Delcath wins approval for Chemosat in Brazil

Delcath Systems (OTC:DCTH) said today that it won medical device approval for its Chemosat hepatic delivery system from the national health authority in Brazil.

The New York-based company plans to market and sell Chemosat in Brazil for the percutaneous intra-arterial administration of melphalan hydrochloride to the liver with subsequent extracorporeal filtration of blood.

Delcath will work with a local strategic partner to gain access to the market in Brazil, the company reported. Delcath said it is slated to secure a partnership in the first half of the year and hopes to begin generating revenue by the end of 2019.

The Chemosat system works by isolating the liver’s circulatory system, infusing the liver with chemotherapy and then filtering a patient’s blood before returning it to the patient.

“According to the World Health Organization, liver and bile duct cancers account for over 10,000 deaths in Brazil annually,” president & CEO Jennifer Simpson said in prepared remarks. “With a population of approximately 200 million, we believe there is a significant unmet medical need in Brazil for Chemosat in both primary and metastatic liver cancers.”

Want to stay on top of DDBN content? Sign up for our e-mail newsletter for a weekly dose of drug-device news.