Valcare Medical Announces First U.S. Transseptal AMEND™ Implant in Early Feasibility Study

WILMINGTON, Del., Feb. 11, 2026 /PRNewswire/ -- Valcare Medical, Inc., a pioneer developer in transcatheter mitral valve repair solutions, today announced the successful first U.S. transseptal implantation of its AMEND™ Transcatheter Mitral Valve Repair (TMVr) Annuloplasty System as part of the ongoing AMEND TS Early Feasibility Study (EFS).

The milestone procedure was performed by Dr. Paul Sorajja, a nationally recognized expert in interventional cardiology and structural heart disease, at Banner – University Medical Center in Phoenix.

"For many patients with mitral regurgitation, open-heart surgery is either too risky or simply not an option due to age or other health conditions," said Dr. Sorajja. "The AMEND transseptal approach offers physicians a percutaneous alternative designed to deliver a surgical-style repair option for their patients with less pain, faster recovery, and the potential for excellent long-term outcomes."

The AMEND™ System delivers a closed, D-shaped, semi-rigid annuloplasty ring through catheter in a transseptal approach. It is specifically designed to mimic the anatomical remodeling and clinical results achieved by traditional surgical annuloplasty—the technique used in most open-heart mitral valve repairs. Unlike other transcatheter mitral repair technologies, the AMEND System is designed to preserve future treatment options if clinically required later.

"Annuloplasty has served as the foundation of more than 95% of surgical mitral valve repairs for decades," said Steve Sandweg, CEO of Valcare Medical. "Applying this proven surgical technique through a percutaneous, transcatheter approach represents a significant step forward. We are grateful to Dr. Sorajja, Banner Health, and all participating investigators and their teams for helping bring this important therapy one step closer to patients suffering from significant functional mitral regurgitation."

About the AMEND TS Early Feasibility Study

The AMEND TS EFS (NCT06951672) is a prospective, single-arm study evaluating the safety and performance of the AMEND Transseptal System in patients with symptomatic moderate-to-severe (3+) or severe (4+) functional mitral regurgitation who are anatomically suitable for transcatheter annuloplasty. The study will treat 15 patients in seven investigational sites in the United States.

About Valcare Medical

Valcare Medical, Inc. is committed to transforming the treatment of mitral regurgitation by providing transcatheter solutions that deliver the efficacy and durability of surgical annuloplasty while avoiding the risks and invasiveness of open-heart surgery. The company's flagship technology, the investigational AMEND™ Transcatheter Mitral Valve Repair Annuloplasty System, is designed to restore normal mitral valve geometry and function through a percutaneous approach. Valcare Medical is a privately held company in Wilmington, Delaware. For more information, visit www.valcaremedical.com or follow us on LinkedIn.

CAUTION: The Valcare AMEND System is an investigational device. Limited by Federal (U.S.) law to investigational use only. Not available for sale.

SOURCE Valcare Medical