Sutra Medical

What Sutra Medical does

Sutra Medical, Inc. is a privately-held, pre-commercial cardiovascular medical device company headquartered in Lake Forest, California, developing transcatheter heart valve replacement systems. Its flagship program is the Sutra Hemi-Valve Transcatheter Mitral Valve Replacement (TMVR) System, designed to treat mitral regurgitation (MR) — a condition affecting an estimated 23 million people globally — via a catheter-delivered approach that avoids open-heart surgery. The company is also developing a transcatheter pulmonary valve replacement device, positioning a broader structural heart platform.

The Hemi-Valve uses a hemi-valve architecture that has advanced to First-in-Human clinical activity. Sutra secured FIH regulatory approvals across New Zealand, Uzbekistan, and the Republic of Georgia in February 2025, and completed the world's first successful human implantation on August 31, 2025, at Waikato Hospital in New Zealand. The company subsequently presented clinical data at TCT 2025 in October 2025. Leadership is anchored by CEO and founder Dr. Wei Sun (former Edwards Lifesciences R&D, Georgia Tech professor) and CTO/Co-Founder Dr. Thuy Pham.

Sutra currently has no commercial product revenue and operates with a team of 1–10 employees. Capitalization to date is primarily non-dilutive, exceeding $4 million in NIH SBIR grants. The implied long-term business model is standard for structural heart devices: hospital-channel sales of a premium-priced implant following eventual U.S. PMA approval, though no commercial pricing, partnership, or distribution arrangements have been disclosed.

Name

Sutra Medical

Legal name

Sutra Medical, Inc.

Website

https://sutramedical.com

Company type

Private

Founded year

2021

Operating status

Operating

Headcount range

1–10 employees

Short description

Sutra Medical is a pre-commercial cardiovascular device company developing the Hemi-Valve transcatheter mitral valve replacement system and a pulmonary valve program for patients with valvular heart disease.

Ownership category

akta.pro rank

Product category

Structural Heart Medical Devices

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510)

SIC

Surgical & Medical Instruments & Apparatus (3841), Orthopedic, Prosthetic & Surgical Appliances & Supplies (3842)

akta.pro primary industry

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

Keywords

• Transcatheter mitral valve replacement
• Structural heart devices
• Cardiovascular medical devices
• Mitral regurgitation treatment
• Transcatheter heart valves

Headquarters

HQ city

Lake Forest

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Distribution channels1 record

Marketing channels2 records

Core offering

Sutra Medical develops transcatheter heart valve replacement devices for the treatment of structural heart disease, with a primary focus on mitral regurgitation. Its flagship product, the Sutra Hemi-Valve TMVR System, is a nature-inspired posterior leaflet replacement designed to coapt with the native anterior leaflet via a proprietary transfemoral, trans-septal delivery system. All products are investigational and currently in First-in-Human clinical investigation.

Product overview

Sutra Medical develops cardiovascular medical devices focused on structural heart disease. Its flagship product is the Sutra Hemi-Valve Transcatheter Mitral Valve Repair System, a novel posterior leaflet replacement device designed to coapt with the native anterior leaflet to eliminate mitral regurgitation. The company also develops transcatheter pulmonary valve replacement devices. All products are investigational devices for clinical investigation use only and not approved for commercial sale.

Differentiator

Problem solved

Functional benefit

Products and services

• Sutra Hemi-Valve TMVR System A nature-inspired posterior leaflet replacement device designed to coapt with the native anterior leaflet, effectively eliminating mitral regurgitation (MR) while preserving left ventricular outflow tract (LVOT). Uses a proprietary transfemoral, trans-septal delivery system. Investigational device for clinical investigation use only.
• Transcatheter Pulmonary Valve Replacement Devices Medical devices for transcatheter pulmonary valve replacement intended for the treatment of valvular heart diseases. Currently in investigational/pre-clinical development.

Quantifiable outcome

• MR reduced from severe (4+) to trace–mild in first human case
• +1 more outcomes

Named customers1 record

Segments1 record

Ideal customer profiles1 record

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature1 record

Scale indicators3 records

Recent moves4 records

Expansion highlights5 records

Broad incumbents

• Abbott: Abbott markets the MitraClip TEER device (the standard-of-care transcatheter mitral repair) and is developing Tendyne, a transcatheter mitral replacement. It is a direct competitor for the same patient population Sutra targets.
• Medtronic: Medtronic is developing the Intrepid TMVR system and has a major structural-heart franchise; it competes directly in transcatheter mitral replacement with deep clinical-trial infrastructure.
• Boston Scientific: Boston Scientific has invested in transcatheter mitral technologies (acquired Millipede, Apollo) and competes broadly in structural heart. Sutra advisor Andrew Tymkiw's background at Boston Scientific reinforces the comparability.
• Edwards Lifesciences: Edwards Lifesciences is the dominant structural heart incumbent with the approved SAPIEN TAVR platform and a development pipeline in transcatheter mitral therapies (e.g., PASCAL, Evoque). It is the most relevant comparator given Sutra CEO Dr. Sun's Edwards pedigree and the overlapping TMVR/SAVR space.

Emerging players

• HighLife Medical: HighLife Medical is developing a transcatheter mitral valve replacement system and has been a notable early-stage TMVR competitor, often compared alongside other emerging TMVR players like Sutra.
• NaviGate Cardiac Structures: NaviGate Cardiac Structures is an early-stage company developing transcatheter atrioventricular valve technologies, including for mitral and tricuspid positions, making it a comparable emerging TMVR/transcatheter valve peer.
• Cardiac Dimensions: Cardiac Dimensions markets the Carillon Mitral Contour System, a transcatheter mitral repair device for functional MR. It addresses a similar patient population to Sutra via a different mechanism.
• 4C Medical Technologies: 4C Medical Technologies is developing the AltaValve TMVR system for mitral regurgitation, positioning it as a direct emerging competitor addressing MR patients unsuitable for surgery or TEER.
• Ancora Heart: Ancora Heart is developing the AccuCinch ventricular repair system for functional mitral regurgitation. It targets the same MR patient population via a transcatheter, non-valve-replacement approach, making it a relevant therapeutic-area peer.
• Mitralix (Mitralex Medical / Mitralix): Mitralix is an early-stage company developing transcatheter solutions for mitral regurgitation. As a small, niche TMVR/transcatheter mitral player, it is comparable to Sutra in stage and category.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks7 records

Key highlights7 records

Customer concentration

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 records

Funding overview

Funding rounds

Investors

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M&A

Investments

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Frequently asked questions about Sutra Medical