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About Delcath Systems, Inc.
Delcath Systems, Inc. (NASDAQ: DCTH) is a specialty pharmaceutical and medical device company at the forefront of interventional oncology, focusing on the treatment of primary and metastatic liver cancers. With its innovative approach to liver-directed therapies, Delcath addresses a critical unmet need in oncology, where effective and targeted treatment options for liver tumors remain limited. The company’s mission is to enhance outcomes for patients with liver-dominant cancers by combining advanced pharmaceutical and medical device technologies.
Core Technology: Melphalan/HDS
Delcath’s flagship product is the Melphalan Hydrochloride for Injection, used in conjunction with the proprietary Delcath Hepatic Delivery System (HDS). This drug-device combination is designed to deliver high-dose chemotherapy directly to the liver while minimizing systemic exposure and associated side effects. The HDS isolates the liver during treatment, enabling loco-regional delivery of chemotherapy and filtration of hepatic venous blood. This innovative approach allows for higher drug concentrations in the liver, potentially improving tumor response rates while reducing systemic toxicity.
Market Applications and Regulatory Approvals
In the United States, Delcath’s product is marketed under the brand name HEPZATO KIT™, a combination drug and device approved by the FDA for the treatment of metastatic uveal melanoma (mUM) with unresectable hepatic metastases. The HEPZATO KIT allows for precise targeting of liver tumors, making it a valuable option for patients with limited systemic disease. In Europe, the device-only configuration of the HDS is marketed as the CHEMOSAT® Hepatic Delivery System for Melphalan. It is classified as a Class III medical device and is used in percutaneous hepatic perfusion procedures at leading cancer centers across the region.
Operational Strategy
Delcath’s operational strategy focuses on expanding clinical adoption, securing reimbursement, and training healthcare professionals to perform its specialized procedures. The company has steadily grown its presence in Europe, with over 250 CHEMOSAT treatments conducted at more than 20 leading cancer centers. In the U.S., Delcath is building a network of treatment centers to increase access to the HEPZATO KIT, supported by a dedicated field force and comprehensive training programs.
Competitive Positioning
Delcath operates in a niche segment of the oncology market, where its unique drug-device combination differentiates it from traditional chemotherapy and systemic therapies. Competitors may include other interventional oncology companies and liver cancer treatment providers, but Delcath’s ability to isolate the liver and deliver high-dose chemotherapy provides a distinct advantage. This approach not only enhances therapeutic efficacy but also aligns with the growing demand for precision medicine in oncology.
Challenges and Opportunities
While Delcath’s technology offers significant clinical benefits, the company faces challenges such as navigating complex regulatory frameworks, securing reimbursement, and competing in a crowded oncology market. However, its focus on a specialized therapeutic area, coupled with robust clinical data and growing adoption, positions it well for long-term success.
Conclusion
Delcath Systems, Inc. exemplifies innovation in interventional oncology with its proprietary technologies for liver-directed chemotherapy. By addressing a critical unmet need in liver cancer treatment, the company is poised to make a meaningful impact on patient outcomes while carving out a unique position in the oncology market.
Delcath Systems (Nasdaq: DCTH) will host a conference call on March 25, 2022, at 8:30 AM ET, to discuss fourth quarter and full year results for 2021. Participation is available via phone or online. The webcast link provides additional access for investors globally.
Delcath specializes in interventional oncology, focusing on liver cancers. Their proprietary PHP system delivers high-dose chemotherapy with minimal systemic exposure, and is known as HEPZATO KIT in the U.S. and CHEMOSAT in Europe.
Delcath Systems, Inc. (DCTH) will present at the 34th annual Roth Conference on March 14, 2022, at 3:30 PM PT. The presentation focuses on the company's innovative treatment for liver cancers, specifically the percutaneous hepatic perfusion (PHP) system, known as HEPZATO in the U.S. for metastatic ocular melanoma. In Europe, this system is marketed as CHEMOSAT. A webcast of the presentation will be available online. For further inquiries or one-on-one meetings, interested parties are encouraged to contact Delcath's investor relations.
Delcath Systems, Inc. (Nasdaq: DCTH) announced that its CHEMOSAT Hepatic Delivery System received certification under the new EU Medical Device Regulation (MDR) as of February 28, 2022. This transition from Class IIb to Class III signifies enhanced scrutiny, requiring more evidence on safety and performance. CHEMOSAT had previously been certified under the Medical Device Directive since 2012. The MDR ensures greater oversight, including post-marketing surveillance and unique device identification. The device is utilized for treating various liver cancers in major medical centers.
Delcath Systems, Inc. (Nasdaq: DCTH) announced its decision to resume direct responsibility for the sales, marketing, and distribution of the CHEMOSAT® Hepatic Delivery System in Europe effective March 1, 2022. This move comes after medac GmbH held the license for the product since December 2018. Delcath aims for a smooth transition to ensure patient access to CHEMOSAT, a proprietary device that delivers high-dose chemotherapy to the liver while managing systemic exposure. The product has been used in major medical centers for treating liver cancers since its EU launch in 2012.
Delcath Systems (Nasdaq: DCTH) announced its participation in two upcoming virtual investor conferences. The first is the BTIG Virtual MedTech, Digital Health, Life Science & Diagnostic Tools Conference on February 17, 2022, at 11:00 AM ET, which will not be webcast. The second event is the 2022 SVB Leerink Global Healthcare Conference on February 18, 2022, at 9:20 AM ET, which will be available via webcast. Delcath focuses on interventional oncology, particularly using its proprietary PHP system for treating liver cancers.
Delcath Systems (Nasdaq: DCTH) announced the appointment of Anthony Dias as the new Vice President of Finance. Bringing over 20 years of financial leadership experience in the healthcare sector, Dias will oversee the company's financial planning, reporting, accounting, and treasury. Previously, he held senior finance roles at Advanced Group and PAREXEL, where he was instrumental in a $5.5 billion sale. Alongside his appointment, Delcath granted him options to purchase 30,000 shares, with a vesting schedule linked to his continued employment.
Delcath Systems announced promising results from a retrospective study on the use of its CHEMOSAT® Hepatic Delivery System for patients with liver dominant metastatic uveal melanoma. The study revealed a hepatic disease control rate of 88.9%, a hepatic response rate of 66.7%, and an overall response rate of 60.5% across 81 patients. Following a median follow-up of 12.9 months, the median progression-free survival (PFS) was 8.4 months and overall survival (OS) was 14.9 months. The study emphasized a favorable safety profile with no fatal treatment-related adverse events.
Delcath Systems, Inc. (NASDAQ: DCTH) has appointed David Hoffman as General Counsel and Corporate Secretary. Hoffman brings over 20 years of biotechnology legal experience, previously serving at Vericel Corporation and Sunovion Pharmaceuticals. His expertise spans healthcare law, compliance, and business transactions. CEO Gerard Michel emphasized Hoffman's contributions as essential for advancing Delcath's mission to commercialize therapies targeting liver cancers. Delcath focuses on innovative treatments including the HEPZATO KIT, designed for localized chemotherapy delivery.
Delcath Systems (DCTH), an interventional oncology company, has announced its participation in the H.C. Wainwright BioConnect Virtual Investor Conference from January 10-13, 2022. The presentation will be available on-demand starting at 7:00 AM ET on January 10. Delcath will also hold one-on-one investor meetings during the event. The company focuses on innovative treatments for liver cancers, utilizing its proprietary percutaneous hepatic perfusion system, HEPZATO, in the U.S. and CHEMOSAT in Europe.
Delcath Systems announced encouraging results from the phase 3 FOCUS study of its treatment HEPZATO for metastatic ocular melanoma.
The study showed a median duration of response of 14 months, with an overall response rate (ORR) of 31.4% and a 12-month survival hazard ratio (HR) of 0.37 (p=0.01) compared to the Best Alternative Care (BAC) arm.
HEPZATO also demonstrated a disease control rate of 65.7% and improved progression-free survival (PFS) compared to BAC. A new NDA submission is anticipated by mid-2022.
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