What Berlin Heart Inc. does

Berlin Heart Inc. is the wholly owned North American subsidiary (founded October 2005, headquartered in The Woodlands, Texas) of Berlin Heart GmbH, a German medical device company that develops, manufactures, and markets ventricular assist devices (VADs) for mechanical circulatory support. The company's core technology centers on paracorporeal, pulsatile membrane pumps connected to the heart via implantable silicone cannulae, enabling left, right, or biventricular support. Berlin Heart's lead product is the EXCOR Pediatric — the only VAD system specifically designed for infants, children, and adolescents with life-threatening heart failure refractory to optimal medical therapy — which received FDA HDE approval in December 2011 and FDA PMA approval in June 2017. The portfolio has expanded to include the EXCOR Adult VAD (CE-marked internationally but not FDA approved), the EXCOR Venous Cannula (CE approved March 2021 for failing Fontan / single-ventricle patients), and the investigational EXCOR Active device under IDE# G200252.

Berlin Heart positions itself as the only company worldwide able to provide mechanical circulatory support to patients of every age and size, supported by an extensive range of blood pump sizes and cannula configurations. The company monetizes through direct hardware sales of EXCOR systems to specialized cardiac centers and hospitals, complemented by recurring cannula and pump replacement revenue, with quote-based institutional pricing that is not publicly disclosed. Distribution is handled by the wholly owned North American subsidiary (covering the U.S., Canada, and Mexico) and the German parent (covering Europe and international markets), reaching 170+ specialized centers worldwide. Since first clinical use in 1990, EXCOR Pediatric has supported more than 2,000 young patients, with published IDE study outcomes including 96% 30-day survival (vs. 67–75% for ECMO comparators) and 73% successful bridge-to-transplant or weaning rates.

The business model combines an enterprise field-sales GTM motion with deep clinical support: a Clinical Affairs Team advises implanting centers on patient selection, device choice, implantation, and postoperative management, supplemented by annual training symposia, onsite education, and a 24/7 medical and technical hotline. Strategic co-development partnerships with three leading heart centers — German Heart Institute Berlin, Hospital for Sick Kids Toronto, and Texas Children's Hospital Houston — together with support for the ACTION learning network anchor Berlin Heart's clinical ecosystem. The company is privately held under family-investment ownership with 11–50 employees in the U.S. subsidiary and no disclosed external funding rounds.

Name

Berlin Heart Inc.

Legal name

Berlin Heart GmbH

Website

https://berlinheart.com

Company type

Private

Founded year

2005

Operating status

Operating

Headcount range

11–50 employees

Short description

Berlin Heart Inc. develops and markets the EXCOR family of paracorporeal pulsatile ventricular assist devices, providing mechanical circulatory support as bridge-to-transplant for pediatric and adult patients with severe heart failure at 170+ specialized cardiac centers worldwide.

Ownership category

akta.pro rank

Product category

Mechanical Circulatory Support Devices

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510)

SIC

Electromedical & Electrotherapeutic Apparatus (3845)

akta.pro primary industry

Mechanical Circulatory Support (VAD, IABP, ECMO) (HLAHAFAG)

akta.pro secondary industries

Cardiac Surgery Devices (Cannulas, Clamps, Closure, Grafts) (HLAHAFAH), Cardiac Assist & Heart Failure Therapies (Implantables, Neuromodulation) (HLAHAFAL)

Keywords

• Mechanical circulatory support
• Ventricular assist devices
• Pediatric cardiac devices
• Heart failure therapy
• Medical device manufacturing

Headquarters

HQ city

The Woodlands

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Medical Device Sales: Berlin Heart develops, produces and markets innovative devices for mechanically supporting the heart. The company generates revenue through the sale of their EXCOR mechanical circulatory support systems to hospitals and healthcare institutions worldwide.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

Berlin Heart Inc. develops, manufactures, and supports ventricular assist device (VAD) systems under the EXCOR product line, including paracorporeal pulsatile membrane pumps and implantable silicone cannulae that provide left, right, or biventricular support as a bridge to transplant or recovery. The portfolio spans pediatric and adult patients and is sold to specialized cardiac care hospitals and healthcare institutions, primarily in North America.

Product overview

Berlin Heart develops, manufactures, and markets innovative ventricular assist devices (VADs) for mechanical circulatory support. The company offers two core products: the EXCOR Pediatric and EXCOR Adult mechanical circulatory support systems. The EXCOR system uses paracorporeal, pulsatile membrane pumps with implantable silicone cannulae to provide left ventricular, right ventricular, or biventricular support for patients of all ages and sizes. As of 2021, the company expanded its portfolio with the CE-approved EXCOR Venous Cannula for Fontan patients. The EXCOR Pediatric is FDA-approved (PMA, 2017) for bridge-to-transplant use in pediatric patients, while EXCOR Adult and several other configurations are not yet FDA approved.

Differentiator

Problem solved

Functional benefit

Products and services

• EXCOR Pediatric
• EXCOR Adult
• EXCOR Venous Cannula
• EXCOR Active

Quantifiable outcome

• 96% 30-day survival rate in IDE study cohort 1 (vs 75% for ECMO group)
• +4 more outcomes

Named customers5 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

Feature3 records

Partnerships

Four partnerships are on record, tiered core.

• German Heart Institute Berlin (DHZB)coreStrategic or Co-development PartnerStrategic partnership with one of the world's leading heart centers. Part of Berlin Heart's strategic international expansion focused on innovative products and partnerships.
• Hospital for Sick Kids (Toronto, Canada)coreStrategic or Co-development PartnerStrategic partnership with one of the world's leading heart centers. Part of Berlin Heart's strategic international expansion focused on innovative products and partnerships.
• Texas Children's Hospital (Houston, Texas)coreStrategic or Co-development PartnerStrategic partnership with one of the world's leading heart centers. Berlin Heart Inc. is located in Texas and maintains close partnership with this major pediatric cardiac center.
• ACTION (Advanced Cardiac Therapies Improving Outcomes Network)coreStrategic or Co-development PartnerACTION brings together clinicians, researchers, parents, and patients from across medical institutions to improve outcomes for children with heart failure. Berlin Heart supports this learning network and collaborative practices methodology for quality improvement.

Scale indicators4 records

Recent moves6 records

Expansion highlights5 records

Broad incumbents

• Medtronic: Medtronic acquired HeartWare International and its HVAD System, a miniaturized implantable centrifugal VAD for advanced heart failure. Broad incumbent with significant VAD clinical data and global commercial reach; overlaps with Berlin Heart in the VAD category though concentrated in adult continuous-flow devices.
• Terumo (Terumo Cardiovascular): Terumo developed the DuraHeart LVAD and broader mechanical circulatory support portfolio through Terumo Cardiovascular. Broad incumbent in cardiac surgery and mechanical support products with overlapping VAD technology, though not focused on pediatric niche.
• Abbott: Abbott markets HeartMate 3, the leading continuous-flow LVAD for adult advanced heart failure, and CentriMag for short-term circulatory support. Broad incumbent in mechanical circulatory support with overlapping technology, larger portfolio, and vastly greater resources, though focused on adult rather than pediatric indications.

Direct peers

• SynCardia Systems: SynCardia manufactures the only FDA-approved total artificial heart (TAH), a pulsatile mechanical circulatory support device used as bridge to transplant. Directly comparable to Berlin Heart as a niche manufacturer of pulsatile mechanical circulatory support devices for severe heart failure.
• Jarvik Heart: Jarvik Heart develops the Jarvik 2000, a continuous-flow LVAD for destination therapy and bridge to transplant, and has explored pediatric applications. Comparable as a small, focused VAD developer with overlapping bridge-to-transplant clinical use case.
• ReliantHeart: ReliantHeart developed the aVAD, a small continuous-flow VAD with remote monitoring capability for advanced heart failure. Direct peer in the VAD space targeting bridge-to-transplant and destination therapy indications.

Emerging players

• BiVACOR: BiVACOR is developing a total artificial heart using magnetic levitation rotor technology for severe biventricular failure. Emerging player with overlap in mechanical circulatory support category, though targeting total heart replacement rather than ventricular assist.
• Carmat: Carmat develops a bioprosthetic total artificial heart as bridge to transplant for end-stage heart failure. Emerging player in mechanical circulatory support with overlapping use cases though differentiated technology; CE-marked in Europe and pursuing further indications.
• CorWave: CorWave is developing a next-generation LVAD using a wave-membrane pumping mechanism to reduce blood trauma. Emerging player in mechanical circulatory support with overlapping clinical use case for advanced heart failure.
• Evaheart, Inc. Evaheart developed a continuous-flow LVAD (EvaHeart2) targeting destination therapy. Emerging VAD competitor with overlap in the bridge-to-transplant and long-term mechanical support category.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xxing.com/companies/berlinheartgmbh/updates
• YouTubeyoutube.com/channel/UCWjvfgzjFW_w4sz5505jRNA/featured
• LinkedInlinkedin.com/company/berlin-heart-inc

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 records

Subsidiaries1 record

Funding overview

Funding rounds

Investors

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 Berlin Heart Inc.