LITTLETON, Colo., April 09, 2024 (GLOBE NEWSWIRE) -- Vivos Therapeutics, Inc. (“Vivos” or the “Company”) (NASDAQ: VVOS), a leading medical device and technology company specializing in the development and commercialization of highly effective proprietary treatments for sleep related breathing disorders (including all severities of obstructive sleep apnea (OSA) in adults), today announced receipt of all required regulatory approvals to enable Medicare reimbursement for its CARE oral medical devices.

科罗拉多州利特尔顿，2024年4月9日（环球通讯社）--Vivos Therapeutics，Inc.（“Vivos”或“公司”）（纳斯达克：VVOS），一家领先的医疗器械和技术公司，专门开发和商业化针对睡眠相关呼吸障碍（包括成人阻塞性睡眠呼吸暂停（OSA）的所有严重程度）的高效专有治疗方法，今天宣布收到所有必需的监管批准，以使医疗保险能够报销其护理口腔医疗器械。

Effective immediately, this milestone achievement allows millions of Medicare beneficiaries coverage and reimbursement for allowable charges billable to Medicare..

这一里程碑式的成就立即生效，可为数百万医疗保险受益人提供保险，并报销可向医疗保险支付的允许费用。。

“Prior to these latest developments, moderate to severe OSA patients on Medicare were relegated almost entirely to a lifetime of some form of CPAP—something most patients find undesirable. Our CARE oral medical devices, on the other hand, can significantly improve and even resolve OSA in about 12 months, with no further intervention required in most cases,” said Kirk Huntsman, Vivos Chairman and Chief Executive Officer.

Vivos董事长兼首席执行官柯克·亨茨曼（KirkHuntsman）表示：“在这些最新发展之前，医疗保险中的中度至重度OSA患者几乎完全被降级为某种形式的CPAP，这是大多数患者认为不可取的。另一方面，我们的护理口腔医疗设备可以在大约12个月内显着改善甚至解决OSA，在大多数情况下无需进一步干预。”。

“We are very pleased the Centers for Medicare and Medicaid Services (CMS) recognizes and validates the benefits our FDA cleared devices can have on the lives of patients diagnosed with OSA. Now these novel and patented devices, which have been proven effective for all levels of OSA severity in adults from mild to severe, can be accessible to more people with less out of pocket cost.

“我们很高兴医疗保险和医疗补助服务中心（CMS）认识到并验证了我们FDA批准的设备可以对诊断为OSA的患者的生活产生的益处。现在，这些新颖且获得专利的设备已被证明对从轻度到重度的成人OSA严重程度的所有程度都有效，可以让更多人以更少的自付费用获得。

We believe this latest regulatory approval represents an inflection point for our devices and will open the door for more OSA patients who have Medicare or commercial medical insurance coverage to receive treatment from Vivos-trained professionals utilizing our proprietary core technology and treatment protocols.

我们认为，这项最新的监管批准代表了我们设备的一个转折点，并将为更多拥有医疗保险或商业医疗保险的OSA患者打开大门，让他们利用我们专有的核心技术和治疗方案接受Vivos培训的专业人员的治疗。

This should also drive increased patient count and utilization of our Vivos Devices and Method.”.

这也应该推动患者数量的增加以及我们Vivos设备和方法的利用率。”。

Vivos provider and nationally renowned medical billing expert Chris Farrugia, DDS, DABSB, commented, “This coding decision from CMS now aligns with standard commercial billing practices for the device under the code K1027 as an oral device appliance used to reduce upper airway collapsibility, without a fixed mechanical hinge.

Vivos提供商和全国著名的医疗计费专家Chris Farrugia，DDS，DABSB评论道：“CMS的这一编码决定现在符合标准商业计费实践，该设备的代码为K1027，作为一种用于减少上呼吸道塌陷的口腔器械，没有固定的机械铰链。

This is a big step in making Vivos’ therapy accessible to Medicare beneficiaries as well as the millions of OSA patients covered by commercial insurers.”.

这是使医疗保险受益人以及商业保险公司覆盖的数百万OSA患者能够获得Vivos治疗的一大步。”。

According to CMS, as of December 2023, 66.9 million people were enrolled in Medicare, and many of these beneficiaries may suffer from OSA. OSA is a serious and chronic disease that negatively impacts a patient’s sleep, health, and quality of life. According to a 2019 article published in Chest Physician, it is estimated that OSA afflicts 54 million adults in the U.S.

据CMS统计，截至2023年12月，6690万人参加了医疗保险，其中许多受益人可能患有OSA。OSA是一种严重的慢性疾病，对患者的睡眠，健康和生活质量产生负面影响。根据《胸科医生》2019年发表的一篇文章，估计美国有5400万成年人患有OSA。

alone. According to the study, 'Global Prevalence of Obstructive Sleep Apnea (OSA)” conducted by an international panel of leading researchers, nearly 1 billion people worldwide have sleep apnea. Research has shown that when left untreated, OSA can increase the risk of comorbidities, such as high blood pressure, heart failure, stroke, diabetes, dementia, chronic pain and other debilitating, life-threatening diseases.

独自一人。根据一个由国际顶尖研究人员组成的小组进行的“阻塞性睡眠呼吸暂停（OSA）的全球患病率”研究，全球近10亿人患有睡眠呼吸暂停。研究表明，如果不及时治疗，阻塞性睡眠呼吸暂停低通气会增加合并症的风险，如高血压、心力衰竭、中风、糖尿病、痴呆、慢性疼痛和其他致命疾病。

The Vivos Method is estimated to be indicated and potentially effective (within the scope of the FDA cleared uses) in approximately 80% of cases of OSA where patients are compliant with clinical treatments..

据估计，在大约80%的OSA患者符合临床治疗的情况下，Vivos方法被指示并可能有效（在FDA批准的使用范围内）。。

About Vivos Therapeutics, Inc.

关于Vivos Therapeutics，Inc。

Vivos Therapeutics, Inc. (NASDAQ: VVOS) is a medical technology company focused on developing and commercializing innovative diagnostic and treatment methods for patients suffering from breathing and sleep issues arising from certain dentofacial abnormalities such as obstructive sleep apnea (OSA) and snoring in adults.

Vivos Therapeutics，Inc.（纳斯达克股票代码：VVOS）是一家医疗技术公司，专注于为患有某些面部异常（如阻塞性睡眠呼吸暂停（OSA）和成人打鼾）引起的呼吸和睡眠问题的患者开发和商业化创新的诊断和治疗方法。

The Vivos Method represents the first clinically effective nonsurgical, noninvasive, nonpharmaceutical and cost-effective solution for treating mild to severe OSA. It has proven effective in over 42,000 patients treated worldwide by more than 1,900 trained dentists..

Vivos方法是治疗轻度至重度OSA的第一种临床有效的非手术，无创，非药物和成本效益的解决方案。它已被证明对全世界超过42000名接受1900多名训练有素的牙医治疗的患者有效。。

The Vivos Method includes treatment regimens that employ the proprietary CARE appliance therapy and other modalities that alter the size, shape and position of the soft tissues that comprise a patient’s upper airway and/or palate. The three Vivos CARE devices open airway space and may significantly reduce symptoms and conditions associated with mild-to-severe OSA, such as lowering Apnea Hypopnea Index scores.

Vivos方法包括采用专有护理器具治疗的治疗方案和其他改变患者上呼吸道和/或上颚软组织大小，形状和位置的方式。这三种Vivos护理设备可以打开气道空间，并可以显着减轻与轻度至重度OSA相关的症状和病症，例如降低呼吸暂停低通气指数评分。

Vivos also markets and distributes SleepImage diagnostic technology under its VivoScore program for home sleep testing in adults and children. The Vivos Integrated Practice (VIP) program offers dentists training and other value-added services in connection with using The Vivos Method..

Vivos还在其VivoScore项目下销售和分销SleepImage诊断技术，用于成人和儿童的家庭睡眠测试。Vivos综合实践（VIP）计划提供牙医培训和其他与使用Vivos方法相关的增值服务。。

For more information, visit www.vivos.com.

For more information, visit www.vivos.com.

Cautionary Note Regarding Forward-Looking Statements

关于前瞻性声明的注意事项

This press release and statements of the Company’s management made in connection therewith contain “forward-looking statements” (as defined in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended) concerning future events. Words such as “may”, “should”, “expects”, “projects,” “intends”, “plans”, “believes”, “anticipates”, “hopes”, “estimates”, “goal” and variations of such words and similar expressions are intended to identify forward-looking statements.

本新闻稿和公司管理层就此发表的声明包含有关未来事件的“前瞻性声明”（定义见1933年《证券法》第27A节（修订版）和1934年《证券交易法》第21E节（修订版）。诸如“可能”、“应该”、“期望”、“项目”、“打算”、“计划”、“相信”、“期望”、“希望”、“估计”、“目标”等词语以及这些词语和类似表达的变体旨在识别前瞻性陈述。

These statements involve significant known and unknown risks and are based upon several assumptions and estimates, which are inherently subject to significant uncertainties and contingencies, many of which are beyond Vivos’ control. Actual results (including the actual impact of the Medicare regulatory approval described herein on Vivos’ future revenues and results of operations) may differ materially and adversely from those expressed or implied by such forward-looking statements.

这些报表涉及重大的已知和未知风险，并基于若干假设和估计，这些假设和估计固有地受到重大不确定性和意外事件的影响，其中许多不受Vivos的控制。实际结果（包括本文所述的医疗保险监管批准对Vivos未来收入和运营结果的实际影响）可能与此类前瞻性声明中明示或暗示的结果存在重大不利差异。

Factors that could cause actual results to differ materially include, but are not limited to: (i) the risk that Vivos may be unable to generate additional revenue from its receipt of the Medicare reimbursement code described herein or from other strategies aimed at increasing revenues, (ii) the risk that some patients may not achieve the desired results from using Vivos’ products, (iii) risks associated with regulatory scrutiny of and adverse publicity in the sleep apnea treatment sector; (iv) the risk that Vivos may be unable to secure additional financing on reasonable terms when needed, if at all, or maintain its Nasdaq listing and (v) other risk factors described in Vivos’ filings with the SEC.

可能导致实际结果产生重大差异的因素包括但不限于：（i）Vivos可能无法从收到本文所述的医疗保险报销代码或其他旨在增加收入的策略中产生额外收入的风险，（ii）一些患者使用Vivos产品可能无法达到预期结果的风险，（iii）与睡眠呼吸暂停治疗部门的监管审查和不良宣传相关的风险；（iv）Vivos可能无法在需要时以合理条款获得额外融资（如果有的话）或维持其在纳斯达克上市的风险，以及（v）Vivos向SEC提交的文件中描述的其他风险因素。

Vivos’ filings can be obtained free of charge on the SEC’s website at www.sec.

维沃斯的档案可以在美国证券交易委员会的网站www.SEC上免费获得。

Vivos Investor Relations and Media Contact:

Vivos投资者关系和媒体联系：

Julie Gannon

Julie Gannon

Investor Relations Officer

投资者关系官

720-442-8113

720-442-8113

jgannon@vivoslife.com

jgannon@vivoslife.com