What Nyra Medical does

Nyra Medical is a clinical-stage medical device company developing the Cardiac Leaflet Enhancer (CARLEN) System, a transcatheter mitral valve repair technology designed to treat functional mitral regurgitation (FMR). Founded in 2019 and headquartered in Atlanta, Georgia, the company was established by Dr. Murali Padala, Dr. Eric Sarin, and Dr. Kirthina Suresh based on intellectual property developed at Emory University, which was exclusively licensed by Nyra in 2021. The CARLEN System employs a differentiated single-leaflet approach that modifies native valve leaflets while preserving native valve function, in contrast to conventional transcatheter edge-to-edge repair (TEER) devices that approximate both leaflets. The target population includes FMR patients who are TEER-suitable as well as those historically underserved by existing transcatheter therapies.

The company initiated its first-in-human clinical trial in October 2025, enrolling more than 10 patients across international centers, and presented 12-month follow-up outcomes at New York Valves 2026. Nyra delivered three presentations at EuroPCR 2026, including physician-led sessions by Dr. Susheel Kodali and Dr. Azeem Latib and an executive presentation by CEO Lori Chmura. In June 2026 the company received the Jon DeHaan Foundation Award for Cardiovascular Innovation, providing third-party validation of the differentiated approach within the cardiology community.

Nyra Medical's business model centers on future direct hospital sales of the CARLEN System upon regulatory approval; products are currently classified as investigational devices not commercially available in any geography. The go-to-market motion is enterprise field sales targeting leading interventional cardiologists and cardiac surgeons at major academic medical centers, with clinical conference presence (EuroPCR, New York Valves) as the primary commercial vehicle. The company is led by CEO Lori Chmura, who joined in 2023, and has raised approximately $20 million in a Series A financing round co-led by Vensana Capital and a large global medical device company, with additional participation from Broadview Ventures, Epidarex Capital, and Georgia Research Alliance.

Name

Nyra Medical

Legal name

Nyra Medical, Inc.

Website

https://nyramed.com

Company type

Private

Founded year

2019

Operating status

Operating

Headcount range

11–50 employees

Short description

Nyra Medical is a clinical-stage medical device company developing the CARLEN System, a transcatheter mitral valve repair technology using a single-leaflet approach to treat functional mitral regurgitation while preserving native valve function. The company targets FMR patients underserved by existing TEER therapies.

Ownership category

akta.pro rank

Product category

Transcatheter Heart Valve Repair

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510)

SIC

Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Structural Heart Valves (TAVR/SAVR) & Valve Repair (HLAHAFAB)

Keywords

• Transcatheter mitral valve repair
• Structural heart devices
• Cardiac leaflet repair
• Functional mitral regurgitation therapy
• Investigational cardiovascular devices

Headquarters

HQ city

Atlanta

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales

Revenue model

1. Medical Device Sales (Future): Nyra Medical is a pre-commercial medical device company developing the CARLEN System for transcatheter mitral valve repair. The company is currently in the clinical development stage (first-in-human trials), with products designated as investigational devices not available for commercial use. Revenue will be generated through direct sales of the CARLEN System to hospitals and cardiac centers upon regulatory approval.

Go-to-market motion2 records

Distribution channels1 record

Marketing channels5 records

Core offering

Nyra Medical develops the CARLEN (Cardiac Leaflet Enhancer) System, a transcatheter mitral valve repair device designed to treat functional mitral regurgitation by modifying native valve leaflets through a single-leaflet approach. The investigational device preserves native valve function and is intended to expand treatment options for both TEER-suitable patients and those historically not well-served by existing transcatheter edge-to-edge repair technologies. The product is currently in first-in-human clinical trials and is not yet available for commercial use.

Product overview

Nyra Medical is a single-product company offering the CARLEN (Cardiac Leaflet Enhancer) System, a transcatheter mitral valve repair technology designed to treat functional mitral regurgitation. The system is an investigational device that modifies native valve leaflets through a single-leaflet approach, preserving native valve function. The company operates exclusively with this one product, which is currently in early clinical development stages and not available for commercial use.

Differentiator

Problem solved

Functional benefit

Products and services

• CARLEN (Cardiac Leaflet Enhancer) System A transcatheter mitral valve repair technology designed to treat functional mitral regurgitation (FMR) by modifying native valve leaflets through a single-leaflet approach. The system preserves native valve function and is intended for interventional cardiologists and cardiac surgeons treating patients who are TEER-suitable as well as those historically left behind by existing transcatheter edge-to-edge repair therapies. It is an investigational device, currently in first-in-human clinical trials and not yet commercially available.

Quantifiable outcome

• Successful first-in-human clinical experience with 12-month outcomes data presented at New York Valves 2026

Segments1 record

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Two partnerships are on record, tiered minor and core.

• Clinical AcceleratorminorGTM or Marketing Partner · 1 January 2026Clinical Accelerator sponsored two sessions at EuroPCR 2026 where Nyra Medical presented clinical insights from its First-in-Human study of the CARLEN System. The partnership facilitated physician engagement and clinical thought leadership visibility at the conference.
• Emory UniversitycoreTechnology or Integration · 1 January 2021Nyra Medical licensed its core technology, CARLEN, from Emory University in 2021. The intellectual property was developed at Emory University by Dr. Murali Padala, the company's founder. This inbound technology licensing agreement forms the foundation of Nyra Medical's entire product portfolio.

Scale indicators6 records

Recent moves8 records

Expansion highlights5 records

Direct peers

• Abbott: Abbott's MitraClip is the market-leading transcatheter edge-to-edge repair (TEER) device for mitral regurgitation and the dominant incumbent Nyra Medical's CARLEN is positioned against. Both target FMR via transcatheter delivery and compete for the same interventional cardiologist and cardiac surgeon customers at structural heart centers.
• Edwards Lifesciences: Edwards' PASCAL transcatheter mitral repair system directly competes with CARLEN in the FMR treatment space, sharing the same transcatheter catheter-delivery mechanism, structural-heart call point, and clinical-evidence-driven go-to-market motion (EuroPCR, TVT). PASCAL Precision is the second-mover TEER platform Nyra must differentiate against.
• Cardiac Dimensions: Cardiac Dimensions' Carillon system is a transcatheter mitral annuloplasty device for functional mitral regurgitation, directly competing with CARLEN for the same FMR patient population via a different mechanism (indirect annuloplasty vs. leaflet enhancement). Comparable indication, comparable stage, and same KOL channels make it a highly relevant direct peer.

Broad incumbents

• Medtronic: Medtronic's Intrepid transcatheter mitral valve replacement program and broader structural heart portfolio compete in the same FMR indication with significantly larger R&D resources. As a global structural-heart incumbent, Medtronic represents both a direct competitor and a potential strategic acquirer of CARLEN-stage assets.
• Boston Scientific: Boston Scientific has an active structural heart franchise and is investing in transcatheter mitral and tricuspid technologies. While its WATCHMAN FLX is its flagship structural product, the company is a credible strategic acquirer of differentiated mitral assets like CARLEN and competes for the same hospital budget and physician mindshare.

Emerging players

• 4C Medical Technologies: 4C Medical is developing the AltaValve and AltaValve HD transcatheter mitral valve replacement systems for FMR and mitral regurgitation. Like Nyra, it is a venture-backed emerging player targeting the same FMR patient population with a novel transcatheter architecture, making it one of the closest stage-comparable peers in the space.
• CroíValve: CroíValve is developing a transcatheter tricuspid coaptation/leaflet-enhancement device with a similar single-leaflet-modification philosophy to CARLEN's approach for mitral regurgitation. Comparable in stage and mechanism philosophy, it represents a peer emerging player tackling adjacent structural-heart leaflet pathology with transcatheter delivery.
• Anteris Technologies: Anteris is a structural heart company developing the DurAVR transcatheter aortic valve system and exploring transcatheter mitral applications. As a venture-stage peer building novel transcatheter valve platforms with biomaterial and delivery IP, it is comparable in stage and strategic posture to Nyra Medical.
• Polares Medical: Polares Medical is developing a transcatheter mitral valve replacement system targeting FMR and degenerative MR. As a venture-backed peer at a similar development stage with a novel transcatheter mitral architecture, it competes for the same strategic acquirer attention and clinical-investigator bandwidth as CARLEN.
• InnovHeart: InnovHeart has been developing the Saturn transcatheter mitral valve replacement platform for FMR. As a venture-stage structural-heart company targeting the same patient population with a novel transcatheter architecture, it represents a comparable emerging peer in the mitral regurgitation treatment space.

Market position

Strengths4 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/NyraMedical
• LinkedInlinkedin.com/company/nyra-medical

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 records

Funding overview

Funding rounds7 records

Investors5 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Nyra Medical