LIFE bioCEEd has announced an investment in a breakthrough regenerative medicine project originating from the Jagiellonian University in Kraków, Poland focused on the development of a novel biological therapy for fibrosis, a group of progressive diseases that collectively contribute to an estimated 35% of all deaths worldwide. This marks LIFE bioCEEd’s second transaction in Poland within the first half of 2026, further reinforcing the company’s strategic commitment to Central European biomedical innovation.

UNDERSTANDING FIBROSIS

Fibrosis is a progressive pathological process in which healthy, functional tissue is gradually replaced by scar tissue (fibrotic matrix), causing affected organs to stiffen and lose their normal function over time. It plays a central role in a wide spectrum of life-threatening conditions, including idiopathic pulmonary fibrosis (IPF), liver cirrhosis, cardiac fibrosis, and chronic kidney disease.

Despite decades of research, no currently approved therapy is capable of reversing established fibrotic tissue damage. Existing treatments — such as nintedanib and pirfenidone for IPF, can slow disease progression but cannot restore lost organ function. This profound unmet clinical need has driven growing global interest in regenerative approaches.

THE SCIENCE: A NEW APPROACH TO HEALING

The therapeutic platform developed at the Jagiellonian University takes a fundamentally different approach to current standards of care. Rather than merely inhibiting the progression of fibrosis, the technology aims to actively stimulate tissue repair by targeting the core biological mechanisms responsible for scarring.

A critical innovation of this platform is the production of EVs under hypoxic (low-oxygen) conditions, which has been shown in preclinical studies to substantially enhance their anti-fibrotic and regenerative potency. This approach leverages the physiological stress response: cells cultivated under reduced oxygen tension upregulate the secretion of factors associated with tissue repair and immunomodulation.

PRECLINICAL RESULTS & DEVELOPMENT PIPELINE

Preclinical studies conducted to date have demonstrated highly encouraging results, including measurable reductions in tissue scarring markers, attenuation of pro-inflammatory signalling, and inhibition of myofibroblast activation — the primary cellular driver of fibrotic matrix deposition.

The platform shows potential for application across multiple fibrotic indications:

🔹Idiopathic Pulmonary Fibrosis (IPF) — a fatal lung disease with no curative treatment

🔹Liver fibrosis & cirrhosis — a leading cause of liver failure worldwide

🔹Cardiac fibrosis — associated with heart failure and arrhythmia

LIFE bioCEEd is entering the project at a stage where substantial proof-of-concept preclinical data have already been generated. The investment will fund the transition of the technology into formal preclinical development, encompassing manufacturing process optimisation, regulatory preparation (IND-enabling studies), and safety pharmacology — the steps required to prepare the therapy for first-in-human clinical trials. The current development plan targets first-in-human studies within 24 months, with total anticipated investment into the programme expected to surpass €15 million.

SCIENTIFIC LEADERSHIP

The project originates from the Jagiellonian University, one of the most prestigious and internationally recognized academic institutions in Central Europe, with a strong tradition in biomedical research and translational medicine.

The project is led by Dr. Sylwia Bobis-Wozowicz, PhD, Assistant Professor at the Department of Cell Biology, Jagiellonian University. Dr. Bobis-Wozowicz has dedicated her research career to regenerative medicine and extracellular vesicle biology, and has led multiple internationally collaborative programmes in the field.

The clinical and translational development dimensions of the programme are reinforced by Dr. Marcin Piejko, MD, PhD, Interim Director of Jagiellonian Center for Clinical Research Support, who brings extensive experience in advanced biological therapies, clinical trial design, and the manufacturing of innovative cell and gene-based treatments. Together, the team combines deep academic expertise with the translational and regulatory capabilities required for successful clinical development.

STATEMENTS

“Fibrosis remains one of the largest areas of unmet medical need in modern medicine. Despite the enormous burden these diseases place on patients and healthcare systems, current therapies remain unable to reverse established tissue damage. What makes this project particularly compelling is the combination of rigorous scientific foundations, a highly experienced team, and the potential to fundamentally change how fibrosis is treated. We believe this platform has what it takes to become a genuine gamechanger in regenerative medicine.” — Stefan Savić, CEO, LIFE bioCEEd

“We are very pleased to be working with LIFE bioCEEd. This project is precisely the kind of innovative translational research that can move beyond academia and create meaningful impact for patients worldwide. LIFE bioCEEd brings not only capital, but also the strategic and development expertise necessary to advance this technology toward clinical application.” — Gabriela Konopka-Cupial, PhD, Director of Centre for Technology Transfer CITTRU, Jagiellonian University