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SI-BONE Announces Global Clinical Strategy for Minimally Invasive iFuse Sacroiliac Joint Fusion
Date:8/1/2011

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
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SOURCE SI-BONE, Inc.
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