TruLeaf Medical

What TruLeaf Medical does

TruLeaf Medical is an Israel-based, clinical-stage medical device company founded in 2017 that develops the RoseDoc platform for minimally invasive transcatheter mitral valve replacement (TMVR). The platform enables heart valve replacement via catheterization rather than open-heart surgery, targeting high-risk patients with diseased mitral valves, including those suffering severe heart failure caused by valve disease, who are not candidates for traditional surgical valve replacement. Following successful first-in-human trials (December 2025) that delivered rapid clinical improvements, the company is advancing toward broader regulatory approvals and commercialization, with clinical trial approval already secured in Uzbekistan and expansion planned to additional countries.

The company's product strategy is centered on a single core platform, RoseDoc, which leverages a proprietary catheter-based delivery method highlighted by a novel "needle-stick" procedure that replaces heart valves without open-heart surgery. TruLeaf operates as a wholly-owned subsidiary of AllMeD Solutions, the entity that directly conducted the first-in-human procedure. The company has been primarily funded through six non-dilutive grants from the Israel Innovation Authority, totaling approximately NIS 11.5 million (~$3.14 million), with the most recent grant of NIS 1.5 million (~$410,000) awarded in August 2024.

TruLeaf Medical's business model is structured around hardware sales of the RoseDoc transcatheter valve replacement system upon receipt of regulatory approvals, supplemented by clinical and regulatory milestone-driven grant funding today. Commercial pricing has not been publicly disclosed, and no distribution or marketing channels have been established, consistent with a pre-commercial clinical-stage profile. The company employs 1-10 people, is based in Or Akiva, Israel, and serves a global patient population across Central Asia initially, with broader geographic expansion as a stated priority.

Name

TruLeaf Medical

Legal name

TruLeaf Medical

Website

https://truleaf-medical.com

Company type

Private

Founded year

2017

Operating status

Operating

Headcount range

11–50 employees

Short description

TruLeaf Medical develops the RoseDoc platform for minimally invasive transcatheter mitral valve replacement via catheterization, targeting high-risk heart valve patients who cannot undergo open-heart surgery. It is a clinical-stage subsidiary of AllMeD Solutions, based in Or Akiva, Israel.

Ownership category

akta.pro rank

Product category

Transcatheter Heart Valve Devices

NAICS

Surgical and Medical Instrument Manufacturing (339112)

SIC

Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

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

akta.pro secondary industry

Interventional Cardiology (PCI/Structural Heart) (HLAKABAB)

Keywords

• Transcatheter mitral valve replacement
• Minimally invasive cardiac devices
• Heart valve replacement
• Catheter-based therapy
• Structural heart devices

Headquarters

HQ city

Or Akiva

HQ country

Israel

HQ region

Middle East

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: Revenue expected from sale of the RoseDoc transcatheter valve replacement system following regulatory approval and commercialization. The company is advancing through clinical trials toward market entry.

Go-to-market motion1 record

Core offering

TruLeaf Medical develops the RoseDoc platform, a novel transcatheter mitral valve replacement (TMVR) technology that enables minimally invasive heart valve replacement performed through catheterization. The platform eliminates the need for open-heart surgery and is designed to treat high-risk patients with diseased or malfunctioning mitral valves. The company is advancing the RoseDoc system through clinical trials toward regulatory approval and commercialization.

Product overview

TruLeaf Medical, a subsidiary of AllMeD Solutions, has developed the RoseDoc platform as its core product. This is a medical device platform designed for minimally invasive transcatheter mitral valve replacement procedures performed through catheterization. The technology aims to eliminate the need for open-heart surgery and reduce associated risks, targeting millions of high-risk patients globally. The platform is currently advancing through clinical trials following regulatory approval for trials in Uzbekistan.

Differentiator

Problem solved

Functional benefit

Brands

• RoseDoc: Novel technology platform for valve replacement performed through catheterization, designed to reduce risks associated with open-heart surgery and serve high-risk patients

Products and services

• RoseDoc Platform A novel transcatheter mitral valve replacement (TMVR) technology platform that performs minimally invasive valve replacement through catheterization, eliminating the need for open-heart surgery. Designed for hospitals, cardiac surgery centers, and interventional cardiology teams treating high-risk patients with diseased mitral valves.

Quantifiable outcome

• First-in-human trial delivered rapid clinical improvements in patients with severe heart failure caused by valve issues

Segments2 records

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature2 records

Partnerships

One partnership is on record.

• AllMeD SolutionscoreStrategic or Co-development PartnerTruLeaf Medical is a subsidiary of AllMeD Solutions. AllMeD Solutions successfully completed the first-in-human landmark needle-stick heart valve replacement trial, advancing the technology toward regulatory approval and commercialization.

Scale indicators4 records

Recent moves5 records

Expansion highlights5 records

Broad incumbents

• Edwards Lifesciences: Global leader in transcatheter heart valves (Sapien family for TAVR) and active developer of transcatheter mitral and tricuspid therapies (PASCAL, EVOQUE). Directly comparable structural heart valve competitor with vastly greater resources and clinical experience.
• Abbott: Acquired Tendyne, a transcatheter mitral valve replacement system, and competes across the structural heart space with the MitraClip franchise. A direct large-cap competitor in TMVR with established commercial channels and clinical trial infrastructure.
• Medtronic: Developed the Intrepid transcatheter mitral valve replacement system and is a major structural heart incumbent. Directly comparable as a TMVR competitor with deep clinical, regulatory, and commercial resources.
• Boston Scientific: Active in structural heart with transcatheter mitral and tricuspid programs (e.g., early TMVR work and acquired capabilities). Broad incumbent competing for the same TMVR opportunity with similar product positioning.

Emerging players

• NeoChord: Developer of the NeoChord system for beating-heart mitral valve repair via transapical access. Compares to TruLeaf as a small, venture-backed structural heart company pursuing minimally invasive mitral therapy with a differentiated procedural approach.
• Cardiac Dimensions: Developer of the Carillon system for transcatheter mitral annular remodeling to treat functional mitral regurgitation. Closely comparable as a clinical-stage, venture-backed structural heart company targeting the same minimally invasive mitral regurgitation opportunity.
• HighLife Medical: Developer of a transcatheter mitral valve replacement system using a transseptal, trans-catheter approach. Closely comparable emerging TMVR peer with a similar minimally invasive mitral replacement strategy.
• Coramaze Technologies: Early-stage developer of transcatheter mitral repair and replacement technologies. Comparable emerging player pursuing minimally invasive mitral therapy in a similar stage of clinical development.

Peers

• Mitralix:

Market position

Strengths5 records

Weaknesses5 records

Competitive moat2 records

Key risks6 records

Key highlights7 records

Customer concentration

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds1 record

Investors1 record

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 TruLeaf Medical