Houston-based Cyberonics officials Thursday said the company could begin selling a more innovative version of its VNS (Vagus Nerve Stimulator), nerve-stimulating device to treat epilepsy as early as next spring, pending federal approval.
President and CEO Dan Moore told analysts during Cyberonics’ quarterly earnings call he is hopeful the U.S. Food and Drug Administration, which regulates medical devices, will be satisfied with clinical trial results showing safety and effectiveness of the product, which is being used in Europe. However, the agency could require more testing, he said.
“I feel good about the two trials we’ve done,” said Moore, who released financial results for the company’s 2015 fiscal year second quarter, ending Oct. 24. “There’s a clear benefit. From my perspective, it should easily sail through.”
The nearly 30-year-old company employs about 650 people, with about half of them working at Cyberonics’ offices off Space Center Boulevard in the Clear Lake area. It manufactures a nerve-stimulating, battery-operated device, which is surgically implanted in the upper left side chest just below the skin. A thread-like wire, also implanted under the skin, connects the device to the left vagus nerve in the neck.
Doctors program the device to send electrical signals to the nerve, which activates areas of the brain and reduces seizures in epilepsy patients whose conditions can’t be controlled with medicine. The vagus nerve stimulator long has been used to treat epilepsy.
Cyberonics’ more innovative device awaiting federal approval would automatically boost nerve stimulation when patients’ heart rates spike, which is an indication of a seizure. Currently, patients swipe a wearable magnetic gadget over the device to increase stimulation.
The company typically sells about 14,000 devices worldwide and earns nearly $300 million annually.
On Thursday, Cyberonics reported net income of almost $17.3 million for the second quarter of its 2015 fiscal year.
It reported 65 cents per share for the quarter. That compared with net income of an estimated $13.9 million, or 51 cents a share for same period a year ago.
Cyberonics expects full-year revenue in the range of $292 million to $298 million.
SOURCE: http://www.houstonchronicle.com/local/prognosis/article/Cyberonics-hopes-to-sell-new-epilepsy-device-in-5906428.php
