Spinal Modulation Kicks Off U.S.-Based Trial With First Patient
Spinal Modulation Inc., a privately held global medical device company based in Menlo Park, Calif., has enrolled the first patient in a U.S.-based clinical trial to test a treatment for chronic lower limb pain.
The ACCURATE Study is a prospective, randomized, multi-center,,controlled trial that will evaluate the safety and efficacy of the Axium Neurostimulator System for the treatment of chronic lower limb pain.
“This is a landmark study in the field of spinal cord stimulation,” said Eric Grigsby, M.D., founder and medical director of the Napa Pain Institute and the center’s principal investigator. “The Axium System targets the dorsal root ganglion (DRG), a unique branch of the spinal cord that plays a critical role in the development and maintenance of chronic pain. The recently published European data from a non-randomized study are promising—78 percent of patients experienced pain relief in the lower limbs. I am excited to be the first in the country to participate in this important clinical trial.”
The study is expected to enroll 152 patients in up to 25 medical centers throughout the United States.
The ACCURATE Study will enroll patients with chronic lower limb pain caused by complex regional pain syndrome or nerve damage.
“Chronic post-surgical pain is a major unaddressed need. Up to 35 percent of patients who undergo hernia surgery and 50 to 85 percent of patients who undergo amputations suffer from chronic post-surgical pain. The Axium Neurostimulator System can potentially expand treatment options for this large underserved patient group,” said Tim Deer, M.D., co-study lead and president-elect of the International Neuromodulation Society.
Chronic neuropathic pain is a condition that affects millions of Americans annually. Neuropathic pain is induced by an injury or disease of the nervous system. The most common location for neuropathic pain is the lower limbs, including areas such as the legs, feet and groin area. Patients suffer from a wide variety of pain sensations including stabbing, burning, pins and needles, and numbness.
According to the company, the Axium Neurostimulator System is the only form of spinal cord stimulation that targets dorsal root ganglion. The DRG contains the primary sensory neurons that
transmit pain signals from the peripheral nerves to the brain. The system uses an implantable medical device to deliver mild electrical pulses to the DRG. These pulses mask or interrupt pain signals as they travel to the brain.
The Axium Neurostimulator System has CE mark in the European Union and TGA approval in Australia for the management of chronic, intractable pain.
In addition to its California headquarters, Spinal Modulation has offices in Belgium and Australia. The company is funded by St. Jude Medical, Johnson & Johnson Development Corporation, Medtronic, Kleiner Perkins Caufield and Byers, De Novo Ventures, MedVenture Associates, DFJ InCube Ventures, DFJ ePlanet Ventures, Raffles Venture Partners, The Angels Forum and The Halo Fund.
St. Paul, Minn.-based St. Jude Medical has the exclusive option to acquire the company after it has achieved certain milestones. St. Jude also is the exclusive distributor of the Axium system in international markets where it is approved for sale.