We began a preclinical research project in January 2025. The goal of this endeavor is to complete the remaining preclinical research objectives before we can apply for ethics approval to begin human clinical trials. The estimated timeframe to complete this project is Q4 2025. Thanks to your incredible support, we've already raised more than $100,000 through our recent GoFundMe campaign, enabling us to pursue this critical research. We'll be providing quarterly forecasts of our progress, along with our regular monthly newsletter.
Our core research team is led by Dr. Stanislav Žiaran, a urological surgeon and distinguished researcher in regenerative medicine from Comenius University in Bratislava, Slovakia. As an Associate Professor at Comenius University, Dr. Žiaran brings valuable clinical expertise to our project. He recently co-authored innovative research on foreskin tissue engineering published in European Urology and is leading efforts to collect and process donor tissues for this project. His credentials include MD, PhD, MPH, and he is a Fellow of the European Board of Urology (FEBU).
Working alongside Dr. Žiaran is Ján Kováč, a PhD candidate from Comenius University. Ján has extensive experience with bioreactors, 3D bioprinting, and tissue engineering. He's spearheading the technical development of our bioreactor systems and the optimization of our decellularization and recellularization protocols. His background includes work at the National Institute of Rheumatic Diseases, where he has conducted research since April 2022. His previous role at IQVIA provided him with valuable experience in clinical research protocols and regulatory compliance.
This project is comprised of four essential milestones:
1. Collection of Donor Tissue
We plan to collect 15–20 tissue samples for this project. The redundancy ensures robust and repeatable results.
Our main activities include defining donor criteria, establishing collection methods, and developing storage and transport protocols. We're carefully documenting all procedures to create validated protocols that can be consistently replicated. The outcomes will include validated tissue collection protocols, successfully collected and stored donor samples, and a detailed database containing comprehensive metadata for each sample. Our key focus during this milestone is protocol adherence and maintaining sample integrity throughout the collection process.
2. Dynamic Decellularization
We are finalizing our dynamic decellularization protocol for use in human trials. This process removes all cellular components while preserving the extracellular matrix (ECM) structure. We're using an innovative “dynamic” decellularization strategy and conducting extensive tissue analysis through histology, scanning electron microscopy, and biomechanical testing.
Our goal is to achieve minimal variability across samples with optimal outcomes—no residual cells, no chemical residues, and completely sterile tissue ready for recellularization. We aim to develop a device that can consistently decellularize samples to the same high standard every time. This standardization is crucial for both scientific validity and regulatory approval.
3. Dynamic Recellularization
In our third milestone, we are finalizing our dynamic recellularization protocol using stem cells. This involves seeding the decellularized scaffolds with appropriate cells to regenerate functional tissue. We’re identifying optimal growth factors and visualization methods to track cell integration and development.
Our team will conduct detailed tissue analysis throughout this phase to validate our protocols for cell culture, differentiation, and tissue characterization. Key outcomes will include validated cell culture and differentiation protocols, along with fully characterized recellularized tissue. As with the previous milestone, analysis methods will include histology, scanning electron microscopy, and biomechanical testing to ensure the quality and functionality of the recellularized tissue.
4. Bioreactor Maturation
The final milestone involves bioreactor maturation of the recellularized tissue. We're developing a strict protocol to ensure consistency across large numbers of tissue samples. This approach is critical for ensuring success in human trials and potentially scaling up to treat many patients in the future.
We'll optimize bioreactor components, develop effective tissue maturation methods, and conduct comprehensive final analyses. This phase produces the protocols for implant-ready tissue and the fully characterized samples needed for clinical testing.
This approach offers several significant advantages over alternative methods. It eliminates the need for a two-stage surgery, creating a safer and quicker procedure for patients. The controlled environment leads to more consistent tissue preparation, and the standardized process improves our regulatory approval prospects. Consistency in high-quality production is essential. The bioreactor system could allow us to treat many patients with nearly identical quality of tissue, which is crucial for both scientific validity and patient outcomes.
Looking Ahead
After this project is completed, our next steps include finalizing the surgical plan for human trials, partnering with a Contract Research Organization (CRO), creating the study design for human clinical trials, and applying for ethics approval.
We understand the importance of maintaining comprehensive documentation throughout our work to support these regulatory submissions. The combination of Dr. Žiaran's clinical leadership and Mr. Kováč's specialized expertise in tissue engineering positions us strongly to complete all remaining preparatory steps for human clinical trials in a timely and cost-effective manner. This partnership is a significant step forward in our mission to develop a regenerative medicine solution for circumcised men.
We'll continue to provide updates through our website and newsletter as we reach each milestone. We welcome any questions about our research plan and appreciate your continued interest and support in this important undertaking.
