We look back on 2025 with gratitude for our donors' support, as well as renewed excitement for the new direction and substantial progress of our research. Last year we transitioned our work to Slovakia, where we began a preclinical research project with Dr. Stanislav Žiaran in March. This is intended to be a direct precursor to our future human trials.
We've also fostered stronger transparency and education through new media projects. Each of these matters, because developing a regenerative medicine therapy for circumcised men requires rigorous planning, transparency, and sustained public backing.
Without further ado, here are the biggest successes of 2025:
Launching Our Current Preclinical Project with Dr. Stanislav Žiaran
The most substantial highlight of 2025 was the start of our current preclinical project in Bratislava, Slovakia, led by Dr. Stanislav Žiaran. This is a robust, focused, and structured phase of research needed to transition from our earlier groundwork in Italy toward full readiness for human experimentation. It involves tissue harvesting, decellularization and recellularization protocol refinement, robust documentation standards, and ensuring adequate consistency and reproducibility. By initiating this project with Dr. Žiaran, we are fully preparing the foundation for our next stages of research.
May Site Visit: Promoting Collaboration and Communication
In May, we conducted a site visit in Slovakia—an important milestone for any research organization working across borders. Site visits help ensure that scientific goals, logistical realities, and quality expectations are aligned in a practical, on-the-ground way.
This visit allowed us to deepen coordination with the team, review progress directly, and confirm that the project was proceeding according to plan. It also strengthened working relationships that are essential when conducting multi-phase research with multiple moving parts.
We took this opportunity to film a series of videos showcasing the lab and various techniques that are being developed to fully prepare the foreskin samples. This tour was led by Foregen's Chief Bioengineer Ján Kováč.
Research progress: Milestones 1 and 2 Completed, Steady Progress through Milestone 3
In 2025, Dr. Stanislav Žiaran and Chief Bioengineer Ján Kováč completed the first two milestones of our Slovakia preclinical program by building out donor handling workflows and moving a full study set of samples through dynamic decellularization. This involved harvesting 41 donor foreskin samples and processing them with fluids pumped around the tissue samples that removed all DNA-containing cells. Histology, immunohistochemistry, and tension testing then confirmed consistent decellularization while preserving the ECM architecture needed for downstream recellularization and tissue maturation work.
With that foundation in place, we pushed forward on Milestone 3 (dynamic recellularization). We actively tested recellularization approaches on the scaffolds—including fibroblasts and mesenchymal stem cells—began biomechanical testing on the first recellularized samples, and evaluated multiple protocol proposals to select the approach that best supports effectiveness, scalability, and future compatibility with reinnervation.
Two Matching Campaigns Raised $111,915 in Total
Scientific progress requires resources, and in 2025 our community showed up in a big way.
We held two successful matching campaigns—one in July and one in December—raising a combined total of $111,915 across those two months. Matching campaigns create momentum, strengthen donor confidence, and turn individual contributions into amplified impact.
To everyone who donated, shared, encouraged others, or helped sustain visibility during those campaigns: we thank you. You are the foundation for our project's success. These campaigns directly support the research, logistics, and operations required to keep the project moving forward.
Foregen “Inside the Lab” Series Begins on YouTube
Another major development in 2025 was the launch of the Foregen: Inside the Lab video series on YouTube.
Inside the Lab is part of our commitment to transparency and public education. This series gives supporters a clearer look at the scientific process, the realities of preclinical work, and the personnel driving our mission.
Publication of the Rat Trials Study
In 2025, we published our preclinical animal study, "Immunogenicity and Integration of a Decellularized Extracellular Matrix-Based Scaffold for the Reconstruction of Human Foreskin" in the journal Bioengineering. In this work, Dr. Angela Palumbo and colleagues evaluated a decellularized human foreskin extracellular matrix scaffold in a rat implantation model to assess immunogenicity and early-stage integration.
The results showed a generally mild inflammatory response concentrated early after implantation, with no signs of severe immune rejection, and clear evidence over time of host cell infiltration and new blood vessel formation. These findings support the scaffold's potential as a foundational biomaterial for reconstruction and inform the next steps in our preclinical pathway.
We expect the next and final study from Dr. Palumbo to be published this year, which will report results from our sheep experiments. These focused primarily on assessing vascularity as a key requirement for long-term tissue integration and viability.
Foregen White Paper
In August, we published our official White Paper. This makes the case for our mission in one, concise document. It explains the unmet need for foreskin restoration, outlines the foreskin's anatomy and functional importance, and quantifies public demand, including survey-based estimates of how many circumcised men would consider a regenerative surgical solution.
The white paper also articulates the ethical foundations guiding Foregen's mission, including concepts such as the right to an open future, bodily integrity, and restorative justice.
Just as importantly, the white paper provides a clear, plain-language overview of our regenerative medicine strategy and development pathway. It describes our tissue-engineering approach centered on an extracellular matrix (ECM) scaffold and the core protocols involved: tissue collection, decellularization, recellularization, and bioreactor maturation. It also emphasizes the importance of achieving meaningful reinnervation for functional restoration.
Finally, it lays out a stepwise roadmap from preclinical optimization through surgical planning, CRO partnership, and human clinical trials, helping supporters understand what progress looks like as we move toward our ultimate goals.
Thank You
Thank you for being part of this work, whether you contributed financially, followed our updates, shared our content, or simply stayed engaged. Every element of that support helps move the mission forward.
