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Current & Critical

NASS Preview: Products and Companies to Watch

By Julie Vetalice

Spine-centric product news and personnel announcements are ramping up as we near the mid-October annual meeting of NASS, the North American Spine Society. Recent analyst notes suggest that pure-play companies continue to outperform larger diversified ones, with smaller companies posting revenue growth in the area of 15% vs. single-digit growth for the bigs. Others point up growing interest in the potential use of 3D printing technologies and ongoing investigation of biologic treatments for spine disease.

But what’s been happening in the space? I used the Search Content tool in ORTHOWORLD to suss out recent activities for a variety of companies that will exhibit this year—yielding this list of product launches, clearances, M&A and more about first-time and long-time exhibitors.

We’ll be there, too. Bring us your thoughts on what lies ahead in spine for 2016. Come see Fran Bursic, Mike Casey and Carolyn LaWell in booth 765.
 

4WEB Medical
Frisco, Texas, USA
www.4webmedical.com
Booth 561

  • Manufacturer of 3D-printed ALIF and Cervical Spine Truss devices for use in spine as well as foot/ankle applications
  • Showcasing recent 510(k)-cleared PLIF, TLIF and OLIF Spine Truss Systems (K143258)
  • 3D-printed technology supports the design of structures built to guide bone formation through structural mechanics vs. biologics, actively participating in stimulation of the healing process
  • Seeking to enter even more musculoskeletal sub-segments—e.g. shoulder, knee



Camber Spine Technologies
Wayne, Pennsylvania, USA
Booth 557

  • Specializing in spinal fusion devices; five products 510(k)-cleared since 2013, most recently VERTA Corpectomy Cage: PEEK-based load-bearing frame, hollow center
  • Also carries products for endoscopic hand and extremity surgery



ChoiceSpine
Knoxville, Tennessee, USA
www.choicespine.net
Booth 1757
ChoiceSpine acquired the Baxano VEO® Lateral Access & Interbody Fusion System in 1Q15. Following that, the company:

  • Announced the 1st surgery using the THUNDERBOLT™ Minimally Invasive Pedicle Screw system, designed to provide immobilization and stabilization in skeletally mature patients as an adjunct to fusion
  • Commenced U.S. launch of the BLACKBIRD™ Posterior Cervical System
  • Received approval under the CE Mark for VEO



DeGen Medical
Florence, South Carolina, USA
www.degenmedical.com
Booth 964

  • In 2015, received first FDA 510(k) clearances: F1-Modular Pedicle Screw (K142531) and Hyper-C Anterior Cervical Plate (K150759)
  • Company leadership experience includes Medtronic and Stryker
  • F1 MPS is reportedly the first Cobalt-Chrome alloy modular pedicle screw system to market; its modularity supports complete decortication, easy visualization and larger volume of bone grafting in posterolateral gutters



G Surgical
Boulder, Colorado, USA
www.gsurgical.com
Booth 948

  • Most recent FDA 510(k) clearance for PEEK cervical spacer (K142456), a complement to the T-Lok Anterior Cervical System (the latter used in >5,000 surgeries to date)
  • Other FDA-cleared products include an anterior cervical plate and pedicle screw system
  • Company leadership includes experience at Arthrex, LDR, Medtronic
  • Offices in the U.S., Malaysia and Thailand
  • Also distributes for Biomatlante and Parcus in Malaysia and South Asia



Intelligent Implant Systems
Charlotte, North Carolina, USA
www.intelligentimplantsystems.com
Booth 1739

  • In 1Q15, received FDA 510(k) clearance to market Revolution Spinal System™ (K142939), which debuted at NASS 2014; reportedly the 1st fully-disposable system designed from inception to provide ease of use, cost savings, best outcomes and value
  • In 3Q15, the company received a round of financing for a significant, undisclosed amount in support of ongoing launch and sales of Revolution.
     

Premia Spine
Ramat Poleg, Israel
www.premiaspine.com
Booth 1709

 


MEMBER BENEFIT TIP


 Interested in a company that’s not on this list? Type it into the Search Content tool on the ORTHOWORLD home page to find products cleared and launched, funding achieved, license agreements, collaborations...more!

 

  • First FDA 510(k) clearance received in 3Q15, for ProMIS™ 
    Fixation System (K150380)
  • Developer of TOPS™, designed to stabilize the spine while maintaining the motion segment vs. fusing or leaving it unprotected; at extreme ranges of flexion, extension, lateral bending and axial rotation, peak loads are addressed with a sophisticated biomechanical implant as opposed to a simple rod/screw system
  • Commercially launching ProMIS Fixation System and introducing
    the new TOPS System to U.S. surgeons
  • TOPS update: Premia has reduced the size of the implant from the
    original device that was first implanted in 2005; still investigational in the U.S.; planning to initiate a prospective, randomized trial in 2016

     

Providence Medical Technology (PMT)
Lafayette, California, USA
www.providencemt.com
Booth 623

  • In 3Q15, PMT closed a $12 million financing that will support commercialization and portfolio expansion of DTRAX® cervical fusion products
  • Within 2015, PMT received CE Mark approval for its DTRAX Spinal System, DTRAX Cervical Cage and DTRAX Bone Screw and commenced full U.S. launch of DTRAX Bone Screws, indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion and fracture repair/fixation



Safe Orthopaedics
Headquarters Eragny sur Oise, France
Memphis, Tennessee, USA
www.safeortho.com
Booth 1295
Within 2015, Safe Ortho has:

  • Commenced EU launch of a new fenestrated screw and announced 1st surgeries in patients with osteoporosis; the device combines the screw with preassembled single use instruments to eliminate the risk of cement leakage, with the cement dose housed directly in a cannula in the screwdriver’s handle
  • Announced 1st use of the Auto-Adjust pedicle screw in procedures to repair thoracic and lumbar spinal fractures
  • Announced results from a 45-patient U.S. retrospective clinical study of SteriSpine™ sterile single-use instrumentation for lumbar fusion that indicated no cases of infection nor morbidity/mortality



SeaSpine
Vista, California, USA
www.seaspine.com
Booth 1469

  • SeaSpine has just launched its first product as an independent company, spun out of Integra LifeSciences: the Ventura™ NanoMetalene® transforaminal intervertebral body fusion device, featuring convex surfaces, multiple footprints and a large graft aperture for autogenous bone graft



Spinal Elements
Carlsbad, California, USA
www.spinalelements.com
Booth 1163

  • Just received FDA 510(k) clearance for the Lotus® Posterior Cervical/Thoracic Spinal System (K151705), broadening indications to include placement of screws in the cervical spine in addition to the thoracic spine.
  • Spinal Elements is reportedly 1 of 3 companies in the posterior cervical/thoracic space to receive clearance for these expanded indications.



Titan Spine
Mequon, Wisconsin, USA
www.titanspine.com
Booth 1176

  • In 1Q15, Titan Spine received FDA 510(k) clearance to market the Endoskeleton® TCS interbody fusion device for use in the cervical spine with integrated fixation (K142940)
  • Within 2015, studies demonstrated that Endoskeleton Interbody Devices promoted osteoblastic differentiation and an enhanced bone-forming environment vs. PEEK. Specifically, data showed that fibrous tissue formation around PEEK implants may be due to the creation of an inflammatory environment.
  • Further, studies comparing subsidence rates of spinal implants during continuous cyclic loading demonstrated that the TA ALIF interbody device provided a 410% reduction in rate of subsidence and a 40% reduction in overall subsidence vs. a commercially-available ALIF PEEK implant of a similar footprint.
  • The company continues to expand its geographic reach: in 3Q15, Titan granted MBA rights to distribute Endoskeleton devices in Spain, Portugal, Andorra, Luxembourg, Belgium and the U.K.



Xenco Medical
San Diego, California, USA
www.xencomedical.com
Booth 1689

  • Three products FDA 510(k)-cleared since 2014: cervical interbody (K140786), lumbar interbody (K143158) and pedicle screw (K151733)
  • In early 3Q15, announced 1st U.S. spine surgery at a major hospital using its disposable plastic surgical rasps and implant inserter, in an ACDF procedure; Argus Cervical Interbody System devices are intended for spinal fusion procedures at one level (C3-C7) to treat degenerative disc disease and are disposable to eliminate any chance of infection due to reused, improperly sterilized instruments



Zyga Technology
Minneapolis, Minnesota, USA
www.zyga.com
Booth 1490
Thus far in 2015, Zyga has:

  • Commenced enrollment of up to 50 patients in the 10-site U.S. EVoluSIon Study, a single-arm trial investigating fusion and pain reduction following use of the SImmetry® Sacroiliac Joint Fusion System
  • Announced the 1st implantation of the Glyder® Facet Restoration device in Cyprus, Greece, to address new-onset facet joint pain in a patient with a previous total disc replacement
  • Launched an updated version of the SImmetry system
  • Received FDA 510(k) clearance to market SImmetry using either a 1- or 2-incision technique



Julie Vetalice is Content Coordinator at ORTHOWORLD. Reach her by email.
 

Come by Booth 765 at NASS:
We’ll be at NASS equipped with market intel, partner recommendations, brand-building solutions and more. We look forward to the opportunity to serve you.

Email Fran Bursic beforehand to confirm a meeting.