TissueGene
Kolon TissueGene is a clinical-stage biopharmaceutical company developing first-in-class allogeneic cell and gene therapies, led by TG-C for knee osteoarthritis, for patients with musculoskeletal and degenerative orthopedic disorders.
- Company typePublic
- Founded1999
- HeadquartersRockville, United States
- Headcount11–50
- GTM typeB2B
- OfferingHardware or Manufacturing
What TissueGene does
Kolon TissueGene, Inc. is a Maryland-headquartered, Delaware-incorporated clinical-stage biopharmaceutical company (KOSDAQ: 950160) developing allogeneic cell and gene therapies for musculoskeletal and degenerative orthopedic disorders. Its lead product TG-C (marketed ex-US as Invossa/Invossa-K Inj) is a first-in-class mixed-cell gene therapy that combines non-modified human chondrocytes with TGF-beta1-expressing kidney-derived 293 cells, delivered as a single intra-articular injection. The therapy is being developed for knee osteoarthritis (Phase 3 dosing complete across 1,066 patients in two pivotal US trials, with topline data expected July 2026 and BLA filing targeted for an anticipated 2027 approval), hip osteoarthritis (Phase 2), and degenerative disc disease of the spine (Phase 1). Earlier pipeline candidates include TG-B (bone), TG-D (disc), and TG-N (nerve).
The company's revenue mechanics are pre-commercial licensing and milestone-based rather than product-based. Asia (ex-Japan) rights are licensed to Kolon Life Science, a sister subsidiary of parent company Kolon Group, which received Korean MFDS marketing approval for Invossa-K Inj in July 2017. Japan rights are licensed to Mitsubishi Tanabe Pharma under a deal valued at approximately $24M upfront plus up to $410M in milestones plus double-digit royalties. Kolon TissueGene retains direct commercialization rights for the US, Europe, and South America, and is preparing for US launch with a Lonza commercial manufacturing partnership signed October 2024. Operating funding has been supported by a 2017 KOSDAQ offshore IPO, a $750,000 Maryland Stem Cell Research Fund grant, and consistent annual exempt securities offerings of approximately $30-35M.
The company is majority-owned by the Kolon Group, employs 11-50 people at its Rockville, Maryland headquarters, and is led by a Co-CEO structure (Moon Jong Noh, Sung Han, and Jeon Seung-ho, who joined March 2025 for US commercialization) with a 2026-reorganized board that added Merck/Keytruda and global biotech commercialization talent. Key clinical and regulatory milestones include a 2015 FDA Special Protocol Assessment, an April 2019 FDA Clinical Hold (lifted April 2020), a December 2021 FDA hip OA Phase 2 clearance, and a December 2023 FDA spine IND approval.
TissueGene firmographics
Firmographics- Name
- TissueGene
- Legal name
- Kolon TissueGene, Inc.
- Website
- https://tissuegene.com
- Company type
- Public
- Founded year
- 1999
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- Kolon TissueGene is a clinical-stage biopharmaceutical company developing first-in-class allogeneic cell and gene therapies, led by TG-C for knee osteoarthritis, for patients with musculoskeletal and degenerative orthopedic disorders.
- Ownership category
- akta.pro rank
TissueGene industry classification
Industry- Product category
- Cell and Gene Therapy
- NAICS
- Biological Product (except Diagnostic) Manufacturing (325414), Research and Development in Biotechnology (except Nanobiotechnology) (541714)
- SIC
- Biological Products, (No Disgnostic Substances) (2836), Orthopedic, Prosthetic & Surgical Appliances & Supplies (3842)
- akta.pro primary industry
- Cartilage, Bone & Musculoskeletal Regeneration (HLAAAGAH)
- akta.pro secondary industries
- Stem Cell–Based Regenerative Therapies (HLAAAGAA), Hip & Knee Reconstruction (Arthroplasty) (HLAKALAH)
Keywords
Where TissueGene is headquartered
LocationHeadquarters
- HQ city
- Rockville
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
TissueGene business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Supply Chain, Personnel, Marketing or Sales, Operations
Revenue model
- Product Sales (US, Europe, South America): Direct commercialization of TG-C in markets where Kolon TissueGene retains full rights. The company is preparing for BLA submission to FDA with anticipated approval in 2027.
- Licensing Royalties (Asia): Kolon Life Science holds exclusive rights for Asia (excluding certain regions). Mitsubishi Tanabe has exclusive rights for Japan with upfront payment of $24M plus up to $410M in milestones and double-digit sales royalties.
- Milestone Payments: Achievement-based payments from licensing partnerships including development, regulatory, and commercial milestones. Kolon Life Science partnership with Mitsubishi Tanabe includes up to approximately $434M in total potential payments.
Go-to-market motion2 records
Distribution channels5 records
Marketing channels5 records
TissueGene product offering
Product offeringCore offering
TissueGene (Kolon TissueGene, Inc.) develops TG-C (TissueGene-C / Invossa), an allogeneic cell and gene therapy for osteoarthritis of the knee, administered as a single intra-articular injection. The therapy combines non-modified chondrocytes with gene-modified human cells (kidney-derived 293 cells) engineered to express TGF-beta1, aimed at cartilage regeneration, pain reduction, and disease progression delay. The company is also expanding TG-C into hip osteoarthritis and degenerative disc disease indications, with additional pipeline candidates (TG-B, TG-D, TG-N) for bone, disc, and nerve regeneration.
Product overview
TissueGene (Kolon TissueGene, Inc.) is a Maryland-based biopharmaceutical company developing advanced allogeneic cell and gene therapies for musculoskeletal and degenerative disorders. The core product is TG-C (TissueGene-C), an investigational first-in-class cell and gene therapy for osteoarthritis of the knee delivered as a single intra-articular injection. TG-C has completed Phase III dosing in the US and is pursuing DMOAD designation. The product is also being expanded into hip osteoarthritis (Phase II) and degenerative disc disease (Phase I). The company also holds earlier-stage pipeline candidates TG-B (bone), TG-D (disc), and TG-N (nerve). In Asia (Korea), the marketed version Invossa-K Inj received MFDS marketing approval in July 2017. The company operates through clinical operation partnerships with organizations including Medpace, Chondrometrics, Nordic Bioscience, Boston Imaging Core Lab, ClinMatrix, Medrio, SignantHealth, CLARIO, and Labcorp, and partners with Lonza for commercial manufacturing and Kolon Life Science for Asian commercialization.
Differentiator
Problem solved
Functional benefit
Brands
- Invossa: World's first cell and gene therapy for knee osteoarthritis, also known as TG-C (TissueGene-C). An allogeneic cell therapy involving human chondrocytes genetically modified to produce TGF-beta1.
Products and services
- TG-C (TissueGene-C) An allogeneic cell and gene therapy for osteoarthritis of the knee, delivered as a single intra-articular injection. TG-C uses human chondrocytes (cartilage cells) genetically modified to produce TGF-beta1 for cartilage regeneration, reducing pain, improving function, and slowing disease progression. The therapy is designed to achieve DMOAD (Disease-Modifying Osteoarthritis Drug) designation from the FDA. Being expanded into hip osteoarthritis (Phase II) and degenerative disc disease (Phase I) indications.
- Invossa-K Inj (Invossa-K) The marketed version of TG-C in South Korea, approved by the Korea Ministry of Food and Drug Safety (MFDS) in July 2017 for knee osteoarthritis. Commercialized by Kolon Life Science with marketing support from Mundipharma and Kolon Pharmaceuticals. Asia rights are licensed from Kolon TissueGene.
- TG-B (TissueGene-B) A pipeline product candidate in TissueGene's portfolio for bone regeneration, part of the company's broader portfolio of cell therapy programs for orthopedic disease treatment alongside TG-C, TG-D, and TG-N.
- TG-D (TissueGene-D) A pipeline product candidate in TissueGene's portfolio for disc regeneration, being developed for treatment of intervertebral disc disorders as part of the company's orthobiology portfolio of cell and gene therapies.
- TG-N (TissueGene-N) A pipeline product candidate in TissueGene's portfolio for nerve tissue regeneration, part of the company's four-product portfolio of cell-mediated therapies targeting various orthopedic diseases.
Quantifiable outcome
- VAS pain score reduction: -18.4 (BMI<30), -26.1 (BMI≥30) in Phase 2 trial
- +4 more outcomes
Companies that use TissueGene
Customer profileNamed customers2 records
Segments4 records
Ideal customer profiles3 records
TissueGene technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature4 records
TissueGene partnerships and signals
Strategic signalPartnerships
13 partnerships are on record, tiered core and minor.
- LonzacoreCommercial manufacturing partnership signed October 2024. Lonza, the world's largest pharmaceutical CDMO, will produce TG-C for commercial supply. Collaboration with Kolon Biologics (subsidiary of Kolon Life Science) for manufacturing.
- Kolon Life Science (Middle East Expansion)minorSaudi Arabia and UAE added to license agreement with Kolon Life Science until 2024. Consideration for continued presence following FDA approval.
- Kolon Life SciencecoreKolon Life Science (KOSDAQ: 102940), a subsidiary of Kolon Group, is the exclusive licensee for Asia commercialization of TG-C. Received Korean MFDS marketing approval in July 2017 for Invossa-K Inj. Also partnered with Mitsubishi Tanabe for Japanese market. Kolon Life Science is responsible for manufacturing activities in Asia.
- Mitsubishi Tanabe PharmacoreExclusive licensing and development agreement for Japan market. Mitsubishi Tanabe paid approximately $24 million upfront plus up to $410 million in development, regulatory, and commercial milestones, plus double-digit sales royalties. Japan OA market forecast: 25 million+ patients aged 40+.
- Juniper TherapeuticsminorSingapore-based Juniper Therapeutics entered technology transfer agreement with Kolon Life Science for Japan development and commercialization of TG-C in 2022.
- MEDPACEminorClinical operation network partner for Phase 3 clinical trials providing clinical trial management services.
- ChondrometricsminorClinical operation network partner providing MRI analysis services for clinical trials.
- Nordic BioscienceminorClinical operation network partner for biomarker analysis in clinical trials.
- Boston Imaging Core LabminorClinical operation network partner for imaging core laboratory services.
- ClinMatrixminorClinical operation network partner for clinical data management.
- Molecular Pathology + GENEUITYminorClinical operation network partner for pathology services.
- CLARIOminorClinical operation network partner for endpoint adjudication services.
- LabcorpminorClinical operation network partner for laboratory testing services in clinical trials.
Scale indicators11 records
Recent moves8 records
Expansion highlights6 records
TissueGene competitors and assessment
Company assessmentDirect peers
- Flexion Therapeutics: Developer of Zilretta (intra-articular extended-release corticosteroid) for knee osteoarthritis pain. Most direct US commercial-stage peer to TG-C, targeting the same orthopedic/rheumatology prescribers for knee OA pain management.
- Bioventus: Orthobiologics company offering hyaluronic acid (Durolane, Supartz) and other joint-pain therapies. Directly competes in the knee OA intra-articular injection market with TG-C and shares the same orthopedic surgeon call point.
- Anika Therapeutics: Developer of viscosupplementation products (Monovisc, Orthovisc, Cingal) for joint pain and early-stage regenerative cartilage repair programs. Same intra-articular OA injection category and similar specialty distribution model.
- Vericel: Commercial-stage cell-therapy company selling MACI (autologous cultured chondrocytes for cartilage repair). Closest US-listed peer in orthopedic regenerative cell therapy and shares TG-C's orthopedics/sports-medicine surgeon customer base.
- Mesoblast: Allogeneic mesenchymal stem cell therapy developer with remestemcel-L and pipeline programs targeting inflammatory/orthopedic indications. Comparable cell-therapy platform business model and similar regulatory pathway for biologics in musculoskeletal disease.
Broad incumbents
- Stryker: Global orthopedic devices leader with a significant orthobiologics franchise and joint-replacement franchise. Relevant incumbent competitor covering both the conservative-care (biologics) and surgical (TKA) ends of the knee OA treatment spectrum.
- Zimmer Biomet: Major orthopedic reconstruction and sports medicine company with a broad portfolio including knee implants and orthobiologics. Represents the surgical alternative TG-C aims to delay, making it a critical incumbent context.
- Smith+Nephew: Global medical device company with sports medicine, orthobiologics (Regeneten, Arthroscopic HA products), and knee-reconstruction franchises. Overlaps with TG-C's orthopedic surgeon call point across the conservative-to-surgical spectrum.
- Sanofi (Genzyme – Synvisc): Synvisc/ Synvisc-One is one of the most-prescribed HA intra-articular injections for knee OA globally, distributed through Genzyme/Sanofi's specialty channel. Represents the dominant incumbent therapy TG-C would displace in the same indication and same prescriber base.
Regional players
- Seikagaku: Japan-based specialty company focused on hyaluronic acid intra-articular injections (Artz, Supartz) for knee OA. Closest regional comparable in Japan given Kolon's Mitsubishi Tanabe partnership and shares the intra-articular OA injection modality.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks6 records
Key highlights8 records
Customer concentration
TissueGene social profiles
Digital presenceTissueGene financial estimates
Financial estimateRevenue estimate
Valuation estimate
TissueGene leadership team
Management profileNumber of profiles
Profiles6 records
TissueGene funding detail
Funding detailFunding overview
Funding rounds5 records
Investors5 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
TissueGene 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 TissueGene
What does TissueGene do?
TissueGene (Kolon TissueGene, Inc.) develops TG-C (TissueGene-C / Invossa), an allogeneic cell and gene therapy for osteoarthritis of the knee, administered as a single intra-articular injection. The therapy combines non-modified chondrocytes with gene-modified human cells (kidney-derived 293 cells) engineered to express TGF-beta1, aimed at cartilage regeneration, pain reduction, and disease progression delay. The company is also expanding TG-C into hip osteoarthritis and degenerative disc disease indications, with additional pipeline candidates (TG-B, TG-D, TG-N) for bone, disc, and nerve regeneration.
Is TissueGene a public or private company?
TissueGene is a public company. It is classified as public and is currently operating.
When was TissueGene founded?
TissueGene was founded in 1999. It employs 11 to 50 people.
Where is TissueGene based?
TissueGene is headquartered in Rockville, United States, in the North America region.
How does TissueGene make money?
Three revenue lines are on record. Product Sales (US, Europe, South America) is the primary driver. The others are licensing Royalties (Asia) and milestone Payments.
Who are TissueGene's main competitors?
Direct peers on record are Flexion Therapeutics, Bioventus, Anika Therapeutics, Vericel and Mesoblast. Broad incumbents are Stryker, Zimmer Biomet, Smith+Nephew and Sanofi (Genzyme – Synvisc). Seikagaku is listed as a regional player.
Does TissueGene have an API?
No public API is recorded for TissueGene.
What industry is TissueGene in?
TissueGene's product category is Cell and Gene Therapy. Its primary akta.pro industry code is HLAAAGAH, Cartilage, Bone & Musculoskeletal Regeneration, with a secondary code of HLAAAGAA, Stem Cell–Based Regenerative Therapies. Its NAICS code is 325414 and its SIC code is 2836.