St. Jude’s “Try Before You Buy” Deal With Spinal Modulation, Inc.

St. Jude Medical, Inc. has made a $40 million equity investment in Spinal Modulation, Inc., a company that has developed an innovative neuromodulation therapy that provides a new pain management option for patients with chronic, intractable pain.

Background

Sensibly for St. Jude this agreement allows it to test the success of the product before deciding whether to jump in with both feet. It will now have an exclusive option to distribute the Axium™ Neurostimulator System, developed and manufactured by Spinal Modulation, in international markets where it is approved for sale. St. Jude will have the exclusive option to acquire the Spinal Modulation for up to $300 million plus certain revenue-based milestones following U.S. commercialization.

The Axium Neurostimulator System delivers a form of spinal cord stimulation (SCS) targeting the dorsal root ganglion (DRG). The DRG are small structures that contain nerve fibers, which carry signals to the brain. Stimulating the DRG addresses chronic pain conditions that are apparently currently underserved by traditional SCS technologies and techniques, providing more targeted therapy to patients who have lower extremity pain or very specific areas of pain that are known to be difficult to treat with traditional neurostimulation systems.

The Axium Neurostimulator differs from traditional SCS technologies in that its leads are placed at the DRG, rather than along the dorsal column. As such they provide targeted stimulation to areas that are typically hard to treat, including the lower leg, foot and groin. The system also claims to use approximately 95 percent less power than traditional SCS therapy.

Spinal Motion says there is a growing body of clinical evidence, including numerous peer-reviewed publications, substantiating the scientific approach of this treatment.

Company comments

for St. Jude Medical

“St. Jude Medical is excited to partner with Spinal Modulation and add the unique and complementary Axium Neurostimulator System to our existing neuromodulation portfolio,” said Eric S. Fain, M.D., president of the St. Jude Medical Implantable Electronic Systems Division. “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.”

for Spinal Modulation

David Wood, president and chief executive officer of Spinal Modulation said, “Spinal Modulation is very 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.”

Regulatory status

The Axium Neurostimulator System was CE Marked in November 2011 for the management of chronic, intractable pain. The system is not approved for use in the United States. The company has received an investigational device exemption (IDE) from the U.S. FDA and anticipates beginning enrollment in the second half of this year.

Source: Spinal Modulation, Inc., Business Wire