October 26, 2016

October 26, 2016 – HUNTLEY, Ill.–(BUSINESS WIRE)–

AUDUBON, Pa., Oct. 25, 2016 (GLOBE NEWSWIRE) — Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal implant manufacturer, today announced the introduction of the INDEPENDENCE MIS™ System, an integrated ALIF plate-spacer system designed to simplify implantation and fixation of a commonly challenging procedure.

The INDEPENDENCE MIS™ system features advanced instruments that deploy three pre-loaded anchors through a small protected corridor no larger than the implant itself.  Most integrated ALIF systems either use screws, which tend to require a much larger access to insert due to their orientation, or wide blades impacted into the bone that can be hard to retrieve. INDEPENDENCE MIS™ streamlines the anterior procedure into three simple steps: inserting the implant, deploying the anchors, and locking the anchors.

“This device is a game-changer,” commented Andrew Iott, Senior Vice President of Product Development.  “It builds on the philosophy and success of the INDEPENDENCE^® system by delivering a swift, streamlined procedure that enables surgeons to perform an ALIF in fewer steps while preserving the versatility to use screws.  INDEPENDENCE MIS^™ is another proud addition to our innovative suite of MIS products.”

Indications

INDEPENDENCE^® (including INDEPENDENCE MIS^™, INDEPENDENCE^® TPS, and INDEPENDENCE MIS^™ TPS) Spacers are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). INDEPENDENCE^® Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.

The INDEPENDENCE^® Spacer is a stand-alone interbody fusion device intended to be used with three titanium alloy screws which accompany the implant. The INDEPENDENCE MIS^™ Spacer is an interbody fusion device to be used with three titanium alloy screws or anchors which accompany the implants. When used with screws, the INDEPENDENCE MIS^™ Spacer is a stand-alone interbody fusion device. When used with anchors, the INDEPENDENCE MIS^™ Spacer is intended for use with supplemental fixation (e.g. facet screws or posterior fixation). Hyperlordotic implants (≥25° lordosis) are intended for use with supplemental fixation (e.g. facet screws or posterior fixation).

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 http://www.globusmedical.com.

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 comply with changing laws and regulations that are 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 its 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:
Dan Scavilla
Senior Vice President and Chief Financial Officer
Phone: (610) 930-1800
Email: investors@globusmedical.com
www.globusmedical.com

WARSAW, Ind., Oct. 25, 2016 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced that its Mobi-C^® Cervical Disc Prosthesis is now the most widely covered device for one- and two-level cervical disc replacement by commercial health insurers in the United States.  Mobi-C, acquired as part of Zimmer Biomet’s combination with LDR Holding Corporation in July, is now accessible to more than 200 million insured patients with one-level disc disease and more than 150 million patients with two-level disc disease across more than 90 commercial insurance plans.  Zimmer Biomet achieved this significant milestone when Anthem (formerly WellPoint), which reports nearly 40 million enrollees in its health plans, added Mobi-C to the list of covered devices for one-level disc replacement and as the sole cervical total disc prosthesis covered for two-level surgery.

“The widespread coverage of Mobi-C is a testament to payers accepting the peer-reviewed clinical data and real-world evidence from 40,000 procedures, as validation for the significant advantages Mobi-C offers over invasive spinal fusion for patients in need of cervical disc replacement,” said Adam Johnson, Group President, Spine, Dental, CMF and Thoracic.  “As the most widely insured cervical intervertebral disc prosthesis, Mobi-C is poised to become the standard of care for total cervical disc replacement, which is welcome news for the millions of patients who are looking for a safe and effective option for the treatment of one level or two contiguous levels in the cervical spine.”

Mobi-C was the first cervical disc prosthesis approved by the U.S. Food and Drug Administration for reconstruction of the cervical disc at both one and two levels to treat arm pain and/or neurological deficit caused by various spine disorders or injuries.  Mobi-C is a cobalt chromium alloy and polyethylene mobile-bearing prosthesis that is inserted in a single step, without requiring bone chiseling to accommodate vertebral anchorage such as screws or keels.  Unlike cervical fusion, the current standard of care, which immobilizes the targeted vertebrae, Mobi-C features patented mobile-bearing technology designed to allow the prosthetic disc to self-adjust to facilitate motion similar to that of the natural cervical spine.  To learn more about Mobi-C, visit www.cervicaldisc.com.

“Expanding payer coverage for the Mobi-C Cervical Disc prosthesis has been a critically important priority and solidifies Zimmer Biomet’s foothold as a market leader in cervical disc replacement,” said David Dvorak, President and CEO of Zimmer Biomet. “The Mobi-C Cervical Disc, coupled with our differentiated and comprehensive Spine portfolio of innovative surgical solutions, strengthens Zimmer Biomet’s position for sustainable growth.”

At the annual meeting of the North American Spine Society (NASS) this week, the Company plans to present data from a seven-year study confirming the statistical superiority of two-level cervical disc arthroplasty with Mobi-C over two-level anterior cervical discectomy and fusion (ACDF).

For more information about Zimmer Biomet and its musculoskeletal health offerings, please visit the Company online at www.zimmerbiomet.com.

DALLAS, Oct. 25, 2016 /PRNewswire/ — Pinnacle Spine Group, LLC, a developer of innovative spinal fusion solutions engineered to deliver optimal bone graft volume and graft-to-endplate contact, today announced the launch of its InFill® V2 Lateral Interbody Device. The innovative InFill V2 Lateral Interbody Fusion device features a larger, single graft chamber and a large load-bearing surface area, which helps restore and maintain disc height and facilitates the formation of a robust fusion column.

The V2 Lateral implants, the most recent update to Pinnacle’s patented flagship line of InFill Interbody Fusion Systems, features an expanded size matrix and wide range of lordotic options.

“Science has shown that in many unilateral posterior lumbar interbody fusion procedures, less than 50 percent of the disc area is actually grafted,” said Zach Sowell, President of Pinnacle Spine Group. “Creating a greater opportunity to fill the biologic void is exactly why we developed the only patented Interbody Fusion System designed to deliver optimized graft-to-endplate contact. We are excited to add the V2 Lateral device to our growing line of patented fusion systems.”

Features of the V2 Lateral device include:

• Unique access port to secure the implant to the inserter, ensuring controlled device placement and allowing in situ delivery of optimal bone graft volume
• A larger graft chamber to allow greater volume of bone graft material, promoting a more robust fusion column
• A larger load-bearing surface area to help maintain disc height and reduce chances of subsidence
• Bulleted nose to ease insertion and ensure precise placement for challenging disc conditions
• Implant size matrix to address unique patient anatomy with lengths ranging from 30mm to 60mm, heights ranging from 8mm to 14mm, widths of 18mm, 21mm and 24mm, and lordotic angles of 0°, 7°, 10° and 13°
• Comprehensive instrumentation, including angled instruments and a variety of handles
• Multiple retractor options

Pinnacle Spine Group has pioneered the novel concept for filling the biologic void by placing bone graft material into an implanted device in situ for optimal bone graft volume and contact with vertebral endplates – a critical element for a successful spine fusion outcome.

Pinnacle Spine’s InFill Fusion Systems include a full line of innovative interbody fusion devices engineered for easier insertion, reduced subsidence through maximum contact with the apophyseal ring, a generous bone grafting chamber and compatibility with the InFill® Graft Delivery System. The backbone of the technology is based on controlled and precise in situ placement of bone graft material.

Pinnacle recently announced its first international patent, a Chinese patent, which followed receipt of three U.S. patents on the InFill Fusion System. For more information on Pinnacle Spine Group’s unparalleled innovation, please visit PinnacleSpineGroup.com.

About Pinnacle Spine Group, LLC

Pinnacle Spine Group was founded with the focused goal of developing innovative medical devices, conceived in the operating room, for surgical procedures of the spine. The objective for every device and instrument we develop is a better outcome for the patient, and a better experience for the surgeon and operating room staff. Backed by the pioneering private equity firm Sowell & Co., Pinnacle is dedicated to developing advanced technologies that offer greater opportunities for positive patient outcomes. The team applies innovative thinking to deliver implants and instrumentation that simplify and enhance the surgical procedure.

SOURCE Pinnacle Spine Group, LLC

Related Links

http://PinnacleSpineGroup.com

WEST LAKE HILLS, Texas, Oct. 25, 2016 /PRNewswire/ — Genesys Spine is pleased to announce the release of our latest product line, the TiLock Cortical Spinal System.

The system will be featured at our cadaveric lab being performed during the NASS 2016 Conference at the Boston BioSkills Lab on Thursday, October 27, 2016.

TiLock Cortical Spinal System offers midline screw placement with a medial/ lateral trajectory to provide a substantial anatomy-conserving alternative to traditional pedicular fixation. Its unique tapered, self drilling/tapping feature facilitates an easy start that transitions into a Corticocancellous thread form for maximum fixation in bone. The reduced tulip head profile allows for efficient screw placement with nominal bony removal helping to mitigate the risk of adjacent facet encroachment.

Dr. Matthew Philips, Director of the Brain and Spine Center at SouthCoast Health in Massachusetts and board certified neurosurgeon says, “The Genesys Spine Cortical Screw System is a low profile screw system that requires less dissection and provides superior fixation compared to traditional pedicle screws. The low profile combined with unique thread geometry proved for insertional ease with maximal purchase.”

“Genesys Spine is proud to introduce our latest product offering during the NASS 2016 Conference in Boston,” says Josh Kaufmann, Principal at Genesys Spine. “We feel that this product continues our goal at Genesys of creating products with an eye towards maximizing efficacy while reducing patient risk and morbidity.”

About Genesys Spine:

Founded in 2009, Genesys Spine is a privately held company focused on the design, development and marketing of an array of medical implants and instruments with novel characteristics. These devices, with their award winning proprietary features, all remain within existing parameters for today’s current reimbursement codes.

Media inquiries please contact:
Noelle Corcoran noelle.corcoran@genesysspine.com

www.genesysspine.com
www.nassannualmeeting.org
http://bostonbioskills.com/

This press release was issued through 24-7PressRelease.com. For further information, visit http://www.24-7pressrelease.com.

AUDUBON, Pa., Oct. 25, 2016 (GLOBE NEWSWIRE) — Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal implant manufacturer, continues to innovate in the treatment of complex spinal instability and deformity with today’s announcement of the launch of the QUARTEX™ OCT Stabilization System.

QUARTEX™ offers a variety of solutions to the challenges associated with posterior OCT fusion while delivering paramount reliability and ease of use.  QUARTEX™ screw heads accept 3.5mm or 4.0mm rods in either titanium or cobalt chrome alloy and offer 90^° of conical angulation.  QUARTEX™ allows surgeons to take full advantage of thoracic anatomy through the use of larger screws with diameters up to 5.5mm. Refined instruments facilitate construct assembly with efficient reduction options and intuitive screwdrivers.

“QUARTEX™ provides a single, seamless solution to posterior OCT fixation,” said Chad Glerum, Director of Fixation, Product Development.  “Our design team of engineers and spine surgeons scrutinized every aspect of the implants and instruments to optimize flow and functionality. We are excited to see QUARTEX™ provide a versatile OCT solution to propel Globus’ continued growth in this market.”

Dr. Richard Frisch added, “I’m excited that I can choose a 4.0mm rod for my longer constructs and larger diameter screws in the upper thoracic pedicles. The increased stiffness and bone purchase gives me a lot of confidence in the stability of the construct. The drivers provide firm attachment to the screws and the threaded locking caps engage easily, which help my cases run smoothly. QUARTEX™ is the most versatile system I have used and is a great addition to my practice.”

Indications

The QUARTEX™ Occipito-Cervico-Thoracic Spinal System implants are intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1-C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/ or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. These implants are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. In order to achieve additional levels of fixation, rods may be connected to occipital cervical thoracic or thoracolumbar stabilization systems ranging in diameter from 3.2mm to 6.5mm, using corresponding connectors.

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 http://www.globusmedical.com.

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 comply with changing laws and regulations that are 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 its 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:
Dan Scavilla
Senior Vice President and Chief Financial Officer
Phone: (610) 930-1800
Email: investors@globusmedical.com
www.globusmedical.com

October 25, 2016