Can a bioactive interbody device reduce the cost burden of achieving lateral lumbar fusion? Combining the Simplify Disc with NuVasives C360 portfolio will enable us to provide surgeons with world-class cervical technology, regardless of their preferred procedural approach. WestCMR does not represent or claim any relationship to the respective companies or their equipment or products, names are used for reference only. The cervical segment of the global spine market represents a $2.6 billion opportunity, and the Company is well-positioned to expand its reach with the addition of the Simplify Disc to its C360 portfolio. It will also discuss the Simplify Medical transaction at that time. obtained from Document Control, or a reference copy may be viewed on the NuVasive Network Server. The Attrax ceramic surface has unique microstructure and microporosity that are optimized for bone formation. Conmed Linvatec E9010 CoolFlex E9000 High Speed Drill. JPMorgan is serving as exclusive financial advisor to Simplify Medical, and Wilson Sonsini Goodrich& Rosati and Johnson Winter & Slatteryare serving as its legal counsel. Expected delivery: 2 weeks. Propel DBM is donated human bone that has been demineralized to remove the minerals and cells contained in the bone while retaining the collagen matrix and growth factors, including bone morphogenetic proteins, inherent to the tissue. Transaction Details Attrax Putty is now the first and only synthetic biologic to receive 510(k) clearance for use with thoracolumbar interbody systems. NuVasive introduces new Reline 3D posterior fixation system Transpsoas access 4. NuVasive Company Profile - Office Locations, Competitors, Revenue Prices excluding VAT and shipping. Biomater Sci 2018;6:136-45. Indications For Use NUWAVE is a germicide intended to disinfect non-critical medical devices and equipment surfaces including CPAP masks, tubing and water chambers. Elizabeth Hofheinz, M.P.H., M.Ed. Investor Conference Call The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Pursuant to the terms of the transaction agreement, NuVasive made an upfront payment to Simplify Medical of $150.0 million at closing, subject to customary purchase price adjustments, and agreed to make additional future payments contingent upon milestones related to regulatory approval and net sales from products incorporating the Simplify Cervical Artificial Disc technology. from FortisBC Holdings Inc for C$400 million ($294.68 million). Prices (minimum order quantity 125 pieces)125 - 249- 3,95250 - 500 - 2,90more than 500pieces - pleasecontact usfor a new quote. This reflects the technologys favorable growth and margin profile, combined with NuVasives substantial commercial capability and C360 portfolio integration. All rights reserved. Bone Preparation & Cement Application Kits, Balloon Dilatation Catheters Insertion Kits, Skip to the beginning of the images gallery. 18 0 obj << /Filter /FlateDecode /Length 19 0 R >> stream As NuVasive continues to investigate the root cause of issues with stainless steel-based Precice devices, the company is also looking into how those issues may relate to titanium-based devices. 50 - 99 pieces - 8,75. If you have questions about this letter, contact the Division of Industry and Consumer Education (DICE). Simplify Cervical Artificial Disc provides NuVasive most clinically effective technology in the cervical total disc replacement (cTDR) procedure segment, Expands growth opportunities and further differentiates Companys comprehensive portfolio across ACDF, PCF, and cTDR procedures. Three New Biologic Products for Spine Surgery. JavaScript seems to be disabled in your browser. Clinical benefits ALIF Anterior approaches, such as in ALIF, allow access to the discs at the front of the spine and do not require muscle stripping as in posterior approaches. Build the strongest argument relying on authoritative content, attorney-editor expertise, and industry defining technology. Its shares are down 2% year-to-date, compared to a 10% rise in the shares of Globus Medical. Prices(minimum order quantity 25 pieces)25 - 49 pieces - 17,7550 - 99 pieces - 15,90100 - 150 pieces - 14,70more than 150 pieces - please contact us for a new quote. We are excited about the opportunities this acquisition creates as we work to optimize the surgeon experience, advance the standard of care, and create value for shareholders.. Do not implant more than two devices in a patient at once. NuVasives public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive Acquires Simplify Medical - NuVasive On April 5, 2021, NuVasive posted a statement informing health care providers of ongoing biocompatibility testing with Precice devices and placed a global ship hold for all Precice devices. On November 30, 2021, NuVasive issued a field safety notice to inform health care providers of updated labeling and the ship hold in the United States was lifted for titanium-based Precice devices. Published online June 3, 2022; DOI: 10.3171/2022.4.SPINE211070. gtag('js', new Date()); Fusion is a surgical procedure in which one or more of the vertebrae of the spine are joined together (fused) so that motion no longer occurs between them. Precice devices include adjustable rods placed inside a patient, which are driven by an internal magnetic mechanism. /PRNewswire/ -- NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive,. One position. Quantity: Unhappy? PDF NUVASIVE' 1 Nu Vasive Sage Lateral Plate System '4 Expected delivery: 3 weeks. NuVasive offers solutions to alleviate patient symptoms. As an innovator in the TLIF space, NuVasive technology helps deliver an optimized surgical experience from single-level degenerative to multi-level deformity cases. San Diego, California 92121 Re: K210214 Trade/Device Name: NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX endstream endobj startxref Simplify Medical is located in Sunnyvale, California. Disc space preparation 5. NuVasive is committed to a global approach for assessing, preserving, and restoring spinal alignment in an effort to promote surgical efficiencies, lasting patient outcomes, and improved quality of life. Journal of Neurosurgery Spine. NuVasive and Globus Medical are combining to bring together two well-regarded technology companies in the musculoskeletal industry. NuVasive Launches Modulus ALIF 3D-Printed Porous Titanium Implant for Telephone 1 858 9091800. 3. This can minimize the potential risks while also minimizing the risks associated with repetitive surgical interventions and suboptimal conversion to alternative therapies mid-treatment. We believe in the importance of preoperative decision-making and support toolsinformed by data and clinical experiencepaired with novel, intraoperative tools to execute a surgeon-specific plan. The purpose of this document is to define the standardization of cosmetic and visual acceptance criteria for NuVasive products upon receipt from the manufacturer. N]1N6xB w4C !~)H-,E niwm"mm1PTkYn|,v]Pch%HjSOfSzuE*o ! Expected delivery: 3 weeks. iMedSales is a premier surgical and medical equipment supplier that provides a combina Philips L12-5 Linear Probe - 50mm Compact 256-Element Transducer ~ BRAND NEW ~, Storz Hopkins 27015B 30 Degree Cystoscope Good Clean Image, STRYKER 502-427-030 VIDEO ARTHROSCOPE, 4MM 30 DEG, Conmed Linvatec E9010 CoolFlex E9000 High Speed Drill, Karl Storz 22220154 HD Image 1 H3M Microscope, Dr 3-Chip Camera, Karl Storz 20132020 Xenon Light Source 175 Watt ~ Lamp only has 13 hours, Medical Blue Nitrile Gloves Latex Free, Powder Free, Textured, Disposable, Non-Sterile 100 pieces per box of 1. PDF NVM5 Computer-Assisted Rod Bending Reuters, the news and media division of Thomson Reuters, is the worlds largest multimedia news provider, reaching billions of people worldwide every day. 2Data on file. The FDA believes it is in the best interest of patients to make titanium-based Precice devices available in the United States. NUVASIVE: 2012022 SKU# 2012022-WE1. Prices (minimum order quantity 50 pieces)50 - 99 pieces - 8.40100- 250 pieces - 7.50more than 250pieces - pleasecontact usfor a new quote. function gtag(){dataLayer.push(arguments);} NuVasive has launched its Reline MAS Midline (RMM), the next evolution of its Reline system designed to provide procedural versatility in a compact midline construct. Please close the page and access the Company Store via Okta. D. Device Description. multi-level pathologies. Neurostimulators & Components. It offers solutions for a range of conditions such as degenerative disc disease, lumbar spinal stenosis, degenerative spondylolisthesis, cervical disc degeneration, etc. As the innovation leader in spine, our goal is to provide you with comprehensive procedural solutions and enabling technology to help transform spine surgery, and ultimately change the lives of your patients. Check out The Better Way Back, a free patient support program for those suffering from a spinal condition. That no more than two devices should be implanted at a time. NUVASIVE USA: 'NNUVASIVE' NuVasive, Inc. ~L ~ o 7475 Lusk Blvd. Get your money back!. The sale of this item may be subject to regulation by the U.S. Food and Drug Administration and state and local regulatory agencies. Plenty of storage and clever organisation for life on the go, Store a 15.6" laptop in the dedicated compartment padded with EVA Impact Foam for extra protection, Spacious main compartment with structured slip pockets for a tablet, For organising a portable charger, cables and accessories, Lightweight collapsible pitchfork made of high-quality ABS plastic, Equipped with a magnetic ball marker with Nuvasive logo-doming, Kobaldeck playing cards are of absolute top quality, Back of cards and box are printed with Nuvasive logo, Receptacles for Europe, USA/Japan, Australia/China, All international security-relevant standards and norms, Keeps your drinks cold for 8 hours and hot for 5, Height 25cm, diameter 7cm - Volume: 500 ml, Ergonomic design provides a comfortable fit for your ears, Handy pocket-size power booster - 5000mah. Becoming the number one partner in pediatrics. Products :: NuVasive 2010460 EMG Endotracheal Tube, ENT Kit 6 - Oisto %PDF-1.4 % Malone, H., Mundis, G. M., Jr., Collier, M, et al. Website www.nuvasive.com. combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531- The following important factors, among others, could cause actual results to differ materially from those set forth in the forward-looking statements: the loss of key employees; the risk that the businesses will not be integrated successfully; unexpected variations in market growth and demand for the combined companys products and technologies; and the risk that benefits from the acquisition may not be fully realized or may take longer to realize than expected. PDF NuVasive, Incorporated Ms. Daniela Mahan, Esq., RAC 7475 Lusk Blvd Precice devices are implants intended for patients 18 years and over, to lengthen the limb, shorten or compress the limb, or transport segments of long bones. RCCmyf(&3Tn@}M S,3c6qr|b2#JQ|%^@ZQTK,1gCTS pD"d(GR ~h'! Prices (minimum order quantity 10 pieces)10 - 49 pieces - 22,4050 - 100 pieces - 17,20more than 100pieces - pleasecontact usfor a new quote. NuVasive has struggled with the impact that healthcare staffing shortages and weaker demand for elective surgery have had on its sales since the onset of the COVID-19 pandemic. The most comprehensive solution to manage all your complex and ever-expanding tax and compliance needs. With more than $1 billion in net sales, NuVasive has approximately 2,700 employees and operates in more than 50 countries serving surgeons, hospitals, and patients. You should always talk to your healthcare professional for diagnosis and treatment. Propel DBM Putty and Gel serve as a bone graft extender (extremities, spine, pelvis) and bone void filler of the extremities and pelvis. Following the commercial launch of the NuVasive ACP system and the Simplify Cervical Disc, we have recently introduced a posterior cervical fusion solution, Reline Cervical. 1.0 Purpose. These technologies include neuromonitoring, global alignment, rod bending, radiation reduction, imaging, and navigation. Expected delivery: 2 weeks. -M=wPp4-x1rju]USL,}QBKH`X =!MeB&Tb| For care of patients who currently have one of these devices and weigh less than 50 pounds and/or have more than two devices implanted, the health care team should assess treatment progression and consider removal of nails promptly at the end of treatment. Three New Biologic Products for Spine Surgery 5. Open the catalog to page 2 What is causing my pain? hbbd``b`I3@R $eL :X] BDLv ^e a$@@ He`bd^d100H xl Osteocel provides a complete and physiologic bone graft that contains all of the necessary components for bone growth: the cells, the signals, and the scaffold. Simplify Medical is a medical device company focused on cervical spinal disc arthroplasty, using innovative, MRI-compatible materials designed to optimize diagnostic imaging and decrease the need for ionizing radiation. Provide health care providers and patients access to an adequate supply of titanium-based Precice devices. Follow the actions provided by NuVasive in their, Report any adverse events or suspected events through. NuVasive is the fastest growing, full-line spine company. NuVasive provides patient support and surgeon education. PDF NuVasive, Incorporated September 26, 2019 Mr. Mark Job Responsible