Medical device company profile

Haermonics

Dutch medical device developer building an automated pericardial-flushing system for postoperative cardiac-surgery care.

Medical Device Manufacturer and DeveloperCardiovascular & Vascular

Headquarters🇳🇱Eindhoven, North Brabant, Netherlands

Founded2015

Commercial statusIn developmentClinical-stage Pure pericardial-flushing system; final product configuration in development.

Employees11–50 ^[5]LinkedIn company-size range · Checked 2026-11-04

Estimated revenueNot confirmed

Disclosed funding€4.3 million ^[3][4]Series A financing announced August 2022; currency corroborated by Invest-NL.

Official websitehaermonics.com ↗

Company overview

Haermonics is an Eindhoven-based medical device company founded in 2015 and led by CEO Arash Dodge. It develops the Pure System for continuous postoperative pericardial flushing following cardiac surgery. The approach originated from the work of cardiothoracic surgeon David Koolbergen.

The system is designed to circulate saline through the pericardial space to dilute residual blood and clots and support drainage after surgical closure. Haermonics is working toward an automated product that can standardize a technique previously evaluated using prototypes and investigational equipment.

Pure remains a clinical-stage development programme. Earlier studies and pooled analyses inform the approach, while the 2026 FLUID randomized trial did not demonstrate a reduction in its primary re-exploration outcome. The current company timeline identifies a 2027 product milestone.

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Leadership

6 people

Arash Dodge, PhDChief Executive Officer ^[1]

Maarten HaastChief Financial Officer ^[1]

Andrea FiorenziChief Operating Officer ^[1]

Katarzyna FeliksikDirector, Quality Assurance & Regulatory Affairs ^[1]

Samuela LoosliMarketing & Compliance Lead ^[1]

Lian van LippenClinical Trial Lead ^[1]

Products & regulatory status How does MedTechIndex get this information?

Summary

Haermonics describes Pure as a clinical-stage programme and separates its early prototypes, the 2020 investigational device and a 2027 product milestone. Its website reports FDA Breakthrough status in that development history; this is distinct from marketing authorization for the final system. ^[1]

The 2026 FLUID study randomized 164 patients before being stopped early. Surgical re-exploration for tamponade or excessive non-surgical bleeding occurred in 3.8% of the flushing group and 2.4% of controls, without a statistically significant difference. The authors concluded that the study did not show a reduction in the primary outcome and called for adequately powered additional research. ^[2]

Regulatory snapshot How to read this snapshot

U.S. FDA

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510(k) clearances: —
De Novo grants: —
PMA approvals: —
Recall events

Latest recorded source review: 2026-11-04.

Scope: selected product families.

Commercial portfolio snapshot

No commercially marketed product portfolio has been established in the reviewed material.

Commercial development

Automated pericardial-flushing system

Pure System ↗

Clinical-stage system designed to provide continuous postoperative pericardial flushing after cardiac surgery, diluting residual blood and clots to support drainage. The final automated configuration is in development. ^[1]

Clinical development · Product configuration in development