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ProSomnus® Announces Acceptance of Abstract for Oral Presentation at Prestigious American Thoracic Society 2023 International Conference

ProSomnus® Announces Acceptance of Abstract for Oral Presentation at Prestigious American Thoracic Society 2023 International Conference

ProsoMNus® 宣佈接受美國胸科學會 2023 國際會議上的口頭簡報摘要
GlobeNewswire ·  2023/01/26 08:07

Data from First Line Obstructive Sleep Apnea Treatment Study (FLOSAT) study will be presented for the first time

來自第一線阻塞性睡眠呼吸暫停治療研究(FLOSAT)的數據將首次公佈

SAN FRANCISCO, Jan. 26, 2023 (GLOBE NEWSWIRE) -- ProSomnus, Inc. ("the Company") (NASDAQ: OSA), a pioneer in precision medical devices for the treatment of Obstructive Sleep Apnea (OSA), today announced that an abstract showcasing data from the First Line Obstructive Sleep Apnea Treatment study (FLOSAT) has been accepted for an oral presentation at the American Thoracic Society (ATS) 2023 International Conference, being held from May 19-24 in Washington, D.C.

舊金山,2023年1月26日(環球社)--精密醫療設備治療阻塞性睡眠呼吸暫停(OSA)的先驅公司ProSomnus,Inc.(納斯達克:OSA)今天宣佈,一份展示第一線阻塞性睡眠呼吸暫停治療研究(FLOSAT)數據的摘要已被接受在5月19-24日在華盛頓舉行的美國胸科學會(ATS)2023年國際會議上進行口頭演示。

Designed and conducted by The Antwerp University Hospital (UZA), Belgium, FLOSAT is a prospective, independent, head-to-head, crossover study comparing the effectiveness of precision Oral Appliance Therapy (OAT) as first-line treatment versus Continuous Positive Airway Pressure (CPAP) Therapy in patients with moderate to severe OSA. ProSomnus precision intraoral medical devices are being used exclusively for the precision OAT arm of the study.

FLOSAT由比利時安特衞普大學醫院(UZA)設計和實施,是一項前瞻性、獨立、面對面的交叉研究,比較了精密口腔器械療法(OAT)作為一線治療與持續正壓(CPAP)治療中重度阻塞性睡眠呼吸暫停患者的療效。ProSomnus精密口腔內醫療設備專門用於研究的精密燕麥臂。

Professors Olivier Vanderveken, MD, PhD and Marijke Dieltjens, BMS, PhD, will present the data in a session titled, "Breaking news in OSA: New approaches and new trials," on Sunday, May 21 at 9:00 a.m. eastern time.

Olivier Vanderveken醫學博士和Marijke Dieltjens博士教授將在5月21日(星期日)上午9點舉行的題為“OSA的突發新聞:新方法和新試驗”的會議上公佈這些數據。東部時間。

About ProSomnus
ProSomnus (NASDAQ: OSA) is the first manufacturer of mass-customized Precision Oral Appliance Therapy (OAT) devices to treat OSA, which affects over 74 million people in North America 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. A growing body of research, including studies published by the Journal of Clinical Sleep Medicine and Military Medicine, suggests ProSomnus's Precision OAT devices are an effective treatment for mild to moderate OSA. Additional clinical research has shown that ProSomnus's Precision OAT devices can mitigate common dental side effects and improve economics for payers and providers. With more than 187,500 devices delivered, ProSomnus's devices are the most prescribed Precision OAT in the U.S. ProSomnus's FDA-cleared devices are authorized by the Department of Defense and the U.S. Army, and are often covered by medical insurance, Medicare, and social health programs in key international markets. To learn more, visit .

關於普羅索姆納斯
普羅索姆納斯(納斯達克:OSA)是第一家大規模定製的治療口腔阻塞性睡眠呼吸暫停綜合徵(OAT)設備的製造商,該疾病在北美影響着7400多萬人,與嚴重的共病有關,包括心力衰竭、中風、高血壓、病態肥胖和2型糖尿病。ProSomnus的專利設備是持續正壓(CPAP)治療的一種更舒適、侵入性更小的替代療法,併產生更有效和患者更喜歡的結果。越來越多的研究,包括由臨牀睡眠醫學雜誌軍事醫學ProSomnus的Precision燕麥設備是治療輕到中度OSA的有效方法。其他臨牀研究表明,ProSomnus的Precision OAT設備可以減輕常見的牙科副作用,並提高支付者和提供者的經濟性。ProSomnus的設備交付了超過187,500台設備,是美國處方最多的Precision OAT。ProSomnus的FDA批准的設備是由國防部和美國陸軍授權的,通常包括關鍵國際市場的醫療保險、聯邦醫療保險和社會健康計劃。要了解更多信息,請訪問。

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 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.

關於前瞻性陳述的重要通知
本新聞稿包含1933年證券法和1934年證券交易法所指的某些“前瞻性陳述”,這兩部法案均已修訂。非歷史事實的陳述,包括有關各方觀點和期望的陳述,都是前瞻性陳述。“預期”、“相信”、“估計”、“打算”、“計劃”以及類似的表述均為前瞻性表述。這些前瞻性陳述不是對未來業績的保證,會受到各種風險和不確定性、已知或未知的假設(包括有關一般經濟、市場、行業和經營因素的假設)的影響,這些風險和不確定性可能會導致實際結果與所示或預期的結果大不相同。

Such risks and uncertainties include, but are not limited to: (i) the effect of the announcement or the business combination on ProSomnus's business relationships, operating results and business generally; (ii) risks that the business combination disrupts current plans and operations of ProSomnus; (iii) the outcome of any legal proceedings that may be instituted against ProSomnus or Purchaser related to the business combination; (iv) 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; (v) the ability to implement business plans, forecasts and other expectations after the completion of the business combination, and identify and realize additional opportunities; (vi) the risk of downturns in the market and ProSomnus's industry including, but not limited to, as a result of the COVID-19 pandemic; (vii) 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; (viii) the risk of potential future significant dilution to stockholders resulting from lender conversions under the convertible debt financing; and (ix) 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 Lakeshore's initial public offering prospectus dated June 10, 2021 and in the Company'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 filed with the SEC by Lakeshore in connection with the business combination, 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 the Company and its 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.

此類風險和不確定性包括但不限於:(I)公告或業務合併對ProSomnus的業務關係、經營結果和總體業務的影響;(Ii)業務合併擾亂ProSomnus目前的計劃和運營的風險;(Iii)可能對ProSomnus或與業務合併相關的買方提起的任何法律訴訟的結果;(Iv)ProSomnus經營的競爭性行業的變化、競爭對手經營業績的差異、影響ProSomnus業務的法律法規的變化以及合併後資本結構的變化;(V)業務合併完成後執行業務計劃、預測和其他預期的能力,並發現和實現更多機會;(Vi)市場和普羅索姆納斯行業低迷的風險,包括但不限於,新冠肺炎大流行;(Vii)與交易相關的成本,以及未能實現交易的預期收益或未能實現估計的預計結果和基本假設,包括估計的股東贖回;(Vii)可轉換債務融資項下的貸款人轉換可能導致股東未來遭受重大稀釋的風險;和(Ix)與ProSomnus業務有關的風險和不確定因素,包括但不限於與ProSomnus預計財務信息的不確定性有關的風險;與ProSomnus有限的經營歷史有關的風險;ProSomnus業務的推出以及預期業務里程碑的時間安排;ProSomnus執行其業務計劃和擴大業務規模的能力, 這包括招聘醫療保健專業人員開出ProSomnus口腔器械和牙醫提供ProSomnus口腔器械;牙醫和其他保健專業人員對ProSomnus口腔器械用於輕度至中度OSA的瞭解和採用;對使用ProSomnus口腔器械治療OSA的有效性和治療完成後患者復發的可能性的預期;ProSomnus口腔器械治療患者和使用ProSomnus監測工具給牙醫和其他保健專業人員帶來的潛在經濟利益;ProSomnus口腔器械銷售的潛在利潤率;ProSomnus在牙科實踐中正確培訓牙醫使用ProSomnus口腔器械和其他服務的能力;ProSomnus制定、實施和根據需要修改有效的銷售、營銷和戰略計劃以推動收入增長的能力;ProSomnus在國際上擴張的能力;ProSomnus的知識產權和未來創造的知識產權的可行性;ProSomnus銷售的產品和服務被市場接受的程度;政府法規和ProSomnus獲得適用的監管批准並遵守政府法規的能力,包括根據醫療法律和美國食品和藥物管理局的規章制度;以及美國和國際上患者通過醫療保險報銷的程度。有關風險和不確定因素的進一步清單和描述,請參閲日期為6月10日的Lakeshore首次公開募股招股説明書, 在本公司提交給美國證券交易委員會(“美國證券交易委員會”)的Form 10-Q季度報告和Form 10-K年度報告中,以及隨後提交給美國證券交易委員會(“美國證券交易委員會”)的Form 10-Q季度報告和Form 10-K年度報告中,以及在湖濱提交給美國證券交易委員會的關於業務合併的S-4表格註冊聲明和委託書中,以及各方可能向美國證券交易委員會提交或提交的其他文件中,建議您閲讀這些文件。如果這些風險或不確定性中的一個或多個成為現實,或者基本的假設被證明是不正確的,實際結果可能與這些前瞻性陳述所表明或預期的大不相同。因此,我們告誡您不要過度依賴這些前瞻性陳述。前瞻性陳述僅與前瞻性陳述的發表日期有關,除非法律或適用法規要求,否則公司及其子公司沒有義務更新前瞻性陳述,以反映它們作出之後的事件或情況。

Investor Contact
Mike Cavanaugh
ICR Westwicke
Phone: +1.617.877.9641
Email: Mike.Cavanaugh@westwicke.com

投資者聯繫方式
Mike·卡瓦諾
ICR Westwicke
電話:+1.617.877.9641
電子郵件:Mike.Cavanaugh@westwicke.com

Media Contact
Kyle Evans
ICR Westwicke
Phone: +1.646.277.1295
Email: Kyle.Evans@westwicke.com

媒體聯繫人
凱爾·埃文斯
ICR Westwicke
電話:+1.646.277.1295
電子郵件:Kyle.Evans@westwicke.com


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