Skip to main content

ProSomnus® Announces FDA 510(k) Clearance for ProSomnus EVO™ [PH] Sleep and Snore Device

Device expands ProSomnus’ suite of FDA-cleared Precision Oral Appliance Therapy Devices for treatment of Obstructive Sleep Apnea (OSA)

Device is engineered to provide Medicare beneficiaries and their healthcare providers with new options for treating OSA

SAN FRANCISCO, Nov. 02, 2022 (GLOBE NEWSWIRE) -- ProSomnus (“the Company”), a pioneer in precision medical devices for the treatment of Obstructive Sleep Apnea (OSA), today announced that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for the ProSomnus EVO™ [PH] Sleep and Snore Device. The device joins the Company’s flagship product, the ProSomnus EVO™, in its line of FDA-cleared, patient-preferred, less invasive Precision Oral Appliance Therapy (OAT) devices for the treatment of OSA.

The ProSomnus EVO [PH] Sleep and Snore Device is specifically engineered to meet Centers for Medicare Services coding guidelines, offering Medicare beneficiaries a non-invasive, comfortable, easy-to-use, and effective alternative to CPAP machines, surgical procedures, and legacy oral devices. Per Medicare coding guidelines, the ProSomnus EVO [PH] device uses mechanical hinge components to precisely 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 unique comfort bumps around key components. The device features unique advancement markings and visual indicators to make it easier for beneficiaries to communicate with their healthcare providers throughout treatment.

Every ProSomnus EVO [PH] device is personalized and digitally manufactured based upon the patient’s unique anatomy and healthcare provider’s treatment plan for each patient. The ProSomnus EVO [PH] is the only Herbst-style device made from engineered, Medical Grade Class VI-rated material, the highest material quality grade offered by US Pharmacopeia.

“Receiving FDA clearance for the ProSomnus EVO [PH] is a significant milestone for the Company and for patients suffering from OSA,” said Len Liptak, Co-Founder and Chief Executive Officer of ProSomnus. “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. Successfully addressing OSA starts with giving patients a treatment that is safe, effective, and easier to adhere to, and the EVO [PH] is one more patient-preferred Precision OAT option available to them.”

“This latest FDA milestone is a big step in making Precision OAT available to as many patients as possible,” said John E. Remmers, MD, Chief Scientist of ProSomnus. “Despite the alarming prevalence of OSA and its dire consequences, legacy OSA treatments have not improved at a rate that patients deserve, especially in light of the current issues with CPAP treatment. This makes our commitment to developing less invasive therapies even more important, and we look forward to the difference it will make for patients and providers.”

“Our manufacturing platform allows us to advance the quality of our materials. We are continuously expanding our material selection far beyond dental applications and researching and developing innovative medical grade polymers for our products,” commented Sung Kim, Co-Founder and Chief Technology Officer of ProSomnus. “The improved flexibility of the ProSomnus EVO [PH] makes it even easier for patients to use, while its durability protects it from accidental drops. In addition to being incredibly stain-resistant, the EVO [PH] is precision milled in one piece, so it maintains its fit throughout treatment without deformation, staining or harboring bioburden, unlike soft liner and nylon materials.”

Patients interested in learning more about ProSomnus’ Precision OAT devices for the treatment of OSA can visit or speak with their local ProSomnus sleep dentist.

About OSA
OSA is the recurring collapse of the airway during sleep, resulting in oxygen shortages and abrupt awakenings accompanied by gasping or choking. In addition to daytime sleepiness, OSA is associated with serious comorbidities, including heart failure, stroke, hypertension, morbid obesity and type 2 diabetes. Patients with untreated OSA are 23 times more likely to suffer a heart attack and four times more likely to have a stroke. It is estimated that more than one billion people worldwide and over 74 million people in North America suffer from OSA. Approximately 56 million of those 74 million people in North America are undiagnosed.

About ProSomnus
ProSomnus is the first manufacturer of precision, mass-customized Precision Oral Appliance Therapy devices to treat OSA, which affects over 74 million Americans and is associated with serious comorbidities, including heart failure, stroke, hypertension, morbid obesity and type 2 diabetes. ProSomnus’s patented devices are a more comfortable and less invasive alternative to Continuous Positive Airway Pressure (CPAP) therapy, and lead to more effective and patient-preferred outcomes. With more than 150,000 patients treated, ProSomnus’s devices are the most prescribed Precision Oral Appliance Therapy in the U.S. To learn more, visit

In May 2022, ProSomnus entered a definitive merger agreement with Lakeshore Acquisition I Corp. (Nasdaq: LAAA), a special purpose acquisition company. Upon closing, the combined company is expected to change its name to ProSomnus, Inc. and its Class A common stock is expected to be traded on the Nasdaq Capital Market under the symbol “OSA”.

Important Notice Regarding Forward-Looking Statements
This Press Release contains certain “forward-looking statements” within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, both as amended. Statements that are not historical facts, including statements about the pending transactions among Lakeshore Acquisition I Corp. (together with its successors, the “Purchaser”), LAAA Merger Sub Inc., a Delaware corporation and wholly-owned subsidiary of Purchaser (the “Merger Sub”), ProSomnus, HGP II, LLC, a Delaware limited liability company, as the representative of the stockholders of ProSomnus, and RedOne Investment Limited, a British Virgin Islands company, as the representative of the stockholders of Purchaser, and the transactions contemplated thereby, and the parties’ perspectives and expectations, are forward-looking statements. The words “expect,” “believe,” “estimate,” “intend,” “plan” and similar expressions indicate forward-looking statements. These forward-looking statements are not guarantees of future performance and are subject to various risks and uncertainties, assumptions (including assumptions about general economic, market, industry and operational factors), known or unknown, which could cause the actual results to vary materially from those indicated or anticipated.

Such risks and uncertainties include, but are not limited to: (i) the risk that the transaction may not be completed in a timely manner or at all, which may adversely affect the price of Purchaser’s securities; (ii) the risk that the transaction may not be completed by Purchaser’s business combination deadline and the potential failure to obtain an extension of the business combination deadline if sought by Purchaser; (iii) the failure to satisfy the conditions to the consummation of the transaction, including the approval of the business combination agreement by the stockholders of Purchaser, the satisfaction of the minimum cash amount following any redemptions by Purchaser’s public stockholders and the receipt of certain governmental and regulatory approvals; (iv) the lack of a third-party valuation in determining whether or not to pursue the proposed transaction; (v) the occurrence of any event, change or other circumstance that could give rise to the termination of the business combination agreement; (vi) the effect of the announcement or pendency of the transaction on ProSomnus’s business relationships, operating results and business generally; (vii) risks that the proposed transaction disrupts current plans and operations of ProSomnus; (viii) the outcome of any legal proceedings that may be instituted against ProSomnus or Purchaser related to the business combination agreement or the proposed transaction; (ix) the ability to maintain the listing of Purchaser’s securities on a national securities exchange; (x) changes in the competitive industries in which ProSomnus operates, variations in operating performance across competitors, changes in laws and regulations affecting ProSomnus’s business and changes in the combined capital structure; (xi) the ability to implement business plans, forecasts and other expectations after the completion of the proposed transaction, and identify and realize additional opportunities; (xii) the risk of downturns in the market and ProSomnus’s industry including, but not limited to, as a result of the COVID-19 pandemic; (xiii) costs related to the transaction and the failure to realize anticipated benefits of the transaction or to realize estimated pro forma results and underlying assumptions, including with respect to estimated stockholder redemptions; (xiv) the inability to complete its convertible debt financing; (xv) the risk of potential future significant dilution to stockholders resulting from lender conversions under the convertible debt financing; and (xvi) risks and uncertainties related to ProSomnus’s business, including, but not limited to, risks relating to the uncertainty of the projected financial information with respect to ProSomnus; risks related to ProSomnus’s limited operating history, the roll-out of ProSomnus’s business and the timing of expected business milestones; ProSomnus’s ability to implement its business plan and scale its business, which includes the recruitment of healthcare professionals to prescribe and dentists to deliver ProSomnus oral devices; the understanding and adoption by dentists and other healthcare professionals of ProSomnus oral devices for mild-to-moderate OSA; expectations concerning the effectiveness of OSA treatment using ProSomnus oral devices and the potential for patient relapse after completion of treatment; the potential financial benefits to dentists and other healthcare professionals from treating patients with ProSomnus oral devices and using ProSomnus’s monitoring tools; ProSomnus’s potential profit margin from sales of ProSomnus oral devices; ProSomnus’s ability to properly train dentists in the use of the ProSomnus oral devices and other services it offers in their dental practices; ProSomnus’s ability to formulate, implement and modify as necessary effective sales, marketing, and strategic initiatives to drive revenue growth; ProSomnus’s ability to expand internationally; the viability of ProSomnus’s intellectual property and intellectual property created in the future; acceptance by the marketplace of the products and services that ProSomnus markets; government regulations and ProSomnus’s ability to obtain applicable regulatory approvals and comply with government regulations, including under healthcare laws and the rules and regulations of the U.S. Food and Drug Administration; and the extent of patient reimbursement by medical insurance in the United States and internationally. A further list and description of risks and uncertainties can be found in Purchaser’s initial public offering prospectus dated June 10, 2021 and in Purchaser’s quarterly reports on Form 10-Q and annual reports on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) subsequent thereto and in the Registration Statement on Form S-4 and proxy statement that has been and will be filed with the SEC by the Purchaser in connection with the proposed transactions, and other documents that the parties may file or furnish with the SEC, which you are encouraged to read. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those indicated or anticipated by such forward-looking statements. Accordingly, you are cautioned not to place undue reliance on these forward-looking statements. Forward-looking statements relate only to the date they were made, and Purchaser, Merger Sub, ProSomnus, and their subsidiaries undertake no obligation to update forward-looking statements to reflect events or circumstances after the date they were made except as required by law or applicable regulation.

Investor Contact
Mike Cavanaugh
ICR Westwicke
Phone: +1.617.877.9641

Media Contact
Kyle Evans
ICR Westwicke
Phone: +1.646.277.1295

Primary Logo

Data & News supplied by
Stock quotes supplied by Barchart
Quotes delayed at least 20 minutes.
By accessing this page, you agree to the following
Privacy Policy and Terms and Conditions.