Papillary thyroid cancer (PTC) is the most common form of thyroid cancer, accounting for approximately 80–85% of all thyroid malignancies. Thanks to advances in surgery, radioactive iodine therapy, and long-term monitoring, most patients achieve excellent outcomes and enjoy long, healthy lives. However, not every patient’s journey ends after initial treatment.
Several patients develop persistent or recurrent disease within the lymph nodes of the neck. While these metastatic lymph nodes are often relatively small, their location presents one of the greatest challenges in modern thyroid cancer care. Many tumors are situated immediately adjacent to critical anatomical structures—including the recurrent laryngeal nerve, trachea, esophagus, carotid artery, jugular vein, and parathyroid glands—making treatment increasingly complex. For these patients, physicians are often faced with balancing effective cancer treatment against the risk of complications that can significantly impact long-term quality of life.
The Challenge of Recurrent Disease
The first surgery for papillary thyroid cancer is often highly successful. Unfortunately, when cancer recurs, every subsequent intervention becomes more technically demanding. Scar tissue from previous operations can obscure important anatomical landmarks, increasing the difficulty of safely removing recurrent disease. Repeat surgery may increase the risk of complications such as:
- Injury to the recurrent laryngeal nerve, resulting in vocal cord paralysis or chronic voice changes
- Damage to the parathyroid glands, leading to hypoparathyroidism and lifelong calcium management
- Injury to major blood vessels within the neck
- Increased surgical complexity due to scar tissue and altered anatomy
While surgery remains the standard of care for many patients, it is not always the ideal solution for every recurrence. Other treatment options also have important limitations. External beam radiation therapy can provide local disease control but often exposes surrounding healthy tissues to broader radiation fields. Patients may experience swallowing difficulties, dry mouth, fibrosis, and other long-term effects related to radiation exposure. Systemic therapies, such as tyrosine kinase inhibitors, can be effective for advanced disease but may represent overtreatment for patients with only one or a few isolated lymph node metastases. These medications also carry the potential for significant side effects.
For many patients, clinicians are left choosing between careful observation and treatments that may negatively affect quality of life. This represents an important unmet medical need.
A Different Way to Think About Radiation Therapy
RadioGel® was developed with a different philosophy. Rather than exposing an entire region of the neck to radiation, RadioGel® is designed to deliver radiation directly into the tumor through a precise intratumoral injection. Vivos Inc.’s proprietary hydrogel, PrecisionGel™, carries the therapeutic radioisotope, yttrium-90, directly into the metastatic lymph node. Once injected, the material rapidly forms a gel that helps retain the radioisotope within the tumor. This localized approach is designed to:
- Deliver a concentrated therapeutic radiation dose directly to the tumor
- Minimize migration of the radioisotope beyond the treatment site
- Reduce radiation exposure to surrounding healthy tissues
- Preserve nearby critical structures
Because papillary thyroid cancer lymph node metastases are frequently small—often measuring between 0.5 and 2.0 cm—they may be particularly well suited for the highly targeted treatment approach that RadioGel® can offer.
Preserving What Matters Most
For many patients with papillary thyroid cancer, survival is not the only goal. Most patients have an excellent long-term prognosis, making quality of life an equally important consideration. Protecting the ability to speak clearly, swallow comfortably, maintain normal calcium regulation, and avoid additional surgical complications can have a profound impact on everyday life. RadioGel® was designed to address these challenges precisely. By concentrating treatment within the tumor while limiting radiation exposure to surrounding anatomy, RadioGel® has the potential to provide meaningful local tumor control while preserving the structures responsible for voice, swallowing function, and normal neck anatomy. This tissue-sparing philosophy aligns closely with the broader movement toward precision medicine—delivering effective treatment while minimizing unnecessary harm.
Building on Proven Experience
The scientific foundation supporting RadioGel® did not begin overnight. Its underlying hydrogel technology has already been successfully utilized through IsoPet®, Vivos Inc.’s Precision Radionuclide Therapy™ platform for veterinary oncology. IsoPet® has treated numerous naturally occurring tumors in companion animals, including tumors located near critical anatomical structures where precise localization of radiation is particularly important. In addition, RadioGel® technology has accumulated encouraging early human clinical experience outside the United States, helping inform the continued development of this innovative therapeutic platform.
Together, these experiences have provided valuable insights into the potential advantages of localized radionuclide therapy and have helped lay the groundwork for advancing RadioGel® into U.S. clinical studies.
An Important Regulatory Milestone
Vivos recently achieved a significant milestone when the U.S. Food and Drug Administration approved the Company’s Investigational Device Exemption (IDE), allowing the initiation of its first U.S. human feasibility clinical trial. The study, which will be conducted at Mayo Clinic in Jacksonville, Florida, will evaluate the safety and feasibility of RadioGel® in patients with non-resectable papillary thyroid carcinoma.
This first-in-human U.S. study represents an important step toward determining whether this precision treatment approach can address an area of significant unmet medical need.
Looking Toward the Future
With the recent FDA approval to initiate clinical trials, @RadioGel is advancing the treatment of metastatic tumors while preserving voice, swallowing function, and critical neck anatomy—outcomes that could make a profound difference for patients. Innovation in oncology increasingly focuses not only on extending life but also on preserving the quality of that life. Patients with papillary thyroid cancer often have excellent long-term survival, making it especially important to develop therapies that effectively treat recurrent disease while minimizing treatment-related complications.
RadioGel® represents a new approach to localized cancer therapy, one that combines precise intratumoral delivery with a proprietary hydrogel designed to retain therapeutic radiation where it is needed most. For patients facing recurrent papillary thyroid cancer in anatomically challenging locations, RadioGel® may ultimately offer something that has long been needed: a minimally invasive, tissue-sparing treatment option positioned between watchful waiting and more aggressive interventions.
As Vivos expands its global footprint, the Company is committed to bringing innovative Precision Radionuclide Therapy™ solutions to patients around the world, with the goal of improving outcomes while preserving the functions that matter most. Through its Precision Radionuclide Therapy™ platform, Vivos is pioneering a new generation of localized cancer treatments designed to deliver targeted radiation with precision while minimizing exposure to healthy tissue. By combining scientific innovation with a patient-centred approach, Vivos aims to expand treatment options for patients facing difficult-to-treat cancers and help shape the future of precision oncology.
