Reimagining Treatment for Functional Mitral Regurgitation (FMR)
Functional (secondary) mitral regurgitation (FMR) affects nearly half of all heart failure patients — approximately 3.25 million people in the United States alone.1 Despite its prevalence and significant impact on patient outcomes, FMR remains one of the most undertreated forms of valvular heart disease.
FMR occurs when the mitral valve leaflets are structurally normal but fail to close properly due to changes in the left atrium or ventricle. This results in blood leaking backward into the left atrium during systole, worsening heart failure and increasing the risk of atrial fibrillation, stroke, and mortality. Five-year hospitalization-free survival for patients with severe FMR is just 20% — compared to 60% in those without FMR.2
A Gap in Available Therapies
CARLEN technology overcomes many of the common limitations known with approved therapies. While TEER, the only approved transcatheter therapy for treatment of FMR, has shown clinical benefit in select patients, it has significant limitations:
Narrow anatomical suitability
Patients with atrial FMR (Type 1A) or commissural/central ventricular FMR (Type IIIb) often fall outside current transcatheter repair eligibility due to leaflet geometry and coaptation zone challenges.
Reduced valve function
Current therapies alter diastolic mitral valve physiology, increasing the risk of mitral stenosis and limiting diastolic filling.
No forward compatibility
Current treatment options can complicate future mitral valve interventions.
Representing an estimated market of
$11.5B
Plus nearly
80,000
additional patients, representing an estimated $3B market segment for currently underserved patient anatomies.
Nyra’s ANSWERA New Paradigm in FMR Treatment
Nyra Medical was founded to expand access to patients and encourage earlier intervention. Our proprietary technology – the Cardiac Leaflet Enhancer (CARLEN) – is designed to address the broad range of patient anatomies and make challenging TEER cases streamlined by offering a sutureless, single-leaflet solution that:
- Augments the native leaflet to restore coaptation at the site of regurgitation
- Preserves natural valve motion and orifice area, avoiding mitral stenosis
- Enables treatment across a broader range of anatomical etiologies
- Maintains options for future interventions, surgical or transcatheter
- Treats both TEER-eligible patients and those not anatomically compatible
As an investigational device, CARLEN has been used in extensive nonclinical studies and has now been successfully implanted in First-in-Human procedures. Physicians describe the system as “intuitive” and noted a short learning curve, reinforcing its potential for widespread clinical adoption.
The Path Forward
As we expand our global clinical footprint and prepare for a U.S. Feasibility Study, Nyra Medical remains committed to transforming the treatment landscape for FMR — developing a solution that is anatomically versatile, physiologically sound, and built for the future of structural heart interventions.
References:
- HF STATS 2024: Heart Failure Epidemiology and Outcomes Statistics An Updated 2024 Report from the Heart Failure
Society of America. Bozkurt, Biykem et al. Journal of Cardiac Failure, Volume 31, Issue 1, 66 – 116 - Asgar AW, Mack MJ, Stone GW. Secondary mitral regurgitation in heart failure: pathophysiology, prognosis, and therapeutic considerations. J Am Coll Cardiol. 2015 Mar 31;65(12):1231-1248. doi: 10.1016/j.jacc.2015.02.009. Erratum in: J Am Coll Cardiol. 2015 May 26;65(20):2265. PMID: 25814231.
