ST. PAUL, Minn.--(BUSINESS WIRE)--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced it has completed the acquisition of Spinal Modulation, Inc., developer of the Axium™ Neurostimulator System. The acquisition was completed on May 1, 2015.
With the closing of the acquisition, St. Jude Medical has become the only medical device manufacturer in the world to offer radiofrequency ablation (RFA), spinal cord stimulation (SCS) and dorsal root ganglion (DRG) stimulation therapy solutions for the treatment of chronic pain.
Commenting on the acquisition, St. Jude Medical’s chief operating officer Michael T. Rousseau said: “Completing the acquisition of Spinal Modulation, Inc. is another important step forward in building momentum and accelerating sales growth across our neuromodulation product portfolio. We’re confident the Axium system will further support our goal of providing physicians multiple options to tailor treatment for patients with chronic pain.”
The Axium system has CE Mark in the European Union for the management of chronic intractable pain and TGA approval in Australia for the management of chronic, intractable pain of the trunk and/or limbs. In December 2014, Spinal Modulation announced that enrollment in its ACCURATE U.S. IDE trial had been completed and subsequently submitted its PMA application to the FDA in support of marketing approval in the United States. The full results from the ACCURATE Study will be presented at the 12th annual International Neuromodulation Society (INS) Congress, to be held in Montreal, Quebec, Canada from June 6-11, 2015.
About the Axium™ Neurostimulator System
The Axium system is a form of spinal cord stimulation (SCS) that targets a neural structure within the spine called the dorsal root ganglion (DRG). 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 system has CE Mark in the European Union for the management of chronic intractable pain and TGA approval in Australia for the management of chronic, intractable pain of the trunk and/or limbs.
About the ACCURATE Study
The ACCURATE Study is a prospective, randomized, multi-center, controlled study to evaluate the safety and efficacy of the Axium system for the treatment of chronic pain affecting the lower limbs. It is the largest U.S. pivotal trial to evaluate spinal cord stimulation therapy in patients with lower limb pain due to nerve injuries (peripheral causalgia) or complex regional pain syndrome (CRPS).
About St. Jude Medical
St. Jude Medical is a global medical device manufacturer dedicated to transforming the treatment of some of the world’s most expensive epidemic diseases. The company does this by developing cost-effective medical technologies that save and improve lives of patients around the world. Headquartered in St. Paul, Minn., St. Jude Medical has four major clinical focus areas that include cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit sjm.com or follow us on Twitter @SJM_Media.
About the St. Jude Medical Chronic Pain Portfolio
Chronic pain affects approximately 1.5 billion people worldwide, more than heart disease, cancer and diabetes combined. The condition can negatively impact personal relationships, work productivity and a patient’s daily routine. St. Jude Medical offers multiple solutions for patients to manage debilitating chronic pain, including spinal cord stimulation, spinal cord stimulation targeting the DRG and radiofrequency ablation.
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings and market shares. The statements made by the Company are based upon management’s current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company’s control and the risk factors and other cautionary statements described in the Company’s filings with the SEC, including those described in the Risk Factors and Cautionary Statements sections of the Company’s Annual Report on Form 10-K for the fiscal year ended January 3, 2015. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.