Fundacja Rozwoju Kardiochirurgii im. prof. Zbigniewa Religi

What Fundacja Rozwoju Kardiochirurgii im. prof. Zbigniewa Religi does

Fundacja Rozwoju Kardiochirurgii im. prof. Zbigniewa Religi is a Polish non-profit foundation founded in December 1991 by Prof. Zbigniew Religa, the surgeon who performed Poland's first successful heart transplant. Headquartered at ul. Wolności 345a in Zabrze, the Foundation operates the Institute of Heart Prostheses (Instytut Protez Serca) and runs the Artificial Heart Laboratory with four ISO 7-classified labs (Construction, Research, Processing, Technological), the Biocybernetics Laboratory, the Bioengineering Laboratory, and a tissue-handling operation. Its mission is to develop and clinically deploy domestically manufactured mechanical circulatory support systems for Polish cardiac surgery, reducing dependence on imported prostheses.

The Foundation's core technology portfolio centers on the ReligaHeart family of ventricular assist devices (VADs): the extracorporeal pulsatile ReligaHeart EXT, the long-term implantable pulsatile ReligaHeart IMPL (up to 2 years), the miniature centrifugal rotary ReligaHeart ROT with a magnetically levitating bearingless impeller (first in Europe to reach preclinical animal trials), and the pediatric ReligaHeart PED available in three sizes (20/30/45 ml) for children aged 2–12. Supporting technologies include pneumatic controllers (PDU-402, PDU-501, DUO), Moll-type titanium/PEEK mechanical disc valves, the ElastoKard biomaterial platform (fatty acid/vitamin E-modified PET), glow-discharge nitrided titanium surface treatments, an ultrasonic flow-measurement and microembolus-detection system, and the Robin Heart surgical robotics platform including an AI-equipped variant with telesurgery capability. The Foundation holds ISO 9001:2015 (since 2001, valid through 2028) and ISO 13485:2012 medical-device QMS certifications, a 2004 Center of Excellence designation, and a portfolio of registered and pending patents. Its experimental team has conducted nearly 800 in-vivo animal experiments over ~30 years, and ~280 clinical applications of the POLCAS pneumatic mechanical circulatory support system have been recorded.

The Foundation is registered as a Polish public benefit organization (OPP, KRS 0000069136) and does not sell products commercially. Revenue flows from individual donations (including 1.5% income tax redirection), corporate sponsorships from ~40 listed Polish companies and foundations (notably JSW Foundation and PGNiG Foundation, each contributing ~50,000 PLN grants in recent years), charitable events (the annual "Serce za Serce" concert series, now in its 31st edition; Religa Golf Cup; charity galas with Businesswoman & life magazine), and modest training-course fees (e.g., 3,800 PLN per wet-lab course) operated through the subsidiary NZOZ FRK Homograft Sp. z o.o. Active R&D consortia span Polish technical universities (Łódź, Warsaw, Poznań, Silesian) and Polish Academy of Sciences institutes, with documented international collaborations reaching Argentina, Ukraine, and Belarus.

Name

Fundacja Rozwoju Kardiochirurgii im. prof. Zbigniewa Religi

Legal name

Fundacja Rozwoju Kardiochirurgii im. prof. Zbigniewa Religi

Website

https://frk.pl

Company type

Private

Founded year

1991

Operating status

Operating

Headcount range

11–50 employees

Short description

Polish non-profit foundation (Zabrze, est. 1991) operating the Institute of Heart Prostheses to develop and clinically deploy domestically manufactured ventricular assist devices (ReligaHeart EXT, IMPL, ROT, PED), heart valves, biomaterials, and Robin Heart surgical robotics for cardiac surgery patients and partner clinical institutions across Poland.

Ownership category

akta.pro rank

Product category

Cardiac Mechanical Circulatory Support Devices

NAICS

Research and Development in the Physical, Engineering, and Life Sciences (54171), Scientific Research and Development Services (5417)

SIC

Electromedical & Electrotherapeutic Apparatus (3845), Surgical & Medical Instruments & Apparatus (3841), Orthopedic, Prosthetic & Surgical Appliances & Supplies (3842)

akta.pro industry

PRIMARYHLAHAFAL

Cardiac Assist & Heart Failure Therapies (Implantables, Neuromodulation)

Healthcare & Life Sciences/Medical Devices & Diagnostics/Cardiovascular Devices (Stents, Valves, Rhythm Management)

Keywords

• Mechanical circulatory support devices
• Ventricular assist devices
• Cardiac surgery research
• Medical robotics systems
• Biological heart valves

Headquarters

HQ city

Zabrze

HQ country

Poland

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Individual donations and bequests: Polish citizens can donate 1.5% of their income tax to the Foundation as a public benefit organization (OPP). Direct bank transfers and online donations are also accepted.
2. Corporate sponsorships and institutional grants: Support from Polish corporate sponsors (JSW Foundation, PGNiG Foundation, Lewiatan Network, and ~40 other companies listed on the website). Funds directed toward research equipment and laboratory expansion.
3. Charitable events revenue: Revenue from 'Serce za Serce' charity concerts (31st edition), Religa Golf Cup tournaments, calendar and book auctions organized with partners like Businesswoman & life magazine. All proceeds support statutory activities.
4. Medical training course fees: Revenue from practical surgical training courses (wet-lab) organized for healthcare professionals. Courses include cornea transplantation, oculoplasty, urology, and cardiovascular procedures. NZOZ FRK Homograft Sp. z o.o. operates as a subsidiary running courses, priced at 3800 PLN per course.

Pricing tiers

Go-to-market motion2 records

Distribution channels3 records

Marketing channels10 records

Core offering

Fundacja Rozwoju Kardiochirurgii im. prof. Zbigniewa Religi is a Polish non-profit foundation that develops, manufactures, and clinically applies proprietary mechanical circulatory support devices — including the ReligaHeart family of pulsatile and rotary ventricular assist devices (VADs), pediatric VADs, mechanical heart valves, and pneumatic controllers — as well as the Robin Heart medical robotics system. The Foundation also operates an ISO-certified cleanroom production facility, a heart tissue bank, medical training courses, and annual scientific conferences.

Product overview

Fundacja Rozwoju Kardiochirurgii im. prof. Zbigniewa Religi is a cardiac surgery development foundation offering a portfolio of medical devices centered on heart support systems and mechanical circulatory support. The core product family includes the ReligaHeart series of heart support pumps (EXT for extracorporeal use, IMPL for implantable long-term support, ROT for centrifugal rotary support, and PED for pediatric applications),配套 controllers (PDU-402, PDU-501, DUO), and mechanical heart valves. The foundation also develops Robin Heart medical robotics for cardiac surgery, and operates tissue banking and medical training services. The offering represents an integrated approach to cardiac care spanning from pediatric to adult patients, combining hardware devices with training and research capabilities.

Differentiator

Problem solved

Functional benefit

Products and services

• ReligaHeart EXT Extracorporeal pneumatic pulsatile blood pump for prolonged cardiac support in hospital settings, equipped with dual mechanical disc valves and inflow/outflow cannulae; used as bridge-to-recovery or bridge-to-transplant for adult patients with advanced heart failure.
• ReligaHeart IMPL Implantable pneumatic pulsatile blood pump for long-term cardiac support (up to 2 years), with titanium housing and dual mechanical valves, anatomically shaped to fit the chest cavity and compatible with a portable controller for out-of-hospital use.
• ReligaHeart ROT Miniature centrifugal rotary blood pump implanted through the apex directly into the left ventricle; uses a magnetically levitating, bearing-free impeller rotating at 2500–5500 RPM for long-term cardiac support.
• ReligaHeart PED Pediatric pulsatile ventricular assist device system available in three sizes (45 ml for ages 8–12, 30 ml for ages 4–9, 20 ml for ages 2–5), designed for use with Moll-type mechanical disc valves and novel polyurethane leaflet valves.
• ReligaHeart PDU-402 Portable pneumatic controller for driving ReligaHeart pulsatile VADs, with independent pneumatic power supply and automatic control and monitoring systems.
• ReligaHeart PDU-501 Portable pneumatic controller with built-in battery (up to 5 hours of continuous operation), touchscreen display, modular architecture, and synchronization capability with the native heart.
• ReligaHeart DUO Hybrid controller system combining a docking station with a portable pneumatic control unit for extended cardiac support.
• Moll-type Mechanical Disc Valve Titanium-ring mechanical disc valve with PEEK polymer disc, designed for use in pulsatile ventricular assist devices (extra-corporeal and implantable); available in pediatric sizes 14–20 mm.
• Robin Heart Medical Robot System Medical robot system developed for cardiac surgery and other cardiovascular procedures, including the Robin Heart AI variant equipped with artificial intelligence and telesurgery capabilities.
• Medical Training Courses (Wet-Lab) Practical surgical training (wet-lab) courses for healthcare professionals covering cornea transplantation, oculoplasty, urology, vascular surgery, and cardiac procedures; CME points available; conducted at Foundation facilities in Zabrze.
• Heart Tissue Bank Services Tissue banking services including procurement, processing, preservation, and supply of heart valves and biological cardiovascular tissues for medical applications.
• Biological Heart Valve Laboratory Services Biological heart valve research, development, and production services operated by the Foundation's Research-Development Center.

Quantifiable outcome

• ~280 clinical applications of the POLCAS pneumatic mechanical circulatory support system
• +4 more outcomes

Named customers4 records

Segments4 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability1 record

Feature11 records

Partnerships

20 partnerships are on record, tiered core, major and minor.

• Instytut Maszyn Przepływowych Politechniki ŁódzkiejcoreStrategic or Co-development Partner · 1 January 2026Consortium leader for the pediatric mechanical disc valve project. The Foundation serves as consortium partner in the project 'Development of a series of disc-type mechanical valves for pediatric ventricular assist devices', with FRK team leader mgr inż. Agnieszka Szuber.
• Wydział Inżynierii Materiałowej Politechniki Warszawskiej (WIM PW)coreStrategic or Co-development PartnerConsortium partner in multiple projects including pediatric VAD valves (led by Prof. Tadeusz Wierzchoń) and the glow-discharge surface treatment project for rotary VADs. Contributes expertise in materials science and surface engineering.
• Instytut Inżynierii Materiałowej Politechniki Łódzkiej (IIM PŁ)coreStrategic or Co-development PartnerConsortium partner in the pediatric valve development project (led by Prof. Piotr Niedzielski), contributing materials engineering expertise.
• Politechnika Poznańska (project ElastoKard)coreStrategic or Co-development PartnerLed by Prof. Mirosława El Fray, this project develops innovative biomaterials (fatty acid and vitamin E modified PET) for cardiac support systems. The Foundation conducts biocompatibility and thrombogenicity testing.
• Instytut Podstawowych Problemów Techniki Polskiej Akademii Nauk (IPPT PAN)coreStrategic or Co-development PartnerConsortium partner in the ultrasonic measurement and microembolus detection project for ReligaHeart EXT. Project manager: dr inż. Maciej Gawlikowski (FRK); IPPT PAN lead: dr Marcin Lewandowski.
• Górnośląski Akcelerator Przedsiębiorczości RynkowejmajorStrategic or Co-development PartnerCo-organizer (with the Foundation) of expert meetings within the international BRIDGE project, which aims to develop recommendations for joint R&D and investment projects.
• Uniwersytet Śląski w KatowicachmajorStrategic or Co-development PartnerParticipant in the international BRIDGE project expert meetings organized by the Foundation. Contributes to recommendations for joint R&D and investment projects.
• Politechnika ŚląskamajorStrategic or Co-development PartnerParticipant in the BRIDGE international project expert meetings, contributing to joint R&D recommendations.
• Śląski Uniwersytet MedycznymajorStrategic or Co-development PartnerParticipant in the BRIDGE project expert meetings. Long-standing clinical collaboration partner for cardiac surgery research and training.
• Łukasiewicz — Krakowski Instytut TechnologicznymajorStrategic or Co-development PartnerParticipant in BRIDGE international project expert meetings organized by the Foundation.
• Centrum Leczenia Oparzeń im. dr. Stanisława SakielaminorStrategic or Co-development PartnerParticipant in BRIDGE international project expert meetings organized by the Foundation.
• Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w KatowicachminorStrategic or Co-development PartnerParticipant in BRIDGE international project expert meetings. Collaborates with the Foundation on blood-related research topics.
• Klaster MedSilesiamajorStrategic or Co-development PartnerMedical technology cluster that the Foundation participates in, supporting regional medical technology collaboration and the Medical Robotics Conference.
• Wadim Plast (industrial partner)minorImplementation/ SI/ Consulting PartnerIndustrial manufacturing partner collaborating on the ElastoKard project, providing processing facilities for manufacturing prototype elements of prostheses from the new biomaterial.
• Fundacja Polskiej Sieci Handlowej LewiatanminorGTM or Marketing PartnerSupports the Foundation's 1.5% tax donation campaign, directing collected funds to finance ongoing research projects.
• Businesswoman & life magazinemajorGTM or Marketing PartnerLong-standing charity partner (10+ years) organizing annual charity galas, calendar premieres, and the '50 Business Personalities' and 'Encyclopedia of Business Personalities' publications, with 100% of proceeds directed to the Foundation.
• Centrum Medycyny Doświadczalnej ŚUM w Katowicach-LigociecoreStrategic or Co-development PartnerPermanent ongoing collaboration for conducting in-vivo animal experiments. The Foundation's experimental team includes surgeons, anesthesiologists, veterinarians, and perfusionists.
• American Heart of Poland w KostkowicachcoreStrategic or Co-development PartnerExperimental center used for animal studies in collaboration with the Foundation, providing facilities for preclinical testing of cardiac prostheses.
• Instytut Zootechniki w Krakowie-BalicachminorStrategic or Co-development PartnerResearch institution collaborating with the Foundation on animal studies related to cardiac prosthesis development.
• Uniwersytet Rolniczy im. Hugona Kołłątaja w KrakowieminorStrategic or Co-development PartnerAgricultural university collaborating with the Foundation on animal experiment-related research.

Scale indicators9 records

Recent moves8 records

Expansion highlights8 records

Broad incumbents

• Abiomed: Now part of Johnson & Johnson, Abiomed manufactures the Impella family of catheter-based heart pumps for mechanical circulatory support. Comparable as a broad incumbent offering overlapping percutaneous and surgical mechanical circulatory support capabilities with a global commercial footprint far exceeding the Foundation's.
• Medtronic: Global medical device conglomerate that historically developed the HVAD system. Comparable as a broad incumbent in mechanical circulatory support with substantial R&D resources that dwarf the Foundation's, and a global regulatory/commercialization infrastructure that the Foundation lacks.
• Abbott: Global medical device leader offering the HeartMate 3 LVAD (acquired via Thoratec/St. Jude). Comparable as the dominant global incumbent in the destination-therapy LVAD market where ReligaHeart ROT would compete if it reaches commercialization.

Emerging players

• Evaheart: Japanese manufacturer of the EVAHEART 2 centrifugal LVAD with a hydrodynamically suspended impeller. Comparable as a regional rotary VAD specialist with a similar magnetically/hydrodynamically suspended impeller architecture to ReligaHeart ROT.
• CorWave: French medtech developing next-generation left ventricular assist devices using a proprietary wave-membrane pumping mechanism with magnetic levitation. Comparable because CorWave operates in the same magnetically-levitated rotary LVAD category as ReligaHeart ROT and targets the same bridge-to-transplant/destination therapy segment.
• ReliantHeart: U.S. developer of the HeartAssist5 LVAD, a small, durable rotary VAD with remote monitoring. Comparable as an emerging player in the rotary continuous-flow LVAD category targeting destination therapy, similar in niche positioning to ReligaHeart ROT.
• Calon Cardio: U.K.-based developer of the miniVAD, a next-generation miniaturized ventricular assist device. Comparable as an emerging European competitor developing compact rotary LVADs targeting the same destination-therapy / bridge-to-transplant market as ReligaHeart ROT.

Direct peers

• SynCardia Systems: U.S. manufacturer of the total artificial heart (TAH). Comparable because SynCardia's pulsatile pneumatic TAH addresses the same bridge-to-transplant use case for end-stage heart failure patients that ReligaHeart EXT and IMPL are designed for.
• Carmat: French developer of the Aeson total artificial heart. Comparable because Carmat develops a fully implantable artificial heart using pulsatile/biomembrane technology aimed at bridge-to-transplant — the same clinical indication ReligaHeart IMPL targets, with similar European regulatory pathway dynamics.
• Berlin Heart: German manufacturer of pediatric and adult ventricular assist devices (EXCOR and others). Directly comparable because Berlin Heart is the dominant pediatric VAD specialist globally — ReligaHeart PED competes in the same pediatric mechanical circulatory support niche that Berlin Heart has historically led.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

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Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 records

Funding overview

Funding rounds

Investors

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M&A

Investments

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