An analyst described the results of St. Jude Medical’s clinical trial of its new neuromodulation product to treat chronic migraine as “impressive.”
St. Jude has applied for European market clearance for the Genesis neurostimulator. The system delivers mild electrical pulses from an implanted device to leads placed under the skin at the back of the head that stimulate the occipital nerves.
The Minnesota device maker announced Thursday at the International Headache Congress in Berlin that 67 percent of patients implanted with the Genesis neurostimulator who received the stimulation treatment immediately after the implant reported an improvement in their quality of life after 12 weeks. They also reported a 28 percent decrease in the number of days they suffered from headaches (seven fewer days a month) compared to the placebo group which reported a 4 percent decrease (one less day per month).
Overall, 66 percent of patients — those who immediately got the treatment following the implant and those who didn’t until 12 weeks after the implant — reported excellent or good pain relief after a 12-month period. The study followed 157 participants who, on average, suffered from headache 26 days in a month.
“The results are, in short, impressive and bode well for European approval later this year and the development of a significant new market for St. Jude ….” said J.P. Morgan analyst Michael Weinstein, in a research note Thursday.
The principal investigator of the study also hailed the results.
“Many migraine patients have exhausted all current treatment options and often are disabled by the pain and frequency of migraine attacks,” said Stephen D. Silberstein, director of the Jefferson Headache Center, in a news release. “Achieving a reduction in the number of days they suffer from headache and a significant improvement in their quality of life may be even more important than pain reduction alone.”
Still, the results did not meet the primary endpoint as established by the Food and Drug Administration.
The approval of the product is expected to add 15 percent to 20 percent in the company’s neuromodulation division in the next five years or more, Weinstein projected. In the first quarter of this year, the neuromodulation segment garnered $92 million, up 10 percent from the first quarter of 2010, which includes $1 million of favorable foreign currency translations. St. Jude expects that for the full year, neuromodulation revenue will be $410 million to $435 million.
Citing the pipeline of products coming out of St. Jude Medical, Weinstein noted that the company’s overall growth potential is “best in class” within the large cap medical technology companies.