Irvine, California, July 24, 2024–(BUSINESS WIRE)–Edwards Lifesciences (NYSE: EW) today announced an investment that reflects the company’s deep commitment to advancing patient care through structural heart innovations, addressing significant unmet patient needs and supporting sustainable long-term growth.
Edwards has signed a purchase agreement. Jena Valve TechnologyEdwards is a pioneer in the transcatheter treatment of aortic regurgitation (AR), a condition that currently affects a significant and growing number of patients, most of whom remain untreated. Late last year, JenaValve announced positive results from a pivotal trial for the treatment of symptomatic, severe AR in high-risk patients in the United States. As a pioneer in valve innovation for more than 60 years, Edwards believes it is uniquely positioned to lead this next frontier in the treatment of aortic valve disease. Edwards anticipates FDA approval of the JenaValve Trilogy heart valve system in the second half of 2025, which will be the first approved treatment for patients suffering from AR.
Edwards exercised an option to acquire the company based on its investment made in 2016. EndotronicsEndotronics is a leader in heart failure (HF) management solutions. Many of the structural heart disease patients Edwards currently treats also suffer from HF, for which there are limited treatment options. This acquisition expands Edwards’ structural heart disease portfolio into a new therapeutic area, addressing a significant unmet need for patients suffering from HF. Last month, Endotronics received FDA approval for Cordella, an implantable pulmonary artery pressure sensor that enables earlier targeted therapeutic intervention. A nationwide coverage decision by CMS is expected in early 2025.
“These acquisitions expand our opportunities to address the unmet needs of aortic regurgitation and heart failure patients around the world,” said Edwards CEO Bernard Zovighian. “We are pleased to enter these structural heart therapeutic areas with our innovation, world-class science and clinical evidence to bring life-saving technologies to patients around the world.”
Edwards expects these investments to strengthen its leadership in structural cardiac innovation and provide long-term growth opportunities. Edwards expects these acquisitions to provide minimal earnings contribution in 2025. The aggregate initial purchase price for these strategic investments is approximately $1.2 billion. The acquisition is subject to the satisfaction of certain closing conditions, including the receipt of required antitrust and foreign investment approvals.
About Edwards Lifesciences
Edwards Lifesciences is a global leader in patient-centered innovations for structural heart disease and critical care monitoring. Driven by our passion for patients, we are committed to changing and enhancing lives through partnerships with clinicians and healthcare professionals around the world. For more information, visit www.edwards.com or follow us on Facebook, Instagram, LinkedIn, X and YouTube.
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The Company intends that the forward-looking statements contained in this press release are covered by the safe harbor provisions of these laws. These forward-looking statements may be identified by the use of forward-looking words such as “may,” “might,” “believe,” “will,” “expect,” “plan,” “estimate,” “should,” “anticipate,” “project,” “goal,” “continue,” “seek,” “intend,” “optimistic,” “aspire,” “confident” and other similar expressions and include, but are not limited to, statements by Mr. Zovighian and statements regarding Edwards’ expected continuing performance, the performance of Edwards’, GenaValve’s or Endotronics’ technologies, product and therapy benefits, and patient access and outcomes. the size of the treatable population, leading position, growth opportunities, unmet need in the structural heart disease, aortic regurgitation and heart failure therapeutic areas, potential and expected timelines for FDA approval, potential and expected timelines for positive NCDs by CMS, synergies between JenaValve’s and Endotronix’s respective technologies, businesses and operations and Edwards’ technology, products, portfolio, expertise and operations, the ability to leverage technologies or innovations from these acquisitions or accelerate patient access to life-saving technologies or enable the development of new technologies as a result of these acquisitions, efforts to expand innovation opportunities in structural heart disease, address significant unmet patient need and support sustainable long-term growth, the goal of expanding Edwards’ portfolio into new structural heart disease therapeutic areas, the opportunities and revenue returns of these acquisitions and their contribution to Edwards’ growth and results of operations and expectations regarding the timing of such returns and contributions, the therapeutic approval pipeline for patients suffering from AR, the potential completion of the two acquisitions, other goals and prospects, and other statements that are not historical facts. Forward-looking statements are based on estimates and assumptions made by our management that, while believed to be reasonable, are inherently uncertain and difficult to predict. Our forward-looking statements speak only as of the date they are made, and we undertake no obligation to update any forward-looking statements to reflect events or circumstances after the date they are made. Investors are cautioned not to place undue reliance on such forward-looking statements.
Forward-looking statements involve risks and uncertainties that may cause actual results or experience to differ materially from those expressed or implied by the forward-looking statements. Factors that could cause actual results or experience to differ materially from those expressed or implied by the forward-looking statements include, but are not limited to: (i) Edwards may not be able to complete its respective acquisitions of JenaValve and Endotronix, which could have a material adverse effect on Edwards’ business and the price of Edwards’ common stock; (ii) the occurrence of events, changes or other circumstances that may cause Edwards to abandon its acquisitions of either or both JenaValve and Endotronix; (iii) risks associated with disruptions to management’s attention to Edwards’ ongoing business operations; (iv) the impact of the announcement or pendency of the acquisitions on Edwards’ relationships with customers, results of operations and business generally; and (v) potentially significant transaction costs associated with either or both acquisitions. (vi) the outcome of any legal or regulatory action brought against Edwards or others in connection with one or both of the acquisitions, (vii) Edwards’ ability to execute its strategy and achieve its objectives and other expectations following the closing of one or both of the acquisitions, (viii) legal, regulatory, tax and economic developments affecting Edwards’ business, (ix) the unpredictability and severity of catastrophic events, including, but not limited to, acts of terrorism, outbreaks of war or hostilities, or any current or future pandemics or epidemics, and Edwards’ response to any of the foregoing factors, and (x) other risks detailed in Edwards’ filings with the SEC, which are available at edwards.com.
Edwards, Edwards Lifesciences, and the stylized E logo are trademarks of Edwards Lifesciences Corporation or its affiliates. All other trademarks are the property of their respective owners.
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