Vivos Therapeutics has announced a change in its senior management team, appointing Roman Franklin as its new Chief Financial Officer. The appointment follows the resignation of Bradford Amman, who previously held the CFO role at the biotechnology company.

The company disclosed the leadership transition in a filing with the U.S. Securities and Exchange Commission (SEC). The filing confirms that Roman Franklin assumes the responsibilities of the Chief Financial Officer immediately, ensuring continuity in the company's financial operations.

Bradford Amman's departure marks the end of his tenure as CFO. The SEC filing does not provide specific reasons for his resignation or details regarding any transition period beyond the immediate appointment of his successor.

Leadership Transition

The change in financial leadership is a standard corporate governance update. Vivos Therapeutics, focused on developing therapies for genetic diseases, aims to maintain stability through this executive shift.

This structural adjustment ensures that Vivos Therapeutics continues to have dedicated oversight for its financial strategy and reporting obligations.

Vivos Inc. has received approval from the U.S. Food and Drug Administration (FDA) for its Investigational Device Exemption (IDE) application to begin a first-in-human feasibility study for RadioGel. This approval allows the company to initiate a US-based study using RadioGel, an innovative yttrium-90-based injectable hydrogel for the targeted treatment of cancerous tumors. The study aims to evaluate the safety and feasibility of the therapy in patients with non-resectable papillary thyroid carcinoma.

The clinical trial will be conducted at Mayo Clinic in Jacksonville, FL. The protocol is expected to initially enroll five patients, and the results will help shape subsequent pivotal trials. The FDA determined that the company provided sufficient data to support the initiation of the investigation, with the conditions of approval incorporated into the protocol for Mayo Institutional Review Board (IRB) review.

Study Details and Objectives

The feasibility study focuses on assessing the safety profile of RadioGel in human patients. Preclinical studies in veterinary patients and laboratory animals demonstrated the safety and effectiveness of Yttrium-90 RadioGel precision radionuclide therapy (PRnT) in cancer treatment. Histopathology across multiple studies confirmed no radiation-associated adverse effects in any normal organs or tissues.

Management Commentary

Brad Weeks, President of Vivos Inc., stated that the IDE approval is a major milestone validating the strength of the company's preclinical and clinical data. He emphasized that advancing RadioGel into human studies brings the company closer to delivering a precise, minimally invasive cancer therapy.

Mike Korenko, CEO of Vivos Inc., added that receiving FDA IDE approval represents the culmination of years of dedicated work. He expressed confidence in RadioGel as a breakthrough approach in precision radionuclide therapy and highlighted the partnership with Mayo Clinic as a critical step toward bringing the therapy to patients.

Strategic Focus

Vivos continues to advance its multi-track strategy, which includes expanding commercial adoption of IsoPet for veterinary oncology and advancing non-U.S. clinical research and commercialization opportunities for RadioGel. The company is also pursuing international licensing and monetization opportunities for the PrecisionGel platform while progressing RadioGel through the U.S. regulatory pathway for human cancer therapy.