EnteroMedics (NASDAQ:ETRM) announced this week that it has shipped its first commercially available MaestroRechargeable System to its distribution partner in Australia. The Maestro system deliversVBLOC (vagus nerve-blocking therapy) designed to control both hunger and the feeling of fullness in the human digestive system.
“This first commercial shipment of our Maestro RC System marks a major milestone forEnteroMedics, supporting our evolution to a commercial enterprise and bringing us closer to our goal of delivering safer, effective and sustainable weight-loss treatments to patients worldwide,” saidMark Knudson, EnteroMedics’ president and chief executive officer, in a news release.
The Minnesota device maker also announced that it has signed a multiyear distribution agreement with a Saudi enterprise to sell the Maestro system in the Gulf countries.
While EnteroMedics is making headway abroad, it has still a ways to go to convince the U.S. Food and Drug Administration. The public company had a rough ride when its Empower clinical study failed to meet its efficacy targets in late 2009. It reacted by announcing a 40 percent job cut, although it didn’t affect the company’s ability to raise capital.
Currently, the company is doing another trial — the Recharge clinical trial has completed enrolling patients — in the hope of winning approval for its next-generation Maestro system from U.S. regulators.
The device bears the CE Mark for sale in the European Union.
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