Edwards Lifesciences (EW) Investor Update summary

TRISCEND II trial results and clinical impact

• TRISCEND II is the first randomized trial for tricuspid valve replacement, addressing a significant unmet need and leading to FDA breakthrough designation for EVOQUE.

• The trial demonstrated high technical success (>95%) and significant benefit in the primary hierarchical endpoint, favoring transcatheter tricuspid valve replacement (TTVR) over medical therapy.

• Replacement therapy eliminated tricuspid regurgitation in 99.1% of patients, with 95% achieving mild or less severity at one year.

• Quality of life improvements were substantial, with an 18-point difference at one year, far exceeding the threshold for clinical significance.

• The procedure is efficient, with a mean device time of about one hour and no significant learning curve effect observed.

Market opportunity and adoption dynamics

• There is strong patient and physician demand for tricuspid therapies, with referrals for tricuspid cases now outpacing mitral in some centers.

• The true population size for severe tricuspid regurgitation is likely underestimated, with aging demographics expected to increase prevalence.

• Adoption is expected to accelerate as awareness grows and more treatment options become available, mirroring recent trends in mitral therapies.

• The lack of effective medical or surgical alternatives for tricuspid patients drives high demand for new interventions.

Competitive landscape and therapy selection

• Both repair (TEER) and replacement options are needed, with anatomical and clinical factors guiding therapy choice.

• Replacement is favored when complete elimination of regurgitation is needed or when TEER is unlikely to succeed due to anatomical complexity.

• The overlap between TEER and replacement candidates is significant, and ongoing data collection will clarify optimal patient selection.