Foregen
Foregen is a 501(c)(3) nonprofit developing a tissue-engineered foreskin regeneration therapy for circumcised adult men, using decellularization and recellularization protocols validated in preclinical animal trials and funded entirely by donor contributions.
- Company typePrivate
- Founded2013
- HeadquartersLynnwood, United States
- Headcount11–50
- GTM typeB2C
- OfferingServices
What Foregen does
Foregen is a 501(c)(3) nonprofit organization (EIN 981006983) founded in 2013 and headquartered in Concord, California, dedicated to developing the first regenerative medicine therapy for foreskin restoration in circumcised adult men. The organization's core technology is a tissue engineering pipeline combining dynamic decellularization of donor foreskin tissue (removing cellular components while preserving the extracellular matrix) with recellularization using the patient's own cells, supported by a custom bioreactor system and a dedicated gene expression analysis laboratory for molecular-level verification. Research execution is distributed across an international network of academic partners: Comenius University in Bratislava and Piešťany, Slovakia (preclinical R&D and bioreactor development), University of Camerino in Italy (sheep trials led by Dr. Angela Palumbo Piccionello), University of Oviedo in Spain (neuroscience and histology led by Dr. José A. Vega), Luisenhospital Aachen in Germany (surgical planning with Dr. Dan mon O'Dey), and a research partner in Vienna, Austria (biomechanical testing).
The organization is currently in Stage One (preclinical development) of a three-stage research plan, with milestones including successful revascularization demonstrated in sheep models, 41 harvested foreskin samples, and 20/20 samples passing biocompatibility testing as of October 2025. The product roadmap targets human clinical trials of approximately 15 participants once preclinical work completes, surgical protocols are finalized with CRO support, and ethics approval is secured. Foregen operates as a pre-revenue donation-funded nonprofit with no commercial products, services, or pricing; funding derives from individual donors, GoFundMe campaigns, and recurring dollar-for-dollar matching campaigns anchored by the Lavine family (Emerald Ocean Ventures), with cumulative donations exceeding $1.3 million and monthly recurring donations in the $14,000–$27,000 range during 2025–2026. The target customer is the circumcised adult male seeking to restore bodily integrity and sensory function, with YouGov survey data indicating approximately 18.3 million U.S. men (21% of circumcised males) would consider such a procedure.
Foregen firmographics
Firmographics- Name
- Foregen
- Legal name
- Foregen
- Website
- https://foregen.org
- Company type
- Private
- Founded year
- 2013
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- Foregen is a 501(c)(3) nonprofit developing a tissue-engineered foreskin regeneration therapy for circumcised adult men, using decellularization and recellularization protocols validated in preclinical animal trials and funded entirely by donor contributions.
- Ownership category
- akta.pro rank
Foregen industry classification
Industry- Product category
- Regenerative Medicine Research
- SIC
- Biological Products, (No Disgnostic Substances) (2836)
- akta.pro primary industry
- Wound Healing & Skin Regeneration (advanced dressings, skin substitutes) (HLAAAGAG)
Keywords
Where Foregen is headquartered
LocationHeadquarters
- HQ city
- Lynnwood
- HQ country
- United States
- HQ region
- North America
Offices7 records
Markets served
Foregen business model
Business model- GTM type
- B2C
- Offering type
- Services
- Cost components
- Technology or R&D, Personnel, Operations, Marketing or Sales, Others
Revenue model
- Donations and Charitable Contributions: As a 501(c)(3) nonprofit organization (EIN: 981006983), Foregen operates entirely on donations from supporters. Monthly donations, one-time contributions, and cryptocurrency donations fund all research activities including laboratory work, animal trials, and clinical trial preparations.
- GoFundMe Campaigns: Special fundraising campaigns through GoFundMe platform for specific research milestones, such as the $45,000 final sheep trials campaign and $100,000+ preclinical research campaign.
Go-to-market motion2 records
Distribution channels1 record
Marketing channels7 records
Foregen product offering
Product offeringCore offering
Foregen is developing a regenerative medicine procedure that uses tissue engineering — specifically decellularization of donor foreskin tissue and recellularization with a patient's own cells in a custom bioreactor — to biologically regrow functional foreskin tissue. The therapy is currently in preclinical development and is not yet commercially available.
Product overview
Foregen is a nonprofit 501(c)(3) organization developing a single regenerative medicine therapy for foreskin regeneration. The company's core offering is a tissue engineering procedure that involves decellularizing donor foreskin tissue to create an extracellular matrix scaffold, then repopulating it with the patient's own cells through recellularization using bioreactor technology. The procedure is currently in preclinical development stages, with the goal of eventually conducting human clinical trials. The company does not offer multiple products or modules; it is focused on perfecting this single therapeutic approach through rigorous scientific research, animal trials, and histological studies.
Differentiator
Problem solved
Functional benefit
Products and services
- Foreskin Regeneration Therapy A tissue engineering-based regenerative medicine procedure (in preclinical development) that decellularizes donor foreskin tissue to create an extracellular matrix scaffold and repopulates it with the patient's own cells via a custom bioreactor, intended for circumcised adult men seeking biological restoration of foreskin tissue.
Quantifiable outcome
- 18.3 million potential patients in US alone based on 21% of circumcised men interested in procedure
- +4 more outcomes
Companies that use Foregen
Customer profileSegments2 records
Ideal customer profiles2 records
Foregen technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature4 records
Foregen partnerships and signals
Strategic signalPartnerships
Nine partnerships are on record, tiered supporting and core.
- Slovakian Bioreactor Research PartnerssupportingResearch partners in Slovakia were awarded an independent grant to further refine bioreactor technology. Grant applications being pursued in both EU and USA to support ongoing development of tissue engineering equipment.
- Dr. Stanislav Žiaran / Comenius UniversitycoreDr. Stanislav Žiaran, urological surgeon and Associate Professor at Comenius University in Bratislava, Slovakia, leads Foregen's preclinical research project. He co-authored foreskin tissue engineering research published in European Urology. His team handles tissue collection, decellularization, and recellularization work at the Slovak research facility. Project estimated to complete Q4 2025.
- Dr. Dan mon O'DeycoreRenowned German plastic and reconstructive surgeon who pioneered unique approaches to reconstructive female genital surgery. Serves as Director at Luisenhospital Aachen and external faculty at RWTH-Aachen University. Provides expert consultation on surgical planning for human clinical trials. Fellow of European Board of Plastic Reconstructive and Aesthetic Surgeons (FEBOPRAS).
- Dr. José A. Vega / University of OviedocoreLead Neuroscientist with over 40 years of experience in peripheral nervous system research. Dean of the Sensory Organs and Peripheral Nervous System (SINPOS) research group at University of Oviedo, Spain. Conducting histology study on specialized nerve structures in foreskin (Meissner corpuscles, Krause-like corpuscles). Study published in Journal of Clinical Medicine.
- Dr. Angela Palumbo / University of CamerinocoreLead Veterinary Scientist conducting animal trials in Italy. Collaborates with University of Camerino for sheep trials testing vascularization, re-innervation, and revascularization of decellularized scaffolds. Results have shown successful blood vessel formation and scaffold colonization in sheep models.
- HistologiXcoreUK-based company providing histology, immunohistochemistry, and digital pathology services. Contracted for a histology study to quantify and analyze the anatomical composition of human foreskin tissue at microscopic level. Conducted assay optimization for elastin, collagen-I, and collagen-IV detection.
- Ján Kováč / Comenius UniversitycorePhD candidate from Comenius University working as Chief Bioengineer on Foregen's project. Leads bioreactor development, 3D bioprinting, and tissue engineering technical work. Previously worked at National Institute of Rheumatic Diseases and IQVIA for clinical research experience.
- Dr. Michele RicciosupportingItalian-based scientist conducting cadaver lab work to test and refine surgical techniques for human procedure. Two cadaver lab sessions completed to develop optimal surgical approach for human clinical trials.
- University of CamerinosupportingItalian university partner providing facilities and oversight for sheep trials. Ethics approval obtained through university for animal research. Dr. Palumbo's veterinary team operates from this institution.
Scale indicators8 records
Recent moves7 records
Expansion highlights6 records
Foregen competitors and assessment
Company assessmentDirect peers
- Vericel: Vericel develops autologous cell-based therapies (MACI for cartilage, Epicel for burns) using a patient's own cells expanded ex vivo. Its autologous cell-seeding approach on biological scaffolds parallels Foregen's recellularization strategy of a decellularized foreskin matrix with patient-derived cells.
- Humacyte: Humacyte engineers human acellular tissue vessels (HAVs) using a proprietary decellularization process and has pioneered tissue-engineered vascular grafts. It is highly comparable to Foregen in using decellularization/recellularization methods to build off-the-shelf regenerative tissue products, though at a more advanced clinical/commercial stage and in a vascular indication.
- Tissue Regenix Group: Tissue Regenix develops decellularized tissue scaffolds (dCell technology) for wound care, orthopedics, and cardiac applications. Its core dCell decellularization platform overlaps directly with Foregen's proprietary decellularization protocol for producing biocompatible ECM scaffolds.
- Organogenesis: Organogenesis is a leading regenerative medicine company focused on advanced wound care and skin substitutes (e.g., Apligraf, Dermagraft). Like Foregen, it operates in the skin and soft-tissue regeneration space using biologically derived grafts and tissue engineering, making it a directly comparable commercial-stage peer.
- MiMedx: MiMedx develops and commercializes regenerative wound care and skin substitute products based on placental and tissue-derived biologics. It is comparable to Foregen in using tissue-derived, biologic regenerative approaches aimed at skin/soft-tissue repair, though at a more commercial stage and broader wound-care indication set.
Emerging players
- Lineage Cell Therapeutics: Lineage Cell Therapeutics develops allogeneic cell transplant therapies, with programs in hearing, vision, and spinal cord. It is an emerging peer in cell-based regenerative medicine with a comparable stem/progenitor cell mechanism relevant to Foregen's recellularization step.
- International Stem Cell Corporation (ISCO): ISCO develops stem cell-based regenerative therapies, including for liver, neural, and other applications. It is an emerging regenerative-medicine peer using human cell sourcing aligned with the cell-based end of Foregen's decellularize-then-recellularize workflow.
Others
- Epicentre Technologies (Regenerative Medicine Research): Epicentre provides enzymes, reagents, and services for tissue dissociation and genomic applications used in tissue engineering and regenerative medicine research workflows. It is an enabling tools/supply peer that supports researchers pursuing the type of decellularization and cell seeding workflows Foregen relies on, rather than a direct competitor.
Broad incumbents
- Cook Medical (Regenerative Medicine): Cook Medical has a regenerative medicine portfolio including small intestinal submucosa (SIS) and other ECM-based scaffolds for wound and tissue repair. It is comparable to Foregen as a broad incumbent using biologic ECM materials in regenerative applications, though across a much broader product portfolio.
- Integra LifeSciences: Integra LifeSciences is a larger, established medical device and regenerative tissue company with dermal regeneration templates (e.g., Integra Dermal Regeneration Template) and wound care solutions. It is comparable to Foregen as a broad incumbent offering skin/soft-tissue regeneration products, though across many more indications than Foregen's single foreskin application.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat4 records
Key risks7 records
Key highlights7 records
Customer concentration
Foregen social profiles
Digital presenceForegen financial estimates
Financial estimateRevenue estimate
Valuation estimate
Foregen leadership team
Management profileNumber of profiles
Profiles11 records
Foregen funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Foregen M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Foregen
What does Foregen do?
Foregen is developing a regenerative medicine procedure that uses tissue engineering — specifically decellularization of donor foreskin tissue and recellularization with a patient's own cells in a custom bioreactor — to biologically regrow functional foreskin tissue. The therapy is currently in preclinical development and is not yet commercially available.
Is Foregen a public or private company?
Foregen is a private company. It is classified as nonprofit foundation owned and is currently operating.
When was Foregen founded?
Foregen was founded in 2013. It employs 11 to 50 people.
Where is Foregen based?
Foregen is headquartered in Lynnwood, United States, in the North America region.
How does Foregen make money?
Two revenue lines are on record. Donations and Charitable Contributions are the primary driver. The others are goFundMe Campaigns.
Who are Foregen's main competitors?
Direct peers on record are Vericel, Humacyte, Tissue Regenix Group, Organogenesis and MiMedx. Emerging players are Lineage Cell Therapeutics and International Stem Cell Corporation (ISCO). Epicentre Technologies (Regenerative Medicine Research) is listed as an others. Broad incumbents are Cook Medical (Regenerative Medicine) and Integra LifeSciences.
Does Foregen have an API?
No public API is recorded for Foregen.
What industry is Foregen in?
Foregen's product category is Regenerative Medicine Research. Its primary akta.pro industry code is HLAAAGAG, Wound Healing & Skin Regeneration (advanced dressings, skin substitutes). Its SIC code is 2836.