Delcath Systems
Delcath Systems is a commercial-stage interventional oncology company that develops and sells HEPZATO KIT in the US and CHEMOSAT in Europe, proprietary Hepatic Delivery Systems for Percutaneous Hepatic Perfusion that deliver high-dose melphalan directly to the liver to treat metastatic liver cancers.
- Company typePublic
- Founded1987
- HeadquartersNew York, United States
- Headcount101–250
- GTM typeB2B
- OfferingHardware or Manufacturing
What Delcath Systems does
Delcath Systems, Inc. is a commercial-stage interventional oncology company headquartered in Queens, New York, focused on treating primary and metastatic liver cancers. The company's core technology is the Hepatic Delivery System (HDS), which enables Percutaneous Hepatic Perfusion (PHP): a minimally invasive procedure that temporarily isolates the liver from systemic circulation, delivers a 30-minute high-dose infusion of melphalan chemotherapy directly to the liver, and filters excess drug from the blood through proprietary filters before returning it to the patient. The product is sold as HEPZATO KIT in the United States following FDA approval on August 14, 2023 for adult patients with metastatic uveal melanoma with liver dominant disease, and as CHEMOSAT Hepatic Delivery System for Melphalan in Europe.
The business model is a direct enterprise field-sales motion into major cancer centers and academic hospitals, with each procedure consuming a HEPZATO KIT / CHEMOSAT single-use drug-device combination. In the United States, HEPZATO KIT generated approximately $78.8M in 2025 full-year sales and $23.3M in Q1 2026, while European CHEMOSAT sales contributed $1.7M in Q1 2026. The company is expanding its commercial footprint toward 40 active US treatment centers by year-end 2026 and is conducting clinical trials in metastatic breast and colorectal cancer with liver dominant disease to expand indications beyond uveal melanoma. Revenue grew from $37.2M in 2024 to $85.2M in 2025 (more than 40% volume growth), the company achieved first-time annual net income of $2.7M, and exited 2025 with $91M in cash and no debt.
Beyond the current indication, the company is pursuing label expansion through the CHOPIN Phase 2 trial (results published in The Lancet Oncology showing 54.7% one-year progression-free survival in combination versus 15.8% for PHP alone) and additional investigator-initiated studies presented at ASCO 2026 combining HEPZATO with tebentafusp and with nivolumab/relatlimab. Strategic and clinical partners include Cleveland Clinic, Moffitt, City of Hope, UCLA, and Leiden University Medical Center, with capital backing from Vivo Capital and Rosalind Advisors.
Delcath Systems firmographics
Firmographics- Name
- Delcath Systems
- Legal name
- Delcath Systems, Inc.
- Website
- https://delcath.com
- Company type
- Public
- Founded year
- 1987
- Operating status
- Operating
- Headcount range
- 101–250 employees
- Short description
- Delcath Systems is a commercial-stage interventional oncology company that develops and sells HEPZATO KIT in the US and CHEMOSAT in Europe, proprietary Hepatic Delivery Systems for Percutaneous Hepatic Perfusion that deliver high-dose melphalan directly to the liver to treat metastatic liver cancers.
- Ownership category
- akta.pro rank
Delcath Systems industry classification
Industry- Product category
- Interventional Oncology Medical Devices
- NAICS
- Pharmaceutical Preparation Manufacturing (325412)
- SIC
- Pharmaceutical Preparations (2834)
- akta.pro primary industry
- Medical Oncology (HLAKAFAB)
- akta.pro secondary industries
- Oncology Specialty Pharmaceuticals (HLAIACAA), Gastrointestinal Oncology (HLAKAFAK)
Keywords
Where Delcath Systems is headquartered
LocationHeadquarters
- HQ city
- New York
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
Delcath Systems business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Operations, Technology or R&D, Personnel, Marketing or Sales, Supply Chain
Revenue model
- HEPZATO KIT Sales (US): Revenue from sales of HEPZATO KIT in the United States following FDA approval in August 2023. HEPZATO KIT generated $23.3 million in Q1 2026 US sales and $78.8 million for full year 2025.
- CHEMOSAT Sales (Europe): Revenue from sales of CHEMOSAT Hepatic Delivery System in Europe. CHEMOSAT generated $1.7 million in Q1 2026 European sales.
Go-to-market motion1 record
Distribution channels2 records
Marketing channels7 records
Delcath Systems product offering
Product offeringCore offering
Delcath Systems is a commercial-stage interventional oncology company that develops, manufactures, and sells the Hepatic Delivery System (HDS) used for Percutaneous Hepatic Perfusion (PHP). Its two commercial products are HEPZATO KIT (US, FDA-approved August 2023) and CHEMOSAT (Europe), which deliver high-dose melphalan chemotherapy directly to the liver while proprietary filters remove excess drug from the blood before returning it to systemic circulation. The primary indication is adult patients with metastatic uveal melanoma with liver-dominant disease, with ongoing trials for metastatic breast and colorectal cancer.
Product overview
Delcath Systems is a commercial-stage interventional oncology company with two core product platforms: HEPZATO KIT™ (US) and CHEMOSAT® (Europe), both consisting of a Hepatic Delivery System for percutaneous hepatic perfusion (PHP) that delivers high-dose melphalan chemotherapy directly to the liver. The systems include proprietary filtration technology to remove excess chemotherapy from the blood before returning it to systemic circulation, reducing drug-related side effects. The company is currently conducting clinical trials to expand the indication of these products for metastatic breast cancer and colorectal cancer with liver dominant disease.
Differentiator
Problem solved
Functional benefit
Brands
- HEPZATO KIT™: FDA-approved treatment product for metastatic uveal melanoma in the United States. Melphalan for Injection/Hepatic Delivery System (HDS).
- CHEMOSAT®
Products and services
- HEPZATO KIT (melphalan) for Injection/Hepatic Delivery System (HDS) FDA-approved percutaneous hepatic perfusion system that delivers high-dose melphalan chemotherapy directly to the liver while filtering excess drug from the blood before returning it to systemic circulation. Indicated for adult patients with metastatic uveal melanoma with liver-dominant disease in the United States.
- CHEMOSAT Hepatic Delivery System for Melphalan
Quantifiable outcome
- 1-year progression-free survival of 54.7% vs 15.8% (combination therapy vs PHP alone) in CHOPIN Phase 2 trial
- +3 more outcomes
Companies that use Delcath Systems
Customer profileNamed customers6 records
Segments3 records
Ideal customer profiles1 record
Delcath Systems technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature3 records
Delcath Systems partnerships and signals
Strategic signalPartnerships
Five partnerships are on record, tiered minor and core.
- Cleveland ClinicminorClinical trial site for metastatic breast cancer study (NCT06875128), evaluating HEPZATO in combination with approved cancer treatments.
- Moffitt Cancer CenterminorClinical trial site for metastatic breast cancer study (NCT06875128), evaluating HEPZATO in combination with approved cancer treatments.
- City of HopeminorClinical trial site for metastatic colorectal cancer study (NCT06607458), one of the leading US cancer research and treatment organizations.
- UCLA (University of California, Los Angeles)minorClinical trial site for metastatic colorectal cancer study (NCT06607458), conducting research on liver-directed therapies.
- Leiden University Medical CentercoreLed the CHOPIN Phase 2 clinical trial, published results in The Lancet Oncology demonstrating efficacy of HEPZATO combined with immunotherapy.
Scale indicators12 records
Recent moves6 records
Expansion highlights5 records
Delcath Systems competitors and assessment
Company assessmentEmerging players
- HistoSonics: HistoSonics is developing histotripsy, a non-invasive, non-thermal focused ultrasound platform for destroying liver tumors. It represents an emerging non-thermal alternative to Delcath's PHP for liver-directed tumor ablation in metastatic disease.
- Replimune: Replimune is developing oncolytic immunotherapy approaches (RP1/RP2/RP3) for melanoma and other solid tumors. As immunotherapy-based options expand in metastatic uveal melanoma, Replimune represents an emerging combination or alternative therapy to Delcath's PHP approach.
Direct peers
- Sirtex Medical: Sirtex manufactures SIR-Spheres Y-90 resin microspheres for selective internal radiation therapy (SIRT) in liver-dominant metastatic disease — a directly competing liver-directed interventional oncology modality targeting the same patient population Delcath is pursuing in colorectal and breast cancer indications.
- AngioDynamics: AngioDynamics offers NanoKnife irreversible electroporation and other interventional oncology technologies for liver and other solid tumors. It competes directly with Delcath in the percutaneous, minimally invasive liver-directed interventional oncology segment.
- Immunocore: Immunocore developed tebentafusp (Kimmtrak), the first FDA-approved therapy for metastatic uveal melanoma and current standard-of-care for HLA-A*02:01-positive patients. It competes head-to-head with HEPZATO in the same indication and is the primary competitive threat to Delcath's anchor franchise.
- Boston Scientific (TheraSphere): Boston Scientific acquired BTG's TheraSphere Y-90 glass microsphere franchise, a benchmark interventional oncology liver-directed therapy. CCO Kevin Muir previously led TheraSphere US sales at BTG and Chairman John Sylvester was CCO of BTG plc, underscoring the direct overlap with Delcath's PHP-based approach.
Broad incumbents
- Medtronic: Medtronic operates a broad interventional portfolio including embolization and ablation technologies (e.g., Emprint, OptiSphere) that overlap with Delcath's liver-directed interventional oncology positioning, though Medtronic serves a much wider procedural footprint.
- Inari Medical: Inari Medical is a commercial-stage interventional company (acquired by Stryker) with catheter-based therapies for venous thromboembolism and emerging peripheral interventions. It is comparable as a catheter-based interventional oncology/vascular peer in commercial motion and procedural complexity, though its primary indication set differs.
- Varian Medical Systems (Siemens Healthineers): Varian, now part of Siemens Healthineers, is a global leader in radiation oncology including stereotactic body radiation therapy (SBRT) for liver metastases. It serves the same oncology patient population with an overlapping liver-directed treatment approach but at much greater scale and with broader indications.
- Penumbra: Penumbra is an interventional company with growing oncology and embolization franchises adjacent to hepatic tumor therapy. While not a direct PHP competitor, it shares the minimally invasive interventional oncology commercial channel and customer base of cancer centers.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat4 records
Key risks6 records
Key highlights7 records
Customer concentration
Delcath Systems social profiles
Digital presenceDelcath Systems financial estimates
Financial estimateRevenue estimate
Valuation estimate
Delcath Systems leadership team
Management profileNumber of profiles
Profiles12 records
Delcath Systems funding detail
Funding detailFunding overview
Funding rounds14 records
Investors7 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Delcath Systems 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 Delcath Systems
What does Delcath Systems do?
Delcath Systems is a commercial-stage interventional oncology company that develops, manufactures, and sells the Hepatic Delivery System (HDS) used for Percutaneous Hepatic Perfusion (PHP). Its two commercial products are HEPZATO KIT (US, FDA-approved August 2023) and CHEMOSAT (Europe), which deliver high-dose melphalan chemotherapy directly to the liver while proprietary filters remove excess drug from the blood before returning it to systemic circulation. The primary indication is adult patients with metastatic uveal melanoma with liver-dominant disease, with ongoing trials for metastatic breast and colorectal cancer.
Is Delcath Systems a public or private company?
Delcath Systems is a public company. It is classified as public and is currently operating.
When was Delcath Systems founded?
Delcath Systems was founded in 1987. It employs 101 to 250 people.
Where is Delcath Systems based?
Delcath Systems is headquartered in New York, United States, in the North America region.
How does Delcath Systems make money?
Two revenue lines are on record. HEPZATO KIT Sales (US) is the primary driver. The others are CHEMOSAT Sales (Europe).
Who are Delcath Systems's main competitors?
Emerging players on record are HistoSonics and Replimune. Direct peers are Sirtex Medical, AngioDynamics, Immunocore and Boston Scientific (TheraSphere). Broad incumbents are Medtronic, Inari Medical, Varian Medical Systems (Siemens Healthineers) and Penumbra.
Does Delcath Systems have an API?
No public API is recorded for Delcath Systems.
What industry is Delcath Systems in?
Delcath Systems's product category is Interventional Oncology Medical Devices. Its primary akta.pro industry code is HLAKAFAB, Medical Oncology, with a secondary code of HLAIACAA, Oncology Specialty Pharmaceuticals. Its NAICS code is 325412 and its SIC code is 2834.