SAN JOSE, Calif., Aug. 1, 2011 /PRNewswire/ — SI-BONE, Inc. (San Jose, California), a medical device company with a surgical solution for treating the sacroiliac (SI) joint, announced today that it is launching an intensive clinical research and development plan as part of a key corporate initiative to generate a substantial body of clinical and economic evidence for its iFuse Implant System®. The cornerstone of this effort is MISSION (Minimally Invasive Surgical iFuse Implant System in SI Joint FusiON). A major clinical milestone was reached on Friday, July 22, 2011, with the filing of an Investigational Device Exemption (IDE), entitled MISSION.
The MISSION study is a U.S.-based, prospective, multi-center trial that will examine short- and long-term safety, efficacy, and the economic effectiveness of iFuse when used according to the current product label for SI joint fusion. Enrollment in MISSION is planned to begin at up to 20 sites in the U.S. starting October 2011, pending approval by the FDA. MISSION and other clinical research projects will serve to validate the fusion properties of iFuse and the subsequent impact on patient clinical outcomes and quality of life.
Jeffrey Dunn, President and CEO, commented, “Our clinical strategy has always been targeted at increasing awareness, and enhancing capabilities around diagnosis and surgical options for patients with SI joint dysfunction. While the MISSION IDE study will have a central role in our overall prospective clinical evidence development plan, in conjunction, SI-BONE is also launching a post-market retrospective study that will collect clinical and economic outcomes in patients who have previously been treated with iFuse. We are very pleased by the positive response of surgeons and healthcare providers specializing in the SI joint. Their willingness to work with us in gathering evidence and in allowing us to work with them in this effort is recognition that the SI joint is a significant pain generator, and that iFuse will have a role in helping to address and improve the lives of patients living with low back pain (LBP) and other debilitating musculoskeletal conditions.”
John Glaser, M.D. professor of orthopedic and spine surgery at MUSC in Charleston, SC, has indicated in his experience, “the iFuse represents an alternative to traditional SI joint fusion for patients not responding to conservative therapy. The iFuse procedure may also help treat post-lumbar fusion surgery patients who experience significant SI joint complaints following lumbar surgery. By providing stability, after healing, with minimal dissection, iFuse allows my patients the opportunity to resume normal daily activities.”
From its inception, SI-BONE has been committed to innovation and education in SI joint diagnosis and treatment. In keeping with that goal, SI-BONE announced that it is embarking on a series of major clinical research and development initiatives on the iFuse for SI joint fusion. As part of its clinical strategy, the Company is currently conducting other research initiatives, including post-market retrospective studies, SI joint diagnosis programs, and preclinical examination of animal healing models with emphasis on imaging and histology.
SI-BONE received clearance in November 2008 from the Food and Drug Administration (FDA) to market its iFuse Implant System. The CE mark for European commercialization was obtained in November 2010. The iFuse provides immediate post-operative stabilization and accomplishes the goal of traditional SI joint fusion through an MIS approach. Clinical publications have identified the SI joint as a pain generator for up to 22 percent of low back pain patients. In addition, DePalma, Pain Medicine 2011, identified the SI joint as a pain generator in low back pain in 40 to 61% of post-lumbar fusion patients, so-called ‘failed back surgery’ patients.(1) Effective treatment of the SI joint is a significant unmet clinical need and, when conservative therapy fails, iFuse may provide an option.
In response to increasing awareness of SI joint disruption and dysfunction as debilitating symptom generators, SI-BONE, Inc. developed an innovative, patented, intramedullary implant to treat the SI joint. The company is also embarking on a prospective multicenter study to document acute and long-term clinical outcomes in patients who are proven to be refractory to prior therapies.
The iFuse Implant System is a commercially available device in the U.S. intended for treatment of conditions including sacroiliac joint disruptions and degenerative sacroiliitis. The iFuse procedure uses a minimal incision for delivery and implantation of small, titanium implants. The implants are coated with a porous plasma spray that acts as an interference surface, designed to help decrease implant motion. These implants have substantial thickness and sophisticated metallurgy and are able to produce a much stronger construct than that of conventional pins or screws used to surgically fix boney structures. This implant technology from SI-BONE has been previously used successfully in well over 1,500 cases of dysfunctional foot joints.
About SI-BONE, Inc.
SI-BONE, Inc. (San Jose, California) is the leading sacroiliac joint spine medical device company dedicated to the development of tools and products for diagnosing and treating patients with low back issues related to sacroiliac (SI) joint pathology. The company has developed, and is manufacturing and marketing, less invasive approaches using implants for the treatment of SI Joint pathology. SI-BONE has an experienced management team with extensive experience in orthopedic and spine medical devices.
(1) DePalma, M. Etiology of chronic LBP patients having undergone lumbar fusion. Pain Medicine, 2011;12:732-39.
SOURCE SI-BONE, Inc.