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4 CardioVascular

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4Cardiovascular

SCIENCE FOR LIFE

Mitral repair.
With the future
in mind.

We are developing BRELLO, a suture-based transcatheter system for mitral valve repair. Clinical insight and medical engineering guide every step.

Explore BRELLO
Technology in development. Preclinical research programme.
BRELLOSUTURE-BASED MITRAL REPAIR
BRELLO mitral suturing catheter concept, from the company’s development materials

Inspired by surgical precision.
Designed for a transcatheter approach.

01 / 04

A focused structural heart company

VERONA, ITALYRESEARCH & DEVELOPMENTCALL 4 IDEAS FVG · AWARDED 2025

01 / THE CLINICAL CHALLENGE

Every valve.
A long-term perspective.

Mitral regurgitation calls for treatment decisions that consider the patient’s anatomy, clinical condition and future care.

Transcatheter edge-to-edge repair (TEER) is part of contemporary mitral valve care for selected patients. Our research explores a different way to bring the valve leaflets together: a catheter-delivered suture inspired by the surgical Alfieri technique.

Clinical context: 2025 ESC/EACTS Guidelines

02 / OUR TECHNOLOGY

Meet BRELLO.

A suture-based approach to transcatheter mitral repair.

Illustration of the BRELLO leaflet suturing concept from the company deckCompany concept illustration. Development configuration.

BRELLO is being designed to reproduce the principle of surgical edge-to-edge repair through a percutaneous system. The concept uses separate leaflet stitches and controlled suture approximation.

The catheter concept captures a leaflet and places a suture. The process is repeated on the opposing leaflet.

DESIGN PRIORITIES

These are design objectives under investigation. Clinical performance has not been established.

01

Controlled approximation

Investigating separate stitch placement and assessment before final suture tightening.

02

Limited implanted material

A suture-based concept intended to limit the material remaining on the valve.

03

Future treatment options

Exploring how the repair could support subsequent interventions when needed.

03 / RESEARCH & DEVELOPMENT

Progress through
evidence.

Our programme brings clinical expertise into device development, with defined questions for each stage of validation.

CURRENT FOCUS: PRECLINICAL DEVELOPMENT
01

Prototype development

Refining catheter mechanics, leaflet capture and suture delivery through successive prototype configurations.

02

Preclinical feasibility

The programme plans acute and chronic preclinical evaluation of the system and repair concept.

03

Engineering verification

The development plan includes design verification and a design freeze before clinical translation.

04

Clinical translation

First-in-human investigation is a future stage, subject to supporting evidence and regulatory and ethics approvals.

04 / COMPANY MILESTONES

Building the foundations.

An invention, a dedicated development team and recognition from the life sciences innovation ecosystem.

2020

INTELLECTUAL PROPERTY

The invention takes shape

The suturing catheter patent family traces its priority to 2 April 2020.

EPO publication
2025

REGIONAL INNOVATION AWARD

Call 4 Ideas FVG

A €5,000 prize assigned to 4 Cardiovascular in the second Call 4 Ideas FVG. Official ranking dated 22 January 2025.

Official ranking
2025

EUROPEAN PATENT

EP4125622B1

The EPO publishes the mention of grant on 17 September 2025. The listed proprietor is 4 Cardiovascular S.r.l.

Grant publication
2026

DEVELOPMENT PROGRAMME

Preclinical development

The June 2026 company plan focuses on prototype engineering and preclinical feasibility, with verification ahead of clinical investigation.

Research priorities

The innovation prize recognises the project. It does not constitute clinical validation or a regulatory approval.

05 / OUR PEOPLE

Clinical purpose.
Engineering discipline.

4Cardiovascular is an Italian innovative startup dedicated to mitral valve technology. The founding team combines interventional cardiology with medical device development and life sciences investment.

Francesco Dallavalle

CLINICAL FOUNDER

Francesco Dallavalle

Interventional cardiologist with more than 25 years of experience. Originator of the clinical concept.

Claudio Zuccolotto

CEO & CO-FOUNDER

Claudio Zuccolotto

Life sciences investor and business leader with experience in international expansion and M&A.

Ludwig Compagnoni

CTO & CO-FOUNDER

Ludwig Compagnoni

More than 20 years in medical device R&D, including experience at Invatec and Medtronic.

Gennaro Broya de Lucia

CSO & CO-FOUNDER

Gennaro Broya de Lucia

Medtech entrepreneur and investor focused on interventional cardiology and structural heart technologies.

SCIENTIFIC ADVISORY BOARD

Expertise in cardiac surgery and structural heart intervention.

Ottavio AlfieriMarco VolaGuido GelpiGiuseppe TarantiniHorst Sievert

06 / FOR INVESTORS & PARTNERS

Support the next
stage of research.

We welcome conversations with investors and development partners who understand the pathway from a medical device concept to clinical evidence.

Start an investor conversation

THE DEVELOPMENT CASE

A focused technology thesis

Suture-based mitral repair inspired by an established surgical principle, with an international patent family.

Milestones that matter

Prototype refinement, preclinical feasibility and engineering verification form the next development programme.

Materials for informed diligence

Contact the team for the executive presentation, development plan and a discussion of intellectual property and funding needs.

A CLOSER LOOK

Questions, answered.

What is BRELLO?

BRELLO is a suture-based transcatheter mitral repair system under development by 4Cardiovascular. Its concept takes inspiration from the surgical Alfieri edge-to-edge technique.

Is BRELLO available for clinical use?

BRELLO is in development. The company materials describe a preclinical programme and a future clinical pathway. The system is not presented here as a commercially available or clinically validated treatment.

Are the design advantages clinically established?

No. Control of suture approximation, limited implanted material and preservation of future treatment options are design objectives. Their safety and performance require further verification and appropriate studies.

How can investors and research partners engage?

Email connect@4cardiovascular.com to request company materials or arrange a conversation about the development programme. Investment terms and technical diligence materials are discussed directly with the team.

LET’S CONNECT

The next step starts
with a conversation.

connect@4cardiovascular.com

Verona, Italy

Sources & disclosures

Sources reviewed: 8 October 2026.

This website presents 4Cardiovascular’s research programme. Design objectives are distinguished from clinical results and administrative recognition.

Technology and company information

BRELLO, team and development programme content derives from the company’s June 2026 executive presentation and supplied animation. Device images and photographs are original company assets. The company profile on the FVG Cluster portal describes the transcatheter Alfieri stitch concept.

BRELLO profile on the Cluster Scienze della Vita FVG portal

Clinical context

The 2025 ESC/EACTS Guidelines provide context for mitral treatment options and the role of TEER in selected patients. Evidence for existing TEER devices does not establish BRELLO’s safety or efficacy.

2025 ESC/EACTS Guidelines for the management of valvular heart disease

Call 4 Ideas FVG 2025

The official ranking dated 22 January 2025, Annex A to protocol conc/001/A.2/2025, lists 4 CARDIOVASCULAR SRL in ninth place with a score of 71.50 and a €5,000 prize. This establishes the assignment of the prize, not its payment. Eligibility to apply for a subsequent call is not a grant award.

Official Call 4 Ideas page and rankings

Official ZIP archive containing the January 2025 ranking

Intellectual property

EPO publication EP4125622B1 lists 4 CARDIOVASCULAR S.R.L. as proprietor, Italian priority dated 2 April 2020 and publication of the mention of grant on 17 September 2025. The website does not describe the PCT procedure as a granted patent or infer national validations from designated states.

EP4125622B1, official EPO publication

Programme status

The preclinical stage and future activities reflect the June 2026 company plan. Future dates and durations are planning objectives. This content does not claim marketing authorisation or clinical results for BRELLO.

For updated project information and due diligence materials: connect@4cardiovascular.com.

BRELLO is a technology in development. The information on this website describes a research programme and does not provide medical advice.

BRELLO · Company overview

Company overview with development renders. Not clinical outcome evidence.

Text description of the concept

The concept places a separate suture in each mitral leaflet. A microcatheter guides the suture wires. The leaflets are approximated using a slipknot, with an assessment before final tightening. A dedicated catheter then cuts the wires. The animation illustrates the intended procedure.

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