8-K: Vivos Inc. Files Application for Human Clinical Trials of Radiogel Precision Radionuclide Therapy

Vivos Inc. has submitted an application to the FDA for an Investigational Device Exemption to begin human clinical trials of its Radiogel Precision Radionuclide Therapy.

Summary

• Vivos Inc. has filed an application with the FDA for an Investigational Device Exemption (IDE) to initiate human clinical trials for its Radiogel Precision Radionuclide Therapy.
• This filing is an amendment to a previous application and addresses 63 comments received from the FDA.
• The application includes reports from two studies: RadioGel genotoxicity and the retention of RadioGel at the injection site in rabbit tumors.
• The company received Breakthrough Device Designation from the FDA for Radiogel, which has improved communication with the agency.
• Vivos plans to initially target solid metastatic tumors in lymph nodes associated with papillary thyroid cancer in collaboration with the Mayo Clinic.
• Radiogel uses a hydrogel to deliver Yttrium-90 directly into tumors, providing localized radiation with a short half-life of 10 days.
• This method aims to reduce side effects associated with traditional external-beam radiation therapy.
• The company also has a veterinary product, IsoPet, which uses the same technology and is already generating revenue.

Sentiment

Score: 7

Explanation: The document is generally positive, highlighting the submission of the IDE application and the potential of the technology. However, the anticipation of further FDA comments and the inherent risks of clinical trials temper the overall sentiment.

Positives

• The company has successfully addressed 63 FDA comments in its IDE submission.
• The FDA's Breakthrough Device Designation has improved communication with the agency.
• Radiogel's localized radiation delivery and short half-life offer potential advantages over traditional radiation therapy.
• The company has a revenue-generating veterinary product, IsoPet, using the same technology.
• The collaboration with the Mayo Clinic for initial human trials is a positive step.

Negatives

• The company anticipates further comments from the FDA on the extensive material in the filing.
• The company had to repeat some underlying testing to strengthen their answers to the FDA.

Risks

• The FDA may have further comments on the IDE application, potentially delaying the start of human trials.
• The company's ability to successfully execute its business strategy depends on various factors, including regulatory approvals and market conditions.
• There are risks associated with competition, technology changes, and potential component shortages.

Future Outlook

The company is eager to secure FDA approval for the IDE to begin human clinical trials and submit their plan to the Mayo Clinic's Internal Review Board (IRB).

Management Comments

• Dr. Korenko stated, 'we are mindful that most of the twelve FDA reviewers have joined in the past two years and we anticipate they will have some comments after reviewing the extensive material in our filing, which we are prepared to address promptly.'
• Dr. Korenko stated, 'We are eager to secure the FDAs IDE approval so that we can submit our plan to the Mayo Clinics Internal Review Board (IRB) for clearance to initiate the first in human clinical trials.'

Industry Context

This announcement is significant in the context of the broader oncology therapeutics industry, where there is a growing focus on targeted therapies and localized radiation delivery methods. The company's approach using a hydrogel to deliver radiation directly to tumors aligns with this trend.

Comparison to Industry Standards

• The use of Yttrium-90 is not unique, but the hydrogel delivery system is a differentiator compared to other radiation therapies.
• Traditional external beam radiation therapy can take up to six weeks to deliver a full course of treatment, while Radiogel delivers over 90% of its radiation within 10 days, which is a significant improvement.
• Companies like Sirtex Medical (acquired by CDH Investments) and Bayer have developed Y-90 based therapies, but they are typically delivered via microspheres through the bloodstream, not directly into the tumor using a hydrogel.
• The company's veterinary product, IsoPet, is a unique approach to generating revenue while developing the human therapy.

Stakeholder Impact

• Shareholders may view this as a positive step towards commercialization of Radiogel.
• Employees may be motivated by the progress in clinical development.
• Patients with challenging cancer types may benefit from this new treatment option.
• The company's collaboration with the Mayo Clinic could enhance its reputation and credibility.

Next Steps

• The company will address any further comments from the FDA on the IDE application.
• The company will submit its plan to the Mayo Clinic's Internal Review Board (IRB) for clearance to initiate human clinical trials.
• The company will continue to develop and market IsoPet for veterinary use.

Key Dates

Keywords

Radiogel, Investigational Device Exemption, FDA, Precision Radionuclide Therapy, Yttrium-90, Clinical Trials, IsoPet, Cancer Treatment, Hydrogel, Breakthrough Device Designation