VertiFlex®, Inc. Announces FDA Clearance of Two Key Additions to Technology Portfolio

SAN CLEMENTE, Calif.--(BUSINESS WIRE)--
VertiFlex®, Inc., a leading innovator of advanced minimally invasive
spinal surgery technologiestoday announced FDA 510(k) clearance
of two new products to its portfolio: The Totalis™ Direct Decompression
System and UniVise™ Spinous Process Fixation System.

“These regulatory clearances represent important milestones for
VertiFlex® as we rapidly expand our portfolio of innovative interspinous
technologies,” said Earl R. Fender, President and Chief Executive
Officer of VertiFlex, Inc. “We leveraged the unique benefits of our
Superion® Interspinous Spacer System and strong IP position, to develop
these differentiated products to address two significant market
opportunities. This accomplishment highlights the company’s core
strengths and fundamental commitment to provide physicians with multiple
options to best treat patients in the least invasive methods possible.”

is a unique set of
surgical instruments designed specifically for performing minimally
invasive direct decompressions of the lumbar spine. The system utilizes
VertiFlex’ proprietary interspinous access platform and includes both
reusable and disposable instruments to treat spinal stenosis by removing
targeted bone and soft tissue. The Totalis™ Direct Decompression System
was 510(k) cleared by the FDA in November, 2012.

is a spinal implant
system designed to provide fixation of the spinous processes as an
adjunct to lumbar spinal fusion. The system leverages the company’s core
technology and intellectual property. The UniVise™ system is the least
invasive spinous process fixation system available and was 510(k)
cleared by the FDA in December, 2012.

is a
motion-preserving spinal implant system for the treatment of moderate
lumbar spinal stenosis. Superion® is the most advanced and least
invasive ISS available or in development for performing indirect
decompressions of the lumbar spine. The Superion® implant is delivered
from a posterior midline approach through a proprietary interspinous
access system developed by VertiFlex®. The small incision can be closed
with a single suture and performed under local anesthesia on an
outpatient basis. Once in place, it may reduce pressure on the nerves
that cause pain and allow the return to a more active lifestyle.
Superion® has been CE marked since 2007 and is currently an
investigational device in the U.S. Enrollment completed in the Superion®
pivotal IDE trial with 470 patients in December, 2011. It has been
implanted in over 2000 patients worldwide.

VertiFlex® is a privately held medical device company dedicated to the
advancement of minimally invasive solutions for the treatment of lumbar
spinal stenosis, which is the leading cause of spinal surgery in the
elderly. Founded in 2005 and headquartered in San Clemente, CA,
VertiFlex® has developed a proprietary, minimally invasive interspinous
access platform for performing both indirect and direct decompressions
of the lumbar spine. These technologies fill the MIS procedural gap in
the stenosis treatment continuum between conservative care and
traditional spine surgery. This provides new options for interventional
spine physicians and less invasive options for traditional spine
surgeons to treat patients who would otherwise undergo more invasive
surgery. To date, VertiFlex® has compiled the largest, most rigorous,
body of device clinical evidence, related to lumbar spinal stenosis.

VertiFlex®, Inc.Scott Lynch949-940-1400info@vertiflexspine.comwww.vertiflexspine.com

Source: VertiFlex, Inc.