Vivos Inc., a medical device company pioneering Precision Radionuclide Therapy™ (PRnT) for the treatment of cancerous tumors, has received its State of Washington Radioactive Materials License for the manufacturing of IsoPet®. This regulatory authorization enables the company to commence in-house production of its animal health division's product at its new domestic manufacturing facility. The company anticipates shipping its first production run in the near future to support the expansion of certified IsoPet® treatment centers nationwide.

The license clears the way for manufacturing operations at the Applied Process Engineering Laboratory (APEL) in Richland, Washington. This facility will serve as the production site for IsoPet®, marking a significant step in the company's operational capabilities within the state. David Swanberg, Chief Operating Officer of Vivos Inc., stated that securing the license enables the establishment of reliable, compliant domestic manufacturing capabilities to scale production and meet growing demand from veterinarians and pet owners.

Operational Expansion

The approval allows Vivos to integrate manufacturing directly into its operations at APEL. The facility is positioned to support the production needs of the company's animal health division. Following this grant, Vivos will immediately apply for an amendment to add RadioGel® to the license. This amendment will support clinical trials in the United States and, as necessary, internationally.

Facility Details

IsoPet® delivers a high therapeutic dose of Yttrium-90 directly into the tumor, providing a precise, effective treatment option with minimal impact on surrounding healthy tissue. The company continues to see strong interest and adoption growth in its animal therapy division.

Vivos Therapeutics, Inc. intends to file a registration statement with the U.S. Securities and Exchange Commission (SEC) for a proposed rights offering to raise capital for operations and general corporate purposes. The company plans to distribute transferable subscription rights to shareholders as a dividend, subject to the SEC declaring the registration statement effective. The record date is proposed to be set as the 30th day following the registration statement being declared effective by the SEC, though there is no assurance regarding the timing of effectiveness.

The rights offering includes an exercise price set at the greater of $1.25 per share or 20% above the market price on the day before the record date. Shareholders will have a nine-month period to exercise these rights, which are intended to be listed for trading on a securities exchange pending satisfaction of listing and regulatory requirements. Additionally, the offering features a subsequent "exploding" right, granting holders a similar nine-month trading right upon the exercise of the initial right.

The subsequent right carries an expected exercise price of $1.75 per share or 40% above the market price on the day before the record date, whichever is greater. This structure is designed to incentivize early participation by offering potentially more favorable terms to those who exercise their initial rights promptly. All terms remain preliminary and indicative, with final details to be set forth in the prospectus.

Key Terms of the Proposed Rights Offering

Completion of the offering is subject to several conditions, including the preparation and effectiveness of the registration statement, compliance with exchange rules, and the availability of authorized but unissued shares. This may require an amendment to the company's certificate of incorporation and a shareholder vote. R. Kirk Huntsman, Chief Executive Officer of Vivos Therapeutics, stated that the offering is intended to provide additional capital to support operations, though the company gave no assurance it will be commenced or completed.