SI-BONE, a company that diagnoses and treats lower back pain, has raised $10.6 million in equity funding. New investor Skyline Ventures led the round. Using its iFuse Implant System, the San Jose-based company fuses the sacroiliac joint (SI joint), a joint in the lower pelvis, through a minimally invasive procedure. The company estimates that 15-25% of all low back pain originates from the SI joint.

SI-BONE plans to use the latest funding to increase clinical studies and educate spine surgeons in the United States and Europe. The company previously raised $1.5 million in March 2009.

PRESS RELEASE

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, today announced that it has closed $11.0 million in financing for expansion of clinical and commercial operations. The financing round was led by new investor Skyline Ventures of Palo Alto, California.

The primary purposes of the financing are to dramatically increase investment in 1) worldwide sales and marketing operations 2) expansion of the company’s clinical efforts through a retrospective minimally invasive surgical (MIS) SI joint treatment study, a prospective, multicenter study (MISSION), a European prospective study, additional post-market case studies and an animal study validating arthrodesis with the iFuse implant to further establish clinical efficacy and 3) educate spine surgeons and referring specialists in the US and Europe.

Glenn Reicin, a partner at Skyline Ventures, will join the SI-BONE Board of Directors. Reicin joined Skyline as a Partner in October 2008. From 1993 to 2008, he was a Managing Director at Morgan Stanley, covering medical devices. He was ranked in the Institutional Investor “All-America” team from 1994 through 2008, including six years as first place. In 2008, the Financial Times ranked him the top stock picker in the Medtech sector. His experience includes a leading role in bringing several companies public and provided research coverage in the areas of medical technology and devices.

“One of the reasons we invested in SI-BONE is our belief that the number of patients who suffer from SI joint dysfunction is large and dramatically underserved. Further, we believe that the minimally invasive technology and procedure invented by Dr. Mark Reiley has huge potential based on early patient results that the surgeons currently using the procedure are seeing. We are very confident in the management team led by Jeff Dunn, President and CEO. We look forward to helping them accomplish their mission of helping many patients worldwide,” said Glenn Reicin.

Jeff Dunn, CEO of SI-BONE, commented, “We are pleased that our colleagues at Skyline have agreed to bring their extensive clinical and business experience to our commercial efforts. We expect to benefit from their insights and expertise through Glenn’s board participation. The financing will further help position iFuse as the frontline MIS therapy for patients with SI joint syndromes who are unresponsive to conservative therapy.”

Surgeons across the United States are implanting iFuse and preparing to report their initial clinical data at several significant spine meetings this fall. Upcoming clinical presentations on the iFuse early experience will be made at the North American Spine Surgery (NASS) in Orlando on October 7 on the main floor and at SI-BONE’s Satellite Symposium, the American Association of Pain Management & 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 onNovember 12. Surgeons participating in iFuse clinical evaluation include Steven Garfin, Fred Geisler, David Polly, Leonard Rudolf, J. John Halki, Arnold Graham-Smith and A. Nick Shamie.

In response to increasing awareness of SI Joint dysfunction as a debilitating symptom generator, SI-BONE, Inc. developed an innovative, patented, intramedullary implant to treat the SI Joint. The company is also embarking on a post-market multicenter study to determine its effect over time on SI Joint pathology and on symptoms associated with SI Joint dysfunction.

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.