Nyxoah to Participate in Upcoming Investor Conferences Mont-Saint-Guibert, Belgium – September 5, 2024, 10:30pm CET / 4:30pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), today announced that the Company will participate in three upcoming investor conferences in New York City. Olivier Taelman, Nyxoah’s Chief Executive Officer, will deli ...

Nyxoah Rings the Closing Bell at Nasdaq while Preparing for U.S. Market Launch of Innovative Sleep Apnea Device FDA regulatory submission for the Company’s Genio® device is complete, U.S. approval on track for the end of 2024 U.S. commercial launch, expected at the beginning of 2025, fully funded with over €85 million in new capital raised Nyxoah – NASDAQ Closing Bell Ceremony 29 août 2024 Mont-Saint-Guibert, Belgium – September 2, 2024 10:05pm CET / 4:05PM ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) ...

财务数据和关键指标变化 - 第二季度收入为780,000欧元 [15] - 第二季度总运营亏损为1,330万欧元,较2023年同期的1,190万欧元有所增加,主要由于在美国和欧洲的商业投资加速 [15] - 公司在第二季度通过4,850万欧元的股权发行和欧洲投资银行的3,750万欧元贷款融资了8,500万欧元,使现金跑道延长至2026年中期 [15] - 截至6月30日,现金和金融资产总计7,800万欧元,不包括7月提取的第一笔1,000万欧元EMV贷款 [15] - 第二季度的月现金消耗为400万欧元 [15] 各条业务线数据和关键指标变化 - 无具体披露 各个市场数据和关键指标变化 - 2024年上半年欧洲销售额为200万欧元,较2023年上半年增长29% [13] - 截至6月底,公司在德国有55个活跃植入账户 [13] - 在德国前10大账户中,有9家正在植入Genio,其中5家在24个月内市场份额达到至少30% [17][18] - 根据独立调查数据,超过20%的美国神经刺激植入候选人因担心现有技术的侵入性而拒绝使用,这为Genio在美国市场的扩张提供了支持 [12][18] 公司战略和发展方向及行业竞争 - 公司正在积极建立美国商业组织,以准备2024年底前获得FDA批准后的上市 [6][10] - 公司将初期聚焦美国前85%手术量的顶级神经刺激植入中心,并采取可扩展的销售模式 [31][43][44] - 公司认为Genio产品的特点,如全身1.5T和3T MRI兼容、无植入式电池等,将使其在美国市场具有差异化优势,有望带动市场扩张 [12] - 公司正在与美国耳鼻喉科学会合作,争取在上市时获得临时CPT编码,并正在与商业保险公司进行沟通,希望能够利用现有的神经刺激植入覆盖政策 [23][24] - 公司认为GLP-1药物的出现将增加OSA患者群体,有利于神经刺激植入市场的发展 [50] 管理层对经营环境和未来前景的评论 - 公司对DREAM临床试验结果和即将在美国获批的前景感到非常兴奋 [6][14] - 公司认为德国市场的成功经验为美国市场的成功上市奠定了基础 [17][18] - 公司预计2024年下半年的收入将高于2023年下半年 [28] - 公司预计在获得FDA批准后,将在2025年实现盈利,前提是达到2.5亿美元的销售额 [46] 其他重要信息 - 公司已完成PMA申请的4个模块的提交,预计2024年底或2025年初获得FDA批准 [6][10] - 公司已加强生产能力,为美国市场的发展做好准备 [35][36] - 公司与ResMed的合作有助于识别新的CPAP放弃患者并及时转化为Genio植入患者 [28] 问答环节重要的提问和回答 问题1 **Suraj Kalia 提问** 询问德国市场的经验是否可以应用到美国市场,以及对于患者睡眠姿势的反馈情况 [16] **Olivier Taelman 回答** - 德国市场的成功经验,如打破垄断、扩大神经刺激植入市场等,为美国市场的成功奠定了基础 [17][18] - 在德国,公司在前10大账户中占据主导地位,这也给了公司在美国市场的信心 [17][18] - 德国市场的反馈显示,Genio在仰卧和非仰卧睡眠姿势下都能保持良好疗效,这是一大优势 [9] 问题2 **Edward White 提问** 询问公司在美国的报销策略 [22] **Olivier Taelman 回答** - 公司正与美国耳鼻喉科学会合作,争取在上市时获得临时CPT编码,以确保Medicare的报销 [23] - 公司已与商业保险公司进行沟通,希望能够利用现有的神经刺激植入覆盖政策 [24] 问题3 **Joseph Federico 提问** 询问本季度收入低于预期是否与竞争对手的动态有关 [26] **Olivier Taelman 回答** - 德国市场仍然是一个相对较小的收入市场,受限账户数和植入量的影响,收入存在一定的季度波动性 [27][28] - 公司预计2024年下半年的收入将高于2023年下半年,并期待与ResMed合作带来的积极影响 [28]

Nyxoah SA (NYXH) came out with a quarterly loss of $0.46 per share versus the Zacks Consensus Estimate of a loss of $0.45. This compares to loss of $0.49 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -2.22%. A quarter ago, it was expected that this company would post a loss of $0.45 per share when it actually produced a loss of $0.45, delivering no surprise.Over the last four quarters, the company has surpassed consensus EPS ...

Nyxoah to Release Second Quarter and First Half 2024 Financial Results on August 6, 2024 Mont-Saint-Guibert, Belgium – July 29, 2024, 10:30pm CET / 4:30pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), today announced that the Company will release financial results for the second quarter and first half 2024 on Tuesday, August 6, 2024, aft ...

Nyxoah Appoints Scott Holstine as Chief Commercial Officer Mont-Saint-Guibert, Belgium – July 15, 2024, 8:00am CET / 2:00am ET – Nyxoah SA (NASDAQ:NYXH) ("Nyxoah" or the "Company"), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), today announced the appointment of Scott Holstine as Chief Commercial Officer. In this role, Scott will lead the commercial operations of Nyxoah enabling a successful U.S. launch. Scott b ...

Nyxoah Appoints Scott Holstine as Chief Commercial Officer Mont-Saint-Guibert, Belgium – July 15, 2024, 8:00am CET / 2:00am ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), today announced the appointment of Scott Holstine as Chief Commercial Officer. In this role, Scott will lead the commercial operations of Nyxoah enabling a successful U. ...

Nyxoah Submits Fourth and Final Module in PMA Application for Genio to the US FDA Mont-Saint-Guibert (Belgium), July 1, 2024, 8:00am CET / 2:00am ET – ("Nyxoah" or the "Company"), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), today announced that the Company submitted the fourth and final module of its Premarket Approval (PMA) application for Genio to the U.S. Food and Drug Administration (FDA). Genio is a differ ...

文章核心观点 - 公司已向美国FDA提交了Genio系统的第四和最后一个模块的上市前批准(PMA)申请 [1][2][3] - Genio是一种不同于传统的舌骨神经刺激(HGNS)治疗方法,采用无导线、全身MRI兼容、无植入电池的可穿戴设备供电和控制 [2] - Genio在美国DREAM临床试验中达到了统计学显著的主要疗效指标,且是唯一一种在仰卧和非仰卧睡眠中都显示出相似疗效的HGNS解决方案 [2] 公司概况 - 公司专注于开发和商业化创新性的治疗阻塞性睡眠呼吸暂停(OSA)的解决方案 [4] - Genio系统是公司的主要产品,已于2019年获得欧洲CE认证 [5] - 公司先后在欧洲Euronext Brussels和美国纳斯达克成功完成IPO [5] - 公司还获得了适用于完全环形塌陷(CCC)患者的CE认证,并正在进行DREAM临床试验以获得FDA和美国商业化批准 [5]

REGULATED INFORMATION Information on the total number of voting rights and shares Mont-Saint-Guibert (Belgium), June 28, 2024, 10:30 pm CET / 4:30 pm ET – In accordance with article 15 of the Law of 2 May 2007 on the disclosure of large shareholdings, Nyxoah SA (Euronext Brussels and Nasdaq: NYXH) publishes the below information following the issue of new shares. Share capital: EUR 5,904,962.41 Total number of securities carrying voting rights: 34,373,015 (all ordinary shares) Total number of voting rights ...