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    NUVA   US6707041058

NUVASIVE, INC.

(NUVA)
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NuVasive, Inc. Simplify Cervical Disc Data Publishes in International Journal of Spine Surgery

09/09/2021 | 07:00am EST

NuVasive, Inc. announced the NuVasive Simplify Cervical Disc one-level U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) study data was recently published in the International Journal of Spine Surgery. The data was utilized in the device's FDA pre-market application for one-level indication approval in September 2020. The peer-reviewed study reiterates that the Simplify Cervical Disc has a significantly greater success rate at the 24-month follow up compared to anterior cervical discectomy and fusion (ACDF) when used in treatment for one-level cervical total disc replacement (cTDR). Findings from this study include: Mean Neck Disability Index (NDI), a patient-reported measure for disability related to cervical spinal disorders, was significantly lower for patients who underwent a cTDR with the Simplify Cervical Disc compared to ACDF; Range of motion significantly increased for cTDR patients treated with the Simplify Cervical Disc at three months and was maintained throughout follow ups; and Facet joint degeneration assessment by MRI showed little change from pre- to post-operation in the cTDR patients. This is the first time 24-month follow up MRI scans were used in an IDE study for cTDR. The Simplify Cervical Disc allows for enhanced visualization through MRI postoperatively compared to alternative devices, a key imaging modality in spine. The Simplify Cervical Disc is part of the NuVasive C360™ portfolio, which offers comprehensive, procedurally integrated solutions for the cervical spine across ACDF, posterior cervical fusion, and cTDR procedures. The device is designed with key performance functions that include a radiologic design, anatomic disc heights, and physiologic motion. Overall, the Simplify Cervical Disc demonstrates clinical superiority to ACDF3 and has the highest overall clinical success rate compared to any other approved cervical disc at both one- and two-levels. It is one of three devices approved for use in two-level cTDR procedures.


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Financials (USD)
Sales 2021 1 136 M - -
Net income 2021 -15,5 M - -
Net Debt 2021 655 M - -
P/E ratio 2021 -161x
Yield 2021 -
Capitalization 2 546 M 2 546 M -
EV / Sales 2021 2,82x
EV / Sales 2022 2,53x
Nbr of Employees 2 700
Free-Float 88,0%
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Mean consensus OUTPERFORM
Number of Analysts 17
Last Close Price 49,21 $
Average target price 66,60 $
Spread / Average Target 35,3%
EPS Revisions
Managers and Directors
J. Christopher Barry Chief Executive Officer & Director
Matthew K. Harbaugh Chief Financial Officer & Executive Vice President
Daniel J. Wolterman Chairman
Kyle Malone VP-Clinical, Medical & Regulatory Affairs
Aviva McPherron Vice President-Information Technology
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