Delcath Systems, a medical device company based in New York, NY, met several regulatory milestones in both the United States and Australia for its ChemoSat organ-isolating chemotherapy system.
The company’s second-generation ChemoSat system gained regulatory approval with the Australian Therapeutic Goods Association. In addition, the United States Food and Drug Administration scheduled a June, 2013 standard review for the company’s approved New Drug Application. As of now, the company is legally allowed to sell its second-generation ChemoSat system in Australia. The company may receive FDA 510(k) approval to sell its ChemoSat system in mid to late 2013.
These are only two of several recent wins for the company. In recent weeks, the company gained increased CE Mark approval from the European Union for its ChemoSat system. This approval took place after the company was able to successfully file a second non-disclosure agreement with the US FDA.
The ChemoSat system by Delcath uses a series of specialized tubes to deliver localized chemotherapy pharmaceuticals. Since many chemotherapy pharmaceuticals are cytotoxic, it’s essential to minimize their exposure to healthy tissue in the body. With the new ChemoSat system, it’s possible to deliver targeted pharmaceuticals by isolating an affected organ from the body’s bloodstream. This ensures that chemotherapy drugs won’t migrate to other parts of the body.
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