Cyberonics Mulls Options for Depression Treatment

Cyberonics Inc. made much news in 2005 when its VNS Therapy neuromodulation system received FDA approval to treat depression. But in 2007, CMS denied reimbusement coverage for that indication. Partly as a result of that, Cyberonics restructured itself to focus on growing VNS Therapy as a treatment for epilepsy, which has been approved since 1997 and reimbursed since 1999. The results have paid off so far, and the firm whose future viability was once in question returned to profitability.But there remains the issue of what to do about the depression indication.

October 2, 2008

1 Min Read
Cyberonics Mulls Options for Depression Treatment

In February, the company announced plans to seek a buyer for the rights to it. But yesterday it announced that it has not received any offers that appropriately reflect the value of the indication. The Associated Press reports that the company "is now evaluating alternative actions that could help maintain regulatory approval while lowering its investment in the product." And it reiterated that it will not conduct any new studies on the indication until it finds a partner. It is already spending about $4 million a year on two postmarket studies required by FDA as a condition of approval. That figure will drop in 2011, when the mandate ends.You will be able to read more about Cyberonics in the November issue of MD&DI.

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