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Year in Review

2014: A Recap of Strategic Activities in Spine

Editor’s Note: This segment-specific article is excerpted from the full version, covering major market segments, appearing in ORTHOKNOW January 2015.

To begin 2015, let’s look back at what fueled growth in 2014 in the spine market. Here, we present companies that have merged and emerged, products that launched, projects that received funding. (Please note, ORTHOKNOW July 2014 features a review of 1H14 funding activity.)

Lending perspective from your peers, this issue includes insights gathered at the 2014 Musculoskeletal New Ventures Conference, as well. See companion articles, “Business Development Execs Speak on M&A and Innovation” and “Industry Investments Stay Steady, Focus on Established Technologies.”


Start-ups, spin-outs and subsidiaries identified during 2014 included:

Apollo Implants, LLC
Canton, Ohio, USA

  • Seeks funding to commercialize Injectable Spinal Disc technology that employs nano-polymer to mechanically stabilize the disc from within
  • CEO is lead researcher on one of the first nanotech nucleus pulposus spinal implant devices
  • Attempted to raise funds via Indiegogo and Kickstarter campaigns


GEN2 Medical
Cleveland, Ohio, USA

  • Formed to import, manufacture and sell instruments and devices for use in all surgical specialties, with a primary focus on neurosurgery, orthopaedics and spine
  • Also partners with surgeon inventors to support more control over product development
  • Exclusive U.S. distributor of Rebstock spinal instruments from Germany


SeaSpine
Vista, California, USA

  • SeaSpine was acquired in 2Q11 by Integra LifeSciences for $89MM
  • Now spinning out as a publicly-traded company to develop, market and sell spinal hardware and orthobiologics; expected to close by end of 2015
  • Will operate as an independent entity with an estimated $140MM of trailing 12-month revenue as of 9/30/14


Vexim Inc.
Norcross, Georgia, USA

  • Formed a U.S. subsidiary to support planned early-2015 commercial launch of vertebroplasty and kyphoplasty solutions, such as SpineJack®
  • Parent company headquartered in France



Closures, restructuring and rebranding announced in 2014 included:

  • AxioMed Spine: Acquired by KICVentures, which also backs SpineFrontier; developed technology to restore cervical and lumbar disc function, including the Freedom® artificial disc platform
  • Baxano Surgical: Auctioning product lines (minimally invasive approaches to treat degenerative lumbar spinal conditions); delisted from NASDAQ as of mid-4Q



M&A Activity in 2014:

ORTHOWORLD’s Merger & Acquisition database recorded 41 transactions in 2014. The table below captures select OEM activities with application in spine; visit the M&A database to see all 41, including numerous deals among suppliers.

Also announced in 2014, and not yet closed:

  • Medtronic to acquire Covidien (slated for early 2015)
  • Wright Medical merging with Tornier (slated for 1H15)
  • Zimmer to acquire Biomet (slated for 1Q15)

 

Acquiring Company  Acquired Company
Bioventus Advanced Biologics' OsteoAMP, tissue-based bone biologic
Globus Medical  Excelsius Surgical robotic positioning platform
Globus Medical  Transplant Technologies of Texas allografts/tissue
Stryker CoAlign Innovations interbody fusion device




Fundings identified during 2H14 included:

Amedica raised $13MM in a public offering

  • ~11.44MM units at $1.14/unit
  • Will support R&D and operations during advancement of direct sales of silicon nitride through own channels


Intrinsic Therapeutics raised $17.3MM of a planned $20.8MM round

  • Developed Barricaid® prosthesis for partial anular replacement


Nimbic Systems awarded a $1.5MM grant from the National Institutes of Health

  • To support a pivotal, multi-center clinical trial of the Air Barrier System for the prevention of implant infections in hip arthroplasty, spine fusion, acetabular reconstruction, etc.


Ortho Kinematics raised ~$0.5MM of a planned $0.75MM financing

  • Developed fluoroscopy-based VMA™ (Vertebral Motion Analysis) diagnostic tool to generate patient-specific graphs for each vertebral level


Surgical Frontiers closed a $7MM fund

  • To invest in its incubator focused upon musculoskeletal surgical technology start-ups
  • Initial funding commitments have been made to 3 portfolio companies addressing foot/ankle, sports medicine and trauma


Zyga Technology completed a $10MM financing round

  • To support U.S. sales and marketing in advance of a 2015 Category 1 CPT code implementation for SI joint fusion procedures and 3 clinical studies of the SImmetry Sacroiliac Joint Fusion System and GlyDer Facet Restoration Device



Product launches in 2014 included:

Aurora Spine
ECHO™ (PLIF) and ECHO XL™ (OLIF) MIS Interbody Systems

  • Next-generation lumbar interbody cages featuring TiNano™ titanium spray coating to provide additional roughness and porosity, increased possibility of bone ongrowth and enhanced radiographic visibility
  • TiNano will be available on all Aurora interbody cages, including Cervical, PLIF, OLIF, TLIF, ALIF and LLIF


Benvenue Medical
Kiva® VCF Treatment System

  • Implant-based solution for vertebral augmentation, next-generation alternative to balloon kyphoplasty
  • Data from 3 studies indicate that Kiva met or exceeded balloon kyphoplasty in the reduction of pain and restoration of function in treating VCFs, improved kyphotic angle restoration, reduced the rate of cement extravasation and reduced the rate of adjacent fractures one year after treatment


Medicrea
UNiD

  • Europe launch
  • Patient-specific spinal osteosynthesis rod system designed to eliminate manual bending of rods in the OR during surgery
  • Software + real-time support help surgeons preoperatively analyze, design and order patient-specific rods


Spine Wave
Lateral Access Product portfolio

  • StaXx® XDL and IBL expandable devices, Abacus™ Lateral Spacer, XLR® Lateral Access system and full line of single-use accessories
  • Portfolio offers multiple expandable implant options as well as a more traditional non-expandable PEEK implant


Spineology
VIA™ Spinous Process Fixation System

  • Reportedly 1st Spinous Process Plate with independently compressible superior and inferior plates that are contoured to maximize the fit between the implant and the spinous processes/associated laminae
  • Part of the Anatomy Conserving Technology (ACT™) line


Titan Spine
Warranty for Endoskeleton® spinal interbody fusion devices

  • Provides a 1-time free replacement of any eligible Titan spinal interbody fusion device if revision surgery is required within the 5-year warranty period, per agreement terms
  • Endoskeleton® devices feature proprietary implant surface technology with roughened topographies at the macro, micro and cellular levels to create optimal host/bone response and actively participate in the fusion process


A portion of this article appeared in the December 2014 issue of BONEZONE®.

Sources: Company press releases, earnings calls, filings with the U.S. Securities and Exchange Commission, company web sites, articles in the public domain, etc.


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