Company Announcements

HANGZHOU, China , Aug. 5, 2025 /PRNewswire/ -- Venus Medtech (Hangzhou) Inc. ("Venus Medtech", Stock Code: 02500.HK) recently announced a decisive legal victory for its wholly-owned subsidiary Cardiovalve Ltd. ("Cardiovalve") against Edwards Lifesciences Corporation and Edwards Lifesciences LLC. (collectively "Edwards"). The United States Court of Appeals for the Federal Circuit ("CAFC") has formally issued its mandate in Case 23-1515, affirming the Patent Trial and Appeal Board's ("PTAB") December 2022 ruling that upheld the validity of Cardiovalve's patent. This follows Edwards' failure to file a petition for rehearing within the statutory deadline by July 16, 2025.

This outcome conclusively defends the validity of Cardiovalve's critical patent portfolio, strengthens Venus Medtech's global IP protections, and significantly advances its competitive position in structural heart disease—particularly its integrated "Quad-Valve" strategic platform.

Case Background

The dispute centered on Edwards' challenge to the validity of Cardiovalve's U.S. Patent No. 10,702,385 ("'385 Patent") covering an innovative transcatheter heart valve clamping and support structure for minimally invasive mitral and tricuspid valve therapies.

On June 2, 2021, Edwards petitioned for inter partes review of claims 1-10 of that patent.

PTAB issued Final Written Decision allowing Cardiovalve's motion to amend claims after Edwards failed to prove unpatentability by preponderant evidence on December 6, 2022.

On June 9, 2025, CAFC affirmed PTAB's ruling, validating Cardiovalve's patent claims.

About Cardiovalve

Venus Medtech completed the acquisition of Cardiovalve in January 2022, that marked a strategic milestone in building a comprehensive product portfolio and securing Cardiovalve's foundational technologies.

Cardiovalve, the next-generation transcatheter valve replacement system, is designed for treating regurgitation in both mitral and tricuspid valves, and features transformative technologies:

• Dual frame self-expanding nitinol stent reduces paravalvular leakage
• Low-profile stent design minimizes LVOT obstruction risk
• Transfemoral-transseptal access provides a less invasive alternative to the transapical approach
• Large annular sizing capacity (up to 55mm) accommodates approximately 95% of patient anatomies

The streamlined three-step implantation (Position-Anchor-Release) demonstrates exceptional reproducibility.

Mr. Lim Hou-Sen, CEO of Venus Medtech stated:

"This landmark victory validates Cardiovalve's original innovations and demonstrates the integrity of global IP systems. We remain committed to advancing structural heart therapies through clinically driven innovation."

Mr. Amir Gross, CEO of Cardiovalve emphasized:

"Our 'Innovation Never Stops' philosophy conquered technical barriers in mitral/tricuspid interventions. This four-year legal affirmation accelerates our global clinical strategy to deliver superior solutions for 40+ million regurgitation patients worldwide."

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SOURCE Venus Medtech (Hangzhou) Inc.