SI-BONE, a San Jose, California-based medical device company, completed a $33m growth capital financing round.
Backers included Orbimed and Novo A/S and current investors Skyline Ventures and Montreux Equity Partners. In conjunction with the funding, David Bonita MD, Private Equity Partner at Orbimed, will be joining the Board of Directors.
The company intends to use the funds to expand the U.S. sales organization, add additional resources in R&D, medical affairs, regulatory, compliance and reimbursement, grow outside the U.S. by pursuing regulatory approvals in over a dozen countries in Asia, the Middle East and South America and initiating commercialization in Australia, New Zealand and Hong Kong, as well as to continue its three ongoing prospective clinical studies including:
– SIFI (Sacroiliac Joint Fusion with iFuse Implant System), a U.S. multicenter single arm study,
– INSITE (Investigation of Sacroiliac Fusion Treatment), a U.S. multicenter randomized study and
– iMIA (iFuse Implant System Minimally Invasive Arthrodesis), a European multicenter randomized study.
Led by Jeffrey Dunn, President and CEO, SI-BONE develops tools and products for diagnosing and treating patients with low back issues related to sacroiliac (SI) joint disorders. Its iFuse Implant System® received original 510(k) clearance in November 2008 from the Food and Drug Administration (FDA) for fracture fixation of long bones and large bone fragments of the pelvis for conditions including sacroiliac joint disruptions and degenerative sacroiliitis, and an additional clearance in April 2011 for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
The CE mark for European commercialization was obtained in November 2010.
The iFuse procedure uses a small incision for delivery and implantation of titanium implants. The implants are coated with a porous, titanium plasma spray that acts as an interference surface, designed to help decrease implant motion and provide immediate fixation and allow for biological fixation to support long term fusion.