Groundbreaking Collaboration: Vivos Therapeutics and Cellev8 Nutrition Join Forces to Address Sleep Apnea and Oxidative Stress

Rhea-AI Summary

Cellev8 Nutrition (OTC Pink:CELV) and Vivos Therapeutics announced a strategic joint marketing venture to address obstructive sleep apnea (OSA) and oxidative stress. The collaboration combines Vivos' FDA-cleared oral medical devices for treating OSA with Cellev8's SOD2-based nutraceutical gummies.

The venture targets a significant market, with an estimated 80 million American adults and 10 million children affected by sleep apnea, with up to 80% undiagnosed. The partnership aims to provide a comprehensive solution through Cellev8's nutraceutical products, which have shown efficacy in reducing oxidative stress, inflammation, and improving metabolic health in clinical trials.

The collaboration offers a complementary approach where Vivos devices restore airways while Cellev8's products support bodily rejuvenation and recovery from OSA-related damage.

Positive

• Strategic partnership targeting large market of 90 million potential US customers
• Complementary product offering combining FDA-cleared devices with nutraceuticals
• Clinical trials demonstrate efficacy of Cellev8's products in multiple health aspects

Negative

• None.

WELLINGTON, FL and HIGHLANDS RANCH, CO / ACCESSWIRE / December 10, 2024 / Cellev8 Nutrition Inc. (OTC Pink:CELV) and Vivos Therapeutics, Inc. today announced a strategic joint marketing venture aimed at providing comprehensive solutions for patients with obstructive sleep apnea (OSA) and associated oxidative stress. This collaboration combines Vivos Therapeutics' FDA-cleared oral medical devices for treating moderate to severe OSA in children and adults with Cellev8 Nutrition's proprietary gummy form of nutraceuticals featuring the powerful enzymatic antioxidant, SOD2, designed to mitigate oxidative stress in the body.

Addressing a Significant Health Concern

Eli Lilly recently estimated that approximately 80 million American adults suffer from sleep apnea. On top of that, an estimated 10 million children also suffer. The prevalence is particularly high among older adults, with up to 32% of individuals over 65 experiencing OSA. Alarmingly, the American Academy of Sleep Medicine (AASM) estimates that as many as 80% of people with OSA are undiagnosed. This underdiagnosis represents a significant public health challenge, as untreated OSA can lead to serious health complications and substantial economic costs.

The Complex Relationship Between Sleep Apnea, Oxidative Stress and Inflammation

The relationship between sleep apnea and weight is complex and bidirectional:

• Obesity as a Risk Factor: Obesity is recognized as one of the most important reversible risk factors for obstructive sleep apnea. Studies suggest that obesity is a major factor in 41% of adult OSA cases, including 58% of moderate-to-severe cases.

• Impact of Weight Loss: Weight loss has been shown to improve sleep apnea severity. A 5-10% reduction in body weight can significantly improve OSA symptoms. Some studies suggest that a 10% weight loss is associated with a 26% reduction in the number of apnea events during sleep.

The interplay between weight and sleep apnea underscores the importance of addressing both issues concurrently for effective management and improved health outcomes.

Comprehensive, Natural Approach to Health Management

This collaboration intends to provide an all-natural, scientifically-backed solution through Cellev8 Nutrition's comprehensive lineup of nutraceutical products. The range includes Inflammation and Recovery, Focus and Memory, and the newly introduced SlimCell formulations.Cellev8 Nutrition's proprietary blend of clinically proven ingredients has demonstrated significant efficacy in addressing multiple aspects of health:

• Oxidative Stress Reduction: The formulations have shown a measurable decrease in markers of oxidative stress, a key factor in various chronic conditions including OSA. Importantly, Cellev8 can mitigate the oxidative damage done before and during the OSA treatment that Vivos delivers.

• Long-term Benefits: Even after the permanent improvement sustained by Vivos treatment, Cellev8's nutraceuticals continue to aid in managing other chronic inflammatory causes, providing ongoing support for overall health.

• Anti-Inflammatory Effects: Clinical studies have indicated a reduction in systemic inflammation, which is crucial for overall health and particularly relevant for OSA patients.

• Cognitive Enhancement: The Focus and Memory gummies have demonstrated improvements in various cognitive functions, including attention, memory recall, and processing speed.

• Metabolic Health: The SlimCell product line has shown promising results in weight management, with statistically significant reductions in Body Mass Index (BMI) observed in clinical trials.

• Body Composition Improvements: Participants in studies have experienced reductions in hip and waist circumferences, as well as a decrease in the appearance of cellulite, attributed to the anti-inflammatory properties of the formulations.

These benefits have been observed in controlled studies over periods of 30, 60, and 90 days of daily use, suggesting both short-term and sustained positive effects.

Complementary Approach to Treatment

Kirk Huntsman, CEO of Vivos Therapeutics, elaborated on the partnership's potential: "This joint venture enables us to offer a complementary product to help ameliorate the severe damage caused to virtually every major bodily system in OSA patients. Our Vivos treatment does a great job of restoring an airway, while Cellev8 Nutrition products can help the rest of the body rejuvenate and recover. We can easily see a large portion of our patients taking these products as an important part of their healing process."

Mike Ferraro, CEO of Cellev8 Nutrition, provided additional context: "With as many as 90 million U.S. children and adults having OSA, and prevalence rising to over 50% in those above 65, we're addressing a significant health concern. OSA works through hypoxia's cause of oxidative stress. Our product is designed to balance this impact and alleviate the stress it causes. We are excited to partner with an FDA-approved OSA product proven to prevent permanent OSA in U.S. patients."

Innovative Approach to OSA Management

This collaboration represents a novel, multifaceted approach to addressing both the physical obstruction and oxidative stress associated with OSA. By combining Vivos Therapeutics' device-based treatment with Cellev8 Nutrition's SOD2 based supplements, this partnership aims to provide patients with a more comprehensive solution to manage their conditions.

About the Companies

Vivos Therapeutics, Inc. is a medical technology company focused on developing and commercializing innovative treatments for patients suffering from sleep-disordered breathing, including obstructive sleep apnea (OSA).

Cellev8 Nutrition Inc. (OTC Pink:CELV) specializes in developing innovative nutraceutical products, including their proprietary SOD2-delivering gummy designed to combat oxidative stress.

This strategic partnership has the potential to significantly impact the landscape of OSA treatment, offering patients a more holistic approach to managing this prevalent and serious health condition.

FDA Disclaimer:These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

Forward-Looking Statements Disclaimer: This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as "anticipate," "believe," "could," "estimate," "expect," "goal," "intend," "look forward to," "may," "plan," "potential," "predict," "project," "should," "will," "would" and similar expressions. These forward-looking statements may include, but are not limited to, statements regarding future business activities including the expansion into new markets, future collaborations, future product development, and potential future revenue. Forward-looking statements are not guarantees of future performance and involve risks and uncertainties that may cause the actual results to differ materially from those contemplated by the forward-looking statements. Factors that could cause actual results to differ materially from those in the forward-looking statements include, but are not limited to, uncertainties inherent in the development and commercialization of potential products, uncertainty in the timing of regulatory approvals, changes in the financial markets, regulatory actions, changes in healthcare systems, competitive conditions, and other risks described in our SEC filings. The information in this release is provided only as of the date of this release, and we undertake no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.

Contact Information

Michael Ferraro
CEO
mike@cellev8.com
561-578-0000

SOURCE: Cellev8 Nutrition Inc

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FAQ

What is the purpose of Cellev8 Nutrition (CELV) and Vivos Therapeutics partnership?

The partnership aims to provide comprehensive solutions for patients with obstructive sleep apnea (OSA) and oxidative stress by combining Vivos' FDA-cleared oral devices with Cellev8's SOD2-based nutraceutical gummies.

How many people could benefit from Cellev8 (CELV) and Vivos' joint venture?

According to the announcement, approximately 90 million Americans could benefit, including 80 million adults and 10 million children affected by sleep apnea.

What products will Cellev8 (CELV) offer through this partnership?

Cellev8 will offer nutraceutical products including Inflammation and Recovery, Focus and Memory, and SlimCell formulations, all featuring SOD2 antioxidant in gummy form.