Vivos Inc. Expands its RadioGel® Clinical Trials in India
Today, Vivos Inc. (OTCQB: RDGL) is thrilled to announce significant advancements in their clinical trials for RadioGel® Precision Radionuclide Therapy™, a groundbreaking treatment for solid tumors. This therapy has garnered recognition as a Breakthrough Device from the FDA, reflecting its immense potential in oncology.
Clinical Trial Progress and Outcomes
In our latest update, we share that, building on the initial successes reported earlier this year, we have treated ten patients with cancerous nodes using RadioGel®. The trials have continued to affirm the safety of the therapy, showing no adverse events and excellent patient recovery.
Each patient met the crucial safety endpoint, confirmed through PET imaging, which demonstrated precise retention of the Yttrium-90 isotope. This pinpoint accuracy of the treatment resulted in no damage to surrounding healthy tissues, especially critical for patients with tumors located near vital areas such as the trachea and carotid artery.
Advancements in Technological Techniques
The experience and expertise of the clinical team in India have been instrumental in refining the treatment delivery methods. We have introduced innovative techniques such as deep-needle injection and precision imaging guidance. Additionally, the implementation of saline spacers enhances dose control and maximizes organ protection during the procedure.
Discussions with leading U.S. investigators from Mayo Clinic are progressing, examining the integration of these advancements into a forthcoming parallel study in the United States, aimed at reinforcing the global therapeutic landscape.
Future Directions in Patient Treatment
Our current study in India has received approval to treat a total of 30 patients, with plans to upscale this to 50 patients pending Ethics Committee review. Expanding the trials will allow for a more comprehensive evaluation of RadioGel® across various tumor types, including those that are notoriously challenging to treat, such as lung and pancreatic cancers.
Strengthening Global Presence
In addition to our clinical advancements, Vivos is laying down the framework for sustainable operations in India. We aim to establish a corporate office alongside a manufacturing facility dedicated to yttrium phosphate microparticles. Such an infrastructure will ensure the successful rollout and future commercial availability of RadioGel® in India, marking it as a crucial hub for further global expansion.
Our upcoming submission of clinical data, intended for peer-reviewed publication, is anticipated to significantly bolster awareness among medical professionals, potentially leading to impactful regulatory submissions worldwide.
Strategizing Regulatory Engagement
With the FDA's Breakthrough Device designation of RadioGel®, we are proactively sharing preliminary results from the India trials to facilitate our objective of applying for an Investigational Device Exemption (IDE) within a short timeframe.
While we remain optimistic about our regulatory trajectory, we are cognizant of the unpredictable nature of the U.S. regulatory environment. This awareness drives us to adopt a multi-faceted global strategy, catering not only to U.S. markets but also taking advantage of opportunities in regions with more streamlined regulatory processes.
Market Opportunities and Strategic Vision
The cancer treatment landscape in India is ripe with potential, with a current market valuation of approximately USD 4.21 billion, projected to skyrocket to USD 5.89 billion by the end of the decade. This surge highlights a significant opening for innovative treatments like RadioGel®, providing a compelling opportunity for Vivos to enhance shareholder value through diversification and global recognition.
Dr. Michael Korenko, President and CEO of Vivos Inc., stated, "With each patient treated, RadioGel® reveals its true value. We’re witnessing not only promising outcomes but also reinforcing the confidence in our technology. The FDA's designation of RadioGel® as a Breakthrough Device highlights our commitment to introduce innovative cancer treatment solutions to patients in need." Furthermore, he shared insights about the results emanating from the IsoPet® animal health division, reinforcing the effectiveness of their technologies across both human and veterinary applications.
Frequently Asked Questions
What is RadioGel®?
RadioGel® is a precision radionuclide therapy utilizing Yttrium-90 to deliver targeted radiation directly into tumors, minimizing damage to healthy tissue.
How is the clinical trial in India progressing?
The trial has successfully treated ten patients, showing a strong safety profile and no adverse events this far, which strengthens the foundation for future studies.
What are the next steps for Vivos Inc.?
Vivos plans to expand the clinical trial cohort from 30 to 50 patients and establish operational sites in India to support the treatment rollout.
How does Vivos Inc. view regulatory challenges?
While optimistic about progress, Vivos acknowledges the complexities of the regulatory landscape and is pursuing a diverse strategy to expedite global adoption of RadioGel®.
What industry opportunities does the Indian market present?
The Indian cancer treatment market presents substantial growth potential, with projections indicating significant value increases, indicating a robust opportunity for innovative therapies like RadioGel®.
