California-based Spinal Modulation’s, a spinal device maker backed by industry titan St. Jude Medical (NYSE:STJ), enrolled the 1st patient in the ACCURATE clinical trial to evaluate the safety and effectiveness of the Axium neurostimulator system for the treatment of chronic lower limb pain.
Axium, which holds a CE Mark in Europe and TGA approval in Australia, is an implantable medical device that delivers mild electrical pulses to the dorsal root ganglion, a specific branch of the spinal cord which contains the primary sensory neurons that transmit pain signals from the peripheral nerves to the brain.
"Chronic post-surgical pain is a major unaddressed need," study co-lead and International Neuromodulation Society president elect Dr. Tim Deer said in prepared remarks on behalf of the company. "Up to 35% of patients who undergo hernia surgery and 50 to 85% of patients who undergo amputations suffer from chronic post-surgical pain. The Axium Neurostimulator System can potentially expand treatment options for this large under-served patient group."
The prospective, randomized, multi-center, controlled ACCURATE study will span up to 25 U.S. medical centers, targeting up to 152 patient with chronic lower limb pain caused by Complex Regional Pain Syndrome or nerve damage, according to a press release.
"The recently published European data from a non-randomized study are promising – 78% of patients experienced pain relief in the lower limbs," principal investigator Dr. Eric Grigsby said on behalf of Spinal Modulation. "I am excited to be the 1st in the country to participate in this important clinical trial."
If successfully cleared through E.U. and U.S. regulators, the technology could be the next pain management in St. Jude’s portfolio. St. Jude in June branded Spinal Modulation as its territory with a $40 million equity investment that gave St. Jude international distribution rights and an exclusive option to acquire the company down the road.
St. Jude nabbed immediate distribution rights for the Axium system, as well as longer-term acquisition rights that allow St. Jude to nab Spinal Modulation for up to $300 million, with additional revenue-based payment milestones, once Spinal Modulation achieves U.S. commercialization.