Vincora Receives FDA Approval to Initiate U.S. Early Feasibility Study of Transcatheter Chordal Repair System

MAPLE GROVE, Minn., Oct. 27, 2026 /PRNewswire/ -- Vincora (NeoChord, Inc. d/b/a Vincora), a medical technology company developing transcatheter therapies for mitral valve repair, today announced that the U.S. Food and Drug Administration (FDA) has approved the Company's Investigational Device Exemption (IDE) to initiate a U.S. Early Feasibility Study (EFS) of its investigational Transcatheter Chordal Repair System for the treatment of degenerative mitral valve regurgitation.

The NeXuS System is designed to address the underlying structural pathology of degenerative mitral valve disease by implanting artificial chordae through a transcatheter procedure on a beating heart. The objective is to restore mitral valve sufficiency while preserving the motion of the native valve leaflets and annulus.

Degenerative mitral regurgitation (DMR) affects over 3 million people in the US alone.

A Disease-Specific Approach to Transcatheter Mitral Repair

Transcatheter edge-to-edge repair (TEER) has pioneered catheter-based mitral valve repair as an important therapeutic option for patients with mitral regurgitation. TEER reduces regurgitation by bridging the anterior and posterior mitral valve leaflets but does not preserve the native leaflet function which is desirable in DMR.

"Mitral regurgitation encompasses distinct disease mechanisms, and treatment strategies should reflect the underlying pathology," said Azeem Latib, M.D., Principal Investigator of the study. "In DMR, chordal replacement has been a foundational technique in surgical mitral valve reconstruction for decades. The NeXuS System is designed to translate that established reconstructive principle into a transcatheter, beating-heart procedure."

"We believe mitral valve repair should be considered in the context of a patient's lifetime of care," said Todd Berg, Chief Executive Officer of Vincora. "For patients with DMR, we believe that the ability to repair the valve today while considering the therapies a patient may need tomorrow is an important objective in the overall management of their mitral valve disease".

About Degenerative Mitral Regurgitation

Mitral regurgitation occurs when the mitral valve does not close completely, allowing blood to flow backward from the left ventricle into the left atrium. In degenerative, or primary, mitral regurgitation, elongation or rupture of the chordae tendineae—can cause prolapse or flail of the mitral valve leaflets, resulting in significant regurgitation.

When left untreated, Severe DMR places a progressive volume burden on the heart, causing enlargement of the left atrium and left ventricle as the heart compensates for the backward flow of blood. Overtime, this can lead to irreversible left ventricular dysfunction, atrial fibrillation, heart failure, and reduced survival, even in patients who initially experience few or no symptoms.

Chordal replacement is an established technique used in surgical mitral valve reconstruction to restore leaflet support and valve competence. Vincora is developing transcatheter technology intended to apply this reconstructive principle through a catheter-based, beating-heart procedure without the need for open-heart surgery or cardiopulmonary bypass.

The NeXuS System is an investigational device, limited by U.S. law to investigational use and not available for commercial distribution.

For more information, visit www.vincora.com.

SOURCE Vincora