Sam Brusco, Associate Editor02.24.21
NuVasive has acquired Simplify Medical, privately held developer of the Simplify Cervical Artificial Disc (Simplify Disc) for cervical total disc replacement (cTDR).
The acquisition adds the most clinically effective cTDR technology and further broadens NuVasive's cervical portfolio. The global spine market’s cervical segment represents a $2.6 billion opportunity—NuVasive can now address all key segments of the cervical spine with solutions across anterior cervical discectomy and fusion (ACDF), posterior cervical fusion (PCF), and cTDR procedures.
"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," NuVasive CEO J. Christopher Barry told the press. "Combining the Simplify Disc with NuVasive's C360 portfolio will enable us to provide surgeons with world-class cervical technology, regardless of their preferred procedural approach. 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."
The Simplify Disc is supported by level-1 evidence through FDA investigational device exemption (IDE) study1 and was found superior to ACDF in trial. The device is being evaluated in a separate IDE study in the U.S. for 2-level indications, pending FDA approval.
"As demonstrated by the strong clinical data and the unique design characteristics of the Simplify Disc, we share NuVasive's focus on outcome-driven innovation," said David Hovda, president and CEO of Simplify Medical. "Together, we create a comprehensive, procedurally integrated cervical portfolio differentiated by technology and breadth. NuVasive's scale and global commercial channels will greatly accelerate the ability to bring the Simplify Disc to more surgeons and patients around the world."
Simplify Medical's technology offers surgeons the following capabilities:
NuVasive made an upfront payment to Simplify Medical of $150 million and agreed to make additional future payments contingent upon milestones related to regulatory approval and net sales from products incorporating the Simplify Disc technology. NuVasive funded the upfront payment at closing using available cash on hand.
References
1 Simplify Cervical Artificial Disc – P200022
2 Data on file. Based on review of publicly available materials at the time of this release.
The acquisition adds the most clinically effective cTDR technology and further broadens NuVasive's cervical portfolio. The global spine market’s cervical segment represents a $2.6 billion opportunity—NuVasive can now address all key segments of the cervical spine with solutions across anterior cervical discectomy and fusion (ACDF), posterior cervical fusion (PCF), and cTDR procedures.
"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," NuVasive CEO J. Christopher Barry told the press. "Combining the Simplify Disc with NuVasive's C360 portfolio will enable us to provide surgeons with world-class cervical technology, regardless of their preferred procedural approach. 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."
The Simplify Disc is supported by level-1 evidence through FDA investigational device exemption (IDE) study1 and was found superior to ACDF in trial. The device is being evaluated in a separate IDE study in the U.S. for 2-level indications, pending FDA approval.
"As demonstrated by the strong clinical data and the unique design characteristics of the Simplify Disc, we share NuVasive's focus on outcome-driven innovation," said David Hovda, president and CEO of Simplify Medical. "Together, we create a comprehensive, procedurally integrated cervical portfolio differentiated by technology and breadth. NuVasive's scale and global commercial channels will greatly accelerate the ability to bring the Simplify Disc to more surgeons and patients around the world."
Simplify Medical's technology offers surgeons the following capabilities:
- The disc, comprised of PEEK on ceramic materials, allows enhanced visualization through MRI postoperatively compared to competitive devices, a key imaging modality in spine
- It is anatomically designed and includes 4, 5, and 6mm options. The 4mm, the lowest disc height in the market,2 more closely matches the native disc height of a wide range of patients
- The proprietary disc design provides unique articulation which allows a variable center of rotation for each treated level and is designed to closely mimic a natural spine segment’s motion dynamics
NuVasive made an upfront payment to Simplify Medical of $150 million and agreed to make additional future payments contingent upon milestones related to regulatory approval and net sales from products incorporating the Simplify Disc technology. NuVasive funded the upfront payment at closing using available cash on hand.
References
1 Simplify Cervical Artificial Disc – P200022
2 Data on file. Based on review of publicly available materials at the time of this release.