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Amedica® Closes $30 Million Financing

SALT LAKE CITY, Sept. 7 /PRNewswire/ — Amedica Corporation, a developer of a broad range of innovative, unique spine and total joint implants, announced that it has completed a $30 million financing.  The financing consists of $15 million in private equity and a debt facility of $15 million.  Zions First National Bank provided the debt facility, and Creation Capital of New Yorkand Austin, Texas… Continue reading »

K2M Receives 510(k) Clearance for its CHESAPEAKE Anterior-Lumbar Stabilization System

LEESBURG, Va.–(BUSINESS WIRE)–K2M, Inc., a spinal device company developing innovative solutions for the treatment of complex spinal pathologies, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its new CHESAPEAKE™ Anterior-Lumbar Stabilization System, a unique interbody device designed for stabilization of the spine through an anterior… Continue reading »

NuVasive Poised For Strong Results

Nuvasive Inc. (NYSE: NUVA) plans on holding an analyst meeting on September 14. According to Jefferies, while there may be doubt in the company’s ability to continue its growth targets because of a poor spine market growth, revenue forecasts remain achievable given continued strongmarket share gains.

Jefferies says the major issues roiling… Continue reading »

Mazor wins FDA nod for combined surgical systems

Mazor Surgical Technologies Ltd. (TASE:MZOR) has obtained US Food and Drug Administration (FDA) approval for the company’s combined spinal surgical system comprising the SpineAssist miniature robotic navigation system and C-Insight 3D imaging system.

Mazor believes that the synergy that can be achieved by use of the combined system and the high… Continue reading »

Ortho Kinematics Pursues Large Market Opportunity in Back Pain Diagnostics

Americans spend at least $50 billion per year on low back pain. Hardly surprising when you consider that as many as 80 percent of American adults suffer from low back pain at some point during their lives. That number is expected to increase as our population ages and obesity rises.

Although back pain is… Continue reading »

Canaccord Genuity Reiterates a ‘Buy’ Rating on Exactech (EXAC); Silverbolt Acquisition Adds Fifferentiated MIS Product

Canaccord Genuity reiterates a ‘Buy’ rating on Exactech, Inc. (NasdaqEXAC), lowers PT from $26 to $23.50.

Canaccord analyst says, “We reiterate our rating as the acquisition further strengthens the company’s spine portfolio with the addition of a minimally invasive system. Furthermore, given the dynamics of the spine market right now, the new products… Continue reading »

CareFusion Announces National Launch of Spinal Fracture Device

SAN DIEGO, Aug. 26 /PRNewswire-FirstCall/ — CareFusion (NYSE: CFN), a leading, global medical device company, today announced the national commercial launch of the AVAmax® Vertebral Balloon, a minimally invasive device for use during kyphoplasty, a procedure for treating spinal compression fractures.

The AVAmax Vertebral Balloon represents a competitive breakthrough and is expected to enhance… Continue reading »

Medyssey Spine Receives FDA 510(k) Clearance for Zenius(TM) Thoracolumbar Spinal System in Titanium Alloy (Ti6AL-4V ELI)

LOS ANGELES, Aug. 25 /PRNewswire/ – South Korea-based Medyssey Co., Ltd. announced today that the Company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Zenius(TM) Thoracolumbar Spinal System. Though currently available in limited release, Medyssey will launch the new Zenius(TM) System in the United States in Q4.

The Zenius(TM) System is a Ti… Continue reading »

Welsh, Carson, Anderson & Stowe completes acquisition of majority position in K2M

K2M, Inc., a spinal device company developing solutions for the treatment of complex spinal pathologies, and the private equity firm Welsh, Carson, Anderson & Stowe announced in a press release the closure of a transaction in which Welsh Carson has acquired the outstanding stock and become the majority shareholder of K2M.

The Welsh Carson… Continue reading »

Benvenue Medical Begins Enrollment in Landmark Study Versus Balloon Kyphoplasty

SANTA CLARA, Calif.–(BUSINESS WIRE)–Benvenue Medical, Inc., a developer of minimally invasive solutions for spine repair, announced today that it has enrolled the first patient into the landmark KAST (Kiva® System as a Vertebral Augmentation Treatment – A Safety and Effectiveness Trial) study. The case was performed by Sean Tutton, MD FSIR, Associate Professor of Radiology and Surgery… Continue reading »

Integra LifeSciences Opens State-of-the-Art Center for Research, Education and Training in Irvine, California

PLAINSBORO, N.J., Aug 20, 2010 (GlobeNewswire via COMTEX) — Integra LifeSciences Holdings Corporation(IART 35.76, -0.57, -1.57%) announced today the opening of its state-of-the art Center for Research, Education and Training in Irvine, California. The new facility is designed to accommodate hands-on simulated surgical training, while also creating a laboratory setting for research… Continue reading »

BINDER BIOMEDICAL, INC. Announces Official Launch of the NEWTON™ Intervertebral Body Fusion Spinal Spacer System

BOCA RATON, Fla., Aug. 19 /PRNewswire/ — The NEWTON™ Intervertebral Body Spacer System is comprised of a complete line of lumbar spinal spacers that allow anterior, posterior or lateral insertion angles to reach the intervertebral disc space.  Each implant is designed with a large central window for optimum graft placement. Initial size offerings range from 7 to… Continue reading »

Aesculap Implant Systems, Inc. Receives FDA 510(k) Clearance for the A-Fix™ (SIBD) Spinal System

CENTER VALLEY, Pa.–(BUSINESS WIRE)–The Aesculap Implant Systems A-Fix Spinal System received 510(k) clearance under K100802 by the U.S. Food and Drug Administration (FDA) on July 20, 2010. The A-Fix Spinal System is a stand-alone interbody fusion device developed for the anterior surgical approach and is intended for spinal fusion procedures at one or two… Continue reading »

Paradigm BioDevices, Inc. Wins English High Court Verdict Against Surgicraft Ltd. in Contractual Dispute

ROCKLAND, Mass.–(BUSINESS WIRE)–Paradigm BioDevices, Inc. announced today that the High Court of Justice, Chancery Division in London, England has ruled in Paradigm BioDevices’ favor in a lawsuit against Surgicraft Ltd., a wholly-owned subsidiary of Centinel Spine, LLC. Paradigm BioDevices was granted favorable rectification of a contract between the two companies with the result that… Continue reading »

Integra Adds iPASSAGE Retractor

Recently, Integra Lifesciences Holdings Corporation (IART -Snapshot Report) added a tissue sparing retraction system, iPASSAGE Retractor for Minimally Invasive Surgery of the lumbar spine. The iPASSAGE system allows the surgeon to make smaller cuts, thereby reducing the time of recovery, tissue damage and blood loss