Soon to be listed, ProSomnus has received FDA 510(k) clearance for its flagship product, ProSomnus EVO [PH] Sleep and Snore Device.
ProSomnus EVO is a less invasive Precision Oral Appliance Therapy (OAT) device for Obstructive Sleep Apnea (OSA).
What Happened: ProSomnus EVO [PH] device uses mechanical hinge components to reposition and stabilize the patient's jaw during sleep, increasing pharyngeal space and reducing the risk of upper airway collapse.
The device is approximately 13% smaller than predicate devices and features comfort bumps around key components.
The device features advancement markings and visual indicators to make it easier for beneficiaries to communicate with their healthcare providers.
Why It Is Important: "This expands our industry-leading suite of FDA-cleared precision medical devices to treat OSA, offering patients and their healthcare providers yet another alternative to CPAP, surgery, and legacy oral appliances," said Len Liptak, Co-Founder and CEO of ProSomnus.
In May 2022, ProSomnus announced a merger agreement with Lakeshore Acquisition I Corp LAAA, a special-purpose acquisition company.
Upon closing, the combined company is expected to change its name to ProSomnus Inc and trade on NASDAQ under the symbol "OSA."
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