Globus Medical Announces Launch of ELSA® Expandable Lateral Spacer System

AUDUBON, Pa., April 05, 2018 (GLOBE NEWSWIRE) — Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal solutions company, today announced the launch of two innovative lateral expandable interbody spacers with integrated screw fixation, ELSA® AL and ELSA®-ATP, the latest additions to Globus’ unmatched expandable solutions. These next generation expandable implants provide an optimized fit for the patient, allowing for restoration of sagittal balance and enhanced structural fixation.

Globus Medical is the market leader in expandable interbody spacers with over 20 expandable implant solutions supported by 15 years of clinical experience. Globus Medical’s full line of expandable products has enabled surgeons to treat over 130,000 levels.

“ELSA® AL is the alternative to RISE®-L for selected cases in which maximizing segmental lordosis is indicated,” said Dr. Paul K. Kim, neurosurgeon at Carolina Neurosurgery & Spine Associates. “In conjunction with the ALL (anterior longitudinal ligament) release technique, ELSA® AL has the potential to provide the most amount of segmental lordosis of any device on the market.”

Adjustable Lordosis Technology with ELSA® AL

ELSA® AL’s in situ adjustability and integrated screw fixation are designed to help correct sagittal balance and improve stability. The implant features exclusive adjustable lordotic technology that allows up to 30° of lordosis while maintaining a minimally invasive surgical corridor. With less disruption compared to traditional static spacers, ELSA® AL provides maximum correction and additional fixation for increased segmental stability.

First Expandable Spacer for a Customized ATP Approach

ELSA®-ATP is the only expandable spacer designed to avoid nerve complications associated with the direct lateral technique by using an anterior-to-psoas approach.

The Lateral Lumbar Interbody Fusion (LLIF) technique approaches the spine from the side of the patient, which allows for placement of a larger implant footprint and less disruption of the lower back muscles. The anterior-to-psoas approach is a modified LLIF procedure that avoids the psoas, a large muscle responsible for movement and flexion of the leg. Avoiding this muscle and its integrated nerves may help reduce post-operative complications such as thigh pain.

ELSA®-ATP features angled integrated screws for direct fixation to the adjacent vertebrae. The spacer can be inserted at a minimal height and expanded in situ to minimize tissue disruption and maximize indirect decompression. A full suite of anterolateral access and insertion instruments makes ELSA®-ATP the most comprehensive system on the market.

“Our product development team’s continued commitment to innovation has enabled us to design expandable interbody technology for nearly every surgical approach.  The addition of these two unique ELSA® spacers to our expandable lateral portfolio demonstrates our commitment to listening and responding to our customers’ needs through continuous product innovation,” said Andrew Iott, Senior Vice President of Global Product Development. “The use of an expandable spacer for the ATP approach may help reduce complications associated with the lateral procedure.  With restoration of alignment being of critical importance, these implants were developed as a tool to help surgeons address sagittal imbalance, with the goal of maximizing lordotic correction.”

Learn more about ELSA® and Globus Medical’s full line of expandable interbody spacers at www.GlobusMedical.com/Expandables.

Indications

The ELSA® Spacer is an interbody fusion device 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). The ELSA™ Spacer is to be filled with autograft and/or allogenic bone graft comprised of cancellous and/ or corticocancellous bone, may be used with two bone screws, and is to be used with supplemental fixation. Hyperlordotic (≥20°) implants must be used with the two bone screws and supplemental fixation in addition to the bone screws.

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. 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:
Brian Kearns
Vice President, Business Development and Investor Relations
Phone: (610) 930-1800
Email: investors@globusmedical.com
www.globusmedical.com

NuVasive Sponsors ISASS 2018, Hosts Workshops And Presentations

SAN DIEGOApril 5, 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 Company is a sponsor of the International Society for the Advancement of Spine Surgery, 18th Annual Conference (ISASS) being held April 11-13, 2018, in Toronto, at the Metro Toronto Convention Centre. NuVasive will host a hands-on workshop featuring the latest advances in Lateral Single-Position solutions, as well as a number of podium presentations at ISASS 2018.

The NuVasive Industry Lunch Workshop, Leading. Expanding. Advancing. Insights to Lateral Procedural Solutions, by J. Alex Thomas, M.D., will take place on Thursday, April 12 from 12:00-1:30 p.m. in Room 802A / 802B. For more information, visit http://www.isass.org/education/conferences/isass18-scientific-program/.

“We encourage attendees to participate in the workshop to see firsthand how surgeons are already incorporating Lateral Single-Position solutions to help their patients,” said Matt Link, executive vice president, strategy, technology and corporate development for NuVasive. “This equates to increased OR efficiency by reducing the number of times a patient has to be repositioned and expanding the benefits of lateral surgery to more spinal levels. Since its launch in October 2017, the Lateral Single-Position solution is fully integrated into our portfolio, and we have received extremely positive feedback from early adopters who are seeing great results as they take XLIF® to the next level to create a better and more streamlined surgical experience for both surgeon and patient.”

Additionally, NuVasive will present on podium during ISASS 2018, touching on topics ranging from advanced implant materials such as Porous PEEK™ to biologics:

  • April 1111:14 a.m. Efficacy of a Novel Microstructured Calcium Phosphate-Collagen Bone Graft in a Rabbit Posterolateral Spine Fusion Model. Speaker: Greg M. Williams, Ph.D.
  • April 13, 8:00 a.m. Comparing the Osseointegration of Seven Spinal Interbody Device Materials in an Ovine Bone Implantation Model. Speaker: Greg M. Williams, Ph.D.
  • April 139:00 a.m. PEEK, HA PEEK and Porous PEEK science. Speaker: Prof. Ken Gall

Conference attendees can visit NuVasive Booth #201 to experience the latest innovative spine solutions and systems firsthand from the NuVasive team of experts and also view research posters in the exhibit hall.

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

Paradigm Spine Announces Company Activities And Three Podium Presentations Highlighting coflex® Interlaminar Stabilization® At ISASS 2018

NEW YORKApril 3, 2018 /PRNewswire/ — Paradigm Spine, LLC, a leader in providing motion preservation solutions for the treatment of lumbar spinal stenosis, today announced its Company activities and scientific podium presentations on coflex® Interlaminar Stabilization® at the upcoming 2018 International Society for the Advancement of Spine Surgery (ISASS), being held April 11-13 in Toronto, Canada. coflex® is the only posterior lumbar motion preservation solution with proven long-term outcomes for durable pain relief and stability for patients with moderate to severe spinal stenosis.

“Now backed by two sets of Level I Evidence, coflex is the leading lumbar device shown to significantly maintain foraminal height, increase walking distance, and lower risk of secondary intervention, while still allowing patients a natural range of movement,” said Marc Viscogliosi, Chairman and CEO of Paradigm Spine. “These proven long-term and durable results indicate that surgeons can be more confident when backing up their decompressions for spinal stenosis patients and when additional stabilization is required. We are pleased to be demonstrating the unique capabilities of coflex during three podium presentations, an industry symposium and an interactive workshop at this year’s meeting.”

Paradigm Spine Company Activities:

  • Interactive Bioskills Experience: Demo Workshop for Posterior Lumbar Motion Preservation with coflex
    Date and Time:      Wednesday, April 11th, 6:00 – 8:30 p.m. EDT
    Location:                Hall G, Theater Red

    This interactive demo workshop will be “come and go” style, and provide a closer look at coflex surgical pearls. Those interested in attending can RSVP on www.paradigmspineresources.com, email rsvp@paradigmspine.com or sign up at Paradigm booth #300. Walk-ins are also welcome.

  • Lunch Symposium: Extending the Durability of Decompression with the Exclusive Posterior Lumbar Motion Preservation Solution: Level I Evidence from Two Prospective Randomized Controlled Studies
    Date and Time:      Thursday, April 12th, 12:00 – 1:30 p.m. EDT
    Location:                Room 801B

    Paradigm Spine will host a Lunch Symposium with a panel of speakers, featuring ESCADA author Dr. Joerg Frankeand U.S. IDE Investigator Dr. Hyun Bae, discussing the results of the ESCADA 2-year trial results (European Study of coflex And Decompression Alone), for which researchers concluded decompression with coflex extends the durability and sustainability of a decompression procedure. Those interested in attending can RSVP on www.paradigmspineresources.com, email rsvp@paradigmspine.com or sign up at Paradigm booth #300 as space will be limited.

Paradigm Spine Podium Presentations:

  • General Podium Presentation: Abstract 162 “5-year Follow-up of Interlaminar Stabilization Surgery in the ≤ 65 Year Old Patient: More Value, Less Cost”
    Speaker:                 A.T. Brecevich
    Date and Time:       Wednesday, April 11th, 11:38 – 11:41 a.m. EDT
    Location:                 Hall F
  • Lightning Podium Presentation: Abstract 527 “Medical Cost Savings for Lumbar Spinal Stenosis Treated with Decompression and Interlaminar Stabilization as an Alternative to Fusion”
    Speaker:                 S.R. Golish
    Date and Time:       Wednesday, April 11th, 5:32 – 5:33 p.m. EDT
    Location:                 Room 801B
  • Lightning Podium Presentation: Abstract 341 “Comparison of Decompression with Interlaminar Stabilization vs. Decompression with Fusion in Patients Requiring Surgical Treatment for Spinal Stenosis Grade I Spondylolisthesis at 5 Year Follow-Up”
    Speaker:                 C. Dowe
    Date and Time:       Wednesday, April 11th, 5:47 – 5:48 p.m. EDT
    Location:                 Room 802B

About Lumbar Spinal Stenosis (LSS)
Lumbar spinal stenosis (LSS), affecting 1.6 million patients annually in the United States, is a debilitating and degenerative disease often associated with significant leg and back pain, leg numbness and weakness, and significant reduction in an active lifestyle. Historically, the two traditional surgical treatment options for LSS included decompression alone or decompression with lumbar fusion.  Decompression alone has proven effective at relieving pain symptoms caused by lumbar spinal stenosis, however, patients may not experience long term symptomatic relief, resulting in subsequent epidural injections for pain management, or additional surgeries for conversion to a fusion. Decompression with fusion has proven to provide pain relief and stabilize the diseased segment, but may lead to adjacent level disease requiring subsequent surgeries.

About Paradigm Spine, LLC:
Paradigm Spine, LLC, founded in 2004, is a privately held company and remains focused on the design and development of solutions for the disease management of spinal stenosis.  The Company’s signature product is the coflex® Interlaminar Stabilization® device, which is currently used in over 60 countries worldwide. coflex is the only lumbar spinal device that has produced Level I evidence in two separate prospective, randomized, controlled studies against two different control groups, changing the standard of care for lumbar spinal stenosis treatment. For additional information visit www.paradigmspine.com or www.coflexsolution.com.

 

SOURCE Paradigm Spine, LLC

Related Links

http://www.paradigmspine.com

NuVasive Portfolio Now Includes ALIF Retractor Platform For Lateral And Supine Approaches

SAN DIEGOApril 2, 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 launch of ALIF (Anterior Lumbar Interbody Fusion) Access, the Company’s first-ever MAS® (Maximum Access Surgery) ALIF retractor platform for both lateral and supine spine surgery approaches.

The retractor system’s features help retain the characteristics of a traditional ALIF while giving surgeons options for either a lateral or supine approach based on patient need.

For lateral entry, the Lateral ALIF Access System enables single-position surgery for multilevel cases when integrated with the NuVasive XLIF® procedure, increasing O.R. efficiency by reducing the number of times a patient has to be repositioned and expanding the benefits of lateral surgery to more spinal levels.

“Accessing L5/S1 laterally has historically had its shortcomings, specifically because the existing systems on the market were not designed from the ground up for these approaches,” said Dr. J. Alex Thomas MD. “Access systems used in the past were lacking in various clinically necessary areas. NuVasive has addressed these clinical concerns with their new ALIF Access platform, whether it is a traditional supine approach or as the surgeon moves towards single-position surgery, they’ve created a real game changer for ALIF approaches.”

For the exposure surgeon, the NuVasive ALIF Access platform supports the traditional supine ALIF approach with features to enhance imaging and direct visualization of the spine and goes a step further by offering new opportunities for access from the lateral decubitus position. The learning curve for accessing L5/S1 from the lateral position mimics that of a supine approach, minimizing adoption hurdles for access surgeons. NuVasive has streamlined access for both approaches by creating a flexible platform which fluently translates between the surgeon’s desired approach, based on patient anatomy and pathology.

“ALIF Access exemplifies our commitment to innovation and providing relevant solutions to meet the diverse and evolving needs of our surgeons,” said Matt Link, executive vice president, strategy, technology and corporate development for NuVasive. “XLIF is the foundation on which NuVasive is built, and the Lateral ALIF Access System empowers the surgeon to take XLIF to another level by incorporating a single-position protocol for a better all-around surgeon and patient experience. NuVasive remains laser-focused on delivering game-changing, procedural solutions and systems to market with the tools and training required to create the best clinical outcomes for the patient.”

Regardless of the approach, either lateral or supine, ALIF Access is fully compatible with the NuVasive anterior implant portfolio and comprises a carbon fiber frame for strength and radiolucency as well as customizable retractor blade size and positioning for optimum flexibility.

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

K2M Names Lane Major Chief Operating Officer

Mar 29, 2018

LEESBURG, Va., March 29, 2018 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc.(NASDAQ:KTWO) (the “Company” or “K2M”), a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance, today announced the appointment of Lane Major as Chief Operating Officer, a new position within K2M, effective immediately.

“On behalf of our Board, I am thrilled that Lane will serve as Chief Operating Officer,” said John P. Kostuik, M.D., K2M Chief Medical Officer, Co-founder, and member of the Board of Directors. “Lane’s vision of excellence in medical innovation and his commitment to achieving superior organizational results have made K2M a global leader in the spinal devices market. I am confident that he will continue to positively influence our entire organization, our clients, and most of all—patients.”

“Lane’s appointment to Chief Operating Officer is a strategic milestone for the Company as he embodies the values of K2M,” said K2M Chairman, President, and CEO Eric Major. “I deeply value Lane’s strategic insight, passion for innovation, and business acumen, all of which have been integral to K2M’s well-recognized global brand and best-in-class innovation engine. Lane, along with our accomplished team of executive leaders that represent the talent and diversity of our world-class organization, is committed to organizational excellence and poised to lead K2M well into the future.”

Major brings more than 15 years of spine industry experience, most recently as K2M’s Chief Strategy Officer, a position held following his service as K2M’s Senior Vice President of Global Marketing & Product Development. He has been with K2M since the Company’s inception in 2004 and has been essential to the development and commercialization of K2M’s product portfolio.

Major earned a B.B.A in Marketing and Computer Information Systems from James Madison University and an M.B.A from Northwestern University’s Kellogg School of Management.

“I am incredibly honored to have the opportunity to work with such an impressive and proven team of leaders here at K2M and I look forward to serving as the Company’s first Chief Operating Officer,” said Lane Major. “Our Company is committed to developing innovative solutions that have transformed spinal surgery for the better, as evidenced by our suite of complex spine technologies, our comprehensive Balance ACS® platform and a market-leading portfolio of 3D-printed spinal devices featuring Lamellar 3D Titanium Technology. I passionately believe in K2M and our promise of creating a better tomorrow for people across the globe who suffer from debilitating spinal disorders. Building upon our remarkable success to date, I could not be more excited about contributing to an even brighter future for K2M.”

For more information about K2M, visit www.K2M.com.

About K2M

K2M Group Holdings, Inc. is a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance. Since its inception, K2M has designed, developed, and commercialized innovative complex spine and minimally invasive spine technologies and techniques used by spine surgeons to treat some of the most complicated spinal pathologies. K2M has leveraged these core competencies into Balance ACS, a platform of products, services, and research to help surgeons achieve three-dimensional spinal balance across the axial, coronal, and sagittal planes, with the goal of supporting the full continuum of care to facilitate quality patient outcomes. The Balance ACS platform, in combination with the Company’s technologies, techniques, and leadership in the 3D-printing of spinal devices, enable K2M to compete favorably in the global spinal surgery market. For more information, visit www.K2M.comand connect with us on FacebookTwitterInstagramLinkedIn and YouTube.

Forward-Looking Statements

This press release contains forward-looking statements that reflect current views with respect to, among other things, operations and financial performance.  Forward-looking statements include all statements that are not historical facts such as our statements about our expected financial results and guidance and our expectations for future business prospects.  In some cases, you can identify these forward-looking statements by the use of words such as, “outlook,” “guidance,” “believes,” “expects,” “potential,” “continues,” “may,” “will,” “should,” “could,” “seeks,” “predicts,” “intends,” “plans,” “estimates,” “anticipates” or the negative version of these words or other comparable words. 

Such forward-looking statements are subject to various risks and uncertainties including, among other things: our ability to achieve or sustain profitability in the future; our ability to demonstrate to spine surgeons and hospital customers the merits of our products and to retain their use of our products; pricing pressures and our ability to compete effectively generally; collaboration and consolidation in hospital purchasing; inadequate coverage and reimbursement for our products from third-party payers; lack of long-term clinical data supporting the safety and efficacy of our products; dependence on a limited number of third-party suppliers; our ability to maintain and expand our network of direct sales employees, independent sales agencies and international distributors and their level of sales or distribution activity with respect to our products; proliferation of physician-owned distributorships in the industry; decline in the sale of certain key products; loss of key personnel; our ability to enhance our product offerings through research and development; our ability to maintain adequate working relationships with healthcare professionals; our ability to manage expected growth; our ability to successfully acquire or invest in new or complementary businesses, products or technologies; our ability to educate surgeons on the safe and appropriate use of our products; costs associated with high levels of inventory; impairment of our goodwill and intangible assets; disruptions to our corporate headquarters and operations facilities or critical information technology systems or those of our suppliers, distributors or surgeon users; our ability to ship a sufficient number of our products to meet demand; our ability to strengthen our brand; fluctuations in insurance cost and availability; our ability to remediate the material weaknesses in our IT general controls; our ability to comply with extensive governmental regulation within the United States and foreign jurisdictions; our ability to maintain or obtain regulatory approvals and clearances within the United Statesand foreign jurisdictions; voluntary corrective actions by us or our distribution or other business partners or agency enforcement actions; recalls or serious safety issues with our products; enforcement actions by regulatory agencies for improper marketing or promotion; misuse or off-label use of our products; delays or failures in clinical trials and results of clinical trials; legal restrictions on our procurement, use, processing, manufacturing or distribution of allograft bone tissue; negative publicity concerning methods of tissue recovery and screening of donor tissue; costs and liabilities relating to environmental laws and regulations; our failure or the failure of our agents to comply with fraud and abuse laws; U.S. legislative or Food and Drug Administration regulatory reforms; adverse effects associated with the exit of the United Kingdom from the European Union; adverse effects of medical device tax provisions; potential tax changes in jurisdictions in which we conduct business; our ability to generate significant sales; potential fluctuations in sales volumes and our results of operations over the course of a fiscal year; uncertainty in future capital needs and availability of capital to meet our needs; our level of indebtedness and the availability of borrowings under our credit facility; restrictive covenants and the impact of other provisions in the indenture governing our convertible  senior notes and our credit facility; worldwide economic instability; our ability to protect our intellectual property rights; patent litigation and product liability lawsuits; damages relating to trade secrets or non-competition or non-solicitation agreements; risks associated with operating internationally; fluctuations in foreign currency exchange rates; our ability to comply with the Foreign Corrupt Practices Act and similar laws; increased costs and additional regulations and requirements as a result of being a public company; our ability to implement and maintain effective internal control over financial reporting; potential volatility in our stock price; our lack of current plans to pay cash dividends; potential dilution by the future issuances of additional common stock in connection with our incentive plans, acquisitions or otherwise; anti-takeover provisions in our organizational documents and our ability to issue preferred stock without shareholder approval; potential limits on our ability to use our net operating loss carryforwards; and other risks and uncertainties, including those described under the section entitled “Risk Factors” in our most recent Annual Report on Form 10-K filed with the SEC, as such factors may be updated from time to time in our periodic filings with the SEC, which are accessible on the SEC’s website at www.sec.gov.  Accordingly, there are or will be important factors that could cause actual outcomes or results to differ materially from those indicated in these statements.  These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in this release and our filings with the SEC.

We operate in a very competitive and challenging environment. New risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this release. We cannot assure you that the results, events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results, events or circumstances could differ materially from those described in the forward-looking statements.

The forward-looking statements made in this press release relate only to events as of the date on which the statements are made. We undertake no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. Unless specifically stated otherwise, our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures, investments or other strategic transactions we may make.

Media Contact:

Zeno Group on behalf of K2M Group Holdings, Inc.
Christian Emering, 212-299-8985
Christian.Emering@ZenoGroup.com

Investor Contact:
Westwicke Partners on behalf of K2M Group Holdings, Inc.
Mike Piccinino, CFA, 443-213-0500
K2M@westwicke.com

Primary Logo

Source: K2M Group Holdings, Inc., Photo: K2M Group Holdings, Inc.

Ortho Kinematics Strengthens Leadership Team

March 30, 2018

AUSTIN, Texas–(BUSINESS WIRE)–Ortho Kinematics‚ Inc. (OKI), a privately held healthcare diagnostics company focused on spine imaging informatics, announced today that Erik Wagner has been appointed Interim Chief Executive Officer. Mr. Wagner has been an investor and advisor to OKI for several years.

“The OKI Board of Directors recognized that as the company moves to expand its product offering and market footprint, it needs the experience of a seasoned spine industry executive to usher in the next phase of growth,” said Jerry DeVries, Board Member. “Erik has agreed to help transition the company from a development to a commercial enterprise focused on the launch of the company’s next-generation diagnostic technology.”

Mr. Wagner added, “Ortho Kinematics has the potential to solidify and build on its status as the leader in spine diagnostics. Paul Gunnoe, OKI’s previous CEO, has positioned the company well for success and will be a strategic consultant to the company going forward. We have a tremendous opportunity ahead of us, and I am confident in our ability to accelerate our development and continue to generate value for our shareholders.”

OKI’s core product, the VMA is a diagnostic test for the assessment of spinal motion, instability, and sagittal alignment. Spinal instability and alignment are important considerations for physicians when evaluating candidates for therapies such as surgery and pain management. The VMA has been shown in studies to increase the sensitivity in detecting spinal motion, including instability, with no decrease in specificity relative to the current standard test.

About Erik Wagner

Mr. Wagner has been a co-founder, board member, and held executive management positions in two venture-backed spinal implant companies including Spinal Concepts (1996-2004) and Flexuspine (2007-2014). At Spinal Concepts, he and his partners raised over $40 million in venture capital leading the company to profitability in less than six years on sales exceeding $10 million/month and growing at 70% CAGR. He left Spinal Concepts following the sale of the company to Abbott Labs for $170 million in 2003. His proven record for innovation and leadership continued at Flexuspine where he served as CTO & CEO and led the development and clinical investigation of the world’s first spinal segmental reconstruction device. He is a named inventor on over 80 patents for medical devices ranging from spinal implants to cardiovascular atherectomy devices. He continues to serve as a business consultant and advisor to medical device startups and investor groups.

About Ortho Kinematics

Ortho Kinematics is a privately held diagnostic technology company, focused on spine imaging informatics and committed to the idea that spine motion matters. The company is working with a group of leading clinicians, researchers, and developers who are passionate about leveraging spine biomechanical data to improve the diagnosis and treatment of back pain. Ortho Kinematics is located in Austin, Texas and at www.orthokinematics.com.

Contacts

Ortho Kinematics‚ Inc.
Annie Burke, 512-334-5490

Medicrea Partners with Key Distributor to Form Joint Venture in Belgium

March 29, 2018

LYON, France & NEW YORK–(BUSINESS WIRE)–The Medicrea® Group (Euronext Growth Paris: FR0004178572 – ALMED), pioneering the convergence of healthcare IT and next-generation, outcome-centered spinal device design and manufacturing with UNiD ASI™ (Adaptive Spine Intelligence) technology, announced today that the Company has signed a joint-venture agreement with Motion Medical, Medicrea’s existing distribution partner, to accelerate the adoption of the Group’s products and technologies in Belgium.

Medicrea Belgium capitalizes on Medicrea’s long-standing relationship with its key distributor who has approximately a 15% market share. Motion Medical is headed by Steven Mesdom, who will remain on board with his team to lead the newly-formed subsidiary. Mr. Mesdom, who brings more than a decade of experience with Medicrea’s innovative family of products, stated, “We have had an exceptional track record introducing Medicrea’s flagship platforms to Belgium, including PASS® thoracolumbar fixation. This partnership marks an important step for our continued penetration of the Belgian market.”

Denys Sournac, President and Chief Executive Officer of Medicrea, added, “We are extremely pleased to have successfully negotiated this mutually-beneficial agreement with Mr. Mesdom and to announce the creation of Medicrea Belgium, a direct sales subsidiary. Our collective experience in this market will allow us to capitalize on a direct sales model and immediately generate additional revenue for the group. In addition, we will create new opportunities for growth with the latest patient-specific UNiD ASI™ technologies.”

Medicrea International holds a 51% majority stake in the Medicrea Belgium joint-venture and plans to transition the entity to a fully-owned Medicrea subsidiary over the next years. All revenue generated through the sale of Medicrea products in Belgium will be aggregated in Medicrea’s group consolidated numbers and reported effective from February 2018.

About Medicrea (www.medicrea.com)

Through the lens of predictive medicine, Medicrea leads the design, integrated manufacture, and distribution of 30+ FDA approved spinal implant technologies that have been utilized in over 150,000 spinal surgeries to date. By leveraging its proprietary software analysis tools with big data and machine learning technologies and supported by an expansive collection of clinical and scientific data, Medicrea is well-placed to streamline the efficiency of spinal care, reduce procedural complications and limit time spent in the operating room.

Operating in a $10 billion marketplace, Medicrea is a Small and Medium sized Enterprise (SME) with 175 employees worldwide, which includes 50 who are based in the U.S. The Company has an ultra-modern manufacturing facility in Lyon, France housing the development and production of 3D-printed titanium patient-specific implants.

For further information, please visit: Medicrea.com.

Connect with Medicrea:
FACEBOOK | INSTAGRAM | TWITTER | WEBSITE | YOUTUBE

Medicrea is listed on
EURONEXT Growth Paris
ISIN: FR 0004178572
Ticker: ALMED
LEI: 969500BR1CPTYMTJBA37

Contacts

Medicrea
Denys Sournac
Founder, Chairman and CEO
dsournac@Medicrea.com
or
Fabrice Kilfiger,
Chief Financial Officer
fkilfiger@Medicrea.com
Tel: +33 (0)4 72 01 87 87

Research Shows NuVasive Porous PEEK Structure Maintains High Porosity After Impaction

SAN DIEGOMarch 29, 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 results of the study “Impaction durability of Porous PEEK™ and titanium-coated PEEK interbody fusion devices,” published online in The Spine Journalwhich concluded advantages of the NuVasive Porous PEEK material over titanium-coated PEEK devices1.

In the study, titanium-coated PEEK, smooth PEEK and NuVasive Porous PEEK interbody implants were subjected to impaction loading conditions. Analysis of Porous PEEK showed the surface structure maintained a high porosity (>65%) and exhibited minimal changes to pore size and depth following impaction. This maintenance of porosity and pore depth gives a surgeon confidence that the porous architecture will not collapse during insertion. The titanium-coated devices demonstrated titanium coating loss after impaction that was corroborated with a decrease in surface roughness. Smooth PEEK showed minimal signs of damage, but demonstrated a decrease in surface roughness.

“The findings in this study are significant because they demonstrate the durability and impaction resistance of interbody implants made from Porous PEEK,” said Kevin T. Foley, M.D. “Knowing that the porous structure is seamlessly integrated with the implant, without sacrificing implant strength, and that the implant maintains porosity following impaction means that the opportunity for bony ingrowth is optimized.”

Porous PEEK is manufactured through a proprietary extrusion process which produces a unified porous-to-solid structure designed to enhance osseointegration and maximize bone-to-implant contact. Available for cervical and thoracolumbar applications, Cohere® and Coalesce™ Interbody Fusion Devices are the only Porous PEEK interbody implants available in the market.

“Porous PEEK exemplifies our focus on disruptive technology and materials science. Born out of years of pre-clinical research, this durable implant technology combines the inherent benefits of porosity with the advantageous material properties of PEEK,” said Matt Link, executive vice president, strategy, technology and corporate development for NuVasive. “Designed for enhanced osseointegration, biomechanical, and imaging properties, Porous PEEK and the entire NuVasive Advanced Materials Science™ portfolio, which also includes Modulus® titanium interbody implants, represent the future of porous implant technologies.”

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.

1 Torstrick, B., Klosterhoff, B., Westerlund, E., Foley, K., Gochuico, J., Lee, C., Gall, K., Safranski, D. (2018). Impaction durability of porous polyether-ether-ketone (PEEK) and titanium-coated PEEK interbody fusion devices. The Spine Journal. Doi: 10.1016/j.spinee.2018.01.003

 

SOURCE NuVasive, Inc.

Related Links

http://www.nuvasive.com

Nanovis Announces FDA Clearance of FortiCore® PLIF and TLIF Spinal Interbodies with Nanosurface Features

Carmel, Ind. (March 28, 2018) – Nanovis, today announced the successful FDA clearance of its FortiCore® TLIF and PLIF interbodies featuring a Nanosurface-enhanced deeply porous titanium scaffold intermolded with a PEEK core.

“Implant nano surface science has advanced from the early days when we simply created nanoroughness for implants because tissues have nanoroughness. Now we understand the mechanisms by which nanotopographies can interact with cellular signaling pathways. I’m delighted that with Nanovis’ implants, patients can now benefit from a carefully designed and controlled nanotopography that harnesses this groundbreaking research,” said Thomas Webster, PhD, Chemical Engineering Department Chair, Northeastern University, who with Chang Yao, PhD, were early pioneers in the use of nanosurfaces to enhance bone growth.

Nanovis’ foundational FortiCore interbody fusion platform is well proven with over 4,250 implanted to date. FortiCore interbodies have deeply porous interconnected titanium scaffolds intermolded with a PEEK core, giving surgeons important fixation and imaging advantages. Data comparing the osseointegration strength of the FortiCore scaffold, PEEK, and allograft to the strength of trabecular host bone was published in Spine in late 2016. Now the titanium scaffolds on the FortiCore TLIF and PLIF interbodies are enhanced with a carefully designed and controlled nanosurface.

“The timing for this clearance is very good because surgeons are searching for the best surface technologies. I’ve watched Nanovis methodically develop technology platforms in a surface on a surface bone fixation strategy. Now they offer the most advanced interbody fixation technology with the best imaging profile on the market,” said Dr. Alan McGee, Orthopedics Northeast, a participant in the alpha launch of FortiCore. “My partners and I have implanted over 300 FortiCore interbodies. I can tell my patients I’m giving them the most advanced technology available today, and they have recovered quickly and have been very satisfied. It’s easy for me to assess bone growth through and around the FortiCore implants with plain X-ray. It’s a struggle to assess bone growth through 3D printed titanium interbodies with plain X-ray and I’m hesitant to expose my patients to the extra radiation from an unnecessary CT scan. I’m encouraged by Nanovis’ pre-clinical data for this nanotechnology enhanced surface and look forward to upgrading my use.”

“The science behind this nano technology is very exciting and clearance of the surface provides Nanovis another highly differentiated platform designed to reduce fixation related complications across a wide range of implant systems. In the short term, this nanopatterned surface targets fixation related complications and in the intermediate term this nanopatterned surface is the foundation of a bactericidal program targeting infection related complications,” said Matt Hedrick, CEO, Nanovis.

About Nanovis

Nanovis’ clinical and scientific goals are to reduce fixation and infection related complications. The Company’s patented and proprietary regenerative technology platforms provide differentiated surface advantages enabling the potential for existing medical devices to achieve new outcomes. Nanovis is commercializing science-driven platforms: the deeply porous scaffold and nanopatterned surface on select FortiCore interbody fusion devices and developmental bactericidal technology.

For more information about Nanovis, FortiCore or other proprietary Nanovis science-enhanced technologies, please visit www.nanovisinc.com or call 1-317-507-1058.

Media Contact:

Matt Hedrick

1-317-507-1058

Matt.hedrick@nanovistechnology.com

 

 

NeoSpine Founder, President Richard Wohns, MD, to Speak at 16th Annual Future of Spine + The Spine, Orthopedic and Pain Management-Driven ASC Conference

Becker’s Healthcare is pleased to welcome Dr. Richard Wohns and more than 222 other talented medical professionals as speakers for Becker’s 16th Annual Future of Spine + The Spine, Orthopedic and Pain Management-Driven ASC Conference, June 14 to 16 at the Swissotel in Chicago.

NeoSpine Founder and President Dr. Richard Wohns will deliver exciting content June 14 and 15 on investing in early stage spine and device companies; the future of spine, private practice and more; and investing as a spine surgeon. A board-certified neurosurgeon, he has performed more than 3,000 outpatient cervical and lumbar surgeries and gives international lectures on the clinical, business and legal aspects of outpatient spine surgery.

Pablo Pazmino, MD, an orthopedic spinal surgeon and medical director of Santa Monica, Calif.-based Spine Cal, will share his expertise with Becker’s audience June 16. He’ll discuss techniques, tricks and tips for the cervical hybrid arthroplasty in the outpatient setting. Dr. Pazmino holds hospital privileges in spinal surgery at several locations, including Cedars-Sinai Medical Center and UCLA Medical Center in Los Angeles.

Board-certified neurological surgeon Ying Chen, DO, FACOS, will discuss the relationship between orthopedic and spine practices and their ASCs June 15. Dr. Chen practices at Columbus, Ohio-based OrthoNeuro, where he also serves as chairman on the IT committee. He is a member of the Ohio Osteopathic Association’s House of Delegates with the Columbus chapter.

Conference attendees will have the opportunity to hear from Jamie Baisden, MD, a professor of neurosurgery at the Medical College of Wisconsin in Milwaukee. Dr. Baisden, who has been named one of the “Best Doctors in America” and listed in the “Guide to America’s Top Physicians,” will speak June 15 on key evolutions in the medical device arena.

Becker’s thanks its corporate partner, Johnson & Johnson One Medical Device, for its title sponsor support of the event.

To hear Joe Montana and other great keynotes and speakers, join Becker’s Healthcare at its Future of Spine + The Spine, Orthopedic and Pain Management-Driven ASC Conference, June 14 to 16 by registering here: https://www.regonline.com/registration/Checkin.aspx?EventID=2050742 or contact Jessica Cole by email at jcole@beckershealthcare.com or by phone at 312-929-3675.

For the complete conference brochure, click here: https://www.beckersasc.com/june-conference/.

About Becker’s ASC Review
Becker’s ASC Review offers general business, legal and clinical guidance on topics relevant to outpatient surgery including joint ventures, development and expansion, and regulatory and compliance issues, as well as analysis and insight for specialties including orthopedics and spine, gastroenterology, neurosurgery, ophthalmology, ENT, and anesthesiology. Each of the nine annual issues of the publication reaches a qualified audience of more than 25,000 key ASC leaders, including surgeons, medical directors, directors of surgery and ASC administrators. Every ASC in the nation receives Becker’s ASC Review.

About Becker’s Spine Review
Becker’s Spine Review features news and analysis on business and legal issues relating to spine practices. Each issue of the quarterly publication reaches a qualified audience of approximately 12,500 key spine practice decision-makers, including surgeons and spine practice administrators.