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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® 宣布接受摘要在著名的美国胸科学会2023年国际会议上进行口头陈述
GlobeNewswire ·  2023/01/26 08:07

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

来自第一线阻塞性睡眠呼吸暂停治疗研究(FLOSAT)的数据将首次公布

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.

旧金山,2023年1月26日(环球社)--精密医疗设备治疗阻塞性睡眠呼吸暂停(OSA)的先驱公司ProSomnus,Inc.(纳斯达克:OSA)今天宣布,一份展示第一线阻塞性睡眠呼吸暂停治疗研究(FLOSAT)数据的摘要已被接受在5月19-24日在华盛顿举行的美国胸科学会(ATS)2023年国际会议上进行口头演示。

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由比利时安特卫普大学医院(UZA)设计和实施,是一项前瞻性、独立、面对面的交叉研究,比较了精密口腔器械疗法(OAT)作为一线治疗与持续正压(CPAP)治疗中重度阻塞性睡眠呼吸暂停患者的疗效。ProSomnus精密口腔内医疗设备专门用于研究的精密燕麦臂。

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医学博士和Marijke Dieltjens博士教授将在5月21日(星期日)上午9点举行的题为“OSA的突发新闻:新方法和新试验”的会议上公布这些数据。东部时间。

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 .

关于普罗索姆纳斯
普罗索姆纳斯(纳斯达克:OSA)是第一家大规模定制的治疗口腔阻塞性睡眠呼吸暂停综合征(OAT)设备的制造商,该疾病在北美影响着7400多万人,与严重的共病有关,包括心力衰竭、中风、高血压、病态肥胖和2型糖尿病。ProSomnus的专利设备是持续正压(CPAP)治疗的一种更舒适、侵入性更小的替代疗法,并产生更有效和患者更喜欢的结果。越来越多的研究,包括由临床睡眠医学杂志军事医学ProSomnus的Precision燕麦设备是治疗轻到中度OSA的有效方法。其他临床研究表明,ProSomnus的Precision OAT设备可以减轻常见的牙科副作用,并提高支付者和提供者的经济性。ProSomnus的设备交付了超过187,500台设备,是美国处方最多的Precision OAT。ProSomnus的FDA批准的设备是由国防部和美国陆军授权的,通常包括关键国际市场的医疗保险、联邦医疗保险和社会健康计划。要了解更多信息,请访问。

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.

关于前瞻性陈述的重要通知
本新闻稿包含1933年证券法和1934年证券交易法所指的某些“前瞻性陈述”,这两部法案均已修订。非历史事实的陈述,包括有关各方观点和期望的陈述,都是前瞻性陈述。“预期”、“相信”、“估计”、“打算”、“计划”以及类似的表述均为前瞻性表述。这些前瞻性陈述不是对未来业绩的保证,会受到各种风险和不确定性、已知或未知的假设(包括有关一般经济、市场、行业和经营因素的假设)的影响,这些风险和不确定性可能会导致实际结果与所示或预期的结果大不相同。

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.

此类风险和不确定性包括但不限于:(I)公告或业务合并对ProSomnus的业务关系、经营结果和总体业务的影响;(Ii)业务合并扰乱ProSomnus目前的计划和运营的风险;(Iii)可能对ProSomnus或与业务合并相关的买方提起的任何法律诉讼的结果;(Iv)ProSomnus经营的竞争性行业的变化、竞争对手经营业绩的差异、影响ProSomnus业务的法律法规的变化以及合并后资本结构的变化;(V)业务合并完成后执行业务计划、预测和其他预期的能力,并发现和实现更多机会;(Vi)市场和普罗索姆纳斯行业低迷的风险,包括但不限于,新冠肺炎大流行;(Vii)与交易相关的成本,以及未能实现交易的预期收益或未能实现估计的预计结果和基本假设,包括估计的股东赎回;(Vii)可转换债务融资项下的贷款人转换可能导致股东未来遭受重大稀释的风险;和(Ix)与ProSomnus业务有关的风险和不确定因素,包括但不限于与ProSomnus预计财务信息的不确定性有关的风险;与ProSomnus有限的经营历史有关的风险;ProSomnus业务的推出以及预期业务里程碑的时间安排;ProSomnus执行其业务计划和扩大业务规模的能力, 这包括招聘医疗保健专业人员开出ProSomnus口腔器械和牙医提供ProSomnus口腔器械;牙医和其他保健专业人员对ProSomnus口腔器械用于轻度至中度OSA的了解和采用;对使用ProSomnus口腔器械治疗OSA的有效性和治疗完成后患者复发的可能性的预期;ProSomnus口腔器械治疗患者和使用ProSomnus监测工具给牙医和其他保健专业人员带来的潜在经济利益;ProSomnus口腔器械销售的潜在利润率;ProSomnus在牙科实践中正确培训牙医使用ProSomnus口腔器械和其他服务的能力;ProSomnus制定、实施和根据需要修改有效的销售、营销和战略计划以推动收入增长的能力;ProSomnus在国际上扩张的能力;ProSomnus的知识产权和未来创造的知识产权的可行性;ProSomnus销售的产品和服务被市场接受的程度;政府法规和ProSomnus获得适用的监管批准并遵守政府法规的能力,包括根据医疗法律和美国食品和药物管理局的规章制度;以及美国和国际上患者通过医疗保险报销的程度。有关风险和不确定因素的进一步清单和描述,请参阅日期为6月10日的Lakeshore首次公开募股招股说明书, 在本公司提交给美国证券交易委员会(“美国证券交易委员会”)的Form 10-Q季度报告和Form 10-K年度报告中,以及随后提交给美国证券交易委员会(“美国证券交易委员会”)的Form 10-Q季度报告和Form 10-K年度报告中,以及在湖滨提交给美国证券交易委员会的关于业务合并的S-4表格注册声明和委托书中,以及各方可能向美国证券交易委员会提交或提交的其他文件中,建议您阅读这些文件。如果这些风险或不确定性中的一个或多个成为现实,或者基本的假设被证明是不正确的,实际结果可能与这些前瞻性陈述所表明或预期的大不相同。因此,我们告诫您不要过度依赖这些前瞻性陈述。前瞻性陈述仅与前瞻性陈述的发表日期有关,除非法律或适用法规要求,否则公司及其子公司没有义务更新前瞻性陈述,以反映它们作出之后的事件或情况。

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