iFuse Implant System(TM) Receives CE Mark

By Si-bone Inc., PRNE
Sunday, November 14, 2010

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

SAN JOSE, California, November 15, 2010 - 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 received a CE mark for its
iFuse Implant System(TM). A CE mark is the quality assurance certification
requirement recognized by members of the European Union for sales into those
countries. The company has also received ISO 13485 Certification, which
demonstrates that it provides medical devices and related services that
consistently meet customer and regulatory requirements.

The iFuse Implant System is a minimally invasive surgical (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, which provides
immediate post-operative fixation, accomplishing the goal of traditional open
SI joint fusion through an MIS approach. Clinical publications 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

The first European surgeon training sessions were held in October and
most recently for November in Salzburg, Austria. These sessions are presented
by surgeon faculties who have performed dozens of iFuse surgeries in the
United States
. The company's European Training and Product Manager, Vanes
Frison, 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 unique
minimally invasive surgical approach to SI joint fixation/fusion. The CE mark
will allow our EU Team to develop a presence in selected EU markets to
address the needs of physicians committed to treating patients with SI joint
problems. SI-BONE looks forward to entering these markets because we offer
the only technology which provides an MIS solution to treat these SI joint

"Our product provides a technologically advanced alternative to the
conventional open SI joint fusion as well as an option for patients who have
failed conservative therapy. The key to the iFuse procedure is the device
design and minimally invasive technique. We insert the implants across the SI
joint 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 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 addition to training and engaging key spine surgeons in the EU,
surgeons in the US presented their initial clinical data at NASS in Orlando
on October 7th. Additional retrospective data was also presented at several
significant meetings, 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 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 post-market 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. In
the EU it is intended for 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.

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.

Jeff Polack, Vice President Marketing of SI-BONE, Inc., +1-408-207-0700, ext. 2212, jeffp at si-bone.com

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