N Spine Receives 510(k) Clearance Of Its NFix II Dynamic Stabilization System For The Lumbar Spine

N Spine, Inc., a privately held San
Diego spinal implant company, today announced that it has received FDA
clearance of its NFix(TM) II dynamic pedicle screw and rod system for
stabilization of the lumbar spine as an adjunct to fusion. NFix(TM) II is
now commercially available in the United States.


"Interest from US surgeons in the NFix(TM) II Dynamic Stabilization
System has been extremely strong," said Sean Na, president and chief
executive officer of N Spine. "This enthusiasm reflects the appeal of our
unique design as well as the growing market adoption of dynamic rod
systems."



Outside of the US, early clinical results with the company's NFlex(TM)
Controlled Motion System have been very favorable. NFlex(TM) is the first
product to market that controls shear motion, while allowing a more
physiologic level of flexion, extension and lateral bending. NFlex(TM) is
CE marked for non-fusion indications, and is the subject of an N Spine
sponsored prospective randomized trial comparing it to the Zimmer
Dynesys(R) device.



"I'm very pleased with the results of the three-month motion x-rays on
the first NFlex(TM) patients," stated Hansen Yuan, MD, who is a member of
the N Spine, Inc. Scientific Advisory Board. "It's clear that motion is
maintained."



With clearance of the NFix(TM) II Dynamic Stabilization System for
fusion surgery, and NFlex(TM) as a stand alone motion preservation device
for non-fusion outside the US, the company is well positioned to leverage
its proprietary designs in the $5 billion spinal implant market. "There are
a significant number of patients who will benefit from motion preserving
technologies," stated Na.



Recently, N Spine closed on $2.75 million debt financing by Silicon
Valley Bank and has raised a total of $7.1 million in equity and
non-dilutive financing.



About N Spine, Inc



N Spine, Inc. is a privately held San Diego spine company that designs
and develops devices for dynamic stabilization and motion preservation of
the lumbar spine via minimally invasive surgery (MIS). The company is
positioned to become the market leader in this emerging field.



N Spine has developed a superior platform technology that will serve a
broad set of indications, successfully recruited executives with extensive
spine industry experience, and created an internationally renowned
Scientific Advisory Board.


N Spine, Inc.

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