Medical devices major, St. Jude Medical, Inc. (STJ - Analyst Report) recently announced results from a large-scale clinical study of peripheral nerve stimulus (PNS) of the occipital nerve for managing pain and disability associated with chronic migraine, a condition afflicting millions globally. St. Jude’s Genesis neurostimulation system was used for this study.
The results, published online by Cephalalgia, the journal of the International Headache Society (IHC), demonstrate that the device was safe and effective in reducing the number of migraine headache days per month and helped improve a patient's quality of life. Earlier in June 2011, encouraging preliminary results from this study were presented at the IHC, which also reported PNS therapy to be beneficial.
The Genesis neurostimulation system works by delivering mild electrical pulse to leads placed under the skin at the back of the head, stimulating the occipital nerves. The device has already received European as well as Australian approval to treat patients with intractable chronic migraine.
Per the results of the clinical study, 157 patients treated across 15 medical centers in the U.S., with severe headache for roughly 21 days per month, reported an average of 6 lesser headache days per month after receiving the PNS therapy for 12 weeks. Moreover, disability score improved by 43% based on the Migraine Disability Assessment questionnaire (MIDAS).
In addition, participants reported 42% advancement in pain relief and 52% rated their relief as either good or excellent. However, adverse effects such as pain and/or numbness at the implant site, succeeded by lead migration plagued some of the patients. Nonetheless, these were classified as mild or moderate in terms of severity in most of the cases.
The Genesis system earlier was a part of the Neuromodulation (“NMD”) business of St. Jude. However, the company recently combined its Cardiac Rhythm Management (“CRM”) Division and the NMD Division to form the Implantable Electronic Systems Division (“IESD”). The latest positive data from the study regarding Genesis neurostimulators are likely to further boost IESD’s product sales.
St. Jude’s Neuromodulation revenues are growing steadily, benefiting from new spinal cord and Parkinson's disease devices as well as sustained adoption of the Eon Mini implantable neurostimulator. In the last reported second quarter of 2012, Neuromodulation sales increased 2%, (up 5% in constant currency) year over year to $106 million.
With a market cap of $13.63 billion, St. Jude is a leading medical device manufacturer with a solid rate of growth over the past decade. We are impressed by its solid fundamentals, healthy growth trajectory, strong product mix, robust pipeline and cost management initiatives.
While a host of new growth drivers, including new products and cost saving measures, are expected to boost results in 2013 and beyond, we remain cautious about the increased competition, weakening Euro, the soft CRM market and the overall tough macroeconomic conditions.
A still choppy CRM space overhangs on St. Jude and its peers Medtronic, Inc. (MDT - Analyst Report) and Boston Scientific Corporation (BSX - Analyst Report). We currently have a Neutral recommendation on St. Jude, which carries a short-term Zacks #3 Rank (Hold rating).