Edwards Lifesciences Corp Stock Price, News & Analysis

Edwards Lifesciences (NYSE: EW), the global leader in structural heart innovation, has announced its participation in the BofA Securities 2025 Health Care Conference on May 13, 2025. CEO Bernard Zovighian and CFO Scott Ullem will engage in a fireside chat at 10:40 a.m. Pacific Time. The discussion will be accessible via live webcast on Edwards' investor relations website, with a recorded version available later that day.

Edwards Lifesciences (NYSE: EW) has received FDA approval for its SAPIEN 3 TAVR (transcatheter aortic valve replacement) platform to treat asymptomatic severe aortic stenosis (AS) patients, marking the first such approval for asymptomatic cases. The approval is based on the EARLY TAVR trial results, which showed superior outcomes for TAVR compared to watchful waiting.

Key trial results with 3.8 years median follow-up showed that 26.8% of TAVR patients experienced death, stroke, or unplanned cardiovascular hospitalization, compared to 45.3% in the clinical surveillance group. The study included 455 patients in the TAVR arm and 446 in the surveillance arm. Without treatment, 1 in 10 symptomatic severe AS patients may die within five weeks.

The SAPIEN platform has treated over 1 million patients worldwide and is the most studied valve platform, with nine publications in The New England Journal of Medicine.

Edwards Lifesciences (NYSE: EW) reported strong Q1 2025 financial results with total sales growing 6.2% to $1.41 billion. The company's TAVR sales reached $1.05 billion, growing 3.8% (5.4% constant currency), while TMTT sales showed impressive growth of 58% to $115 million.

Key financial metrics include Q1 EPS of $0.62 (adjusted EPS $0.64) and a gross profit margin of 78.7%. The company received SAPIEN M3 CE Mark approval and achieved multiple TAVR study milestones.

Looking ahead, Edwards raised its TMTT sales guidance to $530-550 million and increased total company sales guidance to $5.7-6.1 billion for 2025. The company reaffirmed its adjusted EPS guidance of $2.40-2.50, accounting for JenaValve dilution and tariff impacts.

Edwards Lifesciences (NYSE: EW) announced groundbreaking eight-year data demonstrating superior outcomes for patients receiving aortic surgical valves with their proprietary RESILIA tissue technology compared to non-RESILIA tissue bioprosthetic valves.

The study of 947 patients showed remarkable durability metrics, with 99.3% freedom from structural valve deterioration (SVD) in the RESILIA group versus 90.5% in the non-RESILIA group. Additionally, freedom from reoperation due to SVD was 99.2% for RESILIA tissue versus 93.9% for non-RESILIA tissue.

RESILIA tissue is currently utilized across Edwards' surgical and transcatheter platforms, including INSPIRIS RESILIA, KONECT RESILIA, MITRIS RESILIA, and SAPIEN 3 Ultra RESILIA valves. Over 450,000 patients worldwide have been treated with Edwards' surgical or TAVR valves featuring RESILIA tissue, marking a significant milestone in structural heart disease treatment.

Edwards Lifesciences (NYSE: EW) has scheduled its Q1 2025 earnings announcement for April 23, 2025, after market close. The company will host a conference call at 5:00 p.m. ET to discuss the quarterly results ending March 31, 2025.

Investors can participate by dialing (877) 704-2848 or (201) 389-0893. The call will be available live and archived on the company's investor relations website at ir.edwards.com.

Edwards Lifesciences, the global leader in structural heart innovation, focuses on developing breakthrough technologies and maintaining partnerships with healthcare stakeholders to deliver life-changing innovations to patients.

Edwards Lifesciences (NYSE: EW) has received CE Mark approval for its SAPIEN M3 mitral valve replacement system, becoming the world's first transfemoral transcatheter mitral valve replacement therapy. The system is approved for treating patients with symptomatic moderate-to-severe or severe mitral regurgitation who are unsuitable for surgery or transcatheter edge-to-edge therapy.

The SAPIEN M3 system utilizes a novel two-step procedure, delivering a dock that wraps around native mitral leaflets followed by valve placement. The system is delivered through a 29F outer diameter steerable guide sheath via the femoral vein. Built on Edwards' proven SAPIEN platform, which has been used in over 8,000 mitral procedures, the technology has shown substantial reduction in mitral regurgitation and improved quality of life.

Results from the ENCIRCLE pivotal trial are expected in late 2025, with a planned European Post-Market Clinical Follow-up Study tracking patients for up to five years.

Edwards Lifesciences (NYSE: EW) presented new scientific evidence at the American College of Cardiology's Annual Session, highlighting important findings about severe aortic stenosis (AS). The DETECT AS study, involving 939 patients and 285 physicians, showed that automatic electronic provider notifications increased aortic valve replacement rates by 11% overall and 14% for symptomatic patients.

The study revealed that 1 in 10 untreated patients with severe AS symptoms may die within five weeks. The EARLY TAVR trial demonstrated superior outcomes for asymptomatic severe AS patients treated with Edwards TAVR compared to watchful waiting. Additional research showed that cardiac biomarkers were not predictive of optimal treatment timing, emphasizing the unpredictable nature of the disease progression.

Intuitive Ventures announced key leadership appointments to scale its investment platform in minimally invasive care. Terri Burke, former head of medtech investments at Epidarex Capital, joins as Senior Partner, while Dr. Ross Jaffe, co-founder of Versant Ventures, joins as Venture Advisor.

Burke brings over two decades of medtech investing and operational experience, including roles as CEO of Protaryx Medical and Vice President at Edwards Lifesciences (EW). Dr. Jaffe contributes extensive experience in medical devices, diagnostics, and venture firm management from his roles at Versant Ventures and Brentwood Venture Capital.

Intuitive Ventures, managing over $250 million in assets, has backed 13 startups since 2020. The firm recently announced its $150 million Fund II, focusing on healthcare access, precision diagnostics, and leveraging healthcare data for minimally invasive care.

Edwards Lifesciences (NYSE: EW) has announced its participation in the TD Cowen 45th Annual Health Care Conference on Tuesday, March 4, 2025. Scott Ullem, chief financial officer, will present at 9:50 a.m. ET.

A live webcast of the presentation will be available on the Edwards Lifesciences investor relations website at http://ir.edwards.com/, with an archived version accessible later the same day.

Edwards Lifesciences is the leading global structural heart innovation company, focused on improving patient lives through breakthrough technologies and partnerships with healthcare stakeholders. The company's patient-focused culture drives its employees to deliver life-changing innovations to those who need them most.