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CREO® and CREO AMP® 4.75 Threaded CoCr

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The CREO® Cobalt chrome (CoCr) platform offers the lowest profile option for the toughest pediatric deformity challenges.

CREO-CREO-AMP-4.75-Threaded-CoCr

  • Low-Profile Implants: The 4.75mm CoCr rod diameter provides the strength of a 5.5mm TAV rod with a lower screw height profile to accommodate small stature and pediatric patients.
  • Solutions for Complex Spinal Pathologies: The cobalt chrome screw heads are ideal for deformity procedures requiring high correction forces.
  • Modular Versatility: CREO AMP® modular screw shanks may be placed prior to the screw head to allow for increased visualization, screw head distraction and more working room.

The post CREO® and CREO AMP® 4.75 Threaded CoCr appeared first on Globus Medical Inc..


Globus Medical Announces CE Mark for Excelsius GPS™

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Globus Medical Announces CE Mark for Excelsius GPS™

Excelsius GPS™ – Robotic Trajectory Guidance and Navigation for Surgery

AUDUBON, Pa., Jan. 05, 2017 (GLOBE NEWSWIRE) — Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal implant manufacturer, today announced that the Excelsius GPS™, a revolutionary system providing robotic trajectory guidance and navigation, is now CE marked. This platform technology supports both minimally invasive and open orthopedic and neurosurgical procedures, with applications ranging from the cervical spine to the sacroilium, long bones and cranium. Excelsius GPS™ seamlessly integrates with Globus Medical implants and instruments and is compatible with pre-operative CT, intra-operative CT and fluoroscopic imaging modalities. The system is designed to minimize radiation exposure, streamline workflow, and reproducibly assist in implant placement.

“Excelsius GPSTM is another example of continued innovation from Globus Medical, utilizing feedback from expert surgeons from different specialties,” said Norbert Johnson, Vice President of Robotics, Imaging, & Navigation. “Our goal with the Excelsius GPS™ System is to improve the continuum of care for patients, surgeons, and hospitals through the application of robotic and navigation technology in the fields of spine, trauma, and cranial surgery.”

About Globus Medical, Inc.
Globus Medical, Inc. is a leading musculoskeletal implant company based in Audubon, PA. The company was founded in 2003 by an experienced team of professionals with a shared vision to create products that enable surgeons to promote healing in patients with musculoskeletal disorders.

Safe Harbor Statements
All statements included in this press release other than statements of historical fact are forward-looking statements and may be identified by their use of words such as “believe,” “may,” “might,” “could,” “will,” “aim,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “plan” and other similar terms. These forwardlooking statements are based on our current assumptions, expectations and estimates of future events and trends. Forward-looking statements are only predictions and are subject to many risks, uncertainties and other factors that may affect our businesses and operations and could cause actual results to differ materially from those predicted. These risks and uncertainties include, but are not limited to, factors affecting our quarterly results, our ability to manage our growth, our ability to sustain our profitability, demand for our products, our ability to compete successfully (including without limitation our ability to convince surgeons to use our products and our ability to attract and retain sales and other personnel), our ability to rapidly develop and introduce new products, our ability to develop and execute on successful business strategies, our ability to successfully integrate the international operations acquired from Alphatec, both in general and on our anticipated timeline, our ability to transition Alphatec’s international customers to Globus Medical products, our ability to realize the expected benefits to our results from the Alphatec acquisition, our ability to comply with laws and regulations that are or may become applicable to our businesses, our ability to safeguard our intellectual property, our success in defending legal proceedings brought against us, trends in the medical device industry, general economic conditions, and other risks. For a discussion of these and other risks, uncertainties and other factors that could affect our results, you should refer to the disclosure contained in our most recent annual report on Form 10-K filed with the Securities and Exchange Commission, including the sections labeled “Risk Factors” and “Cautionary Note Concerning Forward-Looking Statements,” and in our Forms 10-Q, Forms 8-K and other filings with the Securities and Exchange Commission. These documents are available at www.sec.gov. Moreover, we operate in an evolving environment. New risk factors and uncertainties emerge from time to time and it is not possible for us to predict all risk factors and uncertainties, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Given these risks and uncertainties, readers are cautioned not to place undue reliance on any forward-looking statements. Forward-looking statements contained in this press release speak only as of the date of this press release. We undertake no obligation to update any forward-looking statements as a result of new information, events or circumstances or other factors arising or coming to our attention after the date hereof.

Contact:
Daniel Scavilla
Senior Vice President, Chief Financial Officer
Phone: (610) 930-1800
Email: investors@globusmedical.com
www.globusmedical.com

The post Globus Medical Announces CE Mark for Excelsius GPS™ appeared first on Globus Medical Inc..

Globus Medical Schedules Fourth Quarter and Full Year 2016 Earnings Release and Conference Call

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Globus Medical Schedules Fourth Quarter and Full Year 2016
Earnings Release and Conference Call

AUDUBON, Pa., Feb. 07, 2017 (GLOBE NEWSWIRE) — Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal implant manufacturer, will announce its financial results for the fourth quarter and full year ended December 31, 2016 after the market close on Monday, February 27, 2017. A copy of the release will be available on the Globus Medical website at www.globusmedical.com/investors.

Following the announcement, Globus Medical will hold a teleconference to discuss its performance with the investment community at 5:30 p.m. Eastern Time. Globus invites all interested parties to join the call by dialing:

1-855-533-7141 United States Participants
1-720-545-0060 International Participants

There is no passcode for the teleconference.

For interested parties who do not wish to ask questions, the teleconference will be webcast live and may be accessed through a link on the Globus Medical website at www.globusmedical.com/investors.

The call will be archived until Monday, March 6, 2017. The audio archive can be accessed by calling 1-855- 859-2056 in the U.S. or 1-404-537-3406 from outside the U.S. The passcode for the audio replay is 6940- 2658.

About Globus Medical, Inc.
Globus Medical, Inc. is a leading musculoskeletal implant company based in Audubon, PA. The company was founded in 2003 by an experienced team of professionals with a shared vision to create products that enable surgeons to promote healing in patients with musculoskeletal disorders. Additional information can be accessed at www.globusmedical.com.

Contact:
Daniel Scavilla
Senior Vice President, Chief Financial Officer
Phone: (610) 930-1800
Email: investors@globusmedical.com
www.globusmedical.com

The post Globus Medical Schedules Fourth Quarter and Full Year 2016 Earnings Release and Conference Call appeared first on Globus Medical Inc..

Globus Medical Reports Full Year and Fourth Quarter 2016 Results

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Globus Medical Reports Full Year and Fourth Quarter 2016 Results

Download the full report here

AUDUBON, PA, February 27, 2017: Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal implant manufacturer, today announced its financial results for the fourth quarter and year ended December 31, 2016.

Fourth Quarter

  • Worldwide sales increased 6.3% as reported to $151.6 million, or an increase of 6.5% on a constant currency basis
  • Fourth quarter net income was $24.3 million, or 16.0% of sales
  • Diluted earnings per share (EPS) were $0.25
  • Non-GAAP diluted EPS were $0.31
  • Non-GAAP adjusted EBITDA was 37.7% of sales

Full Year 2016

  • Worldwide sales increased 3.5% as reported to $564.0 million, or an increase of 3.8% on a constant currency basis
  • Net income for the year was $104.3 million, or 18.5% of sales
  • Diluted EPS were $1.08
  • Non-GAAP diluted EPS were $1.19
  • Non-GAAP adjusted EBITDA was 37.4% of sales

 
David Paul, Chairman and CEO said, “Fourth quarter sales were $151.6 million, a year-over-year increase of 6.3%. Despite our increased spending in support of our pending robotics and trauma launches, our adjusted EBITDA margins was an outstanding 37.7%. We also delivered EPS of $0.25 and non GAAP EPS of $0.31.

“During the fourth quarter, we continued to make progress with product development, sales force development and integration of Alphatec’s international business. We also further expanded our in-house manufacturing capacity. We are proud of our innovation and product development efforts, which resulted in a total of 17 new product launches in 2016. We have addressed our sales force expansion challenges and are optimistic that we will return to more robust growth rates in the second half of 2017. We also remain confident in our long-term growth prospects and our ability to sustain industry-leading profitability by continuing to execute on our strategy of rapid product introduction, expansion of our U.S. and international sales footprints, and diligent expense control.”

Fourth quarter sales in the U.S. decreased by 2.7% compared to the fourth quarter of 2015, primarily due to one less selling day in the fourth quarter of 2016. International sales increased by 109.0% over the fourth quarter of 2015 on an as reported basis and 111.8% on a constant currency basis.

Fourth quarter GAAP net income was $24.3 million, a decrease of 35.4% over the same period last year resulting from the one-time positive net income impact of $7.6 million in 2015 due to the settlement of outstanding litigation. Diluted EPS for the fourth quarter was $0.25, as compared to $0.39 for the fourth quarter 2015. Non-GAAP diluted EPS, which removes the impact of this litigation and acquisition related expenses, for the fourth quarter was $0.31, compared to $0.32 in the fourth quarter of 2015.

The company generated net cash provided by operating activities of $51.9 million and non-GAAP free cash flow of $37.7 million in the fourth quarter. Cash, cash equivalents and marketable securities ended the quarter at $350.8 million. The company remains debt free.

The company plans to request an extension to file its Annual Report on Form 10-K for the fiscal year ended December 31, 2016 by filing Form 12b-25, Notification of Late Filing with the Securities and Exchange Commission. The company concluded it is not able to compile all information necessary to complete its Form 10-K by March 1, 2017 without unreasonable effort or expense. The company anticipates filing its Form 10-K for the fiscal year ended December 31, 2016 within the extension period.

2017 Annual Guidance
The company projects 2017 full year sales of $625 million and and non-GAAP fully diluted earnings per share of $1.27.

Conference Call Information
Globus Medical will hold a teleconference to discuss its 2016 fourth quarter and full year results with the investment community at 5:30 p.m. Eastern Time today. Globus invites all interested parties to join the call by dialing:

1-855-533-7141 United States Participants
1-720-545-0060 International Participants
There is no pass code for the teleconference.

For interested parties who do not wish to ask questions, the teleconference will be webcast live and may be accessed through a link on the Globus Medical website at investors.globusmedical.com.

The call will be archived until Monday, March 6, 2017. The audio archive can be accessed by calling 1-855-859-2056 in the U.S. or 1-404-537-3406 from outside the U.S. The passcode for the audio replay is 6940-2658.

About Globus Medical, Inc.
Globus Medical, Inc. is a leading musculoskeletal implant company based in Audubon, PA. The company was founded in 2003 by an experienced team of professionals with a shared vision to create products that enable surgeons to promote healing in patients with musculoskeletal disorders.

Non-GAAP Financial Measures
To supplement our financial statements prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”), management uses certain non-GAAP financial measures. For example, Adjusted EBITDA, which represents net income before interest income, net and other non-operating expenses, provision for income taxes, depreciation and amortization, stock-based compensation, changes in the fair value of contingent consideration in connection with business acquisitions and other acquisition related costs, and provisions for litigation, is useful as an additional measure of operating performance, and particularly as a measure of comparative operating performance from period to period, as it is reflective of changes in pricing decisions, cost controls and other factors that affect operating performance, and it removes the effect of our capital structure, asset base, income taxes and interest income and expense. Our management also uses Adjusted EBITDA for planning purposes, including the preparation of our annual operating budget and financial projections. In addition, for the periods ended March 31, 2016 and for other comparative periods, we also define the non-GAAP measure of Free Cash Flow as the net cash provided by operating activities, adjusted for the impact of restricted cash, less the cash impact of purchases of property and equipment. We believe that this financial measure provides meaningful information for evaluating our overall financial performance for comparative periods as it facilitates an assessment of funds available to satisfy current and future obligations and fund acquisitions. Furthermore, we define the non- GAAP measure of sales on a constant currency basis as the current and prior period sales translated at the same predetermined exchange rate. We believe that sales on a constant currency basis provides insight to the comparative increase or decrease in period sales, in dollar and percentage terms, excluding the effects of fluctuations in foreign currency exchange rates.

Adjusted EBITDA, Free Cash Flow and sales on a constant currency basis are not calculated in conformity with U.S. GAAP. Non-GAAP financial measures have limitations as analytical tools and should not be considered in isolation or as a substitute for financial measures prepared in accordance with U.S. GAAP. These measures do not include certain expenses that may be necessary to evaluate our liquidity or operating results. Our definitions of Adjusted EBITDA, Free Cash Flow, and sales on a constant currency basis may differ from that of other companies and therefore may not be comparable.

Safe Harbor Statements
All statements included in this press release other than statements of historical fact are forward-looking statements and may be identified by their use of words such as “believe,” “may,” “might,” “could,” “will,” “aim,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “plan” and other similar terms. These forwardlooking statements are based on our current assumptions, expectations and estimates of future events and trends. Forward-looking statements are only predictions and are subject to many risks, uncertainties and other factors that may affect our businesses and operations and could cause actual results to differ materially from those predicted. These risks and uncertainties include, but are not limited to, factors affecting our quarterly results, our ability to manage our growth, our ability to sustain our profitability, demand for our products, our ability to compete successfully (including without limitation our ability to convince surgeons to use our products and our ability to attract and retain sales and other personnel), our ability to rapidlydevelop and introduce new products, our ability to develop and execute on successful business strategies, our ability to comply with laws and regulations that are or may become applicable to our businesses, our ability to safeguard our intellectual property, our success in defending legal proceedings brought against us, trends in the medical device industry, general economic conditions, and other risks. For a discussion of these and other risks, uncertainties and other factors that could affect our results, you should refer to the disclosure contained in our most recent annual report on Form 10-K filed with the Securities and Exchange Commission, including the sections labeled “Risk Factors” and “Cautionary Note Concerning Forward-Looking Statements,” and in our Forms 10-Q, Forms 8-K and other filings with the Securities and Exchange Commission. These documents are available at www.sec.gov. Moreover, we operate in an evolving environment. New risk factors and uncertainties emerge from time to time and it is not possible for us to predict all risk factors and uncertainties, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Given these risks and uncertainties, readers are cautioned not to place undue reliance on any forward-looking statements. Forward-looking statements contained in this press release speak only as of the date of this press release. We undertake no obligation to update any forward-looking statements as a result of new information, events or circumstances or other factors arising or coming to our attention after the date hereof.

Download the full report here

Contact:
Daniel Scavilla
Senior Vice President, Chief Financial Officer
Phone: (610) 930-1800
Email: investors@globusmedical.com
www.globusmedical.com

The post Globus Medical Reports Full Year and Fourth Quarter 2016 Results appeared first on Globus Medical Inc..

Spine Innovation 4/17

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Rod Link Reducer




 

QUARTEX™

QUARTEX™The QUARTEX™ Occipito-Cervico-Thoracic (OCT) Stabilization System offers a variety of solutions to the challenges associated with posterior OCT fusion to aid in easier construct assembly. With a comprehensive range of instruments, including threaded drivers and streamlined reduction tools, installation of implants is swift and simple in the midst of complex pathologies.

  • Screw Head Capability: The QUARTEX™ screw head accepts a 3.5mm or 4.0mm rod and offers 90° of conical angulation.
  • Refined Instruments: Stable threaded drivers, efficient reduction options and flexible tools facilitate construct assembly.
  • True Thoracic Pedicle Screw Offerings: QUARTEX™ offers true thoracic screws with diameters up to 5.5mm, to accommodate varying patient anatomy with one comprehensive system.

 

 

 

 


 

SECURE-C®



 

ISASS 2017



 

AANS 2017


The post Spine Innovation 4/17 appeared first on Globus Medical Inc..

ViaCell™

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A Cohesive Cellular Allograft with Viable Cells

ViaCell is a cellular allograft containing viable cells including mesenchymal stem cells and osteoprogenitor cells, which are essential requirements for bone formation. The components of ViaCell provide the three essential elements of bone formation:

  • Osteogenic Cells
  • Osteoconductive Scaffold
  • Osteoinductive Growth Factors

ViaCell is a cohesive putty that can easily be molded and delivered to the treatment site.

ViaCell Features

Highest Average Cell Count

ViaCell contains an average of at least 700,000 cells/cc, of which ≥20% are mesenchymal stem cells and osteoprogenitor cells.

Exceptional Handling

The demineralized cortical fibers provide cohesive putty-like handling.

Easy Preparation

The provided cell strainer helps decant cryoprotectant without loss of product, and no additional rinsing is necessary.

Precise Processing

Time-sensitive aseptic tissue processing has been refined for maximum cell viability.

ViaCell is minimally processed human tissue regulated by the FDA under 21 CFR Part 1271and Section 361 of the Public Health Service Act.

The post ViaCell™ appeared first on Globus Medical Inc..

Spine Innovation 5/17

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ViaCell™

A Cohesive Cellular Allograft with Viable Cells

ViaCell is a cellular allograft containing viable cells including mesenchymal stem cells and osteoprogenitor cells, which are essential requirements for bone formation. The components of ViaCell provide the three essential elements of bone formation:

  • Osteogenic Cells
  • Osteoconductive Scaffold
  • Osteoinductive Growth Factors

ViaCell is a cohesive putty that can easily be molded and delivered to the treatment site.

ViaCell Features

Highest Average Cell Count

ViaCell contains an average of at least 700,000 cells/cc, of which ≥20% are mesenchymal stem cells and osteoprogenitor cells.

Exceptional Handling

The demineralized cortical fibers provide cohesive putty-like handling.

Easy Preparation

The provided cell strainer helps decant cryoprotectant without loss of product, and no additional rinsing is necessary.

Precise Processing

Time-sensitive aseptic tissue processing has been refined for maximum cell viability.

ViaCell is minimally processed human tissue regulated by the FDA under 21 CFR Part 1271and Section 361 of the Public Health Service Act.


 

QUARTEX™

QUARTEX™The QUARTEX™ Occipito-Cervico-Thoracic (OCT) Stabilization System offers a variety of solutions to the challenges associated with posterior OCT fusion to aid in easier construct assembly. With a comprehensive range of instruments, including threaded drivers and streamlined reduction tools, installation of implants is swift and simple in the midst of complex pathologies.

  • Screw Head Capability: The QUARTEX™ screw head accepts a 3.5mm or 4.0mm rod and offers 90° of conical angulation.
  • Refined Instruments: Stable threaded drivers, efficient reduction options and flexible tools facilitate construct assembly.
  • True Thoracic Pedicle Screw Offerings: QUARTEX™ offers true thoracic screws with diameters up to 5.5mm, to accommodate varying patient anatomy with one comprehensive system.

 

 

 

 


 

Rod Link Reducer

3-PLANE DEFORMITY CORRECTION TECHNIQUE

Originally developed at the Texas Scottish Rite Hospital for Children, the Rod Link Reducer technique is designed to aid in the correction of severe spinal curvatures with a novel set of instruments. This technique increases leverage to manipulate the spine in the axial, coronal and sagittal planes.

During the procedure, Manipulating Arms are attached to provisional rods which are placed proximal and distal to the apex of the curve. The Manipulating Arms are used to correct the deformity in three planes. The deformity is manipulated into a corrected position, then the construct is rigidly locked in place while a permanent rod is installed on the contralateral side.

Advantages of the Rod Link Reducer Technique

  • Technique may help improve scoliosis correction and reduce operative time compared to traditional methods1
  • Allows controlled correction of severe sagittal, coronal, and axial deformity
  • Holds and maintains correction during rod placement

Securing rod with Manipulating Arm

Securing Rod Manipulating Arms

Rod Link Reducer

1. Sucato, D. J. and Zhang, H. (March 2017). A Novel Posterior Rod-Link-Reducer System Provides Safer Easier and Better Correction of Severe Scoliosis. Paper #097 Presented at AAOS Annual Meeting, San Diego, CA.

REDUCTION TECHNIQUE OVERVIEW

Axial

The first manipulation is axial derotation of the spine and the rib cage for transverse (axial) correction. This is performed by pressing down on the manipulating arms.

axial  correction

Coronal

The second manipulation is compression of the spine on the convexity for coronal correction. This is performed by bringing the manipulating arms together.

coronal correction

Saggital

The third manipulation is to restore thoracic kyphosis for sagittal correction. This is performed
by rotating the handles of the manipulating arms simultaneously.

sagittal correction


 

MONUMENT®

monumentMONUMENT® is a unique ALIF system with an integrated mechanical reduction feature that is designed to aid in spondylolithesis reduction (Grade 1).

  • 8mm of Translation: Integrated mechanical reduction feature allows up to 8mm of continuous translation
  • Enhanced Endplate Fixation: Implant adjustability allows for optimal cortical bone screw purchase
  • Self-Locking Reduction Feature: Simplified procedure with no additional locking step after translation
  • Midline Instruments: Midline implant holder allows for maximum visualization and access through a small insertion window with minimal interference

 

Animation

 

 

 

monument product

The post Spine Innovation 5/17 appeared first on Globus Medical Inc..

Spine Innovation 6/17

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CONCORD Plus™

 

concord plus radiopaque bone cement

We are pleased to announce the launch of our new high viscosity bone cement,
CONCORD-Plus™ and accompanying Cement Mixer and Transfer Pack.

The CONCORD-Plus™ Bone Cement is ready to inject 3 minutes after mixing and has a 12 minute working time. Compared to low viscosity bone cement, CONCORD-Plus™ shortens waiting time while retaining working time. The Cement Mixer and Transfer Pack is comprised of the cement mixer along with a threaded syringe for transferring cement to the filler delivery needles.

 

 

Click Here for printer-friendly instructions
for using CONCORD-Plus™

 

Available Parts
Part Number Description
4129.2020S CONCORD-Plus™ Bone Cement, 20g
4129.4040S CONCORD-Plus™ Bone Cement, 40g
658.959S Cement Mixer and Transfer Pack


Pricing requests must be submitted to pricingcontract@globusmedical.com.
Please note that pricing must be loaded into the system and approved prior to requesting these parts.



 

CREO QUAD™

The Power of 4 CREO AMP QUAD with CREO AMP Stabilization System. One Implant, 4 Solutions, 4 Rods for Increased Strength
Choose Your Deformity Solution

CREO & CREO AMP 4.75mm Threaded CoCr CREO Threaded & CREO AMP Threaded CREO Threaded CoCr & CREO AMP Threaded CoCr CREO & CREO AMP

*Testing on file at Globus Medical.



 

COALITION MIS™

COALITION MIS™COALITION MIS™ is an ACDF System designed to facilitate simplified implantation with a smaller incision and minimal tissue disruption.

The innovative curved anchor fixation is delivered inline to the disc space with instruments approximately the same size as the spacer. Inline instruments help to reduce the amount of retraction and minimize interference with challenging anatomy, particularly minimizing interference with challenging patient anatomy, particularly at upper and lower cervical levels.

When COALITION MIS™ is used with two screws, it is cleared for standalone use at two levels.

  • Inline Integrated Fixation: Innovative instruments facilitate simple implantation regardless of challenging patient anatomy.
  • Intraoperative Versatility: Spacer accommodates COALITION MIS™ anchors and/or screws providing multiple options to secure the spacer to adjacent vertebral bodies.
  • Biomechanical Stability: Biomechanical cadaveric testing showed no significant difference in stability between two COALITION MIS™ screw constructs and a two level cervical plate and spacer construct at two levels.

 



 

INDEPENDENCE MIS™

INDEPENDENCE MIS™ is an integrated lumbar plate-spacer designed to deliver anchor fixation in fewer procedural steps through a less invasive surgical corridor than traditional integrated spacers.INDEPENDENCE MIS™

  • In-Line Integrated Fixation: Innovative instruments facilitate simple implantation even with challenging patient anatomy.
  • Biomechanical Stability: Biomechanically comparable with a traditional stand-alone ALIF system when used with screws.
  • Intraoperative Versatility: Compatible with anchors and screws, providing multiple options for securing the spacer to the vertebral bodies.
  •  

     
    INDEPENDENCE MIS™



     

    SHIELD™

    shield algeaNo two fractures are alike. Providing a choice in technology for the treatment of vertebral compression fractures is essential. SHIELD®’s Barrier Technology™ provides ultimate cement control by directing cement to the central/anterior vertebral body.

    The unilateral, curving design of the SHIELD® system aims to offer the ultimate in safety, reliability and treatment selection.

      • Barrier Technology™: The first of its kind providing the ultimate in cement control, SHIELD® directs cement to the central/anterior vertebral body, creating an optimized cement column.

     

      • Unipedicular Approach: SHIELD®’s unipedicular approach may help reduce the risks associated with vertebral body access and radiation exposure.

     

    • Curved Cavity Creation: Curved instruments prepare a pathway across the sagittal midline into the contralateral side, enabling full vertebral body coverage.

     

    Animation

    algea therapies logo

     

     

     

The post Spine Innovation 6/17 appeared first on Globus Medical Inc..


Rod Reducer

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Rod Link Reducer

3-PLANE DEFORMITY CORRECTION TECHNIQUE

Originally developed at the Texas Scottish Rite Hospital for Children, the Rod Link Reducer technique is designed to aid in the correction of severe spinal curvatures with a novel set of instruments. This technique increases leverage to manipulate the spine in the axial, coronal and sagittal planes.

During the procedure, Manipulating Arms are attached to provisional rods which are placed proximal and distal to the apex of the curve. The Manipulating Arms are used to correct the deformity in three planes. The deformity is manipulated into a corrected position, then the construct is rigidly locked in place while a permanent rod is installed on the contralateral side.

Advantages of the Rod Link Reducer Technique

  • Technique may help improve scoliosis correction and reduce operative time compared to traditional methods1
  • Allows controlled correction of severe sagittal, coronal, and axial deformity
  • Holds and maintains correction during rod placement

Securing rod with Manipulating Arm

Securing Rod Manipulating Arms

Rod Link Reducer

1. Sucato, D. J. and Zhang, H. (March 2017). A Novel Posterior Rod-Link-Reducer System Provides Safer Easier and Better Correction of Severe Scoliosis. Paper #097 Presented at AAOS Annual Meeting, San Diego, CA.

REDUCTION TECHNIQUE OVERVIEW

Axial

The first manipulation is axial derotation of the spine and the rib cage for transverse (axial) correction. This is performed by pressing down on the manipulating arms.

axial  correction

Coronal

The second manipulation is compression of the spine on the convexity for coronal correction. This is performed by bringing the manipulating arms together.

coronal correction

Saggital

The third manipulation is to restore thoracic kyphosis for sagittal correction. This is performed
by rotating the handles of the manipulating arms simultaneously.

sagittal correction

The post Rod Reducer appeared first on Globus Medical Inc..

Globus Medical Announces Acquisition of Robotics Developer KB Medical

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Globus Medical Announces Acquisition of Robotics Developer KB Medical

AUDUBON, Pa., Aug. 02, 2017 (GLOBE NEWSWIRE) — Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal solutions manufacturer, today announced that the acquisition of KB Medical, SA, a robotic developer based in Lausanne, Switzerland, closed during the second quarter of 2017.

“The acquisition of KB Medical demonstrates Globus Medical’s continued commitment and enthusiasm for the potential impact of robotic technology on surgery,” said Dave Demski, President, Emerging Technologies. “The addition of KB Medical will enable Globus Medical to accelerate, enhance and expand our product portfolio in Imaging, Navigation and Robotics. KB Medical’s experienced team of technology development professionals, its strong IP portfolio, and shared philosophy for robotic solutions in medicine strengthen Globus Medical’s position in this strategic area.”

About Globus Medical, Inc.

Globus Medical, Inc. is a leading musculoskeletal solutions company based in Audubon, PA. The company was founded in 2003 by an experienced team of professionals with a shared vision to create products that enable surgeons to promote healing in patients with musculoskeletal disorders.

Safe Harbor Statements

All statements included in this press release other than statements of historical fact are forward-looking statements and may be identified by their use of words such as “believe,” “may,” “might,” “could,” “will,” “aim,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “plan” and other similar terms. These forward-looking statements are based on our current assumptions, expectations and estimates of future events and trends. Forward-looking statements are only predictions and are subject to many risks, uncertainties and other factors that may affect our businesses and operations and could cause actual results to differ materially from those predicted. These risks and uncertainties include, but are not limited to, factors affecting our quarterly results, our ability to manage our growth, our ability to sustain our profitability, demand for our products, our ability to compete successfully (including without limitation our ability to convince surgeons to use our products and our ability to attract and retain sales and other personnel), our ability to rapidly develop and introduce new products, our ability to develop and execute on successful business strategies, our ability to successfully integrate the international operations acquired from Alphatec, both in general and on our anticipated timeline, our ability to transition Alphatec’s international customers to Globus Medical products, our ability to realize the expected benefits to our results from the Alphatec acquisition, our ability to comply with laws and regulations that are or may become applicable to our businesses, our ability to safeguard our intellectual property, our success in defending legal proceedings brought against us, trends in the medical device industry, general economic conditions, and other risks. For a discussion of these and other risks, uncertainties and other factors that could affect our results, you should refer to the disclosure contained in our most recent annual report on Form 10-K filed with the Securities and Exchange Commission, including the sections labeled “Risk Factors” and “Cautionary Note Concerning Forward-Looking Statements,” and in our Forms 10-Q, Forms 8-K and other filings with the Securities and Exchange Commission. These documents are available at www.sec.gov. Moreover, we operate in an evolving environment. New risk factors and uncertainties emerge from time to time and it is not possible for us to predict all risk factors and uncertainties, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Given these risks and uncertainties, readers are cautioned not to place undue reliance on any forward-looking statements. Forward-looking statements contained in this press release speak only as of the date of this press release. We undertake no obligation to update any forward-looking statements as a result of new information, events or circumstances or other factors arising or coming to our attention after the date hereof.

Contact:
Daniel Scavilla
Senior Vice President, Chief Financial Officer
Phone: (610) 930-1800
Email: investors@globusmedical.com
www.globusmedical.com

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Globus Medical Announces FDA 510(k) Clearance for Excelsius GPS™

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Globus Medical Announces FDA 510(k) Clearance for Excelsius GPS™

AUDUBON, Pa., Aug. 17, 2017 (GLOBE NEWSWIRE) — Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal solutions company, today announced that the Excelsius GPS™, a revolutionary robotic guidance and navigation system, has been 510(k) cleared by the U.S. Food and Drug Administration. This platform technology supports minimally invasive and open orthopedic and neurosurgical procedures, with screw placement applications in spine and orthopedic surgery. Excelsius GPS™ seamlessly integrates Globus Medical implants and instruments and is compatible with pre-operative CT, intra-operative CT and fluoroscopic imaging modalities. The system is designed to minimize radiation exposure, streamline workflow, and reproducibly assist in implant placement.

“Excelsius GPS™ is the culmination of years of research and development efforts and demonstrates Globus Medical’s superior product development capabilities,” said Norbert Johnson, Vice President of Robotics, Imaging, & Navigation. “We believe the Excelsius GPS™ System will advance patient care and provide tangible benefits for surgeons and hospitals in terms of time, accuracy and reduced radiation exposure through the application of robotic and navigation technology in spine and orthopedic surgery.”

About Globus Medical, Inc.

Globus Medical, Inc. is a leading musculoskeletal solutions company based in Audubon, PA. The company was founded in 2003 by an experienced team of professionals with a shared vision to create products that enable surgeons to promote healing in patients with musculoskeletal disorders.

Safe Harbor Statements

All statements included in this press release other than statements of historical fact are forward-looking statements and may be identified by their use of words such as “believe,” “may,” “might,” “could,” “will,” “aim,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “plan” and other similar terms. These forward-looking statements are based on our current assumptions, expectations and estimates of future events and trends. Forward-looking statements are only predictions and are subject to many risks, uncertainties and other factors that may affect our businesses and operations and could cause actual results to differ materially from those predicted. These risks and uncertainties include, but are not limited to, factors affecting our quarterly results, our ability to manage our growth, our ability to sustain our profitability, demand for our products, our ability to compete successfully (including without limitation our ability to convince surgeons to use our products and our ability to attract and retain sales and other personnel), our ability to rapidly develop and introduce new products, our ability to develop and execute on successful business strategies, our ability to successfully integrate the international operations acquired from Alphatec, both in general and on our anticipated timeline, our ability to transition Alphatec’s international customers to Globus Medical products, our ability to realize the expected benefits to our results from the Alphatec acquisition, our ability to comply with laws and regulations that are or may become applicable to our businesses, our ability to safeguard our intellectual property, our success in defending legal proceedings brought against us, trends in the medical device industry, general economic conditions, and other risks. For a discussion of these and other risks, uncertainties and other factors that could affect our results, you should refer to the disclosure contained in our most recent annual report on Form 10-K filed with the Securities and Exchange Commission, including the sections labeled “Risk Factors” and “Cautionary Note Concerning Forward-Looking Statements,” and in our Forms 10-Q, Forms 8-K and other filings with the Securities and Exchange Commission. These documents are available at www.sec.gov. Moreover, we operate in an evolving environment. New risk factors and uncertainties emerge from time to time and it is not possible for us to predict all risk factors and uncertainties, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Given these risks and uncertainties, readers are cautioned not to place undue reliance on any forward-looking statements. Forward-looking statements contained in this press release speak only as of the date of this press release. We undertake no obligation to update any forward-looking statements as a result of new information, events or circumstances or other factors arising or coming to our attention after the date hereof.

Contact:
Daniel Scavilla
Senior Vice President, Chief Financial Officer
Phone: (610) 930-1800
Email: investors@globusmedical.com
www.globusmedical.com

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MAGNIFY®

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The MAGNIFY® expandable ALIF spacer system is designed to minimize impaction, maximize indirect decompression, and optimize fusion. Minimized insertion height, continuous expansion, and the ability to backfill autogenous bone graft separates MAGNIFY® from from traditional ALIF spacers.

  • Minimize Impaction: The reduced insertion height eases implant placement without the need for traumatic impaction.
  • Maximize Indirect Decompression: Continuous, controlled distraction maximizes indirect decompression to help restore disc height.
  • Optimize Fusion: Post-expansion delivery of autogenous bone graft optimizes fusion potential by maximizing the graft volume within the spacer.

If Stand-alone ALIF is preferred, click here for Magnify-S®

 

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ELSA™

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ELSA™ is an expandable interbody fusion spacer with integrated fixation designed to maximize segmental lordosis while minimizing disruption to patient anatomy.

Sagittal Alignment
ELSA™ allows for sagittal balance correction from the anterior column.

  • Adjustable Lordosis: Hyperlordotic implants with adjustability from 5° to 20° or 15° to 30° allow for insertion at a smaller starting height for a more precise fit to each patient.
  • Integrated Fixation: Integrated fixation can be delivered through a smaller access window compared to traditional lateral fixation, while screw eyelets maintain ideal placement during implant expansion

 
ELSA™ is an expandable lateral interbody fusion spacer with integrated fixation that is inserted at a minimized profile and expanded to help restore segmental lordosis. ELSA™ allows for sagittal balance correction while minimizing disruption to patient anatomy. Integrated fixation is positioned at the disc space with the spacer in order to minimize retraction. As the spacer expands, the screw eyelets maintain ideal placement.
 

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Globus Medical Schedules Fourth Quarter and Full Year 2016 Earnings Release and Conference Call

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Globus Medical Schedules Fourth Quarter and Full Year 2016
Earnings Release and Conference Call

AUDUBON, Pa., Feb. 07, 2017 (GLOBE NEWSWIRE) — Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal implant manufacturer, will announce its financial results for the fourth quarter and full year ended December 31, 2016 after the market close on Monday, February 27, 2017. A copy of the release will be available on the Globus Medical website at www.globusmedical.com/investors.

Following the announcement, Globus Medical will hold a teleconference to discuss its performance with the investment community at 5:30 p.m. Eastern Time. Globus invites all interested parties to join the call by dialing:

1-855-533-7141 United States Participants
1-720-545-0060 International Participants

There is no passcode for the teleconference.

For interested parties who do not wish to ask questions, the teleconference will be webcast live and may be accessed through a link on the Globus Medical website at www.globusmedical.com/investors.

The call will be archived until Monday, March 6, 2017. The audio archive can be accessed by calling 1-855- 859-2056 in the U.S. or 1-404-537-3406 from outside the U.S. The passcode for the audio replay is 6940- 2658.

About Globus Medical, Inc.
Globus Medical, Inc. is a leading musculoskeletal implant company based in Audubon, PA. The company was founded in 2003 by an experienced team of professionals with a shared vision to create products that enable surgeons to promote healing in patients with musculoskeletal disorders. Additional information can be accessed at www.globusmedical.com.

Contact:
Daniel Scavilla
Senior Vice President, Chief Financial Officer
Phone: (610) 930-1800
Email: investors@globusmedical.com
www.globusmedical.com

The post Globus Medical Schedules Fourth Quarter and Full Year 2016 Earnings Release and Conference Call appeared first on Globus Medical Inc..

ELSA®

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ELSA® is an expandable interbody fusion spacer with integrated fixation designed to maximize segmental lordosis while minimizing disruption to patient anatomy.

  • Adjustable Lordosis: Implants with adjustability from 5° to 20° or 15° to 30° allow for insertion at a smaller starting height for a more precise fit to the patient.
  • Integrated Fixation: Integrated fixation can be delivered through a smaller access window compared to traditional lateral fixation, while screw eyelets maintain ideal placement during implant expansion.

 

Product Animation

 

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HAVEN™ Dual Plate Laminoplasty System

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The HAVEN™ Laminoplasty System is a dual plate system that uniquely offers bilateral lamina support, bridging the posterior arch to help protect the spinal cord.

  • Bilateral Advantage
    Bilateral fixation to the lateral masses provides a rigid supporting structure to bridge the posterior arch with one continuous implant.
     
  • Natural Anatomic Design
    Implant design mimics intact anatomy.
     
  • Fusion and Non-Fusion Plate Configurations
    Offered in a variety of plate configurations for use with or without posterior cervicothoracic fusion systems such as QUARTEX® or ELLIPSE®.

 

 

 

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ELSA®-ATP

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Anterior-to-Psoas Expandable Lateral System

ELSA®-ATP is an expandable lateral system designed to provide access to the lumbar spine anterior to the psoas muscle. Entering the disc space from this approach helps to avoid complications associated with the lateral trans-psoas approach and the lumbar plexus. This anterolateral working corridor also allows for direct access to L4‑L5 where a high iliac crest may complicate the direct lateral approach.

Comprehensive system features

  • ELSA®-ATP expandable interbody spacer with integrated fixation designed to limit psoas retraction
  • Angled inserters designed to insert ELSA®-ATP, RISE®-L, and TransContinental® spacers
  • MARS3VL blades designed to maximize visualization and corridor stability
  • ATP angled lateral disc preparation instruments help facilitate a thorough discectomy
  • ELSA®-ATP requires supplemental fixation, in addition to integrated fixation.

 

 

 

 

 

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CONCORD-Plus™

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concord plus radiopaque bone cement

We are pleased to announce the launch of our new high viscosity bone cement,
CONCORD-Plus™ and accompanying Cement Mixer and Transfer Pack.

The CONCORD-Plus™ Bone Cement is ready to inject 3 minutes after mixing and has a 12 minute working time. Compared to low viscosity bone cement, CONCORD-Plus™ shortens waiting time while retaining working time. The Cement Mixer and Transfer Pack is comprised of the cement mixer along with a threaded syringe for transferring cement to the filler delivery needles.

 

 

Click Here for printer-friendly instructions
for using CONCORD-Plus™

 

Available Parts
Part Number Description
4129.2020S CONCORD-Plus™ Bone Cement, 20g
4129.4040S CONCORD-Plus™ Bone Cement, 40g
658.959S Cement Mixer and Transfer Pack


Pricing requests must be submitted to pricingcontract@globusmedical.com.
Please note that pricing must be loaded into the system and approved prior to requesting these parts.

 

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RISE®-L

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RISE-L imageRISE®-L is an expandable lateral lumbar fusion device that offers up to 7mm of expansion coupled with a large graft chamber and the ability to introduce autogenous bone graft in situ.

  • Minimize Impaction: RISE®-L is inserted at a reduced height to minimize impaction and preserve endplate integrity.
  • Maximize Indirect Decompression: RISE®-L offers controlled, continuous expansion to aid in restoring disc height and maximize indirect decompression.
  • Optimize Fusion: RISE®-L’s large continuous graft chamber, combined with the ability to introduce additional bone graft in situ, is designed to optimize fusion potential.

 
The titanium implant provides continuous in situ expansion and is designed to restore disc height with proper anatomical fit. Available in multiple sizes, in parallel or lordotic profiles, RISE®-L provides options to address proper sagittal balance. A large, single graft chamber can be filled with autogenous bone graft material after insertion and expansion.

 

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REVERE® Derotation

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The REVERE® Derotation System is a comprehensive set of instruments designed to aid in reduction (up to 30mm) and deformity correction.

  • Three derotator options: Two tower options are designed for gradual, sequential reduction. The third option is for derotation only.
  • Low profile: Slim design allows for visualization during correction.
  • Compatible with various maneuvers and techniques: May be used for segmental reduction, coupled derotation, rib hump correction, and translation of coronally displaced vertebrae.

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