GrOwnValve and the EIC Accelerator: Heart Valves From Own Tissue

29 September 20261,205 words7 min

Children born with a faulty heart valve often face a series of operations, because artificial and animal-derived valves do not grow with them and wear out. GrOwnValve, a Berlin company founded in 2019 by paediatric cardiologist Boris Schmitt and Jasper Emeis as a spin-off of the German Heart Center and Charité, wants to replace them with a valve made during the procedure from the patient's own tissue, shaped on a 3D-printed mould and implanted through a catheter.

The European Innovation Council granted €2.5 million towards a €3.61 million project, and the award included an equity component. The project took the valve into its first patient in 2025. The first published result, from one adult, is encouraging. It is also a single case, written by authors employed by the company, in a study that will not complete until 2031.

€2.5MEIC grant, 69% of a €3.61M project
7Patients planned in the first-in-human study
1Patient with published results, July 2026
2031Estimated primary completion of the study

Company file

Legal entity
GrOwnValve GmbH, Berlin-Charlottenburg HRB 209838 B
Founded
September 2019, Berlin
Leadership
Boris Schmitt (CEO), Boris Warnack (CTO)
Products
AdultValve and ChildValve, with a bioresorbable anchor, in development
Clinical study
GECT-DZHK28, Charité-sponsored, seven adults
Other public funding
DZHK, EXIST, federal research ministry, IBB Berlin; €510,874 (2026)
EIC project
GrownValve, 1 Apr 2022 to 31 Jul 2025, closed
EIC funding
Blended finance (grant and equity)

Where GrOwnValve Stands Today

GrOwnValve is in its first clinical study. According to ClinicalTrials.gov, the feasibility study, sponsored by Charité with GrOwnValve as collaborator, started in December 2023, plans to enrol seven patients at the German Heart Center of the Charité in Berlin, was still recruiting in September 2025, and has an estimated primary completion date of January 2031. The first patient was treated in February 2025, according to the CORDIS report, and the company announced it in June 2025, as reported by Cardiovascular Business.

The German register records €510,874 of further public funding in March 2026 for clinical validation of a valve for children, the market the company was built for. We found no announced private funding round.

The Technology: A Valve Made in the Operating Room

The procedure, as described in the first case report, takes a piece of the patient's pericardium, the sac around the heart, and shapes it into a valve on a patient-specific 3D-printed mould based on a CT scan. The valve is mounted on a stent and implanted into the pulmonary position through a catheter, all in one procedure. Because the tissue is the patient's own, the company hopes it will remodel like living tissue, last longer than animal-derived valves and, in children, grow. The EIC project also worked on a bioresorbable stent and a paediatric delivery system.

"Bridge the gap from the laboratory and preclinical trials to our first patients in the clinic."

GrOwnValve on the purpose of its EIC funding, via NKS EIC Accelerator

What the EIC Project Promised, and What CORDIS Shows

The EIC project

The EU paid 69% of a €3.61M project

The GrownValve project ran from April 2022 to July 2025. The award was blended finance; the size of any EIC Fund investment has not been published.

CORDIS project 190188598. Values in € millions.

The project, planned for 36 months according to the German EIC national contact point, ran from April 2022 to July 2025. The CORDIS report lists ISO 13485 certification of the company's quality system, contracts with a notified body, the application and start of the first clinical study, the first-in-human procedures in February 2025 and preclinical testing of bioresorbable stents. It projects savings of about €16 billion a year for Europe's health systems, a figure without published workings.

  1. First use in patientsDeliveredFirst patient treated in February 2025.
  2. Quality system and regulatory pathDeliveredISO 13485 and a notified body contract.
  3. A valve for childrenIn progressPaediatric stent in preclinical testing; clinical validation funded in 2026.
  4. A valve that lasts a lifetimeUnprovenSix months of data in one patient.

The First Published Case

In July 2026 European Heart Journal Case Reports published the first case: a 35-year-old with severe narrowing of a previously implanted pulmonary valve. Six months after the procedure, the maximum pressure gradient across the valve had fallen from 103 to 14 mmHg, regurgitation had halved from 20% to 10%, and the enlarged right ventricle had shrunk. The authors conclude that the case "demonstrates the feasibility" of making and implanting the valve in one procedure. Their conflict of interest statement reads: "All authors are (partially) employed by GrOwnValve Ltd."

The first patient

The valve gradient fell from 103 to 14 mmHg

Maximum pressure gradient across the pulmonary valve in one 35-year-old patient, before the procedure and at six months. Lower is better. One patient is not evidence of safety or durability.

European Heart Journal Case Reports, July 2026.

The evidence

One published case in a seven-patient study

The feasibility study is recruiting at a single site in Berlin.

ClinicalTrials.gov NCT05809856; European Heart Journal Case Reports.

The record

From a Charité idea to a first patient

The first-in-human study is small and long: seven patients, with primary completion estimated for 2031.

  1. Sep 2019Company registeredBerlin; founded by paediatric cardiologist Boris Schmitt and Jasper Emeis, spun out of the German Heart Center and Charité
  2. Jun 2021EIC Accelerator cut-offA heart valve made from the patient's own tissue, for adults and children
  3. Apr 2022EIC project startsISO 13485, notified body and clinical study preparation€2.5M grant
  4. Dec 2023Clinical study startsCharité-sponsored feasibility study in seven adults, per ClinicalTrials.gov
  5. Feb 2025First patient treatedFirst-in-human procedure, per CORDIS; announced in June 2025
  6. Jul 2025EIC project closesFour months later than the original 36-month plan
  7. Mar 2026Paediatric fundingPublic funding for clinical validation of a valve for children€0.51M
  8. Jul 2026First case publishedSix-month results for one patient, by authors employed by the company

German company register via North Data, CORDIS, ClinicalTrials.gov, European Heart Journal Case Reports and GrOwnValve.

The Money

GrOwnValve has been financed largely by public money: the EIC grant, German research funding from the DZHK, EXIST and the federal research ministry, the Berlin development bank IBB, EU projects and the 2026 paediatric grant, as listed on its website and in the register. Its EIC award was blended finance; neither the EIC nor the company has published the size or terms of the EIC Fund's investment, and we found no private venture round.

What cannot be checked

How much equity the EIC Fund holds, how much money the company has left, and how many patients have been treated since the first are not public. Its accounts are filed but not freely displayed.

Why Europe Should Care

The NKS profile cites 400,000 children born each year worldwide with congenital heart valve defects. A valve that grows with the child would spare many of them repeat operations, and the technology comes out of a European public university hospital. So far, public money has carried most of its development.

What the project promised

A lifelong replacement heart valve for adults and children, made from the patient's own tissue.

What the record shows

A first patient treated and one six-month result published by company-employed authors; the child valve is still preclinical.

The Verdict

A real first step on a very long road

The EIC project did what it set out to do: it moved GrOwnValve from animal studies into humans. The single published case looks good, but it is one adult at six months, reported by the company's own staff. A lifelong valve that grows with children needs years more evidence, starting with a study that runs to 2031, and the public record does not show how that road will be financed.

GrOwnValve has not been asked for comment for this article. It is based entirely on public records, company statements, clinical registry data and EU project data, linked throughout.

Industry

HealthMedical devices

Focus
  • Cardiovascular devices
Technologies
  • Tissue engineering
  • 3D printing
  • Transcatheter implantation
Keywords
  • Heart valves
  • Congenital heart disease
  • Paediatric cardiology