Vivos Navigates Regulatory Hurdles, Global Expansion in Precision Radiotherapy Push

By Brenda Thompson

SEATTLE, WA – Vivos Inc., a medical device company focused on precision radiotherapy, is aggressively pursuing regulatory approvals, expanding its global footprint, and demonstrating early success in veterinary applications. The company’s approach centers on innovative hydrogel-based delivery systems for targeted cancer treatment, but navigating the complex regulatory landscape and establishing a strong presence in new markets presents significant challenges.

Regulatory Path Paved with Expertise

Vivos’ core strategy hinges on securing FDA approval for its novel radiotherapy technologies. The company has brought on John Smith, a veteran regulatory affairs consultant with over 25 years of experience in medical device approvals, specifically within brachytherapy. “Expertise in navigating the FDA’s rigorous approval process is paramount for innovative medical technologies,” said an industry analyst familiar with Vivos’ strategy. “Bringing in someone with Mr. Smith’s track record signals a commitment to a robust regulatory pathway.”

The company is currently preparing a second pre-submission to the FDA, focusing on key areas such as radiation dosimetry validation, agent migration studies, and optimized clinical protocol design. This comes after initial submissions and aims to address specific FDA concerns around demonstrating treatment precision and minimizing side effects. “The FDA is increasingly focused on personalized medicine and targeted therapies,” noted a regulatory expert. “Vivos’ approach aligns with this trend, but demonstrating robust clinical data will be crucial.”

India: A Strategic Gateway to Growth

Beyond the US, Vivos is strategically expanding into the Indian market. The company recently established Vivos Scientific India LLP (VISL), a subsidiary dedicated to supporting regulatory approvals, establishing a manufacturing base, and ultimately serving the growing oncology market in India and potentially other regions.

The Indian market presents both opportunities and challenges. The country’s rapidly growing population, increasing cancer incidence, and relatively lower healthcare costs make it an attractive destination for medical device companies. However, navigating India’s complex regulatory framework and establishing a reliable supply chain require significant investment and expertise.

“India is becoming a key player in the global medical device market,” explained a healthcare consultant specializing in emerging markets. “Companies that can establish a strong presence early on will be well-positioned to capitalize on the long-term growth potential.” VISL is now registered with the Central Drugs Standard Control Organization (CDSCO) enabling it to pursue regulatory pathways for its devices.

Beyond Humans: Veterinary Oncology Gains Traction

Vivos is also finding success in a less conventional, but increasingly important, market: veterinary oncology. Its IsoPet therapy, utilizing the same hydrogel-based delivery system as its human treatments, is gaining traction among veterinary clinics across the US and internationally. The company has reported an 800% year-over-year increase in administered therapies, demonstrating growing demand for advanced cancer treatments for animals.

“There’s a growing awareness among pet owners that animals deserve the same level of care as humans,” commented a veterinary oncologist. “IsoPet offers a targeted, minimally invasive treatment option for certain cancers in animals, which is a significant advantage.” This success has broadened Vivos' revenue streams and provides valuable clinical data supporting its overall technology platform. The AVMA has recognized the innovation of IsoPet, further solidifying its market position.

Market Dynamics and Competition

The brachytherapy market, valued at $850 million in 2023, is projected to grow at a CAGR of 6.5% through 2030. Key players like Elekta and Varian Medical Systems dominate the landscape, but emerging technologies, such as liquid brachytherapy sources and hydrogel-based delivery systems, are gaining traction. Vivos will need to differentiate itself through innovation, clinical efficacy, and strategic partnerships.

“Competition in the brachytherapy space is intense,” warned a market research analyst. “Vivos will need to demonstrate a clear clinical advantage and a cost-effective solution to gain market share.”

Financial Outlook and Challenges

Vivos’ recent SEC filings reveal a company heavily invested in research and development. While revenue is growing, expenses remain high, and the company is currently operating at a loss. Maintaining a strong financial position will be critical as it navigates the regulatory approval process and expands its global footprint.

“The path to profitability for medical device companies is often long and challenging,” commented a financial analyst. “Vivos will need to secure additional funding and demonstrate sustainable revenue growth to attract investors.”

Looking Ahead

Vivos Inc. is poised for continued growth, but faces significant challenges. Its success hinges on securing FDA approvals, establishing a strong presence in key global markets, and demonstrating the clinical and economic benefits of its innovative technology. The company's commitment to precision radiotherapy, combined with its strategic expansion into veterinary oncology and emerging markets like India, positions it as a promising player in the evolving landscape of cancer treatment. However, diligent execution, prudent financial management, and continuous innovation will be essential for realizing its full potential.