Vivos Inc. Welcomes FDA Expert Dr. Smith for RadioGel® Project

Vivos Inc. Engages Dr. John J. Smith for Regulatory Guidance

Vivos Inc. has taken an essential step forward in its quest to bring RadioGel® to clinical use by appointing Dr. John J. Smith, M.D., J.D., as its chief regulatory advisor. With a profound background as a board-certified diagnostic radiologist and experience at Harvard Medical School, Dr. Smith is renowned for his expertise in FDA regulations surrounding medical devices. His partnership with Hogan Lovells positions Vivos Inc. for success as they prepare for their FDA Investigational Device Exemption (IDE) submission.

Why Dr. Smith’s Expertise Matters

Dr. Smith’s unique qualifications make him an invaluable asset to Vivos Inc. His extensive background in FDA consulting, particularly within the Division of Radiological Imaging and Radiation Therapy Devices, allows him to offer insights that are both deep and relevant. As the CEO, Dr. Michael Korenko notes, Dr. Smith brings both experience and familiarity with RadioGel®, which will be crucial in navigating the complexities surrounding the IDE submission process.

The Vision Behind RadioGel®

Vivos Inc. is at the forefront of cancer treatment innovation with RadioGel®, an injectable device designed to deliver targeted and high-dose radiation directly to tumors. This localized approach aims to significantly enhance treatment efficacy while minimizing damage to surrounding healthy tissues. Achieving IDE approval is a pivotal moment for Vivos Inc., allowing them to initiate clinical trials in collaboration with the prestigious Mayo Clinic.

Looking Ahead: The Significance of IDE Approval

With Dr. Smith on board, Vivos Inc. is more confidently navigating the regulatory landscape in preparation for IDE approval. This milestone is not just a procedural step; it represents a significant leap toward advancing Vivos' clinical ambitions. The team’s dedication to refining and presenting their submission is underscored by Dr. Smith’s direct involvement, fostering an environment of clarity and confidence.

Healthy Collaboration for Clinical Trials

Collaboration with leading institutions like the Mayo Clinic reinforces Vivos Inc.'s commitment to excellence. Once IDE approval is secured, Vivos can initiate critical clinical trials that may pave the way for innovative cancer therapies to become accessible to patients, revolutionizing the treatment landscape.

What Lies Ahead for Vivos Inc. and RadioGel®

As Vivos Inc. embarks on this significant journey, the company is focused on achieving their goals with precision and determination. The future looks promising for RadioGel®, and with expert guidance from Dr. Smith, Vivos Inc. is set to make significant strides in the field of oncological care.

Frequently Asked Questions

What is Vivos Inc.’s main objective with RadioGel®?

Vivos Inc. aims to gain FDA approval for RadioGel®, facilitating clinical trials that could innovate cancer treatment by delivering localized radiation to tumors.

Who is Dr. John J. Smith?

Dr. John J. Smith is a leading FDA regulatory expert with considerable experience in medical device regulations, serving as Vivos Inc.'s chief regulatory advisor.

What is the role of IDE approval?

The IDE approval allows companies to conduct clinical trials using unapproved devices, a critical milestone for Vivos Inc. in advancing RadioGel® towards the market.

Why is the partnership with Mayo Clinic significant?

The Mayo Clinic is renowned for its leading-edge clinical practices, and partnering with them enhances Vivos Inc.'s credibility and potential success in clinical trials.

How does RadioGel® work?

RadioGel® is designed to deliver high doses of localized radiation directly to tumors, aiming to increase treatment efficacy while protecting surrounding healthy tissues.

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