MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--Aerin Medical Inc., a company dedicated to providing Ear, Nose and Throat (ENT) physicians with non-invasive solutions for the treatment of chronic nasal conditions, today announced that Rhinology Journal has published positive two-year outcomes from the VATRAC trial.

加利福尼亚州山景城（商业新闻）——Aerin Medical Inc.是一家致力于为耳鼻喉（ENT）医生提供治疗慢性鼻部疾病的非侵入性解决方案的公司，今天宣布，《鼻科学杂志》公布了VATRAC试验两年的积极成果。

The study showed a single in-office treatment with VivAer® resulted in sustained improvement in symptoms of nasal airway obstruction (NAO) caused by nasal valve collapse, and reduced both daytime sleepiness and the use of medications and mechanical aids. Previously published three-month results of the randomized controlled trial demonstrated that treatment with VivAer was safe and superior to a sham procedure.1.

该研究表明，使用VivAer®进行单次办公室治疗可持续改善由鼻瓣膜塌陷引起的鼻气道阻塞（NAO）症状，并减少白天嗜睡以及药物和机械辅助的使用。之前公布的随机对照试验的三个月结果表明，维瓦治疗是安全的，优于假手术。

“These data demonstrating the significant and lasting improvements in nasal airway obstruction symptoms mark a breakthrough in addressing a common and often-challenging cause of the condition,” said Joseph K. Han, M.D., professor, chief of the division of rhinology and endoscopic sinus and skull base surgery, and chief for the division of allergy at Eastern Virginia Medical School, who served as the co-principal investigator of the VATRAC clinical trial.

“这些数据表明鼻气道阻塞症状的显着和持久的改善标志着在解决这种疾病的常见且通常具有挑战性的原因方面取得了突破，”JosephK.Han，医学博士，教授，鼻内镜鼻窦和颅底外科主任，东弗吉尼亚医学院过敏科主任，他曾担任VATRAC临床试验的联合首席研究员。

“VivAer offers lasting relief to patients with nasal airway obstruction symptoms and creates new options for complete treatment of the nasal valve.”.

“VivAer为患有鼻气道阻塞症状的患者提供了持久的缓解，并为完全治疗鼻瓣膜创造了新的选择。”。

VATRAC, a prospective, multi-center randomized control trial, enrolled 119 patients who had extreme or severe NAO based on the validated Nasal Obstruction Symptom Evaluation (NOSE) Scale score, with nasal valve collapse as a primary or significant contributor to NAO symptoms. The most common symptoms of NAO include nasal congestion or stuffiness, trouble breathing through the nose, trouble sleeping and difficulty breathing well during exercise or exertion.

VATRAC是一项前瞻性多中心随机对照试验，根据经过验证的鼻塞症状评估（NOSE）量表评分，招募了119名患有极端或严重NAO的患者，其中鼻瓣膜塌陷是NAO症状的主要或重要因素。NAO最常见的症状包括鼻塞或鼻塞，通过鼻子呼吸困难，睡眠困难以及运动或劳累期间呼吸困难。

After primary endpoint analysis, 31 control patients were eligible for crossover and elected to undergo active VivAer treatment. The data in this two-year post-procedure publication includes 73 patients receiving VivAer treatment, including these crossovers..

在主要终点分析后，31名对照患者有资格进行交叉治疗，并选择接受积极的VivAer治疗。这篇为期两年的术后出版物中的数据包括73名接受VivAer治疗的患者，包括这些交叉。。

The long-term follow up from VATRAC confirmed the sustained effectiveness of VivAer, with treated patients reporting durable improvements from baseline through 24 months post-procedure, including in those with documented septal deviation. Key findings included:

VATRAC的长期随访证实了VivAer的持续有效性，接受治疗的患者报告从基线到术后24个月持续改善，包括记录有间隔偏斜的患者。主要调查结果包括：

The responder rate at two years was 90.4%, sustained across all time periods.

两年的应答率为90.4%，在所有时间段都持续存在。

Patient NAO symptoms significantly improved over baseline at all follow-up timepoints; at two years post-treatment, patients maintained a 54.7% improvement in NOSE scores compared to baseline.

在所有随访时间点，患者NAO症状均比基线显着改善；治疗后两年，与基线相比，患者的鼻子评分保持了54.7%的改善。

The presence of septal deviation did not significantly affect treatment outcomes.

间隔偏斜的存在并没有显着影响治疗结果。

Treatment with VivAer was well-tolerated, and there were no serious adverse events related to the procedure or device.

VivAer治疗耐受性良好，没有与手术或装置相关的严重不良事件。

“This publication adds to the deep dossier of clinical evidence for VivAer, with three separate studies now confirming multi-year benefit and with comparable responder rates,” said Matt Brokaw, CEO of Aerin Medical. “We extend our gratitude to the clinical investigators whose dedication has been instrumental in demonstrating that VivAer is a practical and effective innovation changing how and where nasal airway obstruction patients are treated.”.

Aerin Medical首席执行官马特·布罗考（MattBrokaw）说：“这份出版物增加了维瓦尔临床证据的深度档案，现在有三项独立的研究证实了多年的益处，并且有相当的应答率。”。“我们感谢临床研究人员，他们的奉献精神有助于证明VivAer是一种实用有效的创新，改变了鼻气道阻塞患者的治疗方式和地点。”。

NAO takes a heavy toll on daily life. Nasal valve collapse contributes to nasal obstruction for 73% of highly symptomatic individuals,2 but is often under-diagnosed and left untreated. This can have a significant impact on a person’s quality of life, as the nasal valve is the narrowest part of the nasal airway and even small obstructions can create an exponential reduction in airflow.

NAO给日常生活带来了沉重的损失。73%的高症状患者鼻瓣膜塌陷导致鼻阻塞[2]，但通常诊断不足，未经治疗。这可能会对一个人的生活质量产生重大影响，因为鼻瓣膜是鼻气道最窄的部分，即使是很小的阻塞也会导致气流呈指数级减少。

VivAer offers ENT physicians a unique, non-invasive and office-friendly option that durably remodels tissue in the nasal valve to address NAO in appropriate patients..

VivAer为耳鼻喉科医生提供了一种独特的，非侵入性和办公室友好的选择，可以持久地重塑鼻瓣膜组织，以解决适当患者的NAO问题。。

About VivAer

关于VivAer

VivAer is a non-invasive technology that uses patented, temperature-controlled radiofrequency energy and is clinically demonstrated to provide long-term relief from nasal obstruction. VivAer features a thin, wand-like stylus that attaches to a console. The stylus is inserted via the nostril to gently remodel the nasal tissue and improve airflow.

VivAer是一种非侵入性技术，使用专利的温控射频能量，临床证明可长期缓解鼻塞。VivAer拥有一个细长的棒状触笔，可以连接到控制台上。触针通过鼻孔插入，轻轻重塑鼻组织并改善气流。

VivAer does not involve any cutting, removal of nasal tissue or bone, or the use of an implant. Treatment with VivAer may be performed during an office visit with local anesthesia. Patients typically experience little discomfort with minimal to no downtime and are often able to return to normal activities following treatment.

VivAer不涉及任何切割，鼻组织或骨骼的切除或植入物的使用。VivAer治疗可在局部麻醉的办公室就诊期间进行。患者通常很少感到不适，停机时间很少甚至没有，并且在治疗后通常能够恢复正常活动。

The VivAer Stylus received CE Mark in 2016 and FDA 510(k) clearance in December 2017. For more information, visit www.VivAer.com..

VivAer触针于2016年获得CE标志，并于2017年12月获得FDA 510（k）许可。欲了解更多信息，请访问www.VivAer.com。。

About Aerin Medical

关于Aerin Medical

Aerin Medical is a privately held, venture-backed company, with U.S. offices in California and Texas. Aerin’s mission is to expand access to meaningful relief for millions of patients suffering from chronic ENT conditions. The company’s products, VivAer® for nasal airway obstruction and RhinAer® for chronic rhinitis, leverage Aerin’s proprietary temperature-controlled technology, which allows ENT physicians to reliably improve patients’ symptoms with unique technologies that are appealing alternatives to invasive surgery.

Aerin Medical是一家由风险投资支持的私营公司，在加利福尼亚州和德克萨斯州设有美国办事处。Aerin的使命是为数百万患有慢性耳鼻喉科疾病的患者提供有意义的救济。该公司的产品VivAer®用于鼻气道阻塞，RhinAer®用于慢性鼻炎，利用Aerin专有的温控技术，使耳鼻喉科医生能够通过独特的技术可靠地改善患者的症状，这些技术是侵入性手术的诱人替代品。

More than 100,000 patients have been treated with Aerin Medical products to date. For more information, please visit www.aerinmedical.com and follow Aerin Medical on Facebook, X, Instagram, LinkedIn and YouTube..

迄今为止，已有超过10万名患者接受了Aerin医疗产品的治疗。有关更多信息，请访问www.aerinmedical.com，并在Facebook、X、Instagram、LinkedIn和YouTube上关注Aerin Medical。。

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1 Silvers et al., Temperature-controlled radiofrequency device treatment of the nasal valve for nasal airway obstruction: A randomized controlled trial. International Forum of Allergy and Rhinology. July 2021. https://doi.org/10.1002/alr.22861

1 Silvers等，温控射频装置治疗鼻气道阻塞的鼻瓣膜：一项随机对照试验。国际过敏与鼻科学论坛。2021年7月。https://doi.org/10.1002/alr.22861

2 Clark, David; Del Signore, Anthony; Raithatha, Roheen; Senior, Brent; 2018. Nasal airway obstruction: Prevalence and anatomic contributors; 2018 ENT Ear Nose & Throat Journal; 97(6).

2克拉克，大卫；德尔·西诺尔，安东尼；拉伊萨，罗欣；高级，布伦特；鼻气道阻塞：患病率和解剖学贡献者；2018年耳鼻喉科杂志；97（6）。