TissueGene
Kolon TissueGene is a Maryland-based biopharmaceutical company dedicated to developing advanced cell therapies for orthopedic diseases and degenerative disorders. Their mission is to provide safe and effective therapies to reduce pain and improve function. They focus on innovative cell and gene therapy technologies, with a pipeline that includes Invossa™, a first-in-class cell and gene therapy targeting osteoarthritis of the knee. The company has a history of clinical trials, regulatory approvals, and strategic partnerships worldwide, aiming to become a leader in regenerative medicine and to develop therapies that can modify disease progression.
Industries
Nr. of Employees
small (1-50)
TissueGene
9713 Key West Ave. Suite 300, Rockville, MD 20850, United States
Patents
Composition for treating inflammatory disease induced by hyperimmune response
US-11191787-B2
View Details
Composition for treating inflammatory disease induced by hyperimmune response
US-11191787-B2
View DetailsProducts
Allogeneic cell‑and‑gene therapy for osteoarthritis of the knee (single intra‑articular injection)
A clinical‑stage allogeneic cell‑and‑gene therapeutic approach using primary chondrocytes genetically modified to express a therapeutic growth factor, developed for intra‑articular treatment of knee osteoarthritis with objectives of pain reduction, improved function, and potential disease modification.
Allogeneic cell‑and‑gene therapy for osteoarthritis of the knee (single intra‑articular injection)
A clinical‑stage allogeneic cell‑and‑gene therapeutic approach using primary chondrocytes genetically modified to express a therapeutic growth factor, developed for intra‑articular treatment of knee osteoarthritis with objectives of pain reduction, improved function, and potential disease modification.
Services
End‑to‑end management of multicenter randomized clinical trials for cell‑and‑gene therapies, including protocol development, site selection, enrollment coordination, data collection, and long‑term follow‑up.
End‑to‑end management of multicenter randomized clinical trials for cell‑and‑gene therapies, including protocol development, site selection, enrollment coordination, data collection, and long‑term follow‑up.
Expertise Areas
- Clinical trial management (Phase II/III)
- Cell and gene therapy development
- Orthobiologics and musculoskeletal therapeutics
- Regulatory strategy and FDA interactions (SPA, clinical hold management)
Key Technologies
- Allogeneic cell therapy
- Cell‑mediated gene therapy (gene transduction of cells to express therapeutic proteins)
- Intra‑articular delivery
- Magnetic resonance imaging (including contrast‑enhanced MRI)
News & Updates
Kolon TissueGene has dosed its first patient in pivotal US Phase III clinical trials for Invossa, a cell and gene therapy for knee osteoarthritis, aiming for a Disease Modifying Osteoarthritis Drug (DMOAD) label claim.
TissueGene received a $750,000 clinical grant from the Maryland Stem Cell Research Fund to support clinical trials in Maryland for Invossa™, aiming to verify its therapeutic effects on tissue regeneration and inflammation.
Kolon TissueGene announced that the FDA has lifted the clinical hold and approved the start of Phase III trials for Invossa™ in the US, targeting knee osteoarthritis with a plan to seek FDA approval and DMOAD designation.
Korea's MFDS approved Invossa-K Inj., the world's first cell and gene therapy for degenerative arthritis, marking a significant milestone in regenerative medicine.
Changed company name to Kolon TissueGene, Inc.
Rebranded to reflect the support and integration with the Kolon Group, emphasizing a global focus on innovative biopharmaceuticals.
Completed offshore IPO and listed on KOSDAQ
Successfully listed on the Korean stock market, expanding its financial and strategic capabilities.
Kolon TissueGene has dosed its first patient in pivotal US Phase III clinical trials for Invossa, a cell and gene therapy for knee osteoarthritis, aiming for a Disease Modifying Osteoarthritis Drug (DMOAD) label claim.
TissueGene received a $750,000 clinical grant from the Maryland Stem Cell Research Fund to support clinical trials in Maryland for Invossa™, aiming to verify its therapeutic effects on tissue regeneration and inflammation.
Kolon TissueGene announced that the FDA has lifted the clinical hold and approved the start of Phase III trials for Invossa™ in the US, targeting knee osteoarthritis with a plan to seek FDA approval and DMOAD designation.
Korea's MFDS approved Invossa-K Inj., the world's first cell and gene therapy for degenerative arthritis, marking a significant milestone in regenerative medicine.
Changed company name to Kolon TissueGene, Inc.
Rebranded to reflect the support and integration with the Kolon Group, emphasizing a global focus on innovative biopharmaceuticals.
Completed offshore IPO and listed on KOSDAQ
Successfully listed on the Korean stock market, expanding its financial and strategic capabilities.