05.06.15
St. Paul, Minn.-based medical device maker St. Jude Medical Inc. has initiated plans to buy Spinal Modulation Inc., a Menlo Park. Calif.-based company that makes the Axium Neurostimulator system. Following completion of the deal, St. Jude Medical will become the only medical device manufacturer to offer radiofrequency ablation, spinal cord stimulation (SCS) and dorsal root ganglion (DRG) stimulation therapy solutions for the treatment of chronic pain, company officials said.
In June 2013, St. Jude Medical made a $40 million equity investment in Spinal Modulation. Besides providing St. Jude Medical with an exclusive option to distribute the Axium Neurostimulator system in international markets where the technology is approved for sale, the investment also provided St. Jude Medical with an exclusive option to acquire the company. Having exercised its exclusive option, St. Jude Medical expects to complete the acquisition of Spinal Modulation in the second quarter, subject to customary closing conditions.
St. Jude Medical will make a payment of approximately $175 million upon closing with additional payments due upon U.S. Food and Drug Administration (FDA) approval of the Axium system and achievement of certain revenue targets.
The Axium system is designed to provide relief for patients battling chronic pain through stimulation of the dorsal root ganglion. This method especially is useful for treating focal pain areas that are challenging to treat using traditional spinal cord stimulation.
The Axium system originally received CE mark approval in November 2011 for the management of chronic, intractable pain. In December last year, Spinal Modulation announced that enrollment in its Accurate U.S. investigational device exemption trial had been completed. Spinal Modulation subsequently submitted its premarket approval application to the FDA in support of marketing approval in the United States.
“Physicians need a range of options to effectively treat chronic pain, and our acquisition of Spinal Modulation is part of our commitment to providing physicians new therapy options,” said Michael T. Rousseau, chief operating officer of St. Jude Medical. “Dorsal root ganglion stimulation with the Axium system is highly complementary to our current chronic pain product portfolio, and acquiring this technology will further our ability to partner with physicians to reduce the burden of chronic pain.”
Chronic pain affects approximately 1.5 billion people worldwide, more than heart disease, cancer and diabetes combined. The condition can dramatically affect quality of life, negatively impacting personal relationships, work productivity and daily routines. SCS and DRG stimulation both have been proven to relieve chronic pain while restoring lost quality of life.
DRG stimulation works differently than traditional SCS, targeting nerves within the DRG, a structure packed with sensory nerves that transmit information to the spinal cord, which then conducts those signals to the brain. Traditional SCS takes a different approach, targeting nerves along the spinal cord’s dorsal column which often proves challenging to isolate the desired target painful area.
By targeting the DRG, stimulation with the Axium system has been shown to be effective in treating conditions currently underserved by traditional SCS, such as chronic intractable pain in the leg, foot and groin. Research also has shown DRG stimulation can benefit patients suffering post-surgical pain and neuropathic pain.
“We believe adding DRG stimulation to their [St. Jude Medical’s] chronic pain portfolio will have a number of benefits to patients worldwide,” said David Wood, president and CEO of Spinal Modulation.
In June 2013, St. Jude Medical made a $40 million equity investment in Spinal Modulation. Besides providing St. Jude Medical with an exclusive option to distribute the Axium Neurostimulator system in international markets where the technology is approved for sale, the investment also provided St. Jude Medical with an exclusive option to acquire the company. Having exercised its exclusive option, St. Jude Medical expects to complete the acquisition of Spinal Modulation in the second quarter, subject to customary closing conditions.
St. Jude Medical will make a payment of approximately $175 million upon closing with additional payments due upon U.S. Food and Drug Administration (FDA) approval of the Axium system and achievement of certain revenue targets.
The Axium system is designed to provide relief for patients battling chronic pain through stimulation of the dorsal root ganglion. This method especially is useful for treating focal pain areas that are challenging to treat using traditional spinal cord stimulation.
The Axium system originally received CE mark approval in November 2011 for the management of chronic, intractable pain. In December last year, Spinal Modulation announced that enrollment in its Accurate U.S. investigational device exemption trial had been completed. Spinal Modulation subsequently submitted its premarket approval application to the FDA in support of marketing approval in the United States.
“Physicians need a range of options to effectively treat chronic pain, and our acquisition of Spinal Modulation is part of our commitment to providing physicians new therapy options,” said Michael T. Rousseau, chief operating officer of St. Jude Medical. “Dorsal root ganglion stimulation with the Axium system is highly complementary to our current chronic pain product portfolio, and acquiring this technology will further our ability to partner with physicians to reduce the burden of chronic pain.”
Chronic pain affects approximately 1.5 billion people worldwide, more than heart disease, cancer and diabetes combined. The condition can dramatically affect quality of life, negatively impacting personal relationships, work productivity and daily routines. SCS and DRG stimulation both have been proven to relieve chronic pain while restoring lost quality of life.
DRG stimulation works differently than traditional SCS, targeting nerves within the DRG, a structure packed with sensory nerves that transmit information to the spinal cord, which then conducts those signals to the brain. Traditional SCS takes a different approach, targeting nerves along the spinal cord’s dorsal column which often proves challenging to isolate the desired target painful area.
By targeting the DRG, stimulation with the Axium system has been shown to be effective in treating conditions currently underserved by traditional SCS, such as chronic intractable pain in the leg, foot and groin. Research also has shown DRG stimulation can benefit patients suffering post-surgical pain and neuropathic pain.
“We believe adding DRG stimulation to their [St. Jude Medical’s] chronic pain portfolio will have a number of benefits to patients worldwide,” said David Wood, president and CEO of Spinal Modulation.