I think the company has made fabulous progress.....Vivos Inc Successfully Treats Canine Sarcoma with IsoPet™ (RadioGel™)
Richland, WA, May 31, 2018 (GLOBE NEWSWIRE) -- Vivos Inc (OTC: RDGL) successfully treated canine soft tissue sarcoma with its proprietary IsoPet™ (RadioGel™), a hydrogel liquid containing tiny yttrium-90 phosphate particles that may be administered directly into a tumor.
A veterinary cancer specialist at the University of Missouri—Columbia successfully treated a soft-tissue tumor in the hind thigh of a Sheltie. Soft tissue sarcoma is a relatively common tumor in dogs. The treatment procedure demonstrated ability to place yttrium-90 uniformly in the tumor for precision high-dose radiation therapy. The status of the dog patient will be followed over the next six months as we evaluate safety and efficacy of yttrium-90-RadioGel treatment.
Immediately after treatment, the Sheltie was imaged using the University’s new state-of-the-art, high-resolution Celesteion positron-emission tomography/x-ray computed tomography (PET/CT) imaging system, which enables clinicians to evaluate the surgical placement of RadioGel™. Medical imaging showed highly uniform placement of RadioGel™ within the tumor boundaries without significant vascular migration of yttrium-90 to any nearby normal organ or tissue.
This treatment and imaging study provides important validation of RadioGel™ design properties and directly addresses U.S. Food and Drug Administration questions concerning behavior of RadioGel™ within the tumor.
In technical terms, RadioGel™ in the tumor was imaged by virtue of x-ray contrast density provided by the ingredient yttrium phosphate, which was clearly imaged by computed tomography (CT).
The uniform biodistribution of yttrium-90 was confirmed by positron-emission tomography, which maps the origin of radioactive decays from individual Y-90 atoms distributed within the tissues. The images showed a uniformly distributed radiation source in the tumor.
Ability to deliver a very high-dose therapeutic radiation to non-surgically-resectable tumors without significant dose to normal tissues provides a key advantage over conventional external beam therapy.
Mike Korenko, Vivos CEO, said, “The treatment went exceedingly well. We delivered a very high dose to the tumor with negligible radiation to the surrounding healthy tissues, and the post-administration medical imaging confirmed uniform placement. The inherent safety of a pure beta-emitting medical isotope, such as yttrium-90, translates directly to low radiation doses to the treating physician. We believe that this treatment represents a major step toward commercialization of IsoPet for animal therapy. We designed this test series with a dual purpose as part of the testing that the FDA requires before we begin clinical trials for treating cancer in humans. The success of this test is an important milestone in that process.”
We anticipate treating another five or more canine subjects in the current test series. With this continuing series of treatments, we will further refine our product labeling and the training that will be provided to veterinarians that want to use our product in the future. We will also be sharing these data as we continue discussions with private veterinary clinic consortiums.
Photos taken during the first canine treatment are posted on our website: www.RadioGel.com.
Vivos Inc Obtains Trademark Protection for IsoPet®
Richland, WA, July 30, 2018 (GLOBE NEWSWIRE) -- Vivos Inc (OTC: RDGL) obtains IsoPet trademark protection.
The U.S. Patent and Trademark Office (“USPTO”) issued the Certificate of Registration for the mark ISOPET (Reg. No. 5,476,327) in Class 5.
Mike Korenko, Vivos CEO says “This is an important step in protecting our intellectual property. Our other protections include a licensing agreement to key patents and trademark protection of RadioGel in seventeen countries, but our best protection is still the detailed proprietary product formulation and production techniques.”
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.”
