Minimally Invasive Sacroiliac Joint Surgery

SI-BONE Reaches Training Milestone with 150 Surgeons Trained

Company Expects to Train over 400 surgeons in next 12 months in EU and US

San Jose, California, October 18, 2010 / PRNewswire / -- SI-BONE, Inc. (San Jose, California), a medical device company that is pioneering the use of a minimally invasive surgical (MIS) device to treat the sacroiliac (SI) joint announced today that it has reached a surgeon training milestone for its iFuse Implant System™.

SI-BONE announced that over 150 spine surgeons have been trained to date in the use of the iFuse for MIS SI joint fixation/fusion. In mid-September, the largest lab yet, was conducted with 20 surgeons trained with five faculty members and Dr. Frank Phillips as host. , The training session was held at Rush Medical in Chicago, IL Training included a half-day of lecture followed by hands on cadaveric procedures. Notably, the current trend reports over 40% of attending surgeons schedule their first iFuse surgery within 90 days of the training lab.

The iFuse Implant System™ is an MIS system comprised of titanium implants coated with a porous plasma spray that acts as an interference surface fit, which helps decrease implant motion. The iFuse has a substantial thickness and sophisticated metallurgy providing immediate post-operative fixation, accomplishing the goal of traditional open SI joint fusion through an MIS approach. Clinical publications, including Cohen, SJ, Anesthesia & Analgesia, 2005 and Ha, et al., Spine 2008, have identified the SI joint as a pain generator for up to 22% of low back pain patients and that up to 75% of post-lumbar fusion patients develop SI joint degeneration within 5 years of surgery. These represent significant unmet clinical needs and, when conservative therapy fails, iFuse may provide an MIS option.

Jeffrey Dunn, President and CEO, commented, "The iFuse Implant System provides spine surgeons with a unique MIS approach to SI joint fixation/fusion. SI-BONE and all of its employees are very proud that more than 150 surgeons have been trained and are beginning to implant the iFuse. Our training programs and early retrospective data indicate patients may be experiencing significant quality of life improvements as a result of treatment with iFuse. SI-BONE remains committed to further improving patient outcomes through collaborative, prospective clinical efforts with key industry thought leaders specializing in treatment of low back complaints with their origin in the SI joint.”

W. Carlton Reckling, M.D. a thought-leading spine surgeon in Cheyenne, Wyoming, commented, "The iFuse is a technologically advanced alternative to the conventional open SI joint fusion as well as an option for patients who have failed conservative therapy. The iFuse procedure is an MIS technique that can also help treat post-lumbar fusion surgery patients who experience significant SI joint degeneration following surgery. It provides immediate stability and allows my patients an opportunity to resume normal daily activities."

Mark Reiley, M.D. Chief Medical Officer and Founder of SI-BONE, said, “With the iFuse, Si-BONE has pioneered technology that provides the physician the opportunity to treat patients with SI joint problems in an MIS approach. By training an increasing number of spine surgeons, we are making a significant contribution to spine surgery by providing a treatment option for patients with low back complaints due to the SI joint. We are committed to providing our customers with potential solutions to vexing low back problems over the coming years.”

The company received clearance in November 2008 from the Food and Drug Administration (FDA) to market its iFuse Implant System™. The iFuse is indicated for use in fracture fixation of large bones and large bone fragments of the pelvis for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

In anticipation of CE Mark approval, SI-BONE, Inc. has been actively engaging key spine surgeons in the EU in preparation for market launch. Most recently surgeons in the US presented their initial clinical experiences at NASS annual conference in Orlando, FL on October 7th, 2010. Additional retrospective data is being planned for release at several significant meetings this fall, including the American Academy of Physical Medicine and Rehabilitation (AAPM&R) on November 5, the Society of Minimally Invasive Spine Surgery (SMISS) on November 6 and World Congress of Low Back & Pelvic Pain in Los Angeles, CA on November 12.

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 postmarket multicenter study to determine its effect over time on SI Joint pathology and on symptoms associated with SI Joint problems.

The iFuse Implant System is a commercially available device in the US intended for fracture fixation of large bones and large bone fragments of the pelvis for 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 1,000 cases of dysfunctional foot joints.

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About SI-BONE, Inc.
SI-BONE, Inc. (San Jose, California) is a leading spinal 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.