Edwards Lifesciences Expands Structural Heart Portfolio With Acquisitions of JenaValve and Endotronix
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.
Edwards Lifesciences (NYSE: EW) ha annunciato investimenti strategici volti ad espandere il proprio portfolio cardiaco strutturale attraverso l'acquisizione di JenaValve Technology e Endotronix. L'azienda mira a rafforzare la propria leadership nell'innovazione cardiaca e a rispondere a importanti bisogni non soddisfatti dei pazienti.
JenaValve Technology si specializza in trattamenti transcatetere per la rigurgito aortico (AR), una condizione mortale e per lo più non trattata. Edwards prevede l'approvazione da parte della FDA per il sistema di valvole cardiache JenaValve Trilogy entro la fine del 2025.
Endotronix, leader nella gestione dell'insufficienza cardiaca (HF), ha recentemente ricevuto l'approvazione della FDA per Cordella, un sensore di pressione arteriosa polmonare impiantabile. Si prevede un determinazione di copertura nazionale da parte dei CMS all'inizio del 2025.
Le acquisizioni, valutate circa 1,2 miliardi di dollari, dovrebbero fornire un contributo minimo ai ricavi nel 2025 e sono soggette ad approvazioni antitrust e di investimenti esteri.
Edwards Lifesciences (NYSE: EW) anunció inversiones estratégicas dirigidas a expandir su cartera de corazón estructural mediante la adquisición de JenaValve Technology y Endotronix. La empresa busca fortalecer su liderazgo en innovación cardíaca y abordar importantes necesidades no satisfechas de los pacientes.
JenaValve Technology se especializa en tratamientos transcatéter para el regurgitamiento aórtico (AR), una condición mortal y en gran parte no tratada. Edwards espera la aprobación de la FDA para el sistema de válvula cardíaca JenaValve Trilogy a finales de 2025.
Endotronix, líder en gestión de la insuficiencia cardíaca (HF), recibió recientemente la aprobación de la FDA para Cordella, un sensor de presión arterial pulmonar implantable. Se anticipa una determinación de cobertura nacional de CMS a principios de 2025.
Las adquisiciones, valoradas en aproximadamente 1.2 mil millones de dólares, se espera que proporcionen una contribución mínima a los ingresos en 2025 y están sujetas a aprobaciones antimonopolio y de inversión extranjera.
에드워즈 라이프사이언스 (NYSE: EW)는 JenaValve Technology와 Endotronix 인수를 통해 구조적 심장 포트폴리오를 확장하기 위한 전략적 투자 계획을 발표했습니다. 이 회사는 심장 혁신에서의 리더십을 강화하고 환자의 미충족 요구를 해결하는 것을 목표로 하고 있습니다.
JenaValve Technology는 대동맥 역류(AR)를 위한 관상동맥 치료를 전문으로 하며, 이는 치명적이며 대부분 치료받지 않은 상태입니다. 에드워즈는 2025년 말까지 JenaValve Trilogy 심장 밸브 시스템에 대한 FDA 승인을 기대하고 있습니다.
Endotronix는 심부전(HF) 관리의 선두주자로서, 최근 Cordella라는 이식 가능한 폐동맥 압력 센서에 대한 FDA 승인을 받았습니다. 2025년 초에 CMS의 국가적 보장 결정이 있을 것으로 예상됩니다.
약 12억 달러로 평가된 이번 인수는 2025년에 최소한의 수익 기여를 할 것으로 예상되며, 반독점 및 외국인 투자 승인 대상이 됩니다.
Edwards Lifesciences (NYSE: EW) a annoncé des investissements stratégiques visant à élargir son portefeuille de coeur structurel par l'acquisition de JenaValve Technology et Endotronix. L'entreprise vise à renforcer sa position de leader en innovation cardiaque et à répondre à de grands besoins insatisfaits des patients.
JenaValve Technology est spécialisée dans les traitements transcatheter pour la régurgitation aortique (AR), une condition mortelle et largement non traitée. Edwards attend l'approbation de la FDA pour le système de valve cardiaque JenaValve Trilogy d'ici la fin 2025.
Endotronix, un leader dans la gestion de l'insuffisance cardiaque (HF), a récemment reçu l'approbation de la FDA pour Cordella, un capteur de pression de l'artère pulmonaire implantable. Une décision de couverture nationale de CMS est anticipée début 2025.
Les acquisitions, d'une valeur d'environ 1,2 milliard de dollars, devraient contribuer de manière minimale aux revenus en 2025 et sont soumises à des approbations antitrust et d'investissements étrangers.
Edwards Lifesciences (NYSE: EW) hat strategische Investitionen bekannt gegeben, die darauf abzielen, sein Portfolio struktureller Herzlösungen durch die Übernahme von JenaValve Technology und Endotronix zu erweitern. Das Unternehmen strebt an, seine Führungsposition in der Herzinnovation zu stärken und große unerfüllte Patientenbedürfnisse anzusprechen.
JenaValve Technology ist auf Transkatheter-Behandlungen für Aorteninsuffizienz (AR) spezialisiert, eine tödliche und weitgehend unbehandelte Erkrankung. Edwards erwartet, dass die FDA Ende 2025 die Genehmigung für das JenaValve Trilogy Herzklappen-System erteilt.
Endotronix, ein führendes Unternehmen im Management von Herzinsuffizienz (HF), hat kürzlich die FDA-Genehmigung für Cordella, einen implantierbaren Pulmonal-Arterien-Drucksensor, erhalten. Eine nationale Deckungsentscheidung von CMS wird Anfang 2025 erwartet.
Die Übernahmen, die mit etwa 1,2 Milliarden Dollar bewertet werden, sollen 2025 einen minimalen Umsatzbeitrag leisten und unterliegen Genehmigungen nach dem Antitrustrecht und ausländischen Investitionen.
- 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.
- Minimal revenue contribution expected from acquisitions in 2025.
- Acquisitions subject to antitrust and foreign investment approval, introducing regulatory risks.
Edwards Lifesciences' strategic acquisitions of JenaValve and Endotronix mark a significant expansion into new therapeutic areas within structural heart disease. The
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.
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.
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
The AR market represents a significant growth opportunity. Approximately
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
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.
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
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
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.
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Source: Edwards Lifesciences Corporation
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