VIVOS (RDGL) Stock Price, News & Analysis

Vivos Inc. (OTCQB: RDGL) is a radiotherapeutic company in the surgical and medical instrument manufacturing industry. According to company disclosures, Vivos develops isotope-based products for cancer treatment and other therapeutic applications, with a focus on precise delivery of radiation to tumors while limiting exposure to surrounding healthy tissue. Its work spans both human and veterinary medicine, reflecting a strategy built around targeted radionuclide therapies.

The company’s core technologies are RadioGel® for human use and IsoPet® for veterinary applications. Vivos describes RadioGel as a hydrogel-based injectable device designed to deliver localized, high-dose radiation directly to solid tumors. The technology has received FDA Breakthrough Device designation, and Vivos has pursued an Investigational Device Exemption (IDE) to conduct human clinical trials at Mayo Clinic. The company reports that RadioGel is not yet FDA-approved for commercial use in the United States.

IsoPet translates the same Precision Radionuclide Therapy approach to animal health. Company news releases state that IsoPet therapies have been administered to dogs, cats, horses, and exotic animals, and that treatments have included challenging tumor locations such as equine ocular squamous cell carcinoma. Vivos reports that multiple equine eye tumors were treated without ocular damage and with no reported adverse effects, supporting its emphasis on a high therapeutic ratio between tumor dose and healthy tissue exposure.

Precision Radionuclide Therapy platform

Vivos describes its platform as Precision Radionuclide Therapy™ (PRnT), built on proprietary hydrogel and microparticle technologies. In its communications, the company highlights the ability of RadioGel and IsoPet to confine radioactive material to the intended treatment volume, with CT/PET imaging and health physics calculations used to validate minimal radiation uptake in nearby critical structures. Human trial data cited by Vivos include lymph node tumors near the trachea and carotid artery that became undetectable by imaging at follow-up, with no measurable damage to adjacent structures.

The company also references a broader technology family under the name PrecisionGel, a hydrogel polymer used for dispersing therapeutic agents. Vivos has reported that PrecisionGel is available commercially through a third-party website for evaluation by research institutions and pharmaceutical companies, and that its resorption kinetics and agent release characteristics have been characterized across a range of formulations. A new patent application related to PrecisionGel agent-release behavior has been prepared, according to a shareholder update.

Veterinary oncology and IsoPet division

Vivos maintains a dedicated IsoPet division focused on animal therapies. In recent updates, the company reported a significant year-over-year increase in IsoPet therapies administered and more than one hundred treatments performed across multiple species. The company notes growing inbound inquiries from veterinarians and pet owners, and it is expanding a network of certified clinics that can administer IsoPet Precision Radionuclide Therapy.

Vivos has highlighted certifications at facilities such as Sun City Veterinary Surgery Center in El Paso, Texas, and the University of Florida Small Animal Hospital, in addition to an equine IsoPet site at Brazos Valley Equine Hospital in Navasota, Texas. Company statements emphasize that these certifications expand access to IsoPet for both small animal and equine oncology programs. Case study therapies at certain clinics have been subsidized to generate comprehensive clinical data, with Vivos indicating that resulting publications are expected to support further adoption among veterinarians and oncologists.

The company also reports a strategic partnership with Exubrion Therapeutics to co-market IsoPet in equine oncology and to coordinate on clinic relationships, licensing, and manufacturing. Vivos characterizes Exubrion as a veterinary radiotherapeutics company focused on osteoarthritis pain in companion animals, while positioning IsoPet as a cancer therapy, noting that the two product lines address distinct markets.

Human oncology and regulatory pathway

On the human health side, Vivos is working to advance RadioGel through regulatory pathways in the United States and internationally. The company has submitted an IDE application to the U.S. Food and Drug Administration for human clinical trials at Mayo Clinic and has described extensive interactions with multiple FDA reviewers. Following an FDA decision declining a prior IDE submission after the standard review period, Vivos reported that it is addressing items raised in the agency’s letter and preparing additional pre-submission materials focused on topics such as sterilization, dosimetry validation, and migration of the therapeutic agent.

To support this process, Vivos has engaged external regulatory experts with experience in brachytherapy and combination radiotherapy devices and with prior involvement in IDE approvals reviewed by the same FDA branch that oversees RadioGel. The company’s communications indicate that it is using this expertise to align its submissions with established expectations for Class III implantable radiation devices.

International expansion and manufacturing strategy

Vivos has outlined an international strategy centered on building a global platform for RadioGel and IsoPet. The Board of Directors approved the creation of Vivos Scientific India LLP, a wholly owned legal entity in India. According to company filings and updates, this entity is intended to establish a manufacturing center, expand human therapies, and pursue commercialization of therapies in India, while also generating additional human trial data to support U.S. regulatory processes.

The company has discussed pursuing Phase II clinical trial approval under the Drugs Controller General of India at specific hospitals and expanding administration of RadioGel to additional clinics across key oncology regions in India. Vivos also notes that it is evaluating regulatory pathways in other international markets that it views as having high unmet needs in oncology and veterinary care, and that it plans to use an international manufacturing center to support broader distribution of its hydrogel-based products.

In parallel, Vivos has disclosed a transition away from fully outsourced manufacturing. It has selected preferred manufacturing partners for up to two domestic and one international production centers dedicated to RadioGel, IsoPet, and PrecisionGel. Equipment installation and process validation are described as in progress, with the goal of improving scalability, supply reliability, and cost-efficiency.

Hydrogel sterilization and intellectual property

Vivos has reported the validation of an electron beam (E-Beam) sterilization process for its hydrogel under ISO 11137 by an accredited medical device organization. Company statements emphasize that this process achieves a sterility assurance level consistent with critical medical devices that enter the body or compromised tissues. Vivos positions this as both a clinical and manufacturing advantage, citing improved production yield, scalability, and support for global distribution of sterile hydrogel and PrecisionGel for therapeutic agent dispersal.

The company describes an intellectual property portfolio that includes documented developmental data, quality management system documentation for sterile hydrogel and microparticle production, worldwide trademark protection, and patents in numerous countries covering hydrogel composition, microparticles, applicators, and future innovations. Vivos also references third-party laboratory work on rheology and resorption analysis across different hydrogel concentrations, which informs application-specific formulations.

Corporate governance and leadership

Recent SEC filings detail governance developments, including the appointment of a President and a Chief Operating Officer under formal agreements. These filings describe responsibilities related to business development, strategic partnerships, production, user training, regulatory submissions, and intellectual property development, particularly in the context of targeted cancer therapies that deliver radioactive agents directly to tumors while minimizing damage to healthy tissue.

Position within the medical device and radiotherapeutic space

Within the broader surgical and medical instrument manufacturing sector, Vivos presents itself as focused on radiotherapeutic devices and related hydrogel technologies. Its activities span device development, regulatory strategy, manufacturing process design, and clinical collaborations in both human and veterinary oncology. The company’s disclosures emphasize the potential of its technologies to address tumors located near vital organs, supported by animal and international human trial data, and to contribute to new treatment options in oncology and veterinary care.