2022 has come to a close and we are pleased to share our business update for the end of December.
IsoPet® Therapies:
- We treated our second horse, which had a very large tumor, at our new regional clinic, the New England Equine Practice. This one-pound tumor required 500 mCi (millicurie) of yttrium-90 (90Y), and was a healthy test of the limits of our Precision Radionuclide Therapy (PRnT)®.
- Brew’s IsoPet® Therapy on late-stage cancer appears to be successful. The cancer was an advanced sarcoma and had killed a large amount of healthy tissue, but apparently, the IsoPet® killed the cancer. The small animal could not resorb that much necrotic tissue so it was surgically removed. Now it appears to be healing. If this works, IsoPet® prevents an amputation.
Marketing – Precision Radionuclide IsoPet® Therapy:
- Dr. John Hendrick joined our Veterinary Medicine Advisory Board bringing in senior technical and business experience.
- After three (3) years of effort, Vivos Inc. was provided the opportunity to deliver a presentation to the Mars Veterinary Health Pet Cancer Care Alliance. This Alliance is an advisory board to over 3000 clinics across the world.
- We used our contacts to put the word out in Los Angeles that we can treat celebrity pets with cancerous tumors.
(Mike Korenko, Sc.D • CEO • President – Press Release – January 3, 2023)
Preparation for the Investigational Device Exemption ( IDE ):
- We completed the biocompatibility data after almost two years of effort. RadioGel™ passed the test, our most protracted and expensive pre-clinical testing.
- IsoTherapeutics succesfully completed the particle sterility validation testing.
VX-2/Tumor Study:
- Our VX-2/Tumor Study is underway and on-track. When the testing is complete data will be presented to the FDA.
- We contracted Pearl Pathways to be the independent quality control agent as required by the FDA to validate as 'GLP-Like.'
- We prepared a detailed protocol with key tracking points to ensure compliance with the plan.
Intellectual Property:
Vivos Inc issued a press release today January 3, 2023 that they filed a provisional patent application on the system equipment to support precision radionuclide therapy.
This includes Shipping Containers, Shielded Vial Holder, a Peltier chiller, and Syringe Shields.
Previously we could only communicate this effort by jeopardizing the patentability. It has been a long substantial effort to streamline all the system devices that IsoPet®/RadioGel™ use, from shipping to therapy.
These devices are integrated into our standardization effort. They can treat tumors ranging from 0.5-gram human lymph nodes to half-pound equine tumors. This equipment was just tested at our equine therapy in NY.
We will make this equipment available to the Mayo Clinic and the therapists in all our current and future regional clinics.
SHIPPING CONTAINER
Eliminated the can and the lead pig containers and designed the shielding of the new plastic container to improve the ease of unpackaging and to ensure that we can ship to White 1 label (UN2910) standards to reduce the FedEx shipping costs and logistics.
SHIELDED VIAL HOLDER
Designed stability in securing the vials while filing the syringes and maximized the vial holder wall thickness to reduce the relatively low radiation further.
PELTIER CHILLER
- Designed to chill the vial holders and the syringes.
- Avoids the potential contamination from ice baths, a Mayo Clinic concern for human clinical trials.
- Contains an embedded magnetic stirrer to keep the IsoPet solution particles in suspension.
- Each syringe port can be dedicated to a specific human lymph node, a specific VX-2 tumor in animal testing, or as a staging center for treating larger animal tumors.
SYRINGE SHIELD
- Maximized the diameter of the syringe shield to reduce radiation while designing the finger position to optimize ergonomics.
- Received very positive feedback from the therapists about the ergonomics. This flexibility is important to ensure accuracy in precision injections.
Dr. Mike Korenko stated “This equipment development occurred over the entire year while incorporating practical experience and feedback from our therapists. We will make this equipment available to the Mayo Clinic for human clinical trials and to the therapists in all our current and future regional clinics.”
Happy New Year.
Mike Korenko, Sc. D
CEO & President Vivos, Inc.
CONTACT:
Vivos Inc.
Michael K. Korenko, Sc.D.
President & CEO
Home Page Cover Image:
Veterinarian Dr. Michelle Myer from Vista Veterinarian Hospital in Kennewick, WA.
Seen here administering IsoPet® therapy to a feline suffering from a sarcoma.
RadioGel™ is a hydrogel liquid containing tiny yttrium-90 (90Y) phosphate particles that may be administered directly into a tumor. The hydrogel is an yttrium-90 carrier at room temperature that gels within the tumor interstitial spaces after injection to keep the radiation sources 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® Therapy Application(s)
Precision Radionuclide Therapy (PRnT)
Vivos Inc. - (OTCQB: RDGL) Investor Relations
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