In a groundbreaking development for the medical community, Vivos Therapeutics, a leading medical device and technology company, received clearance from the US Food and Drug Administration (FDA) on Wednesday for its oral device designed to address severe obstructive sleep apnea (OSA). The announcement sparked a substantial surge in the company’s shares during premarket trading, with the rally continuing to gain momentum throughout the day.
Shares of Vivos Therapeutics more than doubled, reaching $9.12 in premarket trading and currently maintaining a robust position at $17.65.
At the time of this publication, Vivos Therapeutics Inc stock (VVOS) has witnessed a surge.
Vivos Therapeutics Inc
Current Price: $17.65
Change : +13.26
Change (%): (302.05%)
Volume: 35.1M
Source: Tomorrow Events Market Data
This significant clearance marks a historic milestone as the first-ever approval for an oral appliance, coupled with a respiratory ventilation or exercise training program targeting the muscles around the face, mouth, and tongue. The clearance specifically approves the device for treating moderate and severe OSA in adults, a condition characterized by the intermittent relaxation of throat muscles, leading to the blockage of the airway during sleep.
Vivos’ treatment offers a compelling alternative to existing therapy devices manufactured by industry giants such as Philips (PHG.AS) and ResMed (RMD.N). Unlike devices that deliver pressurized air into a patient’s nose and mouth or surgically placed implants utilizing electrical signals to stimulate the brain, Vivos’ innovative approach garnered FDA support based on study data.
The FDA decision was underpinned by a comprehensive study involving 73 severe OSA patients. The results demonstrated a notable improvement, with at least a 50% enhancement in the index used to evaluate the presence and severity of the disease. This data provided compelling evidence for the efficacy and safety of Vivos Therapeutics’ oral device.
Vivos highlighted that its appliance therapy is designed to gradually reposition both hard and soft tissues defining the airway. This unique approach aims to open up the airway, optimizing its function and facilitating improved airflow. The FDA clearance is expected to position Vivos Therapeutics as a pioneering force in the treatment landscape for OSA, offering patients a novel and effective solution.
In the clearance process, the FDA rigorously reviews safety and performance data to determine if the new device is substantially equivalent to those already available in the market. Vivos Therapeutics successfully navigated this stringent process, securing approval for its groundbreaking oral device.
As the medical community eagerly anticipates the impact of this innovative solution, Vivos Therapeutics’ achievement is not only a testament to its commitment to advancing healthcare but also a significant stride in the ongoing efforts to enhance the quality of life for individuals affected by sleep-related breathing disorders. The surge in the company’s shares reflects the market’s confidence in the potential of this groundbreaking solution, setting the stage for a new era in the treatment of severe obstructive sleep apnea.
