LyGenesis
LyGenesis is a clinical-stage cell therapy company developing allogeneic therapies that use patients' lymph nodes as bioreactors to grow functioning ectopic organs, with a lead Phase 2a liver program for end-stage liver disease and pipeline programs in thymus, pancreas, kidneys, and inborn errors of metabolism.
- Company typePrivate
- Founded2017
- HeadquartersPittsburgh, United States
- Headcount1–10
- GTM typeB2B
- OfferingHardware or Manufacturing
What LyGenesis does
LyGenesis is a clinical-stage biotechnology company headquartered in Pittsburgh, Pennsylvania, developing allogeneic cell therapies that use a patient's own lymph nodes as in vivo bioreactors to grow functioning ectopic organs. The company's lead program, LYG-LIV-001, is an allogeneic liver cell therapy for end-stage liver disease currently in Phase 2a clinical trials (NCT04496479); one donated, otherwise-unmatched liver can potentially treat up to 75 patients via outpatient endoscopic ultrasound engraftment into mesenteric lymph nodes, upending the supply-demand economics of organ transplantation. The platform is being extended to additional organ programs: thymus regeneration (aging and immune tolerance, proof of concept completed), ectopic pancreas for Type 1 diabetes, ectopic kidneys for end-stage renal disease, and a combination drug-biologic product for inborn errors of metabolism led by Maple Syrup Urine Disease.
LyGenesis makes money, in the long run, by commercializing its cell therapies once clinical readouts and regulatory approvals are obtained; today it has no commercial revenue and no publicly disclosed pricing. The business model is pre-commercial biotech, financed through venture capital (cumulative ~$37M across rounds including a $19M Series A-2 led by Prime Movers Lab in October 2023, with Juvenescence and Longevity Vision Fund also participating), non-dilutive grants (Breakthrough T1D), and strategic co-development partnerships with iTolerance (immune tolerance) and Imagine Pharma (Type 1 diabetes). Distribution, when commercial, will occur through transplant centers and hospitals; the lead Phase 2a trial is being run at Houston Methodist Hospital with Dr. Constance Mobley as principal investigator.
The company was co-founded by CEO Michael Hufford (FDA regulatory and clinical development veteran), transplant surgeon Dr. Paulo Fontes (former UPMC Liver Transplant Program Director), and CSO Dr. Eric Lagasse, the world leader in ectopic transplantation research with 30+ years, 60+ publications, and 11,000+ citations, who developed the underlying technology at the University of Pittsburgh's McGowan Institute. Operating with 1-10 employees, LyGenesis sources non-transplantable donor organs from the International Institute for the Advancement of Medicine (IIAM) and processes them under cGMP; a previously pursued merger with AgeX Therapeutics was terminated in July 2021.
LyGenesis firmographics
Firmographics- Name
- LyGenesis
- Legal name
- LyGenesis, Inc.
- Website
- https://lygenesis.com
- Company type
- Private
- Founded year
- 2017
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- LyGenesis is a clinical-stage cell therapy company developing allogeneic therapies that use patients' lymph nodes as bioreactors to grow functioning ectopic organs, with a lead Phase 2a liver program for end-stage liver disease and pipeline programs in thymus, pancreas, kidneys, and inborn errors of metabolism.
- Ownership category
- akta.pro rank
LyGenesis industry classification
Industry- Product category
- Regenerative Medicine
- NAICS
- Research and Development in Biotechnology (except Nanobiotechnology) (541714), Biological Product (except Diagnostic) Manufacturing (325414)
- SIC
- Biological Products, (No Disgnostic Substances) (2836)
- akta.pro primary industry
- Cell Therapy Developers (Allogeneic/Off-the-shelf) (HLAAABAB)
Keywords
Where LyGenesis is headquartered
LocationHeadquarters
- HQ city
- Pittsburgh
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
LyGenesis business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Personnel, Operations, Supply Chain, Marketing or Sales, Others
Revenue model
- Cell Therapy Commercialization: LyGenesis is a clinical-stage biotechnology company developing allogeneic cell therapies. The company does not currently have commercialized products or revenue. Future revenue is anticipated from commercialization of its cell therapy pipeline including LYG-LIV-001 for end-stage liver disease, once clinical trials are successful and regulatory approvals are obtained.
Go-to-market motion2 records
Distribution channels1 record
Marketing channels6 records
LyGenesis product offering
Product offeringCore offering
LyGenesis is a clinical-stage biotechnology company developing allogeneic cell therapies that leverage patients' lymph nodes as in vivo bioreactors to grow functioning ectopic organs. Its lead therapy LYG-LIV-001 uses donor-derived hepatocytes transplanted into mesenteric lymph nodes via endoscopic ultrasound to regenerate ectopic liver tissue for end-stage liver disease patients, with one donated liver capable of treating up to 75 patients.
Product overview
LyGenesis is a clinical-stage cell therapy company that has developed a platform technology using the patient's lymph nodes as in vivo bioreactors to grow functioning ectopic organs. The company's lead product is LYG-LIV-001, an allogeneic cell therapy for end stage liver disease currently in Phase 2a clinical trials. The platform enables one donated liver to treat dozens of patients, using an outpatient endoscopic ultrasound procedure for transplantation. The broader pipeline includes programs for thymus regeneration (aging/immune tolerance), pancreas regeneration (Type 1 diabetes), kidney regeneration (end stage renal disease), and inborn errors of metabolism (orphan pediatric indications). The company also has a second-generation therapy (LYG-LIV-100) in development with iTolerance for immune suppression-free organ regeneration.
Differentiator
Problem solved
Functional benefit
Products and services
- LYG-LIV-001 Allogeneic cell therapy for end-stage liver disease (ESLD) that uses donor-derived hepatocytes to regenerate ectopic liver tissue inside the patient's upper abdominal lymph nodes. The therapy is created from donated but unmatched livers, processed under cGMP, and transplanted via outpatient endoscopic ultrasound. Currently in Phase 2a clinical trials (ClinicalTrials.gov NCT04496479), regulated as an FDA Section 351 Human Cellular Therapy/Product. One donated liver can treat up to 75 patients.
- Thymus Program Cell therapy program focused on ectopic thymus development for aging-related immune decline and immune tolerance induction, currently in preclinical/POC completed stage. Investigates growth of ectopic thymus tissue in lymph nodes to restore immune function.
- Pancreas Program Cell therapy program focused on ectopic pancreas development for treatment of Type 1 diabetes, utilizing the lymph node as a bioreactor to grow functioning pancreatic tissue. Developed in collaboration with Imagine Pharma using T1D Activated Islet Progenitor Cells.
- Kidney Program Cell therapy program focused on ectopic kidney development for treatment of end-stage renal disease, leveraging the lymph node's ability to promote vascularization for engrafted kidney tissues. Currently in POC completed stage.
- Inborn Errors of Metabolism Program Novel combination drug-biologic product for orphan pediatric indications involving inborn errors of metabolism, with lead indication for Maple Syrup Urine Disease (MSUD), affecting 1 in 185,000 newborns. Utilizes a hydrogel with growth factors and a proprietary patent-pending surgical catheter for engraftment under the liver capsule.
Quantifiable outcome
- One donated liver can treat up to 75 patients with end-stage liver disease
- +4 more outcomes
Companies that use LyGenesis
Customer profileNamed customers1 record
Segments6 records
Ideal customer profiles2 records
LyGenesis technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature4 records
LyGenesis partnerships and signals
Strategic signalPartnerships
Five partnerships are on record, tiered core.
- Houston Methodist HospitalcoreHouston Methodist Hospital is a clinical trial site for LyGenesis's Phase 2a clinical trial. Dr. Constance Mobley serves as Principal Investigator and Associate Director of Liver Transplantation at Houston Methodist J.C. Walter Jr. Transplant Center.
- Imagine PharmacoreJoint research collaboration to develop novel cell therapies for Type 1 diabetes. The collaboration leverages Imagine Pharma's Type 1 Diabetes Activated Islet Progenitor Cells (T1D AIPCs) combined with LyGenesis's lymph node bioreactor platform. Both companies are Pittsburgh-based biotechs working to advance preclinical proof of concept.
- iTolerancecoreJoint research collaboration to evaluate iTOL-201 (combining iTolerance's SA FasL immune tolerance platform with LyGenesis's liver cell therapy) to enable ectopic livers to be grown without need for immune suppression. The collaboration has generated in vitro data and is progressing toward animal proof of concept.
- University of Pittsburgh / McGowan Institute for Regenerative MedicinecoreLyGenesis was founded based on research from Dr. Eric Lagasse's laboratory at the University of Pittsburgh's McGowan Institute for Regenerative Medicine. Dr. Lagasse serves as Associate Professor in the Department of Pathology and Director of the Cancer Stem Cell Center at McGowan.
- International Institute for the Advancement of Medicine (IIAM)coreIIAM provides non-transplantable organs to the medical research community. LyGenesis sources donated but unmatched livers from IIAM for processing into cell therapies.
Scale indicators5 records
Recent moves6 records
Expansion highlights5 records
LyGenesis competitors and assessment
Company assessmentBroad incumbents
- United Therapeutics: United Therapeutics is a leading player in organ transplantation and regenerative medicine (including lung, kidney, and xenotransplantation programs), making it a broad incumbent comparable to LyGenesis's mission of addressing organ failure and shortage.
- Humacyte: Humacyte is a regenerative medicine company developing bioengineered human tissues and vessels, comparable as a broad incumbent in the regenerative medicine / tissue engineering space addressing organ and vascular replacement.
- MiMedx: MiMedx is a commercial-stage regenerative medicine company with placental tissue allografts, comparable as a broad incumbent in regenerative medicine and allograft-based therapies addressing large unmet needs.
Direct peers
- Sana Biotechnology: Sana is a clinical-stage cell therapy company developing allogeneic hypoimmune cell therapies for multiple indications, comparable to LyGenesis's allogeneic cell therapy platform and pipeline breadth.
- Vertex Pharmaceuticals: Vertex is developing VX-880, an allogeneic stem cell-derived islet cell therapy for Type 1 diabetes — directly comparable to LyGenesis's pancreas/T1D program and the broader allogeneic cell therapy modality in severe disease indications.
- Sigilon Therapeutics: Sigilon developed encapsulated cell therapies (e.g., for Type 1 diabetes and lysosomal storage diseases) using allogeneic cells, comparable in modality (allogeneic cell therapy for chronic disease) and target indications to LyGenesis.
Emerging players
- eGenesis: eGenesis is developing genetically engineered porcine organs for xenotransplantation as an alternative solution to the donor organ shortage that LyGenesis's ectopic organ regeneration platform also targets.
- ProKidney: ProKidney is developing autologous cell therapy (REACT) for chronic kidney disease, directly comparable as a cell therapy targeting renal indications overlapping with LyGenesis's kidney program.
- Talaris Therapeutics: Talaris developed cell therapy (FCR001) to induce immune tolerance in organ transplant recipients, comparable in the intersection of cell therapy and transplant immunology, an area central to LyGenesis's iTolerance collaboration.
- Seraxis: Seraxis is developing stem cell-derived islet cell therapies for Type 1 diabetes, comparable as an emerging player in the same disease space as LyGenesis's pancreas/T1D program.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks7 records
Key highlights7 records
Customer concentration
LyGenesis social profiles
Digital presenceLyGenesis financial estimates
Financial estimateRevenue estimate
Valuation estimate
LyGenesis leadership team
Management profileNumber of profiles
Profiles8 records
LyGenesis funding detail
Funding detailFunding overview
Funding rounds4 records
Investors3 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
LyGenesis 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 LyGenesis
What does LyGenesis do?
LyGenesis is a clinical-stage biotechnology company developing allogeneic cell therapies that leverage patients' lymph nodes as in vivo bioreactors to grow functioning ectopic organs. Its lead therapy LYG-LIV-001 uses donor-derived hepatocytes transplanted into mesenteric lymph nodes via endoscopic ultrasound to regenerate ectopic liver tissue for end-stage liver disease patients, with one donated liver capable of treating up to 75 patients.
Is LyGenesis a public or private company?
LyGenesis is a private company. It is classified as venture growth investor backed and is currently operating.
When was LyGenesis founded?
LyGenesis was founded in 2017. It employs 1 to 10 people.
Where is LyGenesis based?
LyGenesis is headquartered in Pittsburgh, United States, in the North America region.
How does LyGenesis make money?
One revenue line is on record: cell Therapy Commercialization.
Who are LyGenesis's main competitors?
Broad incumbents on record are United Therapeutics, Humacyte and MiMedx. Direct peers are Sana Biotechnology, Vertex Pharmaceuticals and Sigilon Therapeutics. Emerging players are eGenesis, ProKidney, Talaris Therapeutics and Seraxis.
Does LyGenesis have an API?
No public API is recorded for LyGenesis.
What industry is LyGenesis in?
LyGenesis's product category is Regenerative Medicine. Its primary akta.pro industry code is HLAAABAB, Cell Therapy Developers (Allogeneic/Off-the-shelf). Its NAICS code is 541714 and its SIC code is 2836.