MINNEAPOLIS, June 26, 2024 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (NASDAQ:NUWE) ("Nuwellis" or the "Company"), a medical technology company focused on transforming the lives of people with fluid overload, announced today a 1-for-35 reverse split (the "Reverse Stock Split") of its common stock, par value $0.0001 (the "Common Stock"), effective at 5:00 pm Eastern Time June 27, 2024. Beginning on June 28, 2024, the Company's Common Stock will trade on The Nasdaq Capital Market on a split-adjusted basis. At the Com ...

MINNEAPOLIS, June 25, 2024 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company focused on transforming the lives of people with fluid overload, today announced the recent grant of a new patent from the United States Patent and Trademark Office (USPTO) related to its groundbreaking pediatric continuous renal replacement therapy (CRRT), Vivian™. This patent covers critical advancements that will significantly improve the performance and user experience of Vivian. This is the second ...

MINNEAPOLIS, June 06, 2024 (GLOBE NEWSWIRE) -- Nuwellis, Inc. Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company dedicated to transforming the lives of patients with fluid overload, today announced the extension of its pilot phase under its previously announced supply and collaboration agreement with DaVita Inc. (NYSE: DVA) until August 31, 2024. This program aims to pilot Aquadex® ultrafiltration therapy for adult patients suffering from congestive heart failure and related conditions in select U. ...

MINNEAPOLIS, May 14, 2024 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (NASDAQ:NUWE), a medical technology company focused on transforming the lives of people with fluid overload, today announced the launch of a new pediatric ultrafiltration program utilizing Nuwellis' Aquadex SmartFlow System® at one of the largest health integrated delivery networks (IDN) in Florida. This program marks an expansion by this network to offer ultrafiltration to its pediatric patients, in addition to its current heart failure and criti ...

MINNEAPOLIS, May 09, 2024 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (NASDAQ:NUWE), a medical technology company focused on transforming the lives of people with fluid overload, today announced a new purchase agreement with one of the top 25 largest integrated delivery networks (IDN) in the U.S. Nuwellis has a successful history of collaborating with individual member hospitals within the IDN on Aquadex utilization. This new network-wide agreement signifies a broader commitment to providing advanced ultrafiltration ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to __________ Commission file number 001-35312 NUWELLIS, INC. (Exact Name of Registrant as Specified in its Charter) Delaware No. 68-0533453 (State or Other J ...

Exhibit 99.1 Nuwellis, Inc. Announces First Quarter 2024 Financial Results Minneapolis, MN, May 7, 2024 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company focused on transforming the lives of people with fluid overload, today reported financial results for the first quarter ended March 31, 2024. Highlights: • Revenue of $1.9 million, a 2% increase over the prior-year period. • Consumables sales, representing 82% of total revenue, grew 11% year-over-year. • Pediatric revenue grow ...

财务数据和关键指标变化 - 公司Q1营收为1.9亿美元,同比增长2%,主要由于耗材使用量增加11% [9][20] - 毛利率为64.1%,较上年同期58.4%有所提升,主要由于耗材生产量增加 [21] - 销售、管理及行政费用下降16.1%至4.6亿美元,主要由于人员成本和管理费用降低 [22] - 研发费用为1.3亿美元,较上年同期1.4亿美元略有下降 [22] - 营业亏损为4.7亿美元,较上年同期5.8亿美元有所改善 [24] - 归属普通股东净亏损为3.8亿美元,每股亏损0.60美元,较上年同期6.5亿美元、5.76美元每股有所改善 [25] - 公司于4月30日完成2.7亿美元的公开发行,扣除承销费用后净筹资2.4亿美元 [26][37] 各条业务线数据和关键指标变化 - 儿科客户群体收入增长40%,耗材使用量增加54% [9] - 重症监护客户群体收入持平,但耗材使用量增加9% [20] - 心力衰竭收入下降38%,主要由于使用量和销售下降 [10] 各个市场数据和关键指标变化 - 无具体披露 公司战略和发展方向及行业竞争 - 公司继续推进与DaVita的合作试点,在9家医院开展,结果良好 [17] - 公司与SeaStar Medical合作,获得Quelimmune在儿科患者中的FDA特许使用许可,并开始在5家医院进行商业化 [14][15] - 公司正在开发儿科连续肾脏替代治疗设备Vivian,与Quelimmune设备形成互补 [16] - 公司启动了在密歇根亨利福特健康系统的心力衰竭逆转临床试验 [18] - 公司预计全年资本设备销售将有所增加,因医院资本支出压力有所缓解 [11][32][33] 管理层对经营环境和未来前景的评论 - 公司对2024年的增长势头充满信心,主要由于Aquadex疗效认知度提高和治疗采用率上升 [11][43] - 公司将通过新产品销售,特别是在快速增长的儿科领域,以及推进DaVita合作,来推动未来发展 [13][17] - 公司正在采取成本控制措施,预计全年运营成本将降低约50% [23][35] - 公司目前现金储备有限,需要依靠DaVita合作、APC代码调整等催化剂来获得新一轮融资 [38][39] 问答环节重要的提问和回答 问题1 **Anthony Vendetti 提问** 询问SeaStar分销协议的进展情况,包括销售人员培训、销售情况以及与公司现有业务的协同机会 [28][29][30] **Nestor Jaramillo 回答** 公司已开始培训销售人员,并将分两个阶段在5家医院进行商业化,SeaStar的临床人员将参与支持。公司认为Quelimmune与Vivian设备的结合将为儿科患者带来显著价值 [29][30] 问题2 **Anthony Vendetti 提问** 询问公司资本设备销售与耗材使用量的关系,以及影响因素 [31][32][33] **Nestor Jaramillo 回答** 公司资本设备销售一直较为波动,与医院资本支出环境密切相关。耗材使用量取决于医院各科室对Aquadex疗法的采用程度,使用量可从每季度5-10例到每月20-30例不等 [32][33] 问题3 **Anthony Vendetti 提问** 询问公司如何实现约50%的成本削减目标,是否有任何业务或项目被缩减或终止 [34][35] **Nestor Jaramillo 回答** 公司三大战略举措中,销售营销和心力衰竭逆转项目未受影响,主要通过缩减Vivian儿科设备软件开发的外包支出来实现成本削减 [35]

Investor Presentation March 2024 1 | FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2024 Nuwellis, Inc. Safe Harbor Statement ...

MINNEAPOLIS, April 30, 2024 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (NASDAQ:NUWE) ("Nuwellis" or the "Company"), a medical technology company focused on transforming the lives of people with fluid overload, today announced the closing of its previously announced public offering of 11,250,000 shares of its common stock (or pre-funded warrants in lieu thereof) and warrants to purchase up to an aggregate of 16,875,000 shares of its common stock at a combined public offering price of $0.24 per share (or pre-funded w ...