SAN JOSE, California, November 15, 2010 /PRNewswire/ —

– SI-BONE commences surgeon training at labs in Salzburg, Austria

SI-BONE, Inc. (San Jose, California), a medical device company that ispioneering the use of a minimally invasive surgical (MIS) device to treat thesacroiliac (SI) joint announced today that it has received a CE mark for itsiFuse Implant System(TM). a CE mark is the quality assurance certificationrequirement recognized by members of the European Union for sales into thosecountries. The company has also received ISO 13485 Certification, whichdemonstrates that it provides medical devices and related services thatconsistently meet customer and regulatory requirements.

The iFuse Implant system is a minimally invasive surgical (MIS) systemcomprised of titanium implants coated with a porous plasma spray that acts asan interference surface fit, which helps decrease implant motion. The iFusehas a substantial thickness and sophisticated metallurgy, which providesimmediate post-operative fixation, accomplishing the goal of traditional openSI joint fusion through an MIS approach. Clinical publications haveidentified the SI joint as a pain generator for up to 22% of low back painpatients and that up to 75% of post-lumbar fusion patients develop SI jointdegeneration within 5 years of surgery. These represent significant unmetclinical needs and, when conservative therapy fails, iFuse may provide an MISoption.

The first European surgeon training sessions were held in October andmost recently for November in Salzburg, Austria. These sessions are presentedby surgeon faculties who have performed dozens of iFuse surgeries in theUnited States. The company´s European Training and Product Manager, VanesFrison, is coordinating the labs.

Commenting on the CE Mark and EU launch, Jeff Dunn, President and CEO, said, “The iFuse Implant system provides spine surgeons with a uniqueminimally invasive surgical approach to SI joint fixation/fusion. The CE markwill allow our EU Team to develop a presence in selected EU markets toaddress the needs of physicians committed to treating patients with SI jointproblems. SI-BONE looks forward to entering these markets because we offerthe only technology which provides an MIS solution to treat these SI jointconditions.”

“Our product provides a technologically advanced alternative to theconventional open SI joint fusion as well as an option for patients who havefailed conservative therapy. The key to the iFuse procedure is the devicedesign and minimally invasive technique. we insert the implants across the SIjoint in a one hour procedure and it gives us the stability that we need, “said Mark Reiley, M.D., Chief Medical Officer and founder of SI-BONE.

The CE mark for this system follows the clearance the company received inNovember 2008 from the Food and Drug Administration (FDA) to market its iFuseImplant system. The iFuse is indicated for use in fracture fixation of largebones and large bone fragments of the pelvis for conditions includingsacroiliac joint disruptions and degenerative sacroiliitis.

In addition to training and engaging key spine surgeons in the EU, surgeons in the US presented their initial clinical data at NASS in Orlandoon October 7th. Additional retrospective data was also presented at severalsignificant meetings, including the American Academy of Physical Medicine andRehabilitation (AAPM&R) on November 5, the Society of Minimally InvasiveSpine Surgery (SMISS) on November 6 and World Congress of Low Back & PelvicPain in Los Angeles on November 12.

In response to increasing awareness of SI joint disruption anddysfunction as debilitating symptom generators, SI-BONE, Inc. developed aninnovative, patented, intramedullary implant to treat the SI joint. Thecompany is also embarking on a post-market multicenter study to determine itseffect over time on SI joint pathology and on symptoms associated with SIjoint problems.

The iFuse Implant system is a commercially available device in the US. Inthe EU it is intended for fixation of large bones and large bone fragments ofthe pelvis for conditions including sacroiliac joint disruptions anddegenerative sacroiliitis. The iFuse procedure uses a minimal incision fordelivery and implantation of small, titanium implants. The implants arecoated with a porous plasma spray that acts as an interference surface, designed to help decrease implant motion. These implants have substantialthickness and sophisticated metallurgy and are able to produce a muchstronger construct than that of conventional pins or screws used tosurgically fix boney structures. this implant technology from SI-BONE hasbeen previously used successfully in well over 1,000 cases of dysfunctionalfoot joints.

SI-BONE, Inc. (San Jose, California) is a leading spinal medical devicecompany dedicated to the development of tools and products for diagnosing andtreating patients with low back issues related to sacroiliac (SI) jointpathology. The company has developed, and is manufacturing and marketing, less invasive approaches using implants for the treatment of SI jointpathology. SI-BONE has an experienced management team with extensiveexperience in orthopedic and spine medical devices.

SI-BONE, Inc.