STAT+: Data for Delcath’s liver tumor device are positive, but lingering questions cloud path to approval
Delcath Systems said Wednesday that its liver-tumor treatment device achieved the primary goal of a late-stage clinical trial, but questions about the strength of the data — and whether the results will satisfy regulators — caused the small company’s stock price to fall.
The Delcath device, called Hepzato, consists of clamps, tubes, and a filter that isolate a patient’s liver from the rest of the bloodstream. Once the liver is blocked off, it is bathed in high doses of the chemotherapy melphalan to kill tumors. The Hepzato filter removes the melphalan from the patient before it can escape the liver, enter the bloodstream, and cause severe side effects or death.
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