Positive Outcome of Pre-IND Meeting for CGN001

Munich, November 11, 2025 – Cardiogen GmbH, a preclinical life science company focusing on cardiovascular regeneration and cellular reprogramming, announced that the Pre-IND meeting with the first National Regulatory Agency in Europe was completed successfully and positive feedback on the planned pre- and clinical development program for CGN001 in ST-elevation myocardial infarction was received. The agency stated that it agreed the proposed development plan could support an IND application and first in human clinical studies.

The purpose of the Pre-Investigational New Drug (IND) and Scientific Advice Meeting with the National Regulatory Agency in Europe was receiving feedback on the proposed pre- and clinical development plan for CGN001 in ST-elevation myocardial infarction (STEMI).

The proposed development plan included all remaining pre-clinical studies and the first in human Phase Ib study of CGN001 in patients with anterior STEMI undergoing primary percutaneous coronary intervention.

In response it was confirmed that the agency, in addition to other details, agreed that the proposed pre-clinical development plan and the non-clinical data package could support an IND application for the proposed indication and the planned activities would be sufficient for initiating a Phase I study.

About Cardiogen

Cardiogen’s non-invasive regenerative approach can potentially play a significant role in improving the survival rate and quality of life for patients who experience a heart attack, as well as in various other cardiovascular diseases. 

For more information, visit: https://www.cardiogentx.com/ or contact info@cardiogentx.com