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Delcath Systems Inc. (Nasdaq: DCTH) is a prominent interventional oncology company focusing on the treatment of primary and metastatic liver cancers. The company's flagship product, the HEPZATO KIT™ (comprising Hepzato (melphalan) for Injection and the Hepatic Delivery System), offers a revolutionary approach to liver-directed chemotherapy. This system enables high-dose chemotherapy delivery directly to the liver, minimizing systemic exposure and associated side effects.
HEPZATO KIT is FDA-approved in the United States for treating adult patients with metastatic uveal melanoma (mUM) presenting unresectable hepatic metastases, especially when the metastases affect less than 50% of the liver and there is no extrahepatic disease, or extrahepatic disease limited to specific regions like bone or lymph nodes that can be managed surgically or through radiation. The product's approval followed the pivotal Phase 3 FOCUS study, which demonstrated a significant improvement in overall response rates and progression-free survival compared to historical data.
In Europe and the United Kingdom, Delcath markets the product under the trade name CHEMOSAT® Hepatic Delivery System for Melphalan. This device-only configuration has been utilized in over 250 treatments across 20 leading European cancer centers, establishing itself as a reliable option for liver cancer therapy.
Delcath continues to make strides in enhancing treatment accessibility. Recently, the company launched a Healthcare Setting Locator on their website to help patients, caregivers, and healthcare providers find facilities offering HEPZATO KIT treatment. The company also secured a permanent J-code for HEPZATO, streamlining the reimbursement process and facilitating broader patient access.
Recent business highlights include the first commercial use of HEPZATO KIT at Moffitt Cancer Center and the successful closing of a $7 million private placement to support ongoing commercial endeavors. Delcath has also published significant data from the FOCUS study in the Annals of Surgical Oncology, reinforcing the clinical efficacy of their treatment.
As Delcath Systems Inc. forges ahead, they remain committed to expanding the clinical adoption of their innovative therapies in major markets, thus providing critical treatment options to liver cancer patients worldwide.
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.
Delcath Systems, Inc. (Nasdaq: DCTH) announced an upcoming Investor Update Meeting on December 2, 2021, focusing on its investigational drug/device combination product, HEPZATO KIT. The meeting will feature discussions on the FOCUS trial results and the clinical experience with CHEMOSAT, detailing unmet needs in treating liver cancers. A panel of leading physicians will present key topics including PHP quality of life and future clinical development plans. This event underscores Delcath's commitment to innovative solutions for liver cancer treatment.
Delcath Systems (Nasdaq: DCTH) reported its Q3 2021 results, highlighting key developments including a $20 million debt facility and FDA approval for an expanded access protocol for HEPZATO™ Kit. Product revenue increased to $522,000, up from $466,000 year-over-year. However, the company faced a net loss of $7.1 million compared to $5.0 million in Q3 2020. Operating expenses rose to $7.0 million, influenced by stock option expenses. Cash reserves improved to $29 million from $11.1 million a year prior. Delcath plans to file its HEPZATO NDA mid-2022 and hosted an investor update on December 2.
Delcath Systems, a company specializing in interventional oncology, announced its participation in the Canaccord Virtual MedTech, Diagnostics, and Digital Health & Services Forum on November 18, 2021. The event will consist of one-on-one meetings only. Delcath focuses on treating rare liver cancers using its proprietary percutaneous hepatic perfusion (PHP) system, marketed in the U.S. as HEPZATO KIT and in Europe as CHEMOSAT. This innovative system administers high-dose chemotherapy directly to the liver while minimizing systemic side effects.
Delcath Systems (DCTH) will host an Investor Update on December 2, 2021, from 10 AM to 1 PM ET, focusing on its Hepzato Kit and its applications in treating liver cancers. Physicians will present updated data from the Focus trial and discuss the potential of Hepzato in treating hepatic-dominant metastatic ocular melanoma, colorectal cancer, and intrahepatic cholangiocarcinoma. The event will be accessible via a live webcast, with the archive available afterward on the company's website.
Delcath Systems (DCTH) announced a conference call on November 9, 2021, at 8:30 AM ET to discuss its Q3 2021 results ending September 30, 2021. The company specializes in interventional oncology, focusing on liver cancers through its proprietary percutaneous hepatic perfusion (PHP) system. In the U.S., it markets the system as HEPZATO KIT, while in Europe, it operates as CHEMOSAT Hepatic Delivery System. Interested parties can join the call via toll-free or international numbers, or stream it online.
Delcath Systems, Inc. (DCTH), a leader in interventional oncology, will present at three key healthcare conferences in September 2021. The H.C. Wainwright 23rd Annual Global Investment Conference runs from September 13-15, featuring on-demand presentations starting September 13 at 7:00 AM (ET). Next is the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit on September 20-23, with a presentation on September 21 at 12:25 PM (ET). Lastly, the Cantor Fitzgerald Healthcare Conference will occur September 27-30, with a presentation on September 29 at 4:40 PM (ET).
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