St. Jude Medical, a US-based medical devices company, has made a $40m equity investment in Spinal Modulation, a medical device company based in Menlo Park, California.
It has also signed a series of agreements, which enable St. Jude Medical to gain an exclusive option to distribute the Axium Neurostimulator System, which is developed and manufactured by Spinal Modulation, in overseas markets where it is approved for sale.
Moreover, St. Jude Medical will have the exclusive option to acquire the company for up to $300m in addition to certain revenue-based milestones following US commercialization.
St. Jude Medical Implantable Electronic Systems Division president Eric Fain said, "This investment in our neuromodulation business further demonstrates St. Jude Medical’s commitment to transforming the treatment of debilitating conditions, including chronic pain, which impacts about 10 to 13 percent of the adult population and carries an economic burden of billions of dollars annually."
Spinal Modulation has developed an innovative neuromodulation therapy that offers a new pain management option for patients with chronic pain. Its Axium Neurostimulator System delivers a form of spinal cord stimulation (SCS) targeting the dorsal root ganglion (DRG), which are small structures comprising nerve fibers that carry signals to the brain.
Stimulating the DRG addresses chronic pain conditions that are presently not served well by conventional SCS technologies and techniques, and offer more targeted therapy to patients who have lower extremity pain or particular areas of pain that are difficult to be treated with traditional neurostimulation systems.
Spinal Modulation president and chief executive officer David Wood said that the firm is pleased to begin working with St. Jude Medical to expand the market for chronic pain management and further develop neuromodulation solutions that effectively cover the entire body – head to toe, limb to limb.
"We look forward to collaborating with St. Jude Medical which, through its global scale, expertise and resources, will help us expand the reach of our innovative therapy to more physicians and patients around the world," Wood added.
The Axium Neurostimulator System has secured European CE Mark approval in November 2011. It is not approved for use in the US. The company has received an investigational device exemption (IDE) from the US Food and Drug Administration (FDA) and expects tobegin enrollment in the second half of this year.