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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 Acquires Simplify Medical

NuVasive Acquires Simplify Medical
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 Company s comprehensive portfolio across ACDF, PCF, and cTDR procedures
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SAN DIEGO, Feb. 24, 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 that it has acquired Simplify Medical, a privately held company and developer of the Simplify
® Cervical Artificial Disc (Simplify Disc) for cervical total disc replacement (cTDR). ....

United States , David Hovda , J Christopher Barry , Wilson Sonsini Goodrich , Exchange Commission , Nuvasive Inc , Simplify Medical , Cervical Artificial Disc , Simplify Disc , Disc Heights , Simplify Cervical Artificial Disc , Johnson Winter , Conference Call , Investor Relations , Looking Statements , ஒன்றுபட்டது மாநிலங்களில் , ஜு கிறிஸ்டோபர் பாரி , பரிமாற்றம் தரகு , எளிமைப்படுத்து மருத்துவ , சிஇஆர்விஐசிஏஎல் செயற்கை வட்டு , எளிமைப்படுத்து வட்டு , வட்டு உயரங்கள் , எளிமைப்படுத்து சிஇஆர்விஐசிஏஎல் செயற்கை வட்டு , ஜான்சன் குளிர்காலம் , மாநாடு அழைப்பு , முதலீட்டாளர் உறவுகள் ,

Simplify Medical Announces First Implantation of its Cervical Artificial Disc in the U.S. Following 1-Level Approval from the FDA

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Simplify Medical Announces First Implantation of its Cervical Artificial Disc in the U.S. Following 1-Level Approval from the FDA
Simplify Medical Announces First Implantation of its Cervical Artificial Disc in the U.S. Following 1-Level Approval from the FDA
SUNNYVALE, Calif., Dec. 16, 2020 Simplify Medical, Inc., a privately-held company focused on cervical spinal disc arthroplasty and developer of the Simplify
® Cervical Artificial Disc, today announced its first surgery following the recent FDA approval for 1-level use. The Simplify Disc is designed for MRI compatibility , physiologic motion, and anatomical height-matching, with the goals of improving patient outcomes and expanding treatment options for patients. The Simplify Disc achieved superiority to the fusion control on the trial’s composite primary endpoint (93.0% vs. 73.6%). ....

United States , Fort Worth , Scott Blumenthal , Richard Guyer , Jack Zigler , David Hovda , Bob Yedid , Domagoj Coric , Kelsey Welch , Texas Back Institute , Lifesci Advisors , Company Contact , Department Of Neurosurgery At Carolinas Medical Center , Texas Back Research Institute Foundation , Simplify Medical , Cervical Artificial Disc , Simplify Disc , Simplify Cervical Artificial Disc , Dallas Fort Worth , Disc Replacement , Texas Back Research Institute , Primary Investigator , Primary Investigator Domagoj Coric , Carolinas Medical Center , Simplify Medical Kelsey Welch Director , ஒன்றுபட்டது மாநிலங்களில் ,