Spinal Modulation launches pivotal trial for neurostim device

Spinal Modulation has launched a long-awaited pivotal U.S. trial testing its neurostimulation system to treat chronic pain, with plans to enroll 152 patients. Among those who will be watching the California company's results very closely is St. Jude Medical ($STJ), which recently invested $40 million in the company with an option to buy.

Eligible patients in the trial must be dealing with chronic lower limb pain caused by either nerve damage or complex regional pain syndrome. They'll participate at up to 25 medical centers around the country, Spinal Modulation states. This study is dubbed ACCURATE, and it will be a prospective, randomized, multicenter controlled trial.

All of this will finally put Spinal Modulation's Axium Neurostimulator System to the test as a treatment for lower limb pain. The company bills its product as the only spinal cord stimulation device that targets the dorsal root ganglion in the spinal cord. This, the company notes, contains primary sensory neurons that transmit pain signals from peripheral nerves to the brain. Another selling point: The company bills its implant as using 95% less energy than traditional neuromodulation implants.

In June, St. Jude committed its investment to the company and also obtained an option to buy Spinal Modulation outright for a cool $300 million. The deal gives St. Jude the right to sell Axium in the EU, and it obtained the FDA's blessing a while back to proceed with the large-scale U.S. trial.

It will be interesting to see how Spinal Modulation's pivotal trial fares, and whether St. Jude takes the plunge and buys it outright. Results of the pivotal trial could make or break this. But Spinal Modulation, which launched in 2004 and has financing from Johnson & Johnson ($JNJ), Medtronic ($MDT) and others, is very much on the upswing. So St. Jude's decision to buy the company seems more likely to be a question of "when" rather than "if."

- read the release