Vivos Therapeutics CEO Kirk Huntsman joined Steve Darling from Proactive to share an exciting development for the company.
Vivos has just entered into an exclusive distribution agreement with NOUM DMCC, a Dubai-based company with a strong focus on diagnostic testing and the distribution of treatment products for healthcare providers and hospital networks specializing in obstructive sleep apnea patients across the Middle East-North Africa (MENA) region.
Huntsman elaborated on the significance of this partnership, highlighting how it addresses the growing demand for effective treatment alternatives to Continuous Positive Airway Pressure (CPAP) for individuals suffering from obstructive sleep apnea.
With this agreement, NOUM has been granted exclusive distribution rights for Vivos' innovative products and services in several key countries in the MENA region. This list includes Saudi Arabia, the United Arab Emirates, Qatar, Kuwait, Bahrain, Oman, Jordan, Lebanon, and Palestine.
A noteworthy aspect of this collaboration is that NOUM will promptly initiate the process of seeking regulatory approvals for Vivos' medical devices within the respective countries. These approval timelines are expected to vary, ranging from a few weeks to several months, contingent upon the specific regulatory requirements of each nation.
Huntsman also revealed to Proactive that the company's flagship daytime-nighttime appliance or DNA will undergo a clinical trial at Stanford Medicine. The trial's protocol has been finalized, and participant enrollment is slated to commence in early 2024.
In this clinical trial, individuals diagnosed with moderate to severe obstructive sleep apnea will be randomly assigned to one of two groups for treatment: either using Vivos' innovative DNA appliance or a traditional CPAP machine. The trial will closely monitor and assess the participants' condition through sleep studies conducted before and after the treatment course, using in-lab polysomnography to measure changes in the patients' apnea-hypopnea index.
This clinical trial represents a significant milestone for Huntsman and Vivos as it provides an opportunity to validate the efficacy of their DNA appliance in addressing OSA, a serious and widespread sleep disorder.
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