September 2026 · Summary of Activities Implementing the Strategic Plan
Earlier this month, we conducted our Business Strategy Advisory Board meeting, where we reached consensus on the actions required to complete our current development phase and to launch Vivos into the final major business phase. The following summarizes where those actions stand.
The steps to commercialize RadioGel® human therapy in the United States and internationally are similar, and the approval timelines are universally long. The interim benefits of the international clinical program are substantial and are described below. In the near term, the fastest path to generating a profitable business using this breakthrough technology is through animal therapy.
COMPLETING THE DEVELOPMENT PHASE
Shareholder Communication
A Question-and-Answer section has been established on the Company website to respond to shareholder questions in a public and transparent forum. This channel is intended to provide more direct communication between management and shareholders than is possible through restricted emails or formal press releases.
Peer-Reviewed Scientific Publications
A peer-reviewed paper characterizing the PrecisionGel™ thermogel polymer platform was accepted and published in the Journal of Drug Delivery Science and Technology in September 2026. PrecisionGel™ is one of two independently patented components of both RadioGel® and IsoPet®. Peer-reviewed publication is the gold standard for validating biomedical technology in the pharmaceutical and medical device community and will support both regulatory submissions and licensing discussions with pharmaceutical partners.
APEL Production Center Optimization
This month, we successfully shipped IsoPet® that met specifications to five clinics. We are finalizing a new state-of-the-art clean room installation to further enhance sterility at APEL. The final validation testing is scheduled for next month. Vivos invested in this structure since sterility is our most important manufacturing specification.
LAUNCHING THE MAJOR BUSINESS PHASE
International Human Therapy Clinical Studies
The international clinical program serves four specific objectives:
- Generate clinical data that support and complement the U.S. feasibility study.
- Generate data across multiple indications for use, thereby building the scientific foundation for international centers of excellence to treat several cancers.
- After the years of clinical study that every country requires, obtain international regulatory approval for commercialization in each jurisdiction.
- Use the accumulated international data with the FDA to expand the approved indications for use in the United States.
The Company is pursuing the establishment of a global network of international centers of excellence, each specializing in different indications for use, where patients who currently have no viable treatment options will have access to Precision Radionuclide Therapy™. Citizens of the world will have the opportunity to participate in these studies.
In India, principal investigators at Health Care Global Cancer Centre (HCG) in Bangalore and the Asian Institute of Medical Science (AIMS) have been confirmed. Twelve patients have been treated with consistently favorable results. A Phase 1 clinical trial application to India’s Central Drugs Standard Control Organisation is in preparation for submission in Q12027. A publication on the India human therapy clinical data is also being prepared.
In Mexico, a first engagement visit with a leading national cancer center has been completed. A follow-up visit is scheduled for November 2026 to advance the clinical study relationship.
U.S. Human Therapy Clinical Program
A full high-activity refresher training session is being scheduled at the lead U.S. clinical institution, with the intent to invite a member of the Institutional Review Board to participate. This session will demonstrate successful execution of the FDA-recommended improvements to the protocol, validate the material flow logistics from the new APEL production site, and provide the IRB with direct visibility into our readiness. This is a disciplined and necessary step on the critical path to treating human patients in the U.S. and reflects our commitment to executing the process in a disciplined and thorough manner.
Quality Management and Regulatory Certification
An integrated project plan to meet ISO 13485 quality management system certification requirements is being developed, with a surrogate audit planned as the first step. ISO 13485 is a prerequisite for commercial device registration in the European Union, United Kingdom, Australia, Japan, and South Korea.
Patent and Trademark Protection
A comprehensive patent gap analysis has been completed. The analysis confirmed that both PrecisionGel™ and Sterile Thermogel can be protected in all Tier 1 and Tier 2 target countries, with PCT nationalization deadlines of July 30, 2027, and February 28, 2029, respectively. Trademark protection gaps in the UAE, Saudi Arabia, and Mexico have been identified as urgent prerequisites for commercial engagement in those markets. Filings are being initiated.
IsoPet® Animal Therapy
IsoPet® has been classified by the FDA as a device for commercial veterinary use in the United States. It is the Company’s clearest near-term path to profitability. Unlike human therapy, which requires phased clinical studies before commercial use in any jurisdiction, IsoPet® requires only veterinary device registration, which can be achieved in less than 20 months in several priority countries.
Reducing the cost per therapy at APEL directly determines how quickly the Animal Therapy Division reaches profitability. The ongoing effort to reduce APEL production costs, expand the IsoPet® clinic network, and build international veterinary partnerships is designed to reach that profitability as quickly as possible.
- Market pricing increases are being initiated across the certified clinic network to align with production costs and establish long-term commercial viability.
- International partnership targets have been identified in the Arabian Peninsula for equine and camel therapy, where IsoPet® is the only viable treatment option for solid tumors in large animals.
- Three additional peer-reviewed veterinary publications are in preparation. The standard for marketing in this sector is peer-reviewed data, i.e., the same publications that support regulatory submissions also build veterinarian and oncologist credibility and clinic adoption.
Board of Directors Composition
We intend to increase the size of the Board of Directors to align with the Major Business Phase strategy. Four new directors have been identified and interviewed, each providing expertise directly required for the next phase of execution: an executive with financial and accounting expertise; a physician with direct RadioGel® experience and a record of guiding medical device programs from regulatory authorization to commercial adoption; a recently retired CEO with an excellent record of growing a high-technology company; and an international regulatory and quality systems expert with direct experience in GMP and ISO 13485. We anticipate that these board appointments will occur prior to year-end.
Each of the actions above is a specific step in the strategic plan the advisory board defined this month. Updates on individual milestones will be shared as they are confirmed.
Michael K. Korenko, Sc.D.
Chief Executive Officer, Vivos Inc. (OTCQB: RDGL)
