inc.
Vivos Inc Signs a Standstill Agreement with Debt Holders Designed to Halt the Toxic Selling and Create a Debt Free Company https://www.otcmarkets.com/stock/RDGL/news/story?e&id=1177256 Richland WA, Sept. 21, 2018 (GLOBE NEWSWIRE) -- Vivos, Inc. (OTC PINK: RDGL)
Vivos Inc is pleased to announce that all the debtholders of Vivos convertible debt have agreed to a 10 day standstill, during which time they agree not to convert any more debt into common stock as well as not trade in our security. The purpose of the standstill agreement is to give Vivos time to raise new capital. As part of the standstill agreement, the debtholders will agree to remove the variable rate convertible features from their debt upon the successful completion of the capital raise and convert the balance of their debt into common stock and preferred stock at a fixed price. The new capital coming in would also be common stock, not variable rate convertible debt. Upon the successful completion of these transactions we plan to have a company that is debt free moving forward. We are confident that we will be successful but there is no guarantee that we will complete the transactions. We look forward to providing updates in the next couple of weeks.
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.
© 2018 GlobeNewswire, Inc.
Vivos Inc Sets the Stage for the Introduction of IsoPet® (RadioGel™) to the Veterinarian Community https://www.otcmarkets.com/stock/RDGL/news/story?e&id=1141383 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.
© 2018 GlobeNewswire, Inc.
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