Valcare Medical

What Valcare Medical does

Valcare Medical, Inc. is a privately held, clinical-stage medical device company developing transcatheter solutions for mitral regurgitation and structural heart valve disease. The company is incorporated in Delaware (U.S. headquarters in Wilmington) and conducts development and operations in Herzliya, Israel. Its sole investigational product is the AMEND Transcatheter Mitral Valve Repair (TMVr) Annuloplasty System — a closed, D-shaped, semi-rigid annuloplasty ring delivered via a percutaneous transseptal catheter, designed to replicate the anatomical remodeling achieved by surgical annuloplasty (the gold-standard repair used in over 95% of surgical mitral repairs) while avoiding open-heart surgery. The device's proprietary anchoring and forward-compatibility design are positioned to preserve options for future transcatheter re-intervention, an explicit differentiator versus competing transcatheter mitral technologies.

The AMEND system is investigational and not approved for commercial sale; it is currently limited to clinical study use under FDA IDE and European clinical approvals. Valcare is enrolling in a U.S. Early Feasibility Study (15 patients across seven U.S. sites) and an EU Pilot Study (20 patients across Portugal, Italy, and other European sites), with 33 patients treated in First-in-Human experience to date and 6-month follow-up data published in Circulation: Cardiovascular Interventions. The go-to-market motion targets leading cardiac valve centers and structural heart programs, with distribution planned as direct enterprise sales to hospital catheterization labs and surgical suites upon regulatory approval. The company has disclosed approximately $8M in funding (2012 Accelmed round) plus two undisclosed HBM Healthcare Investments rounds in 2021 and 2022, and underwent a TechWald Next-led restructuring in April 2024 that installed Steve Sandweg (former Boston Scientific, Medtronic, EBR Systems commercial leader) as CEO and an industry-veteran board including Jeffrey B. Jump and Jacques Séguin (founders of MedAlliance and CoreValve, respectively).

Name

Valcare Medical

Legal name

Valcare Medical, Inc.

Website

https://valcaremedical.com

Company type

Private

Founded year

2014

Operating status

Operating

Headcount range

1–10 employees

Short description

Valcare Medical is a privately held, clinical-stage medical device company developing the AMEND Transcatheter Mitral Valve Repair Annuloplasty System — a minimally invasive, D-shaped annuloplasty ring delivered via catheter to treat functional mitral regurgitation in patients unsuitable for open-heart surgery, currently in U.S. and European clinical trials.

Ownership category

akta.pro rank

Product category

Transcatheter Mitral Valve Repair Devices

NAICS

Surgical Appliance and Supplies Manufacturing (339113), Surgical and Medical Instrument Manufacturing (339112)

SIC

Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

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

Keywords

• Transcatheter mitral repair
• Mitral annuloplasty ring
• Structural heart devices
• Minimally invasive cardiac devices
• Transseptal valve delivery

Headquarters

HQ city

Herzliya

HQ country

Israel

HQ region

Middle East

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Medical Device Sales (Future): Valcare Medical is a pre-revenue company developing the AMEND™ Transcatheter Mitral Valve Repair Annuloplasty System. The device is currently investigational and limited by U.S. federal law to investigational use only. Not available for commercial sale. Revenue will be generated through device sales to hospitals upon regulatory approval.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels6 records

Core offering

Valcare Medical designs and develops the AMEND™ Transcatheter Mitral Valve Repair (TMVr) Annuloplasty System, a closed, D-shaped, semi-rigid annuloplasty ring delivered via a percutaneous transseptal catheter to treat symptomatic functional mitral regurgitation. The device is investigational and not yet commercially available; it is currently limited by U.S. federal law to investigational use only through FDA-approved Early Feasibility (U.S.) and EU Pilot Studies.

Product overview

Valcare Medical is a medical device company developing a single core product—the AMEND™ Transcatheter Mitral Valve Repair (TMVr) Annuloplasty System. This is an innovative transcatheter annuloplasty ring designed to treat functional mitral regurgitation by delivering surgical-quality mitral valve repair through a minimally invasive percutaneous approach. The AMEND system is the company's flagship investigational device and is not yet commercially available.

Differentiator

Problem solved

Functional benefit

Products and services

• AMEND™ Transcatheter Mitral Valve Repair (TMVr) Annuloplasty System The AMEND System is an investigational, closed, D-shaped, semi-rigid annuloplasty ring delivered via catheter through a percutaneous transseptal approach, designed to replicate the anatomical remodeling and clinical outcomes of traditional surgical annuloplasty for treatment of symptomatic functional mitral regurgitation. The device is intended for interventional cardiologists and cardiac surgeons at structural heart programs treating patients with moderate-to-severe or severe functional mitral regurgitation who are not suitable for open-heart surgery, and is designed to preserve options for future transcatheter interventions.

Quantifiable outcome

• At 6 months, 11 of 13 patients had MR ≤grade 1 with stable and significant reduction maintained over follow-up period
• +2 more outcomes

Named customers3 records

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Five partnerships are on record, tiered minor and core.

• Circulation: Cardiovascular InterventionsminorOthers · 11 April 2026Six-month results of AMEND First-in-Man cohort accepted for publication in Circulation: Cardiovascular Interventions journal, demonstrating clinical evidence of device safety and efficacy.
• Banner - University Medical Center PhoenixcoreStrategic or Co-development Partner · 11 February 2026First U.S. transseptal implantation of AMEND System performed by Dr. Paul Sorajja at Banner - University Medical Center Phoenix as part of AMEND TS Early Feasibility Study. Site serves as primary investigational center for U.S. clinical trial.
• JACC: Cardiovascular InterventionsminorOthers · 1 February 2025Thirty-day results of AMEND Trans-Septal study published in JACC: Cardiovascular Interventions.
• Maria Cecilia Hospital (Italy)coreStrategic or Co-development Partner · 25 July 2024Italian Ministry of Health approved expansion of AMEND TS EU Pilot Study to Italy. Maria Cecilia Hospital in Cotignola became first Italian site to enroll and treat patient under Dr. Fausto Castriota.
• Vila Nova de Gaia Hospital (Portugal)coreStrategic or Co-development Partner · 14 May 2024Dr. Bruno Melica and team from Vila Nova de Gaia Hospital performed first two patient enrollments in AMEND TS EU Pilot Study. Hospital serves as European clinical trial site.

Scale indicators5 records

Recent moves7 records

Expansion highlights5 records

Broad incumbents

• Boston Scientific: Broad medtech incumbent with structural heart and transcatheter valve ambitions (acquired Millipede, invested in TMVr programs). Comparable as a large competitor with adjacent structural heart capabilities and the resources to compete across mitral indications.
• Medtronic: Largest medtech incumbent with structural heart franchise (TAVR leadership via CoreValve acquisition by board member Jacques Séguin). Comparable as a broad incumbent with significant resources and prior acquisitions of transcatheter heart valve companies relevant to AMEND's strategic exit pathway.
• Edwards Lifesciences: Structural heart leader with the PASCAL transcatheter mitral repair system and Cardioband annuloplasty device. Directly comparable to Valcare as the second major commercial-stage TMVr competitor with deep structural heart commercial infrastructure.
• Abbott: Diversified medtech incumbent with the leading transcatheter mitral product (MitraClip/Tendyne). Most relevant comparable on the device side because Abbott acquired Evalve/MitraClip — a company founded by Valcare board member Chris Richardson — and is the dominant TMVr player.

Emerging players

• InnovHeart: Italian/European early-stage developer of transcatheter mitral valve replacement (TMVR) technologies. Comparable emerging peer operating in the same transcatheter mitral space with overlapping European clinical footprint.
• Cephea Valve Technologies: Early-stage developer of transcatheter mitral valve replacement technologies. Comparable emerging peer targeting the same mitral regurgitation patient population with an alternative transcatheter approach.
• CroíValve: Early-stage Irish medtech developing a transcatheter solution for tricuspid regurgitation with technology overlap in transcatheter annular support. Comparable emerging player focused on transcatheter structural heart repair in a related anatomical space.
• Mitralix: Israeli early-stage company developing transcatheter mitral valve repair technologies. Directly comparable emerging peer working in the same transcatheter mitral space with a similar stage of development.

Direct peers

• NeoChord: Commercial-stage developer of the NeoChord system for beating-heart mitral valve repair via transapical delivery. Direct peer addressing the same mitral regurgitation patient population with a minimally invasive surgical-style repair.
• Cardiac Dimensions: Privately held developer of the Carillon Mitral Contour System, a transcatheter annuloplasty device for functional mitral regurgitation. Direct peer — same transcatheter mitral annuloplasty mechanism of action and same target indication as AMEND.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/valcare-medical

Revenue estimate

Valuation estimate

Number of profiles

Profiles10 records

Funding overview

Funding rounds3 records

Investors2 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 Valcare Medical