The drug-device combo has been available in certain European markets since 2012.
“This is a meaningful milestone for Delcath, one that speaks to the belief physicians in Europe have developed in our product and this therapy for certain types of liver cancers. Our commercialization efforts in Europe have established a considerable body of published and presented research data that demonstrates the safety and efficacy of this therapy in appropriate patients,” president & CEO Jennifer Simpson said in prepared remarks.
“Further, Dutch Health Authorities recently included Chemosat treatment in their published guidelines for ocular melanoma liver metastases, a step toward potential reimbursement coverage of Chemosat in the Dutch market. We continue to leverage this experience to validate the safety and efficacy of the melphalan/Hepatic Delivery System (Chemosat) in our clinical trials.”
The company is evaluating its liver cancer therapy in Phase III trials in the U.S. in the hopes of winning FDA approval.
Delcath pulled the trigger on a 1-for-350 reverse stock split late last year, which reduced the number of issued and outstanding shares of the company’s common stock from 490 million to 1.4 million shares.
In September, Delcath and a group of investors made an end run around the company’s shareholders with a deal that paved the way for the reverse split that stockowners have twice shot down.