Welcome to our dedicated page for Delcath Sys news (Ticker: DCTH), a resource for investors and traders seeking the latest updates and insights on Delcath Sys stock.
Delcath Systems, Inc. develops interventional oncology products for primary and metastatic liver cancers. Its core products include HEPZATO KIT, a melphalan and Hepatic Delivery System combination product approved in the United States as a liver-directed treatment for adult patients with metastatic uveal melanoma, and CHEMOSAT Hepatic Delivery System for Melphalan used in percutaneous hepatic perfusion.
Recurring news covers quarterly operating results, HEPZATO KIT and CHEMOSAT revenue, clinical publications from studies such as FOCUS and CHOPIN, presentations at oncology and interventional radiology meetings, guideline recognition, and studies of melphalan-based percutaneous hepatic perfusion in liver-dominant cancers. Company updates also address FDA-approved product status, European clinical practice references, and capital actions such as common-stock repurchases.
Delcath Systems reported its business highlights and financial results for Q4 and full-year 2021 on March 25, 2022. The company updated positive Phase 3 trial results for the HEPZATO Kit, confirmed a mid-year NDA resubmission to the FDA, and resumed sales of CHEMOSAT in Europe. Q4 product revenue was approximately $0.2 million, with a net loss of $5.3 million, an improvement from Q4 2020. For the year, product revenue totaled $1.3 million, while the net loss increased to $25.6 million. As of December 31, 2021, cash and equivalents totaled $27 million.
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.