Edwards Lifesciences Expands Structural Heart Portfolio With Acquisitions of JenaValve and Endotronix

Rhea-AI Summary

Edwards Lifesciences (NYSE: EW) announced strategic investments aimed at expanding its structural heart portfolio through the acquisition of JenaValve Technology and Endotronix. The company aims to strengthen its leadership in heart innovation and address large unmet patient needs.

JenaValve Technology specializes in transcatheter treatments for aortic regurgitation (AR), a deadly and largely untreated condition. Edwards expects FDA approval for the JenaValve Trilogy Heart Valve System in late 2025.

Endotronix, a leader in heart failure (HF) management, recently received FDA approval for Cordella, an implantable pulmonary artery pressure sensor. A CMS national coverage determination is anticipated in early 2025.

The acquisitions, valued at approximately $1.2 billion, are expected to provide minimal revenue contribution in 2025 and are subject to antitrust and foreign investment approvals.

Positive

• Acquisition of JenaValve Technology positions Edwards Lifesciences at the forefront of AR treatment.
• FDA approval for JenaValve Trilogy Heart Valve System anticipated in late 2025.
• Endotronix's FDA-approved Cordella sensor will enhance HF management solutions.
• Strategic investments expected to strengthen Edwards Lifesciences' leadership in structural heart innovation.
• Aggregate acquisition cost of $1.2 billion demonstrates significant commitment to growth.

Negative

• Minimal revenue contribution expected from acquisitions in 2025.
• Acquisitions subject to antitrust and foreign investment approval, introducing regulatory risks.

Insights

Financial Analyst

Edwards Lifesciences' strategic acquisitions of JenaValve and Endotronix mark a significant expansion into new therapeutic areas within structural heart disease. The $1.2 billion investment demonstrates the company's commitment to innovation and long-term growth strategy.

The acquisition of JenaValve is particularly noteworthy, as it positions Edwards to potentially dominate the untapped market for transcatheter aortic regurgitation (AR) treatment. With FDA approval expected in late 2025, Edwards could gain a first-mover advantage in this space. This move aligns with the company's historical strength in aortic valve innovations and could drive substantial revenue growth in the coming years.

The Endotronix acquisition, building on a previous investment, expands Edwards' reach into the heart failure management sector. The recent FDA approval of Cordella, Endotronix's implantable pulmonary artery pressure sensor, provides Edwards with an immediate entry into this market. The anticipated CMS national coverage determination in early 2025 could significantly boost adoption and reimbursement prospects.

Investors should note that while these acquisitions represent promising long-term growth opportunities, the near-term financial impact will be . Edwards expects minimal revenue contribution from these acquisitions in 2025, suggesting that patience will be required to see the full benefits of these investments reflected in the company's financial performance.

Overall, these strategic moves strengthen Edwards' position in the structural heart market and diversify its product portfolio, potentially mitigating risks associated with market saturation or competitive pressures in its existing product lines.

Medical Research Analyst

Edwards Lifesciences' acquisition of JenaValve represents a significant advancement in the treatment of aortic regurgitation (AR). The JenaValve Trilogy Heart Valve System, pending FDA approval, could become the first approved therapy for AR patients, addressing a critical unmet need in cardiovascular care.

The positive results from JenaValve's U.S. pivotal trial for high-risk AR patients are particularly promising. This suggests a strong clinical foundation for the technology, which could lead to rapid adoption once approved. The potential to treat a previously underserved patient population could not only improve patient outcomes but also expand the overall market for transcatheter valve therapies.

The Endotronix acquisition, centered around the Cordella implantable pulmonary artery pressure sensor, marks Edwards' entry into advanced heart failure management. This technology allows for early, targeted therapeutic intervention, which is important in managing heart failure progression. The ability to monitor pulmonary artery pressure remotely could lead to more proactive patient care, potentially reducing hospitalizations and improving quality of life for heart failure patients.

From a research perspective, these acquisitions position Edwards to generate valuable real-world data on the long-term outcomes of these innovative therapies. This data could further solidify Edwards' leadership in structural heart innovations and potentially inform future product developments.

However, it's important to note that the full clinical impact of these technologies will take time to materialize. Long-term studies and post-market surveillance will be important in establishing the durability and safety profiles of these devices in broader patient populations.

Market Research Analyst

Edwards Lifesciences' strategic acquisitions of JenaValve and Endotronix represent a calculated move to capture emerging markets within the structural heart disease space. The global market for transcatheter aortic valve replacement (TAVR) is expected to reach $13.2 billion by 2030, with a CAGR of 12.4%. By entering the aortic regurgitation (AR) market, Edwards is positioning itself to tap into a potentially lucrative segment that has been largely underserved.

The AR market represents a significant growth opportunity. Approximately 2-5% of the global population suffers from AR, with a higher prevalence in older adults. As the population ages, the demand for AR treatments is likely to increase, providing a long-term growth driver for Edwards.

In the heart failure management space, the acquisition of Endotronix aligns with the growing trend towards remote patient monitoring and personalized care. The global heart failure devices market is projected to reach $32.5 billion by 2027, growing at a CAGR of 8.1%. The Cordella system positions Edwards to compete in this rapidly expanding market segment.

These acquisitions also serve to diversify Edwards' product portfolio, potentially insulating the company from market fluctuations in any single product line. This diversification strategy could appeal to investors looking for companies with balanced risk profiles in the medical device sector.

However, market penetration and adoption rates for these new technologies will be critical to watch. The success of these acquisitions will depend on factors such as physician training, reimbursement policies and the ability to demonstrate clear clinical and economic benefits over existing treatment options.

IRVINE, Calif.--(BUSINESS WIRE)-- Edwards Lifesciences (NYSE: EW) today announced investments that reflect the company’s deep commitment to advancing patient care through structural heart innovation, addressing large unmet patient needs and supporting sustainable long-term growth.

Edwards has entered into an agreement to acquire JenaValve Technology, a pioneer in the transcatheter treatment of aortic regurgitation (AR), a deadly disease that impacts a significant and growing population and is largely untreated today. JenaValve presented positive results of its U.S. pivotal trial for the treatment of symptomatic, severe AR in high-risk patients late last year. As the pioneer in valve innovation for more than 60 years, Edwards believes it is uniquely positioned to lead this next frontier of aortic valve disease treatment. Edwards anticipates FDA approval of the JenaValve Trilogy Heart Valve System in late 2025, which will represent the first approved therapy for patients suffering from AR.

Building on an investment made in 2016, Edwards has exercised its option to acquire Endotronix, a leader in heart failure (HF) management solutions. Many structural heart patients Edwards serves today also suffer from HF with limited options. This acquisition will expand Edwards’ structural heart portfolio into a new therapeutic area to address the large unmet needs of patients suffering from HF. Last month, Endotronix received FDA approval for Cordella, an implantable pulmonary artery pressure sensor allowing early, targeted therapeutic intervention. A CMS national coverage determination 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 Bernard Zovighian, Edwards’ CEO. “We are pleased to enter these structural heart therapeutic areas with innovation, world-class science and clinical evidence to provide access to life-saving technologies for patients around the world.”

Edwards anticipates these investments will strengthen its leadership in structural heart innovation and represent long-term growth opportunities. Edwards expects minimal revenue contribution from these acquisitions in 2025. The aggregate upfront purchase price for these strategic investments is approximately $1.2 billion. The acquisitions are subject to the satisfaction of certain closing conditions, including the receipt of required antitrust and foreign investment approvals.

About Edwards Lifesciences

Edwards Lifesciences is the global leader of patient-focused innovations for structural heart disease and critical care monitoring. We are driven by a passion for patients, dedicated to improving and enhancing lives through partnerships with clinicians and stakeholders across the global healthcare landscape. For more information, visit www.edwards.com and follow us on Facebook, Instagram, LinkedIn, X and YouTube.

This news release includes 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. We intend the forward-looking statements contained in this press release to be covered by the safe harbor provisions of such Acts. These forward-looking statements can sometimes be identified by the use of forward-looking words, such as “may,” “might,” “believe,” “will,” “expect,” “project,” “estimate,” “should,” “anticipate,” “plan,” “goal,” “continue,” “seek,” “intend,” “optimistic,” “aspire,” “confident” and other forms of these words and include, but are not limited to, statements made by Mr. Zovighian and statements regarding our expected continued performance of Edwards; performance of the Edwards, JenaValve or Endotronix technologies; product and therapy benefits; patient access and outcomes; size of treatable population; leading position; growth opportunities; unmet needs in structural heart, aortic regurgitation, and heart failure therapeutic areas; probability of approval by the FDA and in the anticipating timeline; probability of a positive NCD by the CMS and in the anticipated timeline; synergies between the technologies, business, and operations of each of JenaValve and Endotronix and Edwards’ technologies, products, portfolio, expertise, and operations; ability to leverage the technology or innovation from these acquisitions or cause or ensure accelerated access to life-saving technologies for patients or development of novel technologies as a result of these acquisitions; commitment to expand opportunities in structural heart innovation, address large unmet patient needs, and support sustainable long-term growth; objective to expand Edwards’ portfolio into new structural heart therapeutic areas; opportunities and revenue return on these acquisitions and their contribution to Edwards’ growth and performance, as well as the expectations on timing of such returns and contributions; therapy approval pipeline for patients suffering from AR; probability of the closing of the two acquisitions; other objectives and expectations; and other statements that are not historical facts. Forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though they are inherently uncertain and difficult to predict. Our forward-looking statements speak only as of the date on which they are made, and we do not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of the statement. Investors are cautioned not to unduly rely on such forward-looking statements.

Forward-looking statements involve risks and uncertainties that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements. Factors that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements include, but are not limited to: (i) Edwards may be unable to close the acquisitions of each of JenaValve and Endotronix, which may materially and adversely affect Edwards’ business and the price of Edwards’ common stock; (ii) the occurrence of any event, change or other circumstance that could cause Edwards to abandon the acquisitions of either or both of JenaValve and Endotronix; (iii) risks related to disruption of management’s attention from Edwards’ ongoing business operations; (iv) the effect of the announcement or the pendency of the acquisitions on Edwards’ relationships with its customers, operating results and business generally; (v) potential significant transaction costs associated with either or both acquisitions; (vi) the outcome of any legal proceedings or regulatory actions to the extent initiated against Edwards or others related to either or both acquisitions; (vii) the ability of Edwards to execute on its strategy and achieve its goals and other expectations after the closing of either or both 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, outbreak of war or hostilities or current or future pandemics or epidemics, as well as Edwards’ response to any of the aforementioned factors; and (x) other risks detailed in Edwards’ filings with the SEC, which may be found 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240724177261/en/

Media Contact: Amy Hytowitz, 949-250-4009

Investor Contact: Mark Wilterding, 949-250-6826

Source: Edwards Lifesciences Corporation

FAQ

What companies did Edwards Lifesciences acquire?

Edwards Lifesciences acquired JenaValve Technology and Endotronix.

What is the significance of the JenaValve Technology acquisition?

The acquisition allows Edwards to lead in transcatheter treatments for aortic regurgitation (AR), with FDA approval anticipated in late 2025.

How will the Endotronix acquisition benefit Edwards Lifesciences?

Endotronix enhances Edwards' heart failure (HF) management solutions with the FDA-approved Cordella sensor.

What is the expected financial impact of these acquisitions on Edwards Lifesciences in 2025?

The acquisitions are expected to provide minimal revenue contribution in 2025.

What is the aggregate purchase price of Edwards Lifesciences' acquisitions?

The aggregate upfront purchase price is approximately $1.2 billion.

What regulatory approvals are needed for Edwards Lifesciences' acquisitions?

The acquisitions require antitrust and foreign investment approvals.