Dr. Richard L. Rudolph, Chief Medical Officer of Cyberonics, explains how the company’s patented product is providing an innovative way to treat epilepsy and depression
By Roxanne Ridge
During the 1980s, a neuroscientist named Dr Jacob Zabara had a vision. He proposed the idea that epileptic seizures could be treated by stimulating the vagus nerve. In 1987 this vision became one step closer to reality when Cyberonics was founded to design, develop, manufacture and market implantable medical devices using vagus nerve stimulation (VNS).
Impressively, just one year later the first human was treated when a vagus nerve stimulation device was implanted into a patient to treat his pharmacoresistant seizures. A ten-year clinical development program to evaluate VNS Therapy’s effectiveness began.
It was a success. And in 1997, VNS Therapy was approved by the Food and Drug Administration (FDA) as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over twelve years old with partial seizures which can’t be treated with antiepileptic medications.
Just eight years after this, the product was approved again - this time for the adjunctive long-term treatment for patients age 18 or over with chronic or recurrent treatment-resistant depression. Today, VNS Therapy has treated thousands of people for both epilepsy and depression.
Innovative approach
VNS Therapy consists of an implanted pacemaker-like device that delivers mild, intermittently pulsed electrical signals to the patient’s left vagus nerve, which then modulates various areas of the brain,” explains Dr Richard L. Rudolph MD, who joined the company in 2001. Prior to this, he was Senior Director of Clinical Research and Development at Wyeth-Ayerst Research, where he worked for 16 years. He was responsible for numerous clinical studies and research on Effexor (venlafaxine hydrochloride) and Effexor XR - a leading brand of medication for the treatment of patients with depression and generalised anxiety disorder.
“Stimulation of the left vagus nerve has been shown to induce widespread bilateral effects in areas of the brain. Various studies have documented its success. And to this date more than 40,000 epilepsy patients worldwide have used the therapy,” he says.
Jumping hurdles
However, reaching this level of success hasn’t been easy and the net sales for the six months ending October 2007 have actually fallen from the year before. In 2006, they were $67.9 million, in 2007, they’re $58.0 million.
Although net sales in epilepsy actually marginally increased, the overall reduction is down because of a significant reduction in the number of VNS Therapy Systems being implanted in patients with treatment-resistant depression (TRD). This follows both the preliminary and final non-coverage determinations for the depression indication by the Centers for Medicare and Medicaid Services in February and May earlier this year.
The main challenge the company faces is that it has to keep pace with a fast evolving industry. “We have to try to improve the technology and its effectiveness while staying ahead of competing alternative therapies,” explains Dr Rudolph. This is no easy task. “We’re still working towards returning to profitability and we’ve made significant progress.”
Since the new 2008 fiscal year started the company’s domestic epilepsy market has grown by eight per cent and revenue growth in general has been four percent.
“The company has several objectives it aims to meet in the future,” says Dr Rudolph. “It’s aiming to return to positive cash flow and profitability as soon as possible, build substantial growth in the core epilepsy business, right size our expenditures on TRD activities, seek opportunities from our intellectual property and improve communication with all stakeholders. So far in fiscal 2008 we have made significant progress on all these objectives.”
An exclusive future
Currently Cyberonics holds 14 device and 22 method patents covering the VNS generator, nerve stimulation electrode and the application of a pulsed electrical signal to the vagus, hypoglossal and trigeminal nerves for the treatment of a variety of disorders including epilepsy, depression, anxiety, Alzheimer’s disease and eating disorders.
“In addition to the US approvals, the VNS Therapy System is currently approved for sale as an adjunctive treatment for refractory epilepsy in member countries of the European Union, Canada, Australia and other markets,” says Dr Rudolph. “It’s also approved for sale in the European Union and in Canada as an adjunctive treatment for depression in patients with treatment-resistant or treatment-intolerant major depressive episodes. In the future we expect to grow our existing refractory epilepsy and treatment-resistant chronic depression markets both in the US and internationally.”
This would be a wise move – the potential depression market is more than ten times greater than the existing epilepsy market. “The product has the potential of helping so many more people in the future,” says Dr Rudolph.
Staff values
Of course, none of this would be possible without energetic staff. And at Cyberonics all staff are encouraged to live the mission to improve the lives of people touched by epilepsy, depression and other chronic disorders that may prove to be treatable with VNS Therapy.
Many of the staff work directly with doctors and patients to do this.
The company’s headquarters are in Houston, Texas – but Cyberonics also has an additional office in Brussels, Belgium.
Cyberonics has a strong work ethic and views employment training as an important investment – both internal and external to the company. Training opportunities are even offered on web based programmes so employees in different locations can access continuous training.
Some new employees, depending on job responsibilities, participate in a month-long program that includes in-depth information about epilepsy and depression. They’re all taught in great detail how the VNS Therapy System works.
The company also has a strong link with the community. And this is not just directly through the VNS Therapy – virtually all Cyberonics employees are involved in fundraising events to raise money for epilepsy patient support groups.