Cyberonics Stumbles and ANS Lends a Hand

An unexpected and unfavorable ruling from the FDA has left Cyberonics officials angry and frustrated and has put in jeopardy the depression opportunity the company was counting on. Also on Cyberonics' plate: an unwelcome merger bid from rival neurostimulation company, ANS.

It's not often that medical technology companies develop a device with the potential of a pharmaceutical blockbuster. But for much of the last couple of years, that's precisely what executives at Houston-based Cyberonics Inc. felt confident they had, with an expansion of their vagus-nerve stimulation (VNS) technology, currently used in epilepsy, into the field of depression. (See "Cyberonics and Depression's Happy Face," IN VIVO, November 2003 Also see "Cyberonics and Depression's Happy Face" - In Vivo, 1 November, 2003..) Indeed, Cyberonics officials last year predicted that the depression application of their technology alone could account for more than $300 million in annual in sales within three years and $1 billion by ten years post-launch.

But those plans were dealt a serious setback this month when the FDA refused to follow a panel recommendation to...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on In Vivo for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Archive

Final Chance To Have Your Say: Take Our Reader Survey This Week

 

Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Early Development Deals: Ipsen's Strategy For Biomarker-Driven Success

 

Mary Jane Hinrichs, Ipsen’s head of early development, talks to In Vivo about getting ahead of the competition by securing deals for candidates before they enter Phase I trials.   

Shape Our Content: Take The Reader Survey

 

Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in the coverage topics, content format or the method in which you receive and access In Vivo, or if you love it how it is, now is the time to have your voice heard.

In Partnership with Cerba Research

Prioritizing Safety in CAR-T Therapy: Patient Monitoring with Cerba Research’s Testing Portfolio

The cell and gene therapy (CGT) clinical trial landscape in general and CAR-T cell clinical trials in particular are a special focus for the FDA, EMA, and other regulatory agencies. The whole industry is thus aware of the recent FDA safety investigation and requirements for labeling CAR therapy products.

More from In Vivo

AI In Health Delivery: Patients Most Confident When HCPs Are In Charge

 
• By 

Annual survey of patients and professionals shows how attitudes to health system transformation are evolving and what stakeholders are demanding as acceptance of AI tools accelerates.

Medtech Innovators Court London-Based Investors At BioWales 2025

 
• By 

BioWales in London 2025 showcased the efforts healthtech innovators are making to meet investors on their own turf, illustrating changing attitudes and evolving needs.

Rising Leaders 2025: Metsera’s Whit Bernard’s Musical Path To Biotech Leadership

 
• By 

Metsera CEO Whit Bernard applies an unconventional leadership philosophy to develop next-generation obesity therapeutics, including monthly GLP-1 injections and oral peptides.