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"At NuVasive, we remain laser-focused on transforming the lives of patients through disruptive innovation and support of clinical education and research," said Greg Lucier, NuVasive chairman and chief executive officer. "We've made tremendous gains in adult and pediatric spinal deformity innovation, with the versatile RELINE portfolio and MAGEC system. With the upcoming launch of the RELINE Small Stature system available this summer, I'm confident in our ability to outpace the market. We're proud NuVasive has taken the lead in supporting key global initiatives designed to help improve the lives of patients around the world." Part of the Company's investment into pediatric spinal deformity care includes funding research and patient initiatives, such as the Harms Study Group and its Setting Scoliosis Straight Foundation, as the exclusive sponsor of the Power Over Scoliosis event. NuVasive is also providing research funding for the Children's Spine Study Group and the Growing Spine Study Group. NuVasive was a key sponsor of EPOSNA 2017, the combined meeting of EPOS and POSNA, held earlier this month in Barcelona, Spain. In July, NuVasive is the leading sponsor of IMAST 2017, the International Meeting on Advanced Spine Techniques hosted by the Scoliosis Research Society. The Company is also the leading sponsor of ICEOS, the International Congress of Early-onset Scoliosis, in November. The Company also announced the launch of a monthly podcast series, MAGEC Matters, featuring interviews with leading surgeons in pediatric deformity discussing tips for the treatment of early onset scoliosis, which is now available on iTunes, SoundCloud and other leading podcast platforms. Other events supported by NuVasive throughout 2017 include: About NuVasive NuVasive, Inc. (NASDAQ: NUVA) is a world leader in minimally invasive, procedurally-integrated spine solutions. From complex spinal deformity to degenerative spinal conditions, NuVasive is transforming spine surgery with innovative technologies designed to deliver reproducible and clinically proven surgical outcomes. NuVasive's highly differentiated, procedurally-integrated solutions include access instruments, implantable hardware and software systems for surgical planning and reconciliation technology that centers on achieving the global alignment of the spine. With $962 million in revenues (2016), NuVasive has an approximate 2,300 person workforce in more than 40 countries around the world. 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. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/nuvasive-announces-educational-initiatives-in-support-of-spines-fastest-growing-spinal-deformity-portfolio-300461217.html


LEESBURG, Va., July 11, 2017 (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 that the Company will participate in the Scoliosis Research Society’s (SRS) 24th International Meeting on Advanced Spine Techniques (IMAST), July 12–15 in Cape Town, South Africa. K2M will exhibit (Stand #9) its solutions for advancing spine surgery, including its latest product offerings, several of its 3D-printed products featuring Lamellar 3D Titanium Technology™, and its Balance ACS™ (BACS™) platform. The Company will also host four educational workshops, led by distinguished leaders in spine surgery, on the latest technologies and techniques for treating a diverse range of spinal pathologies. “K2M is proud to participate in this year’s IMAST, a prestigious and dynamic meeting that brings together leading surgeons from around the world to advance knowledge, technologies, and techniques in spine surgery,” said John P. Kostuik, MD, Chief Medical Officer and Co-founder at K2M, and past President of the SRS. “This year, we are pleased to highlight our Balance ACS platform and 3D-printed product portfolio, as well as debut our latest technologies aimed at achieving spinal balance in complex spine, MIS, and degenerative procedures. Our continued innovation in spine surgery, coupled with our dedication to advancing medical education, demonstrates our commitment to improving surgical outcomes for spine patients around the world.” K2M will exhibit differentiated technologies from the Company’s comprehensive complex spine, minimally invasive, and degenerative product portfolios, including many of its newest product offerings: Additionally, K2M will showcase the 3D-printed CASCADIA™ Interbody Systems featuring Lamellar 3D Titanium Technology, the EVEREST® Spinal Systems (EVEREST Deformity, EVEREST Minimally Invasive, and EVEREST Minimally Invasive XT), the MESA® Spinal Systems (MESA Deformity, MESA 2, and MESA Small Stature), and the RAVINE® Lateral Access System, and more. The Company will also feature its Balance ACS platform, which provides solutions to balance the spine by addressing each anatomical vertebral segment with a 360-degree approach to the axial, coronal, and sagittal planes, emphasizing Total Body Balance as an important component of surgical success. K2M will demo the BACS System—which includes BACS Preauthorization, BACS Surgical Planner, BACS Anatomical Models, and BACS Data Management—and the BACS app, a convenient portal for surgeons to access the BACS System. During the meeting, K2M will host four hands-on workshops facilitated by global leaders in spine surgery. The workshops will address the latest technologies and techniques for treating a variety of spinal pathologies, as well as clinical applications of the Balance ACS platform and the Company’s Lamellar 3D Titanium Technology. For more information on K2M’s comprehensive product portfolio, visit www.K2M.com. For more information on Balance ACS, visit www.BACS.com. 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.com and connect with us on Facebook, Twitter, Instagram, LinkedIn, and YouTube. 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 the merits of our products; pricing pressures and our ability to compete effectively generally; collaboration and consolidation in hospital purchasing; in adequate coverage and reimbursement for our products from third-party payors; 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 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 in our main facility or information technology systems;  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 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 States and 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 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 the 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;  continuing 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; our lack of current plans to pay cash dividends; our ability to take advantage of certain reduced disclosure requirements and exemptions as a result of being an emerging growth company; 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.


NuVasive workshops at the event will include the MAGEC® system, which utilizes innovative magnetic technology within adjustable growing rods to treat early-onset scoliosis (EOS); the Company's flagship XLIF® procedure, the only lateral approach procedure proven by over 10 years of clinical evidence; and the Integrated Global Alignment® (iGA) platform. NuVasive will showcase spine's fastest growing spinal deformity portfolio on the show floor at IMAST 2017, including the iGA platform. The platform is comprised of procedurally based technologies designed to enhance clinical and economic outcomes by increasing the predictability of achieving global alignment in all spinal procedures. NuVasive recently launched the 'Embracing the Journey Together' initiative, which includes pediatric spinal deformity research, education and spinal deformity event support, supporting leading surgeons as they educate surgeons around the world. NuVasive will showcase its market-leading, procedurally-integrated technologies at NuVasive Booth #33 on the IMAST exhibit floor. NuVasive hands-on workshops include: iGA: A comprehensive Approach to Planning and Achieving Integrated Global Alignment Christopher I. Shaffrey, M.D., Juan S. Uribe, M.D. Friday, July 14 at 12:00-13:00 Meeting Room 1.43 Visit here for more details and schedule of events. NuVasive, Inc. (NASDAQ: NUVA) is transforming spine surgery and beyond with minimally invasive, 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 $962 million in revenues (2016), NuVasive has an approximate 2,300 person workforce in more than 40 countries serving surgeons, hospitals and patients. For more information, please visit www.nuvasive.com. 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.


News Article | June 1, 2017
Site: www.prweb.com

A research study led by Drs. David Skaggs, Behrooz Akbarnia and Michael Vitale compared the health-related quality of life of patients with early-onset scoliosis using two different surgical techniques. One group of patients was treated with traditional growing rods (TGR), a surgical technique that involves repeated surgical lengthening of spinal rods to correct the spinal deformity and continue to allow growth of the child’s spine and thorax. The other group of patients was treated with magnetically-controlled growing rods (MCGR). MCGR was cleared by the U.S. Food and Drug Administration in 2014 and provides surgeons the ability to lengthen spinal rods non-invasively with the use of a remote control. MCGR rod lengthenings can be performed during routine office visits without the use of surgery or anesthesia. Compared with TGR patients who underwent repetitive surgical lengthenings, MCGR patients had improved post-operative quality of life scores in 3 of 10 domains: Transfer (ability to get around town), Daily Living and Emotion. All other domains were similar between the groups. The study, conducted in partnership with the Growing Spine Foundation and Children's Spine Foundation, will be presented at the 24th International Meeting on Advanced Spine Techniques (IMAST), July 12-15, 2017 in Cape Town, South Africa. The Growing Spine Foundation (GSF) and Children's Spine Foundation (CSF) are 501(c)(3) charitable, non-profit organizations aimed at supporting medical education and scientific research to optimize the quality of life of children with Early Onset Scoliosis (EOS). Find more information at http://www.growingspine.org and http://www.childrenspinefoundation.org.


Aurilia M.,IMAST | Piscitelli F.,CNR Institute of Composite and Biomedical Materials | Piscitelli F.,University of Naples Federico II | Sorrentino L.,CNR Institute of Composite and Biomedical Materials | And 2 more authors.
European Polymer Journal | Year: 2011

Organo-modified layered silicates (OMLSs) can largely improve mechanical properties of Thermoplastic polyurethanes (TPUs) as well as affect their microdomain morphology. Nanocomposite TPU containing OMLSs were prepared by melt blending at different concentrations. The addition of OMLS has both induced variation in enthalpy of melting of hard and soft phases, and influenced the glass transition temperature of soft domains, as result of the microdomain phase segregation measured by means of fourier transform infrared spectroscopy (FT-IR). Small angle X-ray scattering (SAXS) analysis has shown that the mean distance between hard domains was mostly unaffected by the filler. However, its distribution broadened with the increasing concentration of the OMLSs, resulting in increased extent of the hard domain interface. The storage modulus of TPU nanocomposites incremented with the silicate content, while the dynamic strain scan tests showed pronounced non linear viscoelastic behavior. The analysis of morphological data obtained by SAXS and FT-IR measurements were correlated to thermal and dynamic mechanical properties of TPU samples suggesting a crucial role of the soft domains interface. The storage modulus and loss tangent of TPU nanocomposites were found to increase with the increasing of the interface area of soft domains with both hard domains and OMLS stacks. © 2010 Published by Elsevier Ltd.


Aurilia M.,IMAST | Sorrentino L.,CNR Institute of Composite and Biomedical Materials | Sanguigno L.,IMAST | Iannace S.,CNR Institute of Composite and Biomedical Materials
Advances in Polymer Technology | Year: 2010

Polyethersulfone (PES) is high performance thermoplastic polymer; however, its applications are limited by the poor resistance to several classes of solvents. Fumed silica and expanded graphite nanoparticles were used to prepare nanofilled PES by a melt-compounding technique with the view to improve the barrier properties. Solvent uptake at equilibrium and solvents resistance of nanofilled PES compounds were investigated by three different methodologies: (1) weight increase by methylene chloride absorption in a vapor-saturated atmosphere, (2) solvent uptake of acetone at equilibrium, and (3) decay of storage modulus induced by acetone diffusion. The storage modulus decay was measured by means of dynamic mechanical analysis on samples immersed in an acetone bath. The collected data were fitted to an ad hoc model to calculate the diffusion coefficient. The produced nanofilled PES showed a significant improvement in barrier properties and considerable reduction in acetone uptake at equilibrium, in comparison with the neat PES. Nanofilled PES compounds were also used to produce continuous glass fiber composites by the film-stacking manufacturing technique. The composites exhibited, by and large, improvements in flexural and shear strength. Their solvent resistance was evaluated by measuring the variation of mechanical properties after exposure to acetone for 1 and 5 days. These tests showed that the composites produced with the nanocomposite matrix did not exhibit higher solvent resistance than those prepared with neat PES, probably because of the deterioration of the fiber/nanocomposite-matrix interfacial bond in the wet state. © 2010 Wiley Periodicals, Inc.


Aurilia M.,IMAST | Sorrentino L.,CNR Institute of Composite and Biomedical Materials | Iannace S.,CNR Institute of Composite and Biomedical Materials
Polymer Composites | Year: 2010

An innovative manufacturing process for continuous fiber composites with the polymeric matrix made up of polypropylene and epoxy resin, as a model reactive low molecular weight component, was developed; variable process parameters give rise to different morphologies of matrix components surrounding the woven fabric reinforcement. Furthermore, the combination of both thermoplastic and thermosetting polymers permitted intimate fibers impregnation, typical of thermosetting matrix composites, with short process cycle time, which usually occurs in manufacturing process of thermoplastic matrix composites. Polypropylene (PP) films, glass fibers fabric, and epoxy resin film were used to produce flat composite through film-stacking technique. The preparation process focused on control of both epoxy resin cure process and polypropylene melting. The process was able to induce the two matrix components to form either a planar (sandwich-like) structure or a three-dimensional (3D) network by means of controlling the process parameters such as pressure and heating rate. The strong enhancement of the mechanical properties (Young's modulus and tensile strength of the composites with the 3D structure were almost twice as high of those of the composites with sandwich-like matrix structure) was due to the different microstructures produced by the interplanar flow of the thermoplastic polymer. © 2010 Society of Plastics Engineers.


Aurilia M.,IMAST | Sorrentino L.,CNR Institute of Composite and Biomedical Materials | Iannace S.,CNR Institute of Composite and Biomedical Materials
European Polymer Journal | Year: 2012

The effects of carbon nanotubes dispersion into thermoplastic polymers are complex and strongly dependent upon their aggregation state. A poly(ethylene terephthalate) (PET) matrix has been reinforced through addition of multiwalled carbon nanotubes (MWCNTs). Such an addition has generated an increase in flexural modulus and a decrease in flexural strength at room temperature, and an increase in both properties above the glass transition temperature (at 100°C). These different behaviours, dictated by temperature, have been investigated through two different micromechanical models that have permitted to put forward hypothesis on failure mechanisms and to shed light on the role played by crystalline phase. The results of thermal analyses have shown that the heat capacity of PET nanocomposites varies according to the MWCNTs content as the flexural modulus. Such a similarity has suggested to modify the Halpin-Tsai equations (H-T), typically used to predict elastic properties of short fibres reinforced composites, in order to determine the relationships occurring between PET specific heat and aspect ratio of dispersed MWCNT. The analyses performed by means of either classical H-T (elastic modulus) or modified H-T (heat capacity) equations, provided very similar estimation of the MWCNT aspect ratios. In addition, a simple elaboration of the modified H-T equations permitted the calculation of rigid amorphous fraction (RAF) into PET. The obtained values were slightly higher than those evaluated by means of a procedure based on the loss tangent peak variation measured through dynamic mechanical experiments. The detected strength decrease at 25°C have been attributed to crack propagation through a percolative path between crystalline coating layer of MWCNTs and PET (favoured by matrix brittleness), while at 100°C the crack propagation is hampered by rubbery behaviour of the matrix. © 2011 Elsevier Ltd. All rights reserved.


Aurilia M.,IMAST | Sorrentino L.,CNR Institute of Neuroscience | Berardini F.,University of Naples Federico II | Sawalha S.,An Najah National University | Iannace S.,CNR Institute of Neuroscience
Journal of Thermoplastic Composite Materials | Year: 2012

We have shown in an earlier work that the addition of both organomodified layered silicates and micrometric calcium carbonate (CaCO3) into a polypropylene (PP) matrix resulted in improved mechanical properties due to synergistic effect of the fillers. In this study, we analyzed the feasibility of producing continuous glass fibers composites with micro/nanoreinforced matrix. In particular, either highly filled matrices with micrometric CaCO3 (22, 40, and 50-wt %) or micro/nanoreinforced matrix were used to prepare composites in order to investigate the effect of fillers on both mechanical and thermomechanical properties. The best mechanical performances were obtained when nano- and microsized particles were combined to reinforce the thermoplastic matrices employed in the film stacking manufacturing method. In such systems, the micro/nanocomposites have improved the flexural properties of the continuous fiber laminate, producing an increase of both flexural modulus (60%) and flexural strength (130%). Moreover, storage modulus of glass fibers composite prepared with micro/nanoreinforced matrix was higher than modulus of the composites manufactured with either neat PP matrix or microreinforced matrix in -40/150°C temperature range. © The Author(s) 2011.


Borriello C.,ENEA | Masala S.,ENEA | Bizzarro V.,IMAST | Nenna G.,ENEA | And 4 more authors.
AIP Conference Proceedings | Year: 2010

Luminescent PVK:CdS and P3HT:CdS nanocomposites with enhanced electrooptical properties have been synthesized. The nucleation and growth of CdS nanoparticles have been obtained by the thermolysis of a single Cd and S precursor dispersed in the polymers. The size distribution and morphology of the nanoparticles have been studied by TEM analyses. Monodispersive and very small nanoparticles of diameter below 3 nm in PVK and 2 nm in P3HT, have been obtained. The application of such nanocomposites as emitting layers in OLED devices is discussed. © 2010 American Institute of Physics.

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