Announcement • Jul 28
Vivos Inc. Receives FDA Approval for Feasibility Investigational Device Exemption Application and Provides Update on Precision Radionuclide Therapy Clinical Trials and Product Pipeline Vivos Inc. received approval from the U.S. Food and Drug Administration (FDA) for its Feasibility Investigational Device Exemption (IDE) application. This clearance enables the company to initiate its first-in-human feasibility study at Mayo Clinic in Jacksonville, Florida, targeting patients with non-resectable papillary thyroid carcinoma. The study aligns with the company's Breakthrough Device Designation and will initially enroll five patients to evaluate safety and feasibility. Data from this trial will inform the design of subsequent pivotal studies. Following structured communications with the FDA, the agency reduced the safety follow-up period from five years to the standard 24 months. The company has been working closely with the Mayo Clinic in parallel with the IDE submission to ensure submission to the Mayo Institutional Review Board (IRB) within their required process and as quickly as reasonably possible. The company is now in the final stages of that submission. The company made significant progress with its clinical work in India, which provided important supportive data for its FDA IDE approval. The Principal Investigator recently reported that the company now has sufficient patient data, after meeting several clinical follow-up endpoints, to prepare and submit an article for publication in a peer-reviewed scientific journal. Multiple clinical trials at the Healthcare Global Enterprises Hospital (HGC) study hospital, including the company's, were temporarily paused as part of a broader internal review and audit process undertaken by new HGC management. This pause was unrelated to RadioGel® or the company's clinical study results, which remain very favorable. The hospital’s Ethics Committee and Clinical Trials Registry (CTRI) approvals for this study remain in place. The company anticipates receiving The Drugs Controller General of India (DCGI) approval for its Principal Investigator at HGC to resume human treatments under the FDA-aligned protocol by the end of 2026. The company is also in active discussions with its regulatory experts in India and DCGI regarding next steps. Following their guidance, the company is preparing submissions for DCGI approval to conduct a formal Phase I/II clinical trial at HGC. In addition, the company has identified two additional hospitals for the expansion of clinical trials, which will broaden its intended use. The company is working closely with its regulatory experts to leverage its clinical data from the RadioGel® trials in India to support a commercialization strategy. The animal therapy business continues to expand steadily. The company now supports 17 certified clinics across the U.S. that have treated more than 200 small animals and horses. These cases have consistently demonstrated the safety and effectiveness of IsoPet therapy. The company has recently signed agreements with two veterinary clinics in California and one in North Carolina, and has a strong pipeline of additional clinics in the works. The company is prioritizing peer-reviewed publications, including studies on treating surgical margins of resected tumors and equine ocular tumors, in which it eliminated tumors on the eye without damaging that critical organ. The company believes it offers the leading and often only practical therapeutic option for equine therapy. These publications will support strategic price adjustments to move toward break-even and help internally fund the company's human development programs. The required validation activities are underway at Applied Process Engineering Laboratory (APEL) and nearing completion with strong emphasis on sterility and the company's robust Quality Management System. The company is on target to ship IsoPet from this facility for veterinary use by the end of this quarter. The company also expects to produce material at APEL to support the resumption of human therapies in India once their DCGI approval is granted. APEL will further serve as a key site to support additional international clinical trials. The company is adding an ISO Class 7 clean room for enhanced protection and will also use the facility for ongoing process improvements. The company has executed a contract with a reputable supplier of radioactive pharmaceuticals to replicate its production capabilities at APEL and has begun procuring the necessary equipment. The company's Vivos Scientific India LLP positions it for efficient supply to India and neighboring markets while preparing for broader international commercialization. The recent FDA IDE approval has already opened doors for increased interest from other countries in expanding clinical trials. The company will be conducting a strategic meeting in Fourth Quarter 2026 with Key Opinion Leaders (KOLs) to gain consensus on the optimum path to expand RadioGel® and IsoPet® therapy internationally, initially produced from its two facilities. The company is currently in high level discussions with investigators at leading institutions in several countries. Over the past several years, the company has been optimizing the properties of its proprietary hydrogel. Its unique thermogelling characteristics allow it to remain liquid when mixed with the company's yttrium-90 phosphate particles, enabling hydrostatic pressure to perfuse the patented particles deep into the tumor, where it then gels upon exposure to body temperature. Akina Inc. has recently submitted a paper for publication in a scientific journal sharing a portion of the company's data. The company is currently evaluating the release characteristics of its hydrogel with a variety of therapeutic agents. In addition to its patent protection, the company is offering the polymer and sterile hydrogel for research sale and has received interest from universities and major pharmaceutical companies. The company anticipates this effort will generate moderate cash flow while growing gradually. 
