Healthcare Industry News: Zimmer
News Release - September 25, 2006
N Spine Announces the First Clinical Use of Its NFlex(TM) Dynamic Stabilization System and Close of Series B Round Led by a Major Spine CompanyAdditional Milestones Include Achievement of CE Mark Certification and the Start of a Clinical Trial Comparing NFlex to Dynesys From Zimmer Spine
SAN DIEGO, Sept. 25 (HSMN NewsFeed) -- N Spine, Inc., a privately held San Diego company that designs and develops devices for posterior fusion and dynamic stabilization of the lumbar spine, today announced the first clinical use of its NFlex(TM) Posterior Dynamic Stabilization System. The company also announced it has closed on its Series B round led by a market leader in the rapidly growing $3.2 billion spinal implant industry.
Additionally, N Spine announced ISO13485 certification of its San Diego facility and receipt of the CE mark on its NFlex Dynamic Stabilization and NFix(TM) Fusion Systems and the start of enrollment in an N Spine-sponsored prospective randomized controlled study to compare NFlex to Zimmer Spine's Dynesys System.
N Spine's lead product, NFlex, is a titanium pedicle screw system with a novel design that provides dynamic support to the spinal motion segment. This will be the first product to market that controls shear motion, while allowing a more physiologic level of flexion, extension and lateral bending. The company's NFix System is FDA cleared in the US for use in skeletally mature patients as an adjunct to fusion. The NFlex System is not available for use in the United States.
"We are very pleased that the NFlex Dynamic Stabilization System will now be used in the clinical setting as we believe it offers major advantages over traditional rigid systems," said Sean Na, president and chief executive officer of N Spine. "From this point on, we will be rapidly expanding into several leading spinal centers."
N Spine's posterior dynamic stabilization system represents an enabling technology which has an immediate role as a stand alone motion preserving device, and may also provide an appropriate level of motion and protection as an adjunct to artificial disc replacement and nucleus replacement. In the future, the company believes that dynamic stabilization will also play an important role in disc regeneration, because it can support the disc environment during stem cell proliferation.
About N Spine, Inc.:
N Spine, Inc. is a privately held San Diego spine company that designs and develops devices for rigid and dynamic stabilization of the lumbar spine via minimally invasive surgery (MIS). The company's main product, NFlex(TM), is a titanium pedicle screw system with a novel design that provides dynamic support (versus rigid fixation) to the spinal motion segment, and may be used in either a non-fusion or hybrid application. 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.
Source: N Spine
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