Obese Australians will be among the first in the world to use a Minnesota company’s therapy that uses an implantable neurostimulator to achieve weight loss.
EnteroMedics (NASDAQ:ETRM) announced this week that it has shipped its first commercially available Maestro Rechargeable System to its distribution partner in Australia. The Maestro system delivers VBLOC (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 for EnteroMedics, 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,” said Mark 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.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
