Valcare Medical Receives FDA Approval to Initiate Early Feasibility Study for its Novel AMEND™ Trans-Septal System

HERZLIYA, Israel and WILMINGTON, Del., March 13, 2025 /PRNewswire/ -- Valcare Medical Inc., a leading innovator in transcatheter-based mitral solutions, today announced the U.S. Food and Drug Administration (FDA) has approved the AMEND™ Trans-Septal System for investigational device exemption (IDE) application to commence an Early Feasibility Study (EFS).

The AMEND™ Trans-Septal System is a trans catheter device intended for treatment of mitral insufficiency with a semi rigid, closed, D-shaped annuloplasty ring that mimics today's surgical gold standard.

The EFS study will evaluate the safety and functionality of the AMEND™ Trans-Septal System in the treatment of subjects with symptomatic moderate-to-severe (3+) or severe (4+) functional mitral regurgitation (FMR) that are anatomically suitable for transcatheter mitral annuloplasty. The EFS will enroll up to 15 subjects in 7 investigational centers in the United States. The study is expected to begin treating patients in the first half of 2025, paving the way for a pivotal study anticipated in 2027.

The primary and secondary endpoints of this trial include safety and device performance assessments such as technical success of ring delivery, implantation, and delivery system retrieval. Patient outcomes such as stroke, myocardial infarction, non-elective cardiovascular surgery for device related complications, and all-cause mortality are to be reported at 30 days and 6 months post implantation.

Additional secondary endpoints will include changes in NYHA functional class, 6-Minute-Walk-Test, quality of life at 30 days and 6 months in addition to reduction of MR grade from baseline by at least 1 grade at 30 days, 6 months and 1 year.

"I am pleased and eager to begin the AMEND™ Trans-Septal System EFS to further evaluate this promising novel technology. The AMEND™ annuloplasty ring has the potential to improve mitral repair for a patient population that are considered poor candidates for currently available therapies," stated Dr. Scott Lim, AMEND EFS Study Chairman and Professor of Medicine & Pediatrics at the University of British Columbia, and Professor Emeritus with Tenure at the University of Virginia. "Furthermore, the AMEND System provides a non-invasive approach to the gold standard surgical repair, and I am excited for its potential to treat patients suffering from severe mitral regurgitation."

"The FDA's approval to begin the AMEND EFS is a critical milestone for Valcare Medical on the path to achieving eventual Pre-Market Approval in the United States. This study will build upon clinical data from the AMEND First-in-Human Study, which will be presented as a Late Breaker Clinical Trial during this year's CRT Conference in Washington DC next month," said Steve Sandweg, President and Chief Executive Officer for Valcare Medical. "I am incredibly proud of the entire Valcare Medical Team for achieving this important milestone."

About Valcare Medical
At Valcare Medical, our mission is to transform mitral valve therapy through the development of advanced, minimally invasive solutions. Our goal is to eliminate the need for open-heart surgery in patients with severe mitral regurgitation. We aim to minimize patient risk and maximize procedural outcomes by providing strong clinical evidence for the effectiveness of our technologies. We aspire to improve patients' quality of life while increasing life expectancy by offering a safer and more effective alternative to traditional surgical methods.

The AMEND™ Trans-Septal System is an investigational device, limited by US federal law for investigational use only. The product is not available for sale or commercial distribution.

SOURCE Valcare Medical