The Company expects the acquisition to accelerate net sales growth and be accretive to non-GAAP diluted earnings per share in 2022. 809 0 obj <>/Filter/FlateDecode/ID[]/Index[789 100]/Info 788 0 R/Length 99/Prev 1608803/Root 790 0 R/Size 889/Type/XRef/W[1 2 1]>>stream 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. Photos are for illustration purposes only and may not depict the exact item. 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. NuVasive provides patient support and surgeon education. NuVasives scale and global commercial channels will greatly accelerate the ability to bring the Simplify Disc to more surgeons and patients around the world.. 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. Expected delivery: 3 weeks. The NuVasive Biologics portfolio includes procedurally integrated allogeneic bone graft substitutes and extenders, and synthetic ceramic bone graft substitutes intended to promote bone fusion. The three essential biologic mechanisms involved in complete bone grafts include osteoconduction (a scaffold for the reparative growth of the natural bone), osteoinduction (signals encouraging undifferentiated cells to become active osteoblasts), and osteogenesis (living bone cells in the graft material contribute to bone remodeling). 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. This is why we show up every day, united and committed to our vision. Prices (minimum order quantity 50 pieces)50 - 99 pieces - 8.40100- 250 pieces - 7.50more than 250pieces - pleasecontact usfor a new quote. NuVasive is headquartered in San Diego, California, the US. The disc is comprised of two parts, a tough and fibrous outer layer (annulus fibrosis), and a soft, gelatinous center (nucleus pulposus). The NuVasive Biologics portfolio includes procedurally integrated allogeneic bone graft substitutes and extenders, and synthetic ceramic bone graft substitutes intended to promote bone fusion. $1,299.99. Osteocel is a comprehensive bone graft developed to mimic the properties of a patient's own bone. NuVasive offers solutions to alleviate patient symptoms. Robert Eastlack and Gregory Mundis. NuVasive provides patient support and surgeon education. Malone, H., Mundis, G. M., Jr., Collier, M, et al. 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. At this time, the overall benefits of the devices outweigh the known risks for on-label use with the updated labeling, compared to alternative treatments. RCCmyf(&3Tn@}M S,3c6qr|b2#JQ|%^@ZQTK,1gCTS pD"d(GR ~h'! The U.S. Food and Drug Administration (FDA) continues to monitor potential biocompatibility concerns associated with NuVasive Specialized Orthopedics Precice devices made from stainless steel and titanium. *Data on file. These technologies include neuromonitoring, global alignment, rod bending, radiation reduction, imaging, and navigation. Tell us something about it and help others to make the right decision, We use UPS, Fedex, USPS and our sellers ship quickly and securely, Customer satisfaction is our top priority, we are not happy until you are happy. Appropriate patient positioning 2. NuVasive plans to announce tomorrow its financial results for the fourth quarter and full year ended Dec. 31, 2020. NuVasive, Incorporated Jessica LeBlanc Senior Specialist, Regulatory Affairs 7475 Lusk Boulevard San Diego, California 92121 Re: K191974 Trade/Device Name: NuVasive AttraX Putty Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV NuVasive funded the upfront payment at closing using available cash on hand. Prices (minimum order quantity 10 pieces)10 - 25- 64,9026- 50 - 61,60more than 50pieces - pleasecontact usfor a new quote. That no more than two devices should be implanted at a time. The NuVasive CPD program focuses on surgeon development through the design and delivery of innovative clinical education programs. Based on review of publicly available materials at the time of this release. Do not implant more than two devices in a patient at once. The acquisition of Simplify Medical advances our previously communicated long-term growth strategy by both expanding, and further distinguishing, our portfolio with industry-leading innovation, said J. Christopher Barry, chief executive officer of NuVasive. Reuters, the news and media division of Thomson Reuters, is the worlds largest multimedia news provider, reaching billions of people worldwide every day. As demonstrated by the strong clinical data and the unique design characteristics of the Simplify Disc, we share NuVasives focus on outcome-driven innovation, said David Hovda, president and chief executive officer of Simplify Medical. Excluding VAT and shipping. You have not been assigned a username and password. 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. The materials on this website are for your general educational information only. (This story corrected name of Globus Medical in the headline from Global Medical). Excluding VAT and shipping. Excluding VAT and shipping. This can minimize the potential risks while also minimizing the risks associated with repetitive surgical interventions and suboptimal conversion to alternative therapies mid-treatment. from FortisBC Holdings Inc for C$400 million ($294.68 million). 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.. Globus, which is a provider of implantable devices and instruments used in spinal and orthopedic surgeries, made an indicative cash-and-stock offer for NuVasive in recent weeks, the sources said. 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. Neurostimulators & Components. Learn how intelligent surgery can change your practice. NuVasives public filings with the Securities and Exchange Commission are available at www.sec.gov. $5,499.99. JPMorgan is serving as exclusive financial advisor to Simplify Medical, and Wilson Sonsini Goodrich& Rosati and Johnson Winter & Slatteryare serving as its legal counsel. Clarification that the device is intended for use only in patients 18 years and older, That patients should weigh 50 lbs. Variation of the bone forming ability with the physicochemical properties of calcium phosphate bone substitutes. hbbd``b`I3@R $eL :X] BDLv ^e a$@@ He`bd^d100H xl The sale of this item may be subject to regulation by the U.S. Food and Drug Administration and state and local regulatory agencies. Surgical efficiency meets reliable versatility. %PDF-1.5 % Surgical efficiency. Quantity: In a single expandable platform, Pulse integrates multiple enabling technologies to improve workflow, reduce variability, and increase the reproducibility of surgical outcomes. 1. Unhappy? We do not practice medicine or provide medical services or advice as a part of this website. Letters to Health Care Providers, Recalls, Market Withdrawals and Safety Alerts, UPDATE: Potential Biocompatibility Concerns with NuVasive Specialized Orthopedics Precice Devices - Letter to Health Care Providers, MedWatch, the FDA Safety Information and Adverse Event Reporting program, July 2021 letter to health care providers, Medical Device Reporting (MDR) regulations, FDA's user facility reporting requirements, Division of Industry and Consumer Education (DICE), Potential Biocompatibility Concerns with NuVasive Specialized Orthopedics Precice Devices - Letter to Health Care Providers, Precice Intra-medullary Limb Lengthening Device. Attrax Putty is now the first and only synthetic biologic to receive 510(k) clearance for use with thoracolumbar interbody systems. Globus Medical Inc has approached NuVasive Inc , a U.S. manufacturer of equipment for minimally invasive spine surgery with a market value of $3 billion, with an acquisition offer, people familiar . Bone grafting is a surgical technique that involves implanting a bone substitute or extender to help the body achieve spinal fusion. Anterior lumbar interbody fusion (ALIF) is a surgical procedure used to treat problems such as disc degeneration, spinal instability, and deformities of the spine. or more while undergoing treatment, and. Propel DBM Putty and Gel serve as a bone graft extender (extremities, spine, pelvis) and bone void filler of the extremities and pelvis. It offers solutions for a range of conditions such as degenerative disc disease, lumbar spinal stenosis, degenerative spondylolisthesis, cervical disc degeneration, etc. You don't have to face this journey alone. D. Device Description The NuVasive Sage Lateral Plate System is an anterior/anterolateral plate system that may be used in the thoracic, lumbar, and sacral spine (TI-SI). STRYKER 502-427-030 VIDEO ARTHROSCOPE, 4MM 30 DEG. Precice devices include adjustable rods placed inside a patient, which are driven by an internal magnetic mechanism. NuVasive and Globus Medical are combining to bring together two well-regarded technology companies in the musculoskeletal industry. Retroperitoneal access 3. Published online June 3, 2022; DOI: 10.3171/2022.4.SPINE211070. Becoming the number one partner in pediatrics. 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. 1Simplify Cervical Artificial Disc P200022. PLoS ONE 2011;6(10):1-8. At NuVasive, we transform surgery, advanced care, and change lives. Based on review of publicly available materials at the time of this release. Screen for heightened risk individual and entities globally to help uncover hidden risks in business relationships and human networks. This power bank is suitable for charging any device. 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. Prices (minimum order quantity 10 pieces)10 - 49 pieces - 22,4050 - 100 pieces - 17,20more than 100pieces - pleasecontact usfor a new quote. Information you read on this website cannot replace the relationship that you have with your healthcare professional. NuVasive provides patient support and surgeon education. The Reline portfolio represents the evolution of posterior fixation technology, providing integrated Open and MAS procedural solutions. A live webcast of the conference call will be available online from the Investor Relations page of the Companys website atwww.nuvasive.com. The forward-looking statements contained herein are based on the current expectations and assumptions of NuVasive and not on historical facts. Voluntary reports can be submitted through, Device manufacturers and user facilities must comply with the applicable, Health care personnel employed by facilities that are subject to the. JavaScript seems to be disabled in your browser. 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. NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, with a mission to transform surgery, advance care, and change lives. Contraindications Discontinue use of NUWAVE if the user develops skin irritation such as acne or a rash around the mask contact area. obtained from Document Control, or a reference copy may be viewed on the NuVasive Network Server. Rethink how you buy and sell surgical supplies. Copyright 2022 Oisto. devices: JNuVasiveo Lateral Plate System (K(061789), NuVasive Anterior Lumbar Plate (K072339) and Synthes Antegra-T System (K08 1568). 8050015: NuVasive NVM5 EMG Needle Module. 3. Through our shared mindset calledThe Cheetah Way, we show up every day united and committed to do just that. This reflects the technologys favorable growth and margin profile, combined with NuVasives substantial commercial capability and C360 portfolio integration. if( $robots ) : ?> NuVasive is developing the operating room of the future. 'VUJ)(h. 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. Follow the actions provided by NuVasive in their, Report any adverse events or suspected events through.