Vivos Inc (RDGL)

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A LOOK BACK ON THE LAST 10 YEARS

Murray Includes $1.25 Million for Cutting-Edge Cancer Research in Kennewick

Oct 15 2009

Funding will allow company to continue developing promising new cancer treatment

(WASHINGTON, D.C.) – Today, U.S. Senator Patty Murray (D-WA) announced that that the the $1.25 million she included for cancer research at Advanced Medical Isotope Corporation in the fiscal year 2010 Senate Energy and Water Development appropriations bill has been included in the final version of the spending bill. The bill has now been approved by both houses of Congress after passing the Senate today by a vote of 80-17 and will now head to the President who is expected to sign it into law.

“This funding will help maintain the Tri-Cities position at the cutting edge of scientific research and development,” said Senator Patty Murray. “I am pleased to support the work of Washington state scientific researchers as they work to develop new technologies to fight cancer.”

Advanced Medical Isotope Corporation’s project will develop, test, and conduct research needed for FDA pre-market approval for a new polymer seed containing millions of tiny yttrium-90 microspheres. The seeds can be surgically implanted in tumors, just as radioactive metal seeds are placed in prostate and brain cancer patients. This treatment will provide an effective, highly localized and efficient method for treating against the more radiation-resistant brain tumors, pancreatic, head and neck tumors, and kidney tumors.

https://www.murray.senate.gov/public/index.cfm/2009/10/murray-includes-$1.25-million-for-cutting-edge-cancer-research-in-kennewick


AMIC Signs Exclusive Global License for Advanced Resorbable Yttrium-90 Brachytherapy Seeds

Oct. 7, 2010 (GlobeNewswire) --

KENNEWICK, Wash., Oct. 7, 2010 (GLOBE NEWSWIRE) -- Advanced Medical Isotope Corporation, ("AMIC") (OTCQB:ADMD), a company engaged in the production and distribution of medical isotopes, is delighted to announce the execution of an exclusive world-wide license for patented technology for a proprietary brachytherapy seed with a fast-dissolving matrix for optimized delivery of radionuclides to cancer tissue.

The resorbable seed provides controlled delivery of insoluble yttrium-90 microspheres. The new seed is a joint invention by radiochemists and medical physicists at Battelle in Richland, Washington, and pharmaceutical chemists at the University of Utah in Salt Lake City, Utah. AMIC is testing and conducting research to develop the new brachytherapy seed, and anticipates filing Premarket Notification (510k) with the FDA in October, 2010. According to AMIC CEO James C. Katzaroff, "Yttrium-90 is an important high-energy beta-emitting medical isotope with outstanding potential for treating highly localized cancer. Controlled delivery of yttrium-90 microspheres in fast-resorbable seeds should provide a unique opportunity to maximize the therapeutic index. This feature should provide high-dose therapy of non-recectable solid tumors with minimal side-effects to neighboring normal tissues."

AMIC anticipates the use of these seeds for prostate cancer as well as for many of the more radiation-resistant cancers such as brain tumors, head and neck tumors, and liver cancer. The resorbable seeds resemble conventional metal brachytherapy seeds and may be placed by direct injection using standard needles, grids, and imaging systems. However, AMIC expects that the technology should enable seed manufacturing at lower-cost relative to conventional welded-metal seeds.

Unlike current seeds that remain in the body emitting low levels of penetrating photon radiation for extended periods of time, yttrium-90 decays with a shorter physical half-life (2.7 days), with negligible radiation outside the patient. The shorter half-life also suggests a potentially higher biological effective dose (BED) value for cancer cell destruction. The insoluble form of the yttrium-90 microspheres effectively confines the radioactivity to the injection site and limits potential dissolution into blood. "Yttrium-90 continues to demonstrate outstanding properties of a preferred medical isotope for cancer treatment, said AMIC Chief Science Officer, Dr. Robert Schenter, "it has been used very effectively as microspheres for treating liver cancer and in cell-directed immunotherapy (Zevalin) for treating non-Hodgkin's Lymphoma. Yttrium-90 is readily available from commercial suppliers.

Advanced Medical Isotope Corporation Files 510(k) Pre-Market Notification for FDA Clearance of Yttrium-90 RadioGel(TM) Brachy...

11/03/2013 @ 7:22PM

"Advanced Medical Isotope Corporation ("AMIC") (OTCBB:ADMD), a company engaged in the development, production and distribution of medical isotopes, today announced that it has filed pre-market notification to the FDA pursuant to Section 510(k) of the U.S. Food, Drug and Cosmetic Act for its Yttrium-90 RadioGel™ patented brachytherapy cancer product.

Pursuant to Section 510(k), the FDA has 90 days in which to clear the device for commercial distribution or to seek additional information. The FDA previously confirmed that it would review the product as a medical device. Following notification of FDA clearance, the Company would immediately have the right to commence manufacturing, marketing and sales of the product in the United States and its possessions subject to FDA jurisdiction.

The Company intends to file FDA pre-market notifications for two related Yttrium-90 "Y-90" brachytherapy products promptly after receiving either clearance from the FDA for the Y-90 RadioGel™ device, or any comments from the FDA to its application.

Brachytherapy uses radiation to destroy cancerous tumors by placing a radioactive isotope inside or next to the treatment area. Annual sales of brachytherapy products exceed $1 billion, about half of which are in the United States. Among the cancers for which brachytherapy is often selected as a treatment are prostate, liver, breast, head and neck cancerous tumors. AMIC's products may also offer treatment options for certain pancreatic cancers.

In the United States, annual sales of brachytherapy products for prostate cancer exceed $160 million. Once it receives FDA clearance, AMIC intends to begin marketing efforts in the United States for its Y-90 RadioGel™ device with a focus on prostate cancer. Thereafter, AMIC intends to offer the device for other cancers. In addition, AMIC intends to seek opportunities to license its products for worldwide sales. Sales outside of the United States will be subject to the applicable local regulatory approvals.

Based on comparisons of the indications for use, design, materials, and functionality, AMIC believes the Y-90 RadioGel™ brachytherapy device is substantially equivalent to predicate devices previously granted clearance by the FDA, as referenced in the 510(k) application. The discussion in this press release is subject to the more complete disclosures and analyses set forth in its 510(k) application.

The composition and uses of AMIC's brachytherapy products are protected by a series of exclusive patent licenses from the Battelle Memorial Institute and the University of Utah.

The three Y-90 brachytherapy devices developed by AMIC are:

Y-90 RadioGel™ – combined insoluble Y-90 microspheres and a polymer carrier that is injected directly into the tumor;
Y-90 Fast-Resorbable Polymer Seeds – intended as a safer, more effective and less expensive alternative to existing metal and glass seeds used in other brachytherapy devices;
Y-90 Polymer Topical Paste – intended as a supplemental treatment to be applied into a surgical incision to kill residual tumor cells.
As noted above, the 510(k) application filed by AMIC pertains only to the Y-90 RadioGel™ device.

AMIC's analyses support an expectation that its brachytherapy products will achieve a higher therapeutic index than existing brachytherapy products, while reducing collateral damage to healthy tissue due to the shorter penetration distance, shorter half-life and other attributes of the device as compared to brachytherapy devices that use isotopes emitting gamma radiation. These features also reduce the risk of radiation exposure to the patient, family members and medical personnel involved in manufacturing and injecting the device. The AMIC Y-90 RadioGel™ device uses a biodegradable carrier with FDA approved components which leaves no metal or glass in the patient.

AMIC anticipates that these features will permit it to reduce the cost of manufacturing, compared to existing brachytherapy products. AMIC intends to pass along a portion of any savings to its customers, permitting medical practice groups, hospitals, insurers and patients to share in the anticipated cost benefit.

Initially, the Company likely will seek to outsource material aspects of manufacturing, distribution, sales and marketing in the United States. Outside of the United States, the Company likely will enter into licensing arrangements. The Company will evaluate its alternatives before finalizing its plans.

The anticipated introduction of the Yttrium-90 products will mark AMIC's transition from a development-stage company to an operating company. AMIC CEO Jim Katzaroff commented: "Once AMIC receives clearance from the FDA for its Y-90 RadioGel™ brachytherapy device, we will commence operations with a product that will help save lives and that we believe offers therapeutic benefits, reduced risk of radiation exposure for healthy tissue and a lower cost of manufacturing. The introduction of these products would begin a new era for AMIC."


KENNEWICK, WA / ACCESSWIRE / May 23, 2017 / Advanced Medical Isotope Corporation (OTC PINK: ADMD).


Dear shareholders,

This letter is to inform you of the progress on our veterinarian market activities (IsoPet).

I have been asked about the status of our first cat that was injected in November at Washington State University to treat feline sarcoma. That cat is alive and well after an objective response without any negative side effects. This first treatment, at a relatively low dose, tested our procedures and provided valuable clinical experience.

On May 12, we treated a second cat at Washington State University with a large sarcoma, escalating the therapy dose by about 50 percent. The cat has been returned to her owner and we will monitor the progress on response to therapy over the next several weeks. Results of these early clinical studies will help us to respond to questions posed by the FDA on therapeutic efficacy and safety. The detailed procedures that we are refining with these cat therapies are the same that we will be using to treat human skin cancer. Both are tumors at the surface of the skin.

We will initiate pre-clinical tests in surrogate tumor tissue at Colorado State University this month to complete their safety review and evaluation requirements for first clinical therapeutic use, anticipated in June. Likewise, the independent safety review at University of Missouri will be completed in a month, with first therapy to follow in June. We will next assess the University of California at Davis, which has the reputation of being a premier veterinary teaching center in the United States.

On the financial side, as discussed in our 10-Q, we successfully raised additional interim capital to retire some maturing debt and exchanged the remaining maturing debt that was outstanding for debentures that mature in May of 2018. This removes the near term uncertainty and now allows AMI to fully focus on execution of our plan for an uplisting later in the year.

We timely filed our 10-Q with the SEC and we anticipate holding an annual shareholder meeting in late June or early July. Since the 10-Q is now in the public domain, I have purchased another 100,000 shares of stock since, in my opinion, the stock is undervalued by a significant margin.

Mike Korenko
CEO
Advanced Medical Isotope Corporation


Vivos FDA Lawyer John J. Smith, M.D., J.D. Hogan Lovells: Global Lawyers - International Law Firm

As both a physician and a lawyer, John Smith combines clinical and regulatory experience relating to the Food and Drug Administration (FDA) with a practical approach to addressing the FDA regulatory issues facing his clients. He places a particular focus on bringing device-based technologies to market.

A board-certified diagnostic radiologist and former associate professor of radiology at Harvard Medical School, John joined the Hogan Lovells Medical Device Group in 2005. Since then, he has assisted clients in a range of FDA premarket submissions, including 510(k) notices, de novo reclassification petitions, humanitarian device exemption applications, and premarket approval applications, including the advisory panel process.

John identifies successful regulatory strategies and presents them to the FDA via the pre-submission process; he assists with problem submissions through submission-issue meetings and administrative appeals. He also navigates the increasingly challenging FDA compliance landscape, addressing 483 and Warning Letter issues.

Bringing new products to the U.S. market is continually complex and demanding. Having worked in the medical device area in academia, industry, and at Hogan Lovells, John understands how to address both pre- and postmarket FDA regulatory issues. His practical approach has guided clients through successful marketing applications, addressed significant differences of opinion with the FDA through submission-issue meetings and regulatory appeals, and provided crucial support through challenging FDA enforcement actions. To serve his clients, John draws on the broad experience and skills of his colleagues in the Medical Device Group and effectively communicates with reviewers and decision makers at the FDA. A Super Lawyers designee for multiple years, John is a leader in the medical device bar and well known to the FDA.


RICHLAND, Wash., Sep 14, 2017 (GLOBE NEWSWIRE via COMTEX) --

Advanced Medical Isotope Corporation ("AMI") (otc pink:ADMD), a late stage radiation oncology focused medical device company's business plan is to generate initial revenues from animal therapy while pursuing FDA approval to use RadioGel(TM) for skin cancer in humans. The strategy is to prove the safety and effectiveness of the product via testing at four university veterinary hospitals.

Consolidation in the private veterinary clinic space enables the Company to cost-effectively form business arrangements with the large consortiums of private clinics. We met and had discussions with the Veterinary Cancer Group (VCG) and with VCA Inc. to gain firsthand information on the steps required to market RadioGel(TM) in the commercial sector. VCG has 55 veterinary centers feeding into three specialty clinics. VCA has 820 clinics in the US and Canada feeding into approximately 25 specialty treatment centers.

Both consortiums confirmed the importance of learning from the testing that we are sponsoring at the university veterinary centers. They encouraged us to publish the results in a scientific journal. VCG was interested in teaming with the universities by conducting some of the testing in their own facilities. They both emphasized the importance of obtaining a written confirmation from the veterinary side of the FDA that RadioGel(TM) is a device. After the data collection is completed the results will be sent to their internal review boards for approval. The final stage is a business contract to purchase RadioGel(TM) for use in their clinics.

Cancer is the leading cause of death for 32% of cats and 50% of dogs over age ten. Treating just 10% of pet cancers at an average treatment cost of $5,000 could generate $40 million in annual revenue for the Company. RadioGel [TM] will provide a more effective therapy that will benefit both the pets and their owners.

Getting into the field is the best way to start building the relationships and to determine precisely the steps required for implementation. We requested confirmation from the FDA Center for Veterinary Medicine (CVM) that RadioGel [TM] is also designated as a device for use in animals since we have been confirmed since 2013 as a device for use in humans. We anticipate completing the majority of the university testing in the 1 [st] quarter of 2018.

About Advanced Medical Isotope Corporation ("AMI") ADMD
The strategic market sector of Advanced Medical Isotope Corporation (AMI) is isotope applications. Currently, the Company is engaged in the development of RadioGel(TM), an Yttrium-90 based brachytherapy device, for the treatment of tumors. Brachytherapy uses radiation to destroy cancerous tumors by placing a radioactive isotope inside the treatment area.

The company is engaging the FDA for permission to use RadioGel(TM) for the treatment of advanced basal and squamous cell skin cancers. The IsoPet Solutions division of AMI is focused on demonstrating the safety and therapeutic effectiveness for different animal cancers in four different university veterinary hospitals. AMI is positioning itself so that after this demonstration phase, The Company can begin to generate revenues through the sale of RadioGel(TM) to private animal clinics.

The Company currently is outsourcing material aspects of manufacturing of its product in the United States and intends to enter into licensing arrangements outside of the United States for the manufacturing and distribution of RadioGel(TM) in other countries.


Advanced Medical Isotope Corporation Reports Positive Results from Initial Study at WSU

September 26, 2017

RICHLAND, WA--(Marketwired - Sep 26, 2017) - Advanced Medical Isotope Corporation (OTC PINK: ADMD), a late stage radiation oncology focused medical device company, is pleased to report positive results from the initial study of RadioGel™ at Washington State University (WSU).

In the study, researchers at WSU used RadioGel to treat two cats for feline sarcoma. The results indicate RadioGel performed as designed, confirming objective response (destruction of tumor tissue) without any negative or detrimental side-effects.

"We are thrilled to see confirmation of RadioGel's potential," stated Dr. Mike Korenko, CEO of ADMD. "The clinical research team at WSU safely achieved near-uniform placement of RadioGel under ultrasound guidance, using the same parallel injection technique that will also be used to treat human skin cancer tumors."

Subsequent cat subjects referred to WSU will be treated at higher radiation doses to optimize levels for therapy.

The results of the initial study were published in a report, 'A Research Update on RadioGel™ for Treating Feline Sarcomas', which can be viewed on the IsoPet section of ADMD's website https://www.radiogel.com/isopet/animal-studies-updates. Additional status and progress updates of future animal testing will also be made available on this page.

It is estimated six million new cancer diagnoses are made in dogs and a similar number made in cats each year (see http://ccr.nci.nih.gov). Treating 0.5% of these cases, at an estimated price of $5,000, would generate approximately $300 million in annual revenue, significantly higher than the Company's previous conservative projection of $40 million.

About Advanced Medical Isotope Corporation (OTC PINK: ADMD)

The strategic market sector of ADMD is isotope applications. Currently, the Company is engaged in the
development of RadioGel, an Yttrium-90 based brachytherapy device, for the treatment of tumors. Brachytherapy uses radiation to destroy cancerous tumors by placing a radioactive isotope inside the treatment area.

The company is engaging the FDA for permission to use RadioGel for the treatment of advanced basal and squamous cell skin cancers. The IsoPet Solutions division of ADMD is focused on demonstrating the safety and therapeutic effectiveness for different animal cancers in four different university veterinary hospitals. ADMD is positioning itself so that after this demonstration phase, The Company can begin to generate revenues through the sale of RadioGel to private animal clinics.

The Company currently is outsourcing material aspects of manufacturing of its product in the United States and intends to enter into licensing arrangements outside of the United States for the manufacturing and distribution of RadioGel in other countries.


Advanced Medical Isotope Corporation (ADMD) Refines Strategy to Accelerate Penetration of Veterinary Market

RICHLAND, WA, Nov. 17, 2017 (GLOBE NEWSWIRE) -- Advanced Medical Isotope Corporation (OTC PINK: ADMD), a late-stage radiation oncology-focused medical device company, is initially focusing its animal therapy development efforts on canine soft-tissue sarcomas and feline sarcomas; which the Company believes will establish a short-term pathway to market for its RadioGel™ product in the veterinary services industry. Once these therapies are effectively commercialized, the Company plans to expand its efforts into the treatment of other animal cancers.

Mike Korenko, CEO of ADMD, stated, “Our focused strategy will optimize the use of our precious investor dollars and allow us to enter the private clinical market prior to completing the animal testing on the wider variety of cancers. As an added benefit, this same data we generate from our initial animal studies will also be used to fulfill part of the requirement for our human pre-clinical testing.”

In September 2017, the Company filed a request for device product classification from the Center for Veterinary Medicine (CVM), a division of the US Food and Drug Administration (FDA). The Company’s legal team at Hogan Lovells, a top multi-national law firm, is helping to respond to comments received from the CVM, and management believes ultimately RadioGel will receive device classification.

Animal testing of RadioGel is underway at the University of Missouri. RadioGel therapy has completed the university’s Internal Safety Review and the detailed test plan is being reviewed by the Principal Investigator. Because this testing will be used for the pre-clinical testing for application in humans, the test package will also be sent for final review by the human side of the FDA. Therapy treatment on animals will begin as soon as final comments are received from the FDA. This testing now has a dual benefit and is a critical path for both the veterinary and human markets.

After canine therapy testing is complete, the University of Missouri will shift its focus to equine sarcoids as the next animal indication for use. In addition, the University of California at Davis will use RadioGel to demonstrate advanced therapies, such as treating prostate cancer.

“We previously announced our efforts to develop relationships with consortiums of private clinics as the most effective way to expedite our roll-out," commented Korenko. "Through these discussions, it was clear that publishing our results with the Veterinary Cancer Society (VCS) would provide significant benefit. To that end, the first poster on RadioGel was presented at the VCS annual meeting in late October."

At the meeting, held in Portland on October 26-28, Tomoko Takahashi of Nihon University in Japan delivered the first presentation on RadioGel. Takahashi also expressed interest in using RadioGel upon her return to Japan next year, which should benefit the Company’s strategy to obtain international licensing.

During the VCS annual meeting, ADMD personnel met with Phillip Bergman, DVM, MS, PhD., the Director of Clinical Trials for VCA. Dr. Bergman expressed enthusiasm for RadioGel as a novel product that could be used to improve access to radiation therapy beyond the 12 veterinary centers that currently provide traditional radiation therapy treatments. He also emphasized the benefit to patients, owners, and vets of the “once and done” aspect of a RadioGel treatment versus the typical courses of radiation therapy or chemotherapy that require several weeks and multiple exams by the veterinarian.

Dr. Bergman is a former President of VCS and observed several new product launches over the years. He understands the pitfalls that new products may experience and emphasized the importance of garnering the support of key opinion leaders to drive the adoption of a new product in the marketplace. His support will be key to gaining inroads within the veterinary market for a variety of indications for use.

“We believe we’re in a strong position to execute,” concluded Korenko. “As we move forward with this focused strategy, multiple milestones can be achieved in the near-term, setting the stage for sustainable, long-term growth.”

About Advanced Medical Isotope Corporation (OTC: ADMD)

The strategic market sector of ADMD is isotope applications. Currently, the Company is engaged in the development of RadioGel™, an Yttrium-90 based brachytherapy device, for the treatment of tumors. Brachytherapy uses radiation to destroy cancerous tumors by placing a radioactive isotope inside the treatment area.

The company is engaging the FDA for permission to use RadioGel™ for the treatment of advanced basal and squamous cell skin cancers. The IsoPet Solutions division of ADMD is focused on demonstrating the safety and therapeutic effectiveness for different animal cancers in four different university veterinary hospitals. ADMD is positioning itself so that after this demonstration phase, The Company can begin to generate revenues through the sale of RadioGel™ to private animal clinics.

The Company currently is outsourcing material aspects of manufacturing of its product in the United States and intends to enter into licensing arrangements outside of the United States for the manufacturing and distribution of RadioGelTM in other countries.


Advanced Medical Isotope Corporation (ADMD) Announces Corporate Name Change to Vivos Inc., and Ticker Symbol Change to RDGL


Richland, WA, Jan. 02, 2018 (GLOBE NEWSWIRE) -- Advanced Medical Isotope Corporation (OTCPink: RDGL) announced today that it has changed its name to Vivos Inc., and that its shares are scheduled to trade under the new symbol, RDGL, on the OTC Markets on January 2, 2018. Both of these changes represent a rebranding of the Company to reflect its focus on RadioGelTM for the treatment of skin cancer. Our new name, which reflects the giving of life, captures the essence of our Company mission. In addition to these rebranding efforts, management anticipates qualifying the Company’s common stock for quotation on the OTCQB in the near-term with the longer-term goal of a listing on a national exchange.

Mike Korenko, CEO, said “Our new name better reflects the description of our current and near-term product and markets. After obtaining approval to treat skin cancer, we intend to grow by expanding the cancers that we treat over time. We will also consider non-cancer applications, such as treating infections imbedded in bones that currently lead to amputation, which can occur is diabetic patients.”

Mr. Korenko continued, “We are very excited about the prospects for RadioGelTM to treat animals and humans. We continue to believe that our Company’s valuation does not currently reflect the underlying value of RadioGelTM and the large market opportunity in both the animal and human market. We appreciate the continued support of our shareholders and our note holders, who as previously reported on Form 8-K, agreed to eliminate all variable price conversion through April 15, 2018. We are excited about 2018 and maintain a firm belief in our mission to provide patient friendly solutions utilizing the unique RadioGel™ technology and to grow shareholder value.”


Richland, WA, Jan. 12, 2018 (GLOBE NEWSWIRE) -- Vivos Inc (OTC: RDGL) announced today that it has completed its planned dosing schedule to determine the effectiveness of using the Company’s proprietary RadioGel™ therapy to treat feline sarcoma.

An initial study of two cats was completed in September 2017 at Washington State University (WSU). The results of that study indicated RadioGel performed as designed, confirming objective response (destruction of tumor tissue) without any negative or detrimental side-effects.

Subsequently, an additional three cats with advanced cases of sarcoma were treated, two in December 2017 and one in January 2018. As planned, the additional treatment program was completed at higher radiation doses to optimize levels for therapy.

Dosimetry calculations show that lethal doses to the cancer cells will occur over the first ten days, after which, less than 5% of the radiation will remain in the animals. It will take approximately three months for the biopsy and follow-up analysis to further confirm the effectiveness of the therapy.

The final report from these studies will be shared with VCA as part of the Company’s continuing discussions about a business relationship in private veterinarian clinics.

The next step will be to generate data on the treatment of canine sarcoma at the University of Missouri. These data will also be shared with the private clinic consortiums and with the FDA as part of the Company’s pre-clinical testing for the use of RadioGel in humans.

Mike Korenko, CEO of Vivos, stated, “We want to thank our shareholders for the continued support and patience as we execute methodically on the plan we outlined in the fall. A disciplined approach is the best way to succeed in this highly regulated environment, and we continue to make meaningful steps forward toward our goals.”


Vivos Receives FDA Confirmation of RadioGel Device Classification for Animal Skin Cancer Therapy Richland, WA, Jan. 30, 2018 (GLOBE NEWSWIRE)


Vivos Inc (OTC: RDGL) announced today that it has been notified by the FDA that RadioGel™ is classified as a device for animal therapy.

After four months of dialog with the Center for Veterinary Medicine Product Classification Group we received a ruling that RadioGel is classified as a device for animal therapy of feline sarcomas and canine soft tissue sarcomas.

The FDA also reviewed and approved our label, which is a requirement for any device used in animals. Based on the FDA recommendation, RadioGel™ will be marketed as IsoPet™ for use by veterinarians to avoid any confusion between animal and human therapy. Vivos already has trademark protection for the IsoPet name.

The Company’s feline sarcoma therapy series at Washington State University was completed in January. Those tests were designed to optimize our procedures and to determine the optimum dose. The tests demonstrated that RadioGel™ is safe and effective in killing cancer cells.

In February, we plan to start recruiting canine skin cancer patients to be treated at the University of Missouri, incorporating lessons learned at WSU.

The animal therapy data generated from these studies will also be used in the pre-clinical data required by the FDA as part of the testing required for treating skin cancer in humans. After all the pre-clinical testing is completed we will submit an Investigational Device Exemption to obtain permission to initiate human clinical trials.

In April we plan to begin therapy at University of California Davis on canine prostate and liver cancers. Later, we will continue our testing at the University of Missouri to treat equine sarcoids. As we expand the indications for use of IsoPet™ we intend to communicate with the FDA to confirm the device designation applies. Having established a precedent for classification of skin cancer therapy as a device makes it highly likely that subsequent cancers will also be ruled similarly. Obtaining FDA approval in stages should increase the probability of success and provide the fastest path to commercializing our product in the animal sector.

We continue to communicate our progress with potential strategic partners. In the future, we anticipate interacting with their technical review teams to assess the results of our animal therapies and endorse our product. We will then determine the optimum business relationship to sell IsoPet™, with the goal of leveraging the broad national presence of our strategic partner.

Dr. Mike Korenko stated “Obtaining this approval is an important step to set the stage for selling IsoPet to the private clinics for animal therapy. By being labeled a device there are no other regulatory approvals necessary for treating skin cancer, the most common cancer in animals. We chose a conservative path of obtaining FDA classification early with full and open communication on our intent in order to remove any future uncertainty in the regulatory space.”

Richland, WA, May 01, 2018 (GLOBE NEWSWIRE) -- Vivos Inc (OTC: RDGL) announced today the results from the therapy for feline sarcoma.


Five cats were treated at Washington State University over the course of 15 months for feline sarcoma. The cat patients had advanced disease and relatively large tumor masses. The objectives of the study were fulfilled. The technique was refined, the dose was optimized and the treatment was effective in the regions where the Y-90 IsoPet was placed without radiation side-effects.

The final report is near completion and the results will be presented at the Annual Meeting of the Society of Nuclear Medicine and Medical Imaging (SNMMI), June 23-26, 2018, Philadelphia, Pennsylvania.

Dr. Mike Korenko, Vivos Inc CEO, stated “We are now confident that IsoPetTM can be used to effectively treat feline sarcoma. We are sharing these data with the private clinic consortiums. Our next step is to confirm the effectiveness of IsoPetTM in treating canine soft tissue sarcoma via testing at the University of Missouri.” These are positive steps toward demonstrating the effectiveness of this technology as a precision, high-dose therapy for a wide range of cancers.


Vivos Inc Sets the Stage for the Introduction of IsoPet® (RadioGel™) to the Veterinarian Community


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.


Vivos Inc Signs a Standstill Agreement with Debt Holders Designed to Halt the Toxic Selling and Eliminate the Secured Toxic Debt

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™.”


First Successful Treatment of Canine Sarcoma using IsoPet® to be Presented at Veterinary Cancer Society Conference

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.

Vivos Inc Signs Memorandum of Understanding with Private Veterinary Hospital as Pilot Clinic for Commercial IsoPet® Therapy

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.





Request for Withdrawal of Registration Statement on Form S-1 and Pre-Effective Amendment No. 1 on Form S-1/A filed on March 10, 2017 and February 9, 2018, respectively
(File No. 333-216588)

United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549

Vivos Inc


Ladies and Gentlemen:

Pursuant to Rule 477 under the Securities Act of 1933, as amended (the “ Securities Act ”), Vivos Inc (the “ Company ”) hereby requests that the Securities and Exchange Commission (the “ Commission ”) consent to the withdrawal of the Company’s registration statement on Form S-1 (File No. 333-216588), filed with the Commission on March 10, 2017, and pre-effective Amendment No. 1 to such registration statement, filed with the Commission on February 9, 2018 (such registration statement and the amendment to such registration statement, together with all exhibits, collectively, the “ Registration Statement ”).

The Company is seeking withdrawal of the Registration Statement because it no longer wishes to conduct a public offering of securities at this time. The Company believes that withdrawal of the Registration Statement is consistent with the public interest and the protection of investors, as contemplated by Rule 477(a) under the Securities Act. Please note that the Registration Statement was not declared effective by the Commission and no securities of the Company were sold pursuant to the Registration Statement.

Accordingly, the Company requests that the Commission issue an order granting the withdrawal of the Registration Statement (the “ Order ”) effective as of the date hereof or at the earliest practicable date hereafter. Please send copies of the Order to the undersigned at 719 Jadwin Avenue, Richland, Washington 99352.

The Company further respectfully requests that, in accordance with Rule 457(p) under the Securities Act, that all fees paid to the Commission in connection with the filing of the Registration Statement be credited to the Company’s account for future use.

If you have any questions regarding this application for withdrawal, please contact Bruce Jolliff, the Company’s Chief Financial Officer, at 509-736-4000.