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MCRA CRO Assists Simplify Medical, Recently Acquired by NuVasive, on FDA-Approval for Two Level use of its Cervical Disc


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WASHINGTON, May 12, 2021 /PRNewswire/  MCRA, LLC, the leading privately held medical device and biologics advisory firm and Clinical Research Organization (CRO) integrating U.S. and International Regulatory, Clinical Research, Reimbursement, Healthcare Compliance, Quality Assurance, and Medical Device Cybersecurity, is pleased to announce its role in the successful management and execution of Simplify Medical s two clinical studies and approvals by the U.S. Food and Drug Administration (FDA) for the Simplify Cervical Artificial Disc (Simplify Disc) to be used at one-level and two contiguous levels in the cervical spine.
Abigail Allen, MCRA s Vice President of Clinical Affairs, said, MCRA is honored to have supported Simplify Medical with the approval of their two-level disc just six months after the one-level approval. It has been a true testament to the teamwork and collaboration between the two companies, and all of our sites ....

District Of Columbia , United States , New York , Elizabeth Baldacchino , Justin Eggleton , Abigail Allen , Kyle Malone , Clinical Affairs , Drug Administration , Viscogliosi Brothers , International Regulatory , Spine Regulatory Affairs , Regulatory Affairs At Nuvasive Inc , Clinical Research Organization , Clinical Research , Business Development , Healthcare Compliance , Quality Assurance , Medical Device Cybersecurity , Simplify Medical , Simplify Cervical Artificial Disc , Simplify Disc , Vice President , Regulatory Affairs , New York City , Cervical Artificial Disc ,

NuVasive Inc (NUVA) Q1 2021 Earnings Call Transcript


Operator
Good day. And welcome to the NuVasive Inc. Fourth Quarter and Full Year 2020 Earnings Conference Call. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Matt Harbaugh, Executive Vice President and Chief Financial Officer. Thank you. You may begin.
Matt Harbaugh
Executive Vice President and Chief Financial Officer
Thank you. Welcome to NuVasive s Fourth Quarter and Full Year 2020 Earnings Call. The company s earnings release, which we issued earlier this afternoon, has been filed on Form 8-K with the Securities and Exchange Commission. We have also posted supplemental financial information and an overview on the acquisition of Simplify Medical we announced yesterday on our website in the Investor Relations section to accompany our discussion today. Joining me on the call is NuVasive S CEO, Chris Barry. Chris will provide opening remarks and then I will share additional de ....

United States , United Kingdom , Richard Newitter , Matthew Obrien Piper Sandler , Kyle Rose , Robbie Marcus , Shagun Singh , Josh Jennings Cowen , Asia Pacific , Joanne Wuensch , Lilia Celine Breton Lozada , Kyle Rose Canaccord , Josh Jennings , Matthew Obrien , Piper Sandler , Matt Miksic , Matt Harbaugh , Ryan Zimmerman , Chris Barry , Silicon Valley Bank , Joanne Wuensch Citi Bank Analyst , Nuvasive Clinical Services , Credit Suisse , Exchange Commission , Coast Experience Center , Nuvasive Inc ,

NuVasive Announces First Quarter 2021 Financial Results


NuVasive Announces First Quarter 2021 Financial Results
Net sales increase driven by U.S. procedural volume improvement throughout the quarter and strong international growth
Simplify Cervical Artificial Disc receives FDA approval for two-level cervical total disc replacement
R&D investment increase year over year to advance spine procedural segments and enabling technology roadmap
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SAN DIEGO, May 5, 2021 /PRNewswire/ NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, today announced financial results for the quarter ended March 31, 2021. ....

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Peck Madigan Jones rebrands


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PECK MADIGAN JONES REBRANDS: Peck Madigan Jones, one of the top lobbying firms on K Street, announced today that it will drop the name and rebrand as ....

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