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ForTra gGmbH to support 14 research projects in regulatory matters
Bad Homburg v. d. Höhe, February 5, 2026 – ForTra gGmbh for Research Transfer (subsidiary of the Else Kröner Fresenius Foundation) is to finance regulatory advice specifically for the transition from preclinical development to practical application for the first time. Following a recent call for proposals, 14 research projects were selected to receive funding totaling €1.1 million, with the aim of helping researchers to prepare for and conduct consultations with a regulatory authority – a crucial step on the path to clinical studies.
Regulatory requirements a pinch point in translational research
Researchers face a whole host of challenges as they transition from preclinical research to practical application. Among the most significant are the complex regulatory requirements for the approval of clinical studies. During this phase, the expertise of specialized advisors is vital, for example in the strategic preparation of consultations with the Paul Ehrlich Institute (PEI) or the German Federal Institute for Drugs and Medical Devices (BfArM).
ForTra to address specific structural funding gap
While regulatory advice is essential, it remains a nearly unsolvable problem for many academic research groups. Traditional research funding programs generally do not cover these costs and investors are typically only involved at later development stages. With its new call for proposals, ForTra addresses precisely this issue, closing a gap that has long existed in translational research funding.
Of the 35 proposals submitted, 14 projects were selected for funding, with a total funding volume of €1.1 million. “Demand for regulatory advice is huge on the path to clinical studies,” explains Prof. Dr. Martin Zörnig, Managing Director of ForTra gGmbH. “Our funding specifically supports projects planning a clinical study as their next development step, helping to fast-track their transition to practical application.”
Funding for a variety of medical research
The 14 projects selected cover a wide range of research disciplines. In oncology, they include vaccines against melanoma, new immunotherapies, the development of advanced microbeam radiation therapy, and AI-assisted Raman spectroscopy for tumor margin detection during surgery. Other projects focus on respiratory diseases, stroke diagnostics in emergency care, innovative therapies for neuropathic pain, and sterile injection systems. The projects’ variety highlights ForTra’s commitment to supporting outstanding research across diverse medical disciplines on its path to practical application.
Three examples from cardiology, respiratory medicine, and ophthalmology are outlined below:
Less invasive treatment of heart failure: Dr. Florian Meißner, Manuela Schön, Prof. Dr. Wolfgang Bothe, University Heart Center, Freiburg/Bad Krozingen
In the “HeartGate” project, researchers are developing a new, minimally invasive procedure for implanting cardiac assist devices. Worldwide, around 64 million people are affected by heart failure, with a five-year mortality rate of roughly 75 percent in advanced stages. Due to the shortage of donor hearts, mechanical heart assist devices are becoming increasingly important. “HeartGate” is developing an implantation kit that allows such a system to be used without a heart-lung machine, offering new treatment options for high-risk patients. “The regulatory support from ForTra GmbH brings us a big step closer to our goal of ensuring the long-term safety of the surgical treatment of heart failure,” explains Dr. Meißner.
Enhanced safety for preterm and newborn infants: Dr. Navid Bonakdar and Prof. Dr. Patrick Morhart, Friedrich Alexander University of Erlangen-Nuremberg
In their “SMART-NEO” project, Dr. Bonakdar and Prof. Dr. Morhart are developing an intelligent system to safely suction airway secretions in ventilated preterm and newborn infants – a routine procedure that must be performed several times a day. An AI-assisted system monitors the pressure and flow signals in real time and adjusts the suction automatically. This prevents dangerous pressure spikes and helps to protect infants’ delicate lungs. Alone in Germany, around 60,000 babies could benefit from this technology every year. “In a market that is too small for industry, innovations often fail not because of the technology, but rather because of regulatory hurdles. The ForTra funding helps us to overcome these and reach the tiniest patients,” explains Dr. Bonakdar.
Earlier recognition of age-related macular degeneration: Prof. Dr. Thomas Ach, Department of Ophthalmology, University Hospital Bonn
In the field of ophthalmology, ForTra is supporting the “AMDdetector” project led by Prof. Dr. Ach. The aim is to detect early pathological deposits associated with age-related macular degeneration (AMD) many years before they can be identified with the methods currently used as standard. Using high-precision cameras to examine the retina, along with proprietary software and analysis algorithms, AMD and its early stages could in future potentially be detected seven to ten years earlier, opening up new treatment options. “The ForTra funding meets the need for specific support for our “AMDdetector” project to help us address regulatory requirements at an early stage and prepare the ground for future certification and market launch,” emphasizes Prof. Dr. Ach.
ForTra gGmbH für Forschungstransfer der Else Kröner-Fresenius-Stiftung (ForTra)
ForTra is a non-profit subsidiary of the foundation Else Kröner-Fresenius-Stiftung. The purpose of the German limited liability company is the advancement of medical science and research along with the promotion and support of public health through the translation of medical research findings into clinical application to the benefit of both patients and public healthcare. You can find more information about projects funded by ForTra at: https://www.ekfs.de/en/scientific-funding/funding-lines/translational-research
Else Kröner-Fresenius-Stiftung (EKFS) – Advancing research. Helping people.
The Else Kröner-Fresenius-Stiftung is a nonprofit foundation that promotes medical research and supports humanitarian projects. To date the foundation has funded around 2,800 projects. With an annual funding volume currently of approximately 60 million euros, it is the largest foundation in Germany supporting medical advancement. For more information, see www.ekfs.de/en
Press contact:
Else Kröner-Fresenius-Stiftung
Bianka Jerke
Public Relations
Tel.: + 49 6172 8975-24
Email: b.jerke@ekfs.de
ForTra
Prof. Dr. Martin Zörnig
CEO ForTra gGmbH für Forschungstransfer der Else Kröner-Fresenius-Stiftung
c/o EKFS
Tel.: +49 6172 8975-12
Email: m.zoernig@fortra-forschungstransfer.de
https://ekfs.de/en/current-topics/press/theory-practice-eu11-million-regulatory-...
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