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Current & Critical

NASS Preview: New and Notable in Spine

These brief profiles preview newer or noteworthy companies in the spine space—some of whom you will meet on the exhibit floor at the North American Spine Society meeting in October. We’ll be there, too—find us in Booth 1718.

                For a refresher on past newcomers to the spinal scene, visit the ORTHOKNOW archives and check out the October 2011, September and December 2012 and July 2013 issues.

Cardinal Spine, LLC
Louisville, Kentucky, USA
www.cardinalspine.net
NASS Booth 3014

  • Two FDA-cleared products, STCC cervical cage interbody spacer, and STCG vertebral body replacement
  • Trapezoid-shaped, titanium-based devices claimed to have “superior compressive strength compared to cylindrical cages”

 

CoreNexus
Encino, California, USA
www.core-nexus.com

  • Manufacturing a range of minimally invasive spine surgery delivery systems and implants, including the FDA-cleared Nexus anterior cervical plate and Core pedicle screw
  • Developed the NIP (Non Invasive Pain) Procedure that enhances the release of natural endorphins, with application to treat chronic back and neck pain

 

Frontier Medical Devices, Inc.
Marquette, Michigan, USA
www.frontiermd.com

  • First FDA 510(k) clearance in 4Q12 for Lateral Locking Cage for treatment of degenerative disc disease and instability
  • Claims to be first of its kind minimally invasive interbody cage, locks to the vertebra above and below the disc space

 

G6 Spine, Inc.
Newport Beach, California, USA
NASS Booth 448

  • Focus on treatment of advanced degeneration, trauma, scoliosis and spondylolisthesis will include motion preservation, minimal invasive techniques and enhancement of current market fusion treatments

 

Gallini, Srl
Montova, Italy
Gallini U.S.
Caledonia, Michigan, USA
www.gallinimedical.com
NASS Booth 3213

  • Formed over 40 years ago, now entering the bone biopsy, vertebroplasty and percutaneous discectomy market
  • Vertebroplasty needles, Solidus vertebroplasty system, kyphoplasty set, ozotherapy needle for treatment of herniated discs, herniatome discectomy device, etc.

 

Intellirod Spine
Akron, Ohio, USA
www.intellirodspine.com
NASS Booth 3119

  • Formerly OrthoData
  • Developing a wireless implantable microelectronic lumbar spine fusion sensor
  • In 1Q13, received a $1.1MM investment to support prototype development and animal studies; seeking up to $500,000 to complete the series B1 round

 

Interventix
Miamisburg, Ohio, USA
www.interventix.com
NASS Booth 3236

  • Developing devices and methods to support spinal fusion procedures
  • Brands include Silex Sacroiliac Joint Fusion System, Zygafix Facet Fusion System

 

JG Spine, LLC
Ponte Vedra Beach, California, USA

  • Received first FDA 510(k) clearance for Surefix Interspinous Fusion System

 

Mobitor Corporation
San Ramon, California, USA
www.mobitor.com
NASS Booth 2836

  • Not a spine company, but counts several among its customers: DePuy Synthes, Integra, K2M, Stryker…
  • Developed a comprehensive UDID (Unique Device Identifier Database) system
  • SOPIC solution provides manufacturers, distributors and healthcare providers a single-vendor suite to leverage use of UDI information for electronic patient records, adverse event reporting, product recalls, inventory management, etc.

 

Next Orthosurgical, Inc.
Vista, California, USA

  • Received first FDA 510(k) clearance for Interform Interbody Cage System

 

OsteoNovus
Toledo, Ohio, USA
www.osteonovus.com
NASS Booth 551

  • Early-stage company, chaired by Dr. Anand Agarwal
  • Developing novel synthetic calcium phosphate-based cement in injectable, putty, granule and structural block forms for orthopaedic and spine surgery

 

Pan Medical, Ltd.
Gloucester, United Kingdom
www.pan-medical.co.uk
NASS Booth 3123

  • InterV balloon kyphoplasty systems + Vfix bone cement are approved under the CE Mark

 

Providence Medical Technology, Inc.
Lafayette, California, USA
www.providencemt.com
NASS Booth 215

  • Recently received FDA 510(k) for minimally invasive PMT Cervical Cage implant and delivery system for cervical fusion
  • Markets DTRAX Facet System ex-U.S.

 

Safewire LLC
Cooper City, Florida, USA
www.safe-wire.com
NASS Booth 2542

  • In 2012, launched the Y-wire guidewire in the U.S., designed to reduce wire migration and kinking issues common with standard guidewires
  • Recently secured $1.1MM investment to support Tiger Needle for placement of Y-wire to desired depth within vertebral body

 

Shanghai Sanyou Medical Instrument Co., Ltd.
Shanghai, Peoples’ Republic of China
www.sanyoumed.en.gongchang.com

  • Founded in 2005
  • Developing minimally invasive non-fusion spinal products, as well as trauma products
  • Received first FDA 510(k) clearance for the Katia intervertebral body system

 

Southern Spine, LLC
Macon, Georgia, USA
www.southernspine.net
NASS Booth 3215

  • Recently launched StabiLink MIS Spinal Fixation System for use in lumbar fusion
  • Device is implanted with PG Precision Guided Inserter/Compressor, an “all in one” instrument designed to place the implant with or without removal of the interspinous ligaments

 

Spinal Balance, LLC
Holland, Ohio, USA
NASS Booth 955

  • Very recent start-up; limited information available
  • Led by Vijay Goel, Ph.D.

 

Spinal Ventures, LLC
Minneapolis, Minnesota, USA
www.spinalventures.com
NASS Booth 641

  • Founded in 2005 by by orthopaedic industry entrepreneur, designer and developer
  • Developing technologies based on beads flexibly connected on a chain, for treatment of vertebral compression fractures, bone voids and weak or deficient bone Beads deliver the flowable agent at zero pressure; bead chain and agent can be retracted;  precise aliquot of material is delivered per handle pull

 

Spine Soft Fusion Co.
Rio de Janeiro, Brazil
www.spinesoftfusion.com
NASS Booth 236

  • Developing the first translaminar facet PEEK screw, to be placed through percutaneous approach via an all-in-one fluoroscopy-guided technique, addressing lumbar degenerative disease up to 2 levels
  • “Not so rigid as pedicle screws, and not so mobile as lumbar TDR”

 

Sources: Company press releases, web sites, articles in the public domain, FDA 510(k) releasable database, filings with the U.S. Securities and Exchange Commission, etc.