Spine

Aurora Spine Announces Exclusive Patent License Agreement for MIS SI Joint Product

CARLSBAD, Calif., Nov. 16, 2018 (GLOBE NEWSWIRE) — Aurora Spine Corporation (TSXV:ASG) (“Aurora Spine” or the “Company”) announced today that it has acquired an exclusive license to US patent #9,451,986 titled “Percutaneous sacroiliac joint implant and method for surgically inserting and securing the implant into the sacroiliac joint” in an agreement with SILIF Corporation of Buffalo, New York (“SILIF”), the inventor of a posterior SI Fusion technology.

The license will enable Aurora Spine to develop a new Posterior Sacroiliac Joint Fixation System. The implant, named EASiFX™, will feature multiple retaining and bone locking mechanisms. The EASiFX procedure will offer less tissue disruption, decreased operating room time and radiation exposure. The procedure also offers minimal distraction of the SI joint through a safe, posterior method.

The license is another example of Aurora Spine’s vision and leadership in the provision of fusion solutions for a diverse range of spine surgery procedures. EASiFX is expected to add to the Company’s expanding product portfolio of unique implant products and add to the growth of Aurora Spine.

“Aurora Spine is changing spine surgery. The SILIF patent technology, which has been enthusiastically received by surgeons, has the potential to become the standard of care for spine patients with SI Joint pathologies,” said Trent Northcutt, President and CEO of Aurora Spine.  “The license provides access to a procedure that has been growing in excess of 20% in recent years, leverages the core competencies and vision of our minimally invasive spine portfolio of game-changing innovative products and provides new growth opportunities in the U.S.  We believe this opportunity is perfectly aligned with our spine-focused expansion strategy to pursue niche differentiated products, customer retention and support portfolio pull-through along the way.”

“The EASiFX implant is a differentiated product designed to drive fusion and is supported by an expanding market segment. We remain committed to growing our spine portfolio and infusing our expertise to help our hospital, surgeon and distribution partners,” said Northcutt.

“The EASiFX implant prototypes were successfully used in a cadaver lab setting earlier this year along with only a few surgical tools required to complete a successful implant placement,” said Laszlo Garamszegi, Chief Technology Officer of Aurora Spine. “The implants performed remarkably well in our test and we are looking forward to presenting all the benefits the invention offers to patients and physicians.”

According to iData Research, the U.S. minimally invasive spinal implants market is expected to increase to over $2 billion by 2023. The fastest growing implant segment is the MIS sacroiliac joint fusion market. Clinical evidence demonstrates that sacroiliac joint fusion (“SIJF”) is an effective procedure. The popularity of SIJF has grown rapidly over the past five years.  The SIJF market is currently 5 percent of the overall spine market and it’s projected to reach 20 percent by 2021.  By 2024, the SIJF market in the US is expected to exceed $200 million, driven primarily by an increase in procedure volumes and adoption by new surgeons.

As consideration for the license, the Company will issue 1,000,000 common shares of the Company to SILIF at a price of CDN$0.30 per share, with all such shares being subject to a 5 year tiered lock-up agreement, with 20% of the shares released from the lock-up on each anniversary of the closing date of the transaction. In addition, the Company will issue SILIF warrants to purchase up to 1,750,000 common shares of the Company, exercisable at CDN$0.35 for a period of 5 years following the date of grant.  The warrants will vest in 20% increments on each anniversary of the closing date of the transaction.

All securities issued by Aurora Spine in connection with the transaction will be subject to a statutory four-month hold period. The transaction is subject to certain conditions including, but not limited to, the receipt of all necessary approvals, including the approval of the TSX Venture Exchange.

About Aurora Spine

Aurora Spine is an early stage company focused on bringing new solutions to the spinal implant market through a series of screwless, innovative, minimally invasive, regenerative spinal implant technologies. Aurora Spine continues to position itself at the forefront of spinal surgery procedures, focusing on minimally invasive spine surgery technologies.  Aurora Spine is changing spine surgery by focusing on disruptive technologies following the Company’s commitment to – Simplifying the Complex.

Forward-Looking Statements

This news release contains forward-looking information that involves substantial known and unknown risks and uncertainties, most of which are beyond the control of Aurora Spine, including, without limitation, those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Information” in Aurora Spine’s final prospectus (collectively, “forward-looking information”). Forward-looking information in this news release includes information concerning the proposed transaction and Aurora Spine’s ability to complete the transaction. Aurora Spine cautions investors of Aurora Spine’s securities about important factors that could cause Aurora Spine’s actual results to differ materially from those projected in any forward-looking statements included in this news release. Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions or future events or performance are not historical facts and may be forward-looking and may involve estimates, assumptions and uncertainties which could cause actual results or outcomes to differ unilaterally from those expressed in such forward-looking statements. No assurance can be given that the expectations set out herein will prove to be correct and, accordingly, prospective investors should not place undue reliance on these forward-looking statements. These statements speak only as of the date of this press release and Aurora Spine does not assume any obligation to update or revise them to reflect new events or circumstances.

For more information, please contact:

Aurora Spine Corporation

Trent Northcutt
President and Chief Executive Officer
(760) 424-2004

Sarina Mason
Chief Financial Officer
(760) 424-2004

www.aurora-spine.com

Spineway sets up the governing structure for its US subsidiary

Spineway, specialist in surgical implants and instruments for treating disorders of the spinal column (spine), is reorganizing and setting up the governing structure for its US subsidiary with the arrival of a new CEO.

Pursuant to the strategic plan, Stéphane Le Roux, CEO of Spineway SA, launched the reorganization of the US subsidiary in order to revitalize sales in said country. The first steps are the arrival of Jon Luedke as CEO of Spineway Inc. and Philippe Laurito moving to the position of CTO. He will perform his duties within the subsidiary until the end of the year so as to ensure a smooth transition for the new CEO and provide technical follow-up on current business.

Jon Luedke, 54 years old, has over 20 years’ experience in the spine sector. He has held positions as General Manager and Sales Manager with major groups (Zimmer Spine and Centinel Spine) and with innovative SMEs (Wenzel Spine and Prosidyan). During the course of his professional career, he was able to draw on his business-development skills to carry out projects from repositioning companies to reviving business activities, making it possible to improve the sales and profitability of the companies under his stewardship.

His thorough understanding of the spinal-column business and his knowledge of the various players on the US market will be an asset to the Group’s new strategy, make it possible to market competitive products via the various distribution networks in the US.

The new momentum generated as a result of this appointment should allow the Group to create a new growth model for Spineway Inc.

SPINEWAY IS ELIGIBLE FOR THE PEA-PME (EQUITY SAVINGS PLANS FOR SMES)
Find out all about Spineway at www.spineway.com

Meeting for the presentation of the strategic plan on 13 December 2018

This press release has been prepared in both English and French. In case of discrepancies, the French version shall prevail.

Spineway designs, manufactures and markets innovative implants and surgical instruments for treating severe disorders of the spinal column.
Spineway has an international network of over 50 independent distributors and 90% of its revenue comes from exports.
Spineway, which is eligible for investment through FCPIs (French unit trusts specializing in innovation), has received the OSEO Excellence award since 2011 and has won the Deloitte Fast 50 award (2011). Rhône Alpes INPI Patent Innovation Award (2013) – INPI Talent award (2015). ISIN: FR0011398874 – ALSPW      

Contacts:

Shareholder-services line
Available Tuesday through Thursday 
(10 a.m.-12 p.m.)
+33 (0)811 045 555
  Investor relations
Solène Kennis
spineway@aelium.fr

Attachment

NuVasive Launches First-Of-Its-Kind Brigade® Lateral Implant And Instrumentation Optimized For Lateral Anterior Lumbar Interbody Fusion Spine Surgery

SAN DIEGONov. 15, 2018 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, today announced the U.S. commercial launch of Brigade® Lateral, the industry’s first interbody implant and instrumentation optimized for lateral anterior lumbar interbody fusion (ALIF) spine surgery.

NuVasive’s Lateral ALIF™ is a proprietary spine procedure enabling access to L5-S1 from a lateral position, while retaining the characteristics of a traditional ALIF. Brigade Lateral features improved instrumentation, a new insertion method and an expanded lordotic implant offering, all optimized for improved workflow and outcomes through the Lateral ALIF procedure. The technology’s threaded in-line inserter is angled off the midline and positioned on the lateral edge of the implant to better access the L5-S1 spine levels, which have typically been very difficult to treat effectively. The instrumentation is designed to offer surgeons a low-profile and reproducible insertion method, enhancing the overall surgical workflow in the operating room (OR). With a variety of lordotic implant options, Brigade Lateral allows surgeons to customize lordosis based on a patient’s need which is important to preserving and restoring spinal alignment.

“The NuVasive Lateral ALIF procedure, coupled with the Brigade Lateral implant and instrumentation specifically designed for this approach, is a game changer for me and my patients,” said Dr. Michael Cluck, orthopedic surgeon at Bay Area Spine Care in San Jose, California. “When used with minimally invasive surgical techniques, Lateral ALIF allows surgeons to complete a standard ALIF and posterior fixation from one position for both single-level and, more importantly, multi-level lumbar spinal fusions.”

Lateral ALIF is integrated into NuVasive’s lateral single-position surgery platform which is intended to increase OR efficiency by reducing the need for patient repositioning which may result in a patient being under anesthesia for a decreased amount of time.

“NuVasive pioneered the lateral approach in spine surgery, and continues to lead the industry with disruptive procedural solutions that maximize the efficiency of these less invasive techniques while retaining the inherent benefits to surgeons, patients and hospitals,” said Matt Link, president, Strategy, Technology and Corporate Development for NuVasive. “Brigade Lateral is no exception, and extends our comprehensive procedural offering to a wider range of indications from the lateral approach.”

About NuVasive
NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally disruptive, procedurally integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes. The Company’s portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With over $1 billion in revenues, NuVasive has an approximate 2,400-person workforce in more than 40 countries serving surgeons, hospitals and patients. For more information, please visit www.nuvasive.com.

Forward-Looking Statements
NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with acceptance of the Company’s surgical products and procedures by spine surgeons, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive’s products (including the iGA® platform), the Company’s ability to effectually manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties described in NuVasive’s news releases and periodic filings with the Securities and Exchange Commission. NuVasive’s public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.

SOURCE NuVasive, Inc.

Related Links

http://www.nuvasive.com

Simplify Medical Completes Enrollment in U.S. IDE Pivotal Trial of Simplify® Disc for Two-Level Cervical Disc Replacement

SUNNYVALE, Calif., Nov. 14, 2018 (GLOBE NEWSWIRE) — Simplify Medical Pty Ltd., maker of the Simplify® cervical artificial disc, today announced that it has completed the enrollment and treatment of all patients in its U.S. Investigational Device Exemption (IDE) pivotal trial evaluating the Simplify® Disc for two-level cervical disc replacement. The Simplify Disc is designed for biomechanical motion, anatomical height-matching, and MRI compatibility with a goal of simplifying the treatment of degenerative disc disease.

The prospective, multi-center clinical trial enrolled a total of 200 patients at 18 clinical sites across the United States. The primary endpoint of the study is the clinical success rate of Simplify Disc in two contiguous levels from C3 to C7 compared with two-level anterior cervical discectomy and fusion (ACDF). The Company announced the completion of enrollment for its one-level IDE trial in February 2018.

David Hovda, CEO of Simplify Medical, said, “Our two-level trial has generated an exceptional level of interest, which has allowed us to complete study enrollment more quickly than anticipated. We thank all of our dedicated surgeon investigators who have participated in the trial and look forward to working with them to complete the study.”

Domagoj Coric, MD, Chief of Neurosurgery at Carolinas Medical Center and national co-primary investigator for the study as well as co-primary investigator of the one-level study, stated, “Given its compelling feature set and the early positive feedback, I believe the Simplify Disc represents the future of cervical disc arthroplasty. I look forward to providing my patients with this technology as it becomes commercially available and am eager to share clinical data when available.”

Richard Guyer, MD, chairman of the Texas Back Research Institute Foundation and national co-primary investigator for the study as well as co-primary investigator of the one-level study, commented, “The Simplify Disc has the potential to offer an attractive alternative for two-level disease by simplifying procedure complexity compared to other marketed devices, providing motion, and better matching patient anatomy with lower disc heights that avoid excessive wear. We look forward to sharing outcomes at upcoming spine meetings.”

The Simplify Disc is being evaluated in separate IDE trials in the U.S. for one- and two-levels. The Simplify Disc is CE Marked in Europe and commercially available in select European markets. Internationally, early market feedback has shown substantial improvement in patient pain scores and functional improvement after treatment.

About Simplify® Disc
Simplify® Disc is a motion-preserving cervical artificial disc designed to allow for advanced imaging capability of MRI, and to better match patients’ anatomies. It is composed of advanced, primarily non-metal materials (PEEK-on-ceramic) to permit the full diagnostic imaging capability of MRI and may eliminate the need for CT/Myelogram and CT imaging in order to minimize patient exposure to radiation. The Simplify Disc is anatomically designed, offering a broader range of disc heights including low height implant options to better fit patients’ anatomies. With no metal in its articulating components, the disc is also designed for low levels of wear to optimize long-term durability. Implantation of the Simplify Disc is accomplished in a straightforward, three-step procedure.

About Simplify Medical
Simplify Medical is a medical device company focused on cervical spinal disc arthroplasty, using innovative, MRI-compatible materials designed to decrease the need for ionizing radiation and enhance patient options. Simplify Medical is located in Sunnyvale, California. To learn more, visit http://www.simplifymedical.com/.

CAUTION: ­Investigational device. Limited by Federal (or United States) law to investigational use.

Simplify Medical Contacts:

Investor Contact:
Brian Johnston, The Ruth Group
Tel: +1 646-536-7028
Email: bjohnston@theruthgroup.com

Media Contact:
Kirsten Thomas, The Ruth Group
Tel: +1 508-280-6592
Email: kthomas@theruthgroup.com

Nanovis Expands the Range of Footprints for its Signature FortiCore Posterior Lumbar Interbody Fusion System

Nanovis, a leader in nanomedicine for the spine, today announced adding 22mm and 25mm lengths to its FortiCore® rotatable Posterior Lumbar Interbody Fusion (PLIF) devices.

With over 5,000 FortiCore interbodies now implanted, Nanovis plans to further accelerate its technology driven growth with the expansion of their FortiCore PLIF product line with the addition of 22 mm and 25 mm lengths that can be rotated in situ for optimal placement.

“Many of our customers asked for these new sizes so they could treat their lumbar patients after using FortiCore in the cervical spine. Our surgeon customers have converted from titanium, PEEK, plasma sprayed PEEK, and allograft for the benefit of a deeply porous interconnected titanium scaffold to secure the implant and the benefit of a PEEK core to visualize bridging bone. They’ve been very pleased with their patient’s results and are asking for more lumbar FortiCore options because of the difficulties in assessing and achieving the best outcomes with other interbody technologies.” said Matt Hedrick, CEO, Nanovis. FortiCore® interbody fusion devices are comprised of a deeply porous titanium scaffold designed to assist in securing the implant in the intervertebral space. The scaffold is intermolded with PEEK Optima® by InVibio to allow bridging bone visualization. This unique combination of technologies is designed to increase positive outcomes in spinal fusion procedures with the imaging capabilities preferred by surgeons. “These FortiCore sizes complete our lumbar TLIF and PLIF offering. Nanovis is growing quickly with the best technology portfolio for our distributors to build their revenue and their surgeon relationships. The science driven innovation and potential to help patients has helped achieve favorable hospital access as a technology product. Distributors interested in the best possible fixation technology should reach out to me at jeff.shepherd@nanovistechnology.com,” said Jeff Shepherd, VP of Sales, Nanovis. Nanovis’ technology driven growth strategy is based on its FortiCore, nanotube, and NanoPEEK fixation technology platform and it’s bactericidal nanotube and infection prevention and treatment technology platform. The FortiCore scaffold, sold in other orthopedic markets as the OsteoSync™ scaffold by the inventors of the technology, Sites Medical, shows positive results and attractive sales growth. Combined, these technologies provide exceptional fixation capability that supports years of spine and orthopedic implant upgrades, patient benefits, and technology driven sales growth. For more information about Nanovis, FortiCore or other proprietary Nanovis science-enhanced technologies, please visit us http://www.nanovisinc.com.

About Nanovis:

Nanovis’ mission is to develop science-enhanced, life-improving technologies. The Company’s patented and
proprietary regenerative technology platforms provide differentiated surface advantages enabling the potential for existing medical devices to achieve new outcomes. Focused on aggressive, sustainable growth across multiple markets, Nanovis is commercializing science-driven platforms: the deeply porous scaffold currently available with the FortiCore® line of interbody fusion devices; an advanced nanotube surface; and a nanotube surface technology with anti-colonization and anti-microbial capabilities in pre-clinical studies.

Camber Spine Announces First Surgeries With ENZA®-A Titanium ALIF

Managing Partner of KICVentures and Former J.P. Morgan Analyst Predicts Continued Valuation Growth in the Spine Device Market

Aditya Humad, Managing Partner of KICVentures, released an analysis of the spine technology market last week that asserts it is still trending upward with growing valuations based on a largely under-served and expanding global patient population.

Humad’s analysis describes market consolidation, pricing pressure and increased competition as reasons often cited by institutional investors to forgo opportunities in spine. But with spine a $10 billion market and growing, Humad believes that it is not only a hot market for long-term players, but an often-overlooked market for potential investors. Humad cites the Viscogliosi brothers as an example of strategic investors and pioneers that focused on the orthopedic and spine sector to build a private equity firm and several successful transactions over the past 15 years.

Humad states that spine companies with niche solutions or strong growth have attained attractive valuations. “The LDR (Cervical Disc Replacement) was acquired by Zimmer Biomet for $1.1 Billion, K2M (Scoliosis and Complex Spine) was acquired by Stryker for $1.4 Billion, and Nuvasive (MIS and Lateral Approach) is valued $3.2 Billion. Globus Medical is now valued $5.3 Billion which is ~200% growth in valuation over 5 years and trades at 7x revenue,” says Humad.

This bodes well for KICVentures’ own spine portfolio that includes a disruptive innovation with its company AxioMed. KICVentures is a long-term value investor and Humad believes that it is strategically positioned to lead the market in five years because of the growing consensus about the superiority of disc replacement over fusion, and because of a strong interest globally for a viscoelastic disc solution, both of which AxioMed offers.

“AxioMed will disrupt the current spine fusion paradigm and immediately replace the rudimentary ball-and-socket disc designs on the market to provide the most natural disc replacement to the human spine,” says Humad.

About KICVentures

KICVentures is a private investment company founded in 2005 by Harvard-trained Orthopedic Surgeon and Professor Dr. Kingsley R. Chin, who brings unique experience at the intersection of medicine, business and information technology. KICVentures is equipped with a strong advantage in identifying niche healthcare opportunities, and is headquartered in Boston, Mass.

About AxioMed, LLC

AxioMed, LLC was founded to advance the standard of care for patients with degenerative spine conditions by progressing spine technology beyond fusion and first-generation artificial discs. Led by an experienced surgeon team and utilizing patented viscoelastic polymer technology, AxioMed has developed the most advanced next generation of artificial disc replacement solutions for the cervical and lumbar spine.

Company Profiles in Artificial Disc Market| Key Players: Zimmer Biomet, Stryker, Globus Medical, Orthofix, Medtronic, DePuy Synthes Companies, NuVasive

11-09-2018 / Press release from: Global Market Insights Inc.

Cervical artificial disc segment accounted for the largest revenue share of USD 790.1 million in 2017 and is estimated to show significant growth over the forecast period. Cervical disc replacement is a motion preserving surgery and offers benefits over motion creating surgical fusion procedures. According to a clinical trial conducted for cervical artificial discs, cervical discs proved efficient for reducing neck pain by 70-80%. Advantages offered by cervical artificial discs such as better compatibility and ease of insertion, decreases the need for revision surgery. Availability of advanced products as well as increasing demand for minimally invasive surgeries will drive the segmental growth over the forecast timeframe.

Request for a sample of this research report @ www.gminsights.com/request-sample/detail/1183

Lumbar artificial disc segment is estimated to show 21.0% CAGR over the forecast period due to rapidly growing elderly patient population suffering from orthopaedic diseases. Low back pain (LBP) is one of the major disabilities among the geriatric population that limits functionality and decreases the quality of life. Increasing prevalence of LBP will increase the demand for lumbar total disc replacement (LTDR) procedures, thereby boosting the lumbar artificial disc segment growth. Growing applications of LTDR procedure in patients with discogenic pain and degenerated lumbar spine should further accelerate the segmental growth.

Company profiled in this report based on Business overview, Financial data, Product landscape, Strategic outlook & SWOT analysis:
• Medtronic
• DePuy Synthes Companies
• NuVasive
• Zimmer Biomet
• Stryker
• Globus Medical
• Orthofix
• Paradigm Spine, LLC
• SPINEART
• Simplify Medical, Inc.
• K2M Design, Inc.
• AxioMed, LLC
• BKK B. Braun Melsungen AG

North America market dominated industry with 52.0% revenue share in 2017 and is forecasted to show lucrative growth over the forecast period. Rising prevalence of degenerative disc diseases due to sedentary lifestyle is the major factor that will spur the artificial disc market size. Moreover, established presence of key industry players in the region will subsequently increase availability of new and advanced devices among people, thereby driving the North America artificial disc market in foreseeable future. Partial government support for disc replacement procedures due to its advantages over the traditional methods will further augment the regional growth.

Make an inquiry for purchasing this report @ www.gminsights.com/inquiry-before-buying/1183

Artificial Disc Market, by Material, 2013-2024 (USD Million)
• Metal-on-Metal
• Metal-on-Biopolymer

Artificial Disc Market, by Type, 2013-2024 (USD Million)
• Cervical artificial disc
• Lumbar artificial disc

Global Market Insights Inc. is a global market research and management consulting company catering to leading corporations, non-profit organizations, universities and government institutions. Our main goal is to assist and partner organizations to make lasting strategic improvements and realize growth targets. Our industry research reports are designed to provide granular quantitative information, combined with key industry insights, aimed at assisting sustainable organizational development.

Global Market Insights, Inc.
4 North Main Street
Selbyville, Delaware 19975 USA
Phone: 1-302-846-7766
Toll Free: 1-888-689-0688
Email:sales@gminsights.com

This release was published on openPR.

 

NuVasive’s Proprietary Porous PEEK™ Implant To Be Used In Flagship XLIF® Procedure

SAN DIEGONov. 8, 2018 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for use of its COHERE® Porous PEEK™ implant in eXtreme Lateral Interbody Fusion (XLIF®) surgical spine procedures.

NuVasive’s patented Porous PEEK technology offers a unique three-dimensional architecture combined with the radiolucent properties of PEEK. Based on preclinical studies, this porous structure promotes bone ongrowth and ingrowth, which is key to facilitating fusion that leads to better clinical outcomes. This unique, proprietary technology – combined with the radiolucent properties of PEEK – provides increased clarity in postoperative x-rays and imaging, allowing surgeons to more easily assess fusion following procedures.

“COHERE XLIF with its one-of-a-kind Porous PEEK technology provides surgeons the best implant for treating patients. It is designed to allow early incorporation of bone into the inter-body spacer, which may lead to the prevention of expulsion and promotion of early fusion which allows a quicker and better way back to an active lifestyle for my patients,” said Dr. Christopher R. Brown, orthopedic spine surgeon for Duke Health. “Incorporating COHERE Porous PEEK implants into XLIF procedures keeps imaging characteristics that we all love about PEEK implants intact. COHERE XLIF takes the gold standard of lateral interbody fusion and raises the bar, allowing our patients to receive the best surgery with the best implant possible.”

The 510(k) clearance supports the Company’s strategic expansion of its Advanced Materials Science™ technologies into complementary NuVasive procedures. An abstract recently published by Biomaterials, further validates that Porous PEEK implant surfaces provide a stronger osseointegration response than smooth PEEK surfaces. The conclusion is based on results from an in vitro cell study and in vivo small animal model.

“It’s exciting to extend our patented interbody technology to the Company’s flagship XLIF procedure, an integral part of our single-position surgery portfolio, as we further our mission to improve patient lives,” said Matt Link, president, Strategy, Technology and Corporate Development for NuVasive. “COHERE XLIF represents the first buildout of a Porous PEEK implant by NuVasive, and we look forward to extending this proprietary technology into additional applications across the Company’s comprehensive procedural solutions.”

The FDA 510(k) indications for COHERE allow surgeons to use the interbody implant with autograft and/or allograft in skeletally mature patients for thoracolumbar pathologies including degenerative disc disease, degenerative spondylolisthesis, and degenerative scoliosis. NuVasive worked alongside highly experienced XLIF surgeons to pioneer the design of the COHERE XLIF implant to achieve the optimal shape and geometry for lateral insertion.

COHERE XLIF is expected to launch commercially in the U.S. in second quarter 2019.

About NuVasive
NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally disruptive, procedurally integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes. The Company’s portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With over $1 billion in revenues, NuVasive has an approximate 2,400-person workforce in more than 40 countries serving surgeons, hospitals and patients. For more information, please visit www.nuvasive.com.

Forward-Looking Statements
NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with acceptance of the Company’s surgical products and procedures by spine surgeons, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive’s products (including the iGA® platform), the Company’s ability to effectually manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties described in NuVasive’s news releases and periodic filings with the Securities and Exchange Commission. NuVasive’s public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.

SOURCE NuVasive, Inc.

Related Links

http://www.nuvasive.com

VGI Medical Announces Completion of New Office Buildout and Lab in Largo, FL

VGI Medical is dedicated to creating the next generation of spinal implants and procedures to improve the quality of life for its patients. To do so, VGI Medical is excited to announce the completion of the renovation of its corporate headquarters in Largo, FL. To enhance the training experience for surgeons and distributors, the renovation included the creation of a world-class lab as a focal point of the building.

VGI Medical was founded in 2007 based on an invention developed by Tov Vestgaarden, PhD. It has become a leader in bringing innovation to the market including VerteLoc, CerLoc, SiJoin and VerteLP. The VerteLoc system is specifically designed to stabilize and fuse the facet joint by utilizing a unique patented dual geometric design to limit motion of the affected spinal segment. Applying the principles of this success, VGI Medical has added SiJoin for Sacroiliac Fusion. VerteLP is one of the latest innovations offering an improved implant for lateral procedures featuring its proprietary Talon Technology.

VGI Medical has a robust product pipeline ahead and is looking to continue to provide world-class service offered to its surgeon partners. With an open-door policy, the new buildout encourages surgeons, distributors and hospital administrators alike to gain first-hand experience with this compelling product portfolio.

“An inhouse training facility gives us the ability to quickly respond to a surgeon’s always-changing schedule,” said Tov Vestgaarden, cofounder and CEO of VGI Medical.

“With the growing number of players in the spine market, it is not enough to simply have unique products.  To differentiate ourselves further from the competition, we wanted to create an environment that caters to the development of long-term relationships with our surgeon and distributor partners.  We believe with the completion of the renovations, and more specifically the surgical skills lab, we have the additional means to foster those relationships,” said Mike Anderson, President of VGI Medical.

_______

About VGI Medical

VGI Medical is a disruptive force in the spinal implant industry by creating four unique technologies specifically designed to enhance patient outcomes and improve the overall surgeon experience. Our calling is to provide the ideal solution to each clinical challenge faced with the existing technologies on the market today. With over 12,500 implants used since our inception, our implants and instruments have been thoroughly tested with exceptional results.