NuVasive in 2021: 10 spine updates

Spinal Tech

From a $150 million acquisition to the launch of its Pulse system and rumors of a potential takeover, here are 10 key developments from NuVasive this year:

1. In December, NuVasive lifted its voluntary ship hold on Precice titanium devices in the U.S. after the FDA raised safety concerns about them in July. The hold was lifted after NuVasive held discussions with the FDA on biocompatibility testing results and the overall risks and benefits of the devices. The FDA said it is "in the best interest of patients to make titanium-based Precice devices available."

2. NuVasive's stock jumped 9 percent on Nov. 15 after rumors of an acquisition by Globus Medical. Traders revealed that the spine companies held early discussions about a potential takeover, but analysts doubt a deal will come to fruition because spine transactions can be challenging to integrate and Globus Medical tends to pay modest prices for assets.

3. In the third quarter, NuVasive's net sales decreased 8.3 percent year over year to $270.8 million. The company said revenue was partly affected by challenges with the COVID-19 pandemic and elective surgery halts.

4. The first commercial cases using NuVasive's Pulse platform for spine surgery were performed in Ohio and Texas. Approved by the FDA in July, Pulse is an integrated platform that aims to improve safety and efficiency in spine surgery.

5. NuVasive is developing a virtual reality spine surgery training module for its X360 system. The VR platform was made in collaboration with PrecisionOS developers and will integrate NuVasive's lateral approach to single-position spine surgery.

6. In September, NuVasive opened its East Coast Experience Center in New York City. The facility focuses on training surgeons on techniques including the X360, XLIF and C360 procedures. It has educational training rooms and a dedicated site to demonstrate its Pulse platform.

7. NuVasive lifted a U.S. voluntary ship hold on its Magec system and made a modified Magec X device available for sale, effective July 15. The scoliosis rods were recalled in February 2020 after a separation of an actuator end cap component was reported in some devices post-implantation. The modified device has been made available "because the overall benefits of the device outweigh the known risks for on-label use in the U.S. compared to alternative treatments," according to the FDA. NuVasive is investigating the root cause of the issues and working with the FDA to determine whether there is any clinically meaningful impact to patients with Magec devices.

8. Gregory Lucier, former NuVasive CEO, retired from the company's board of directors May 18. Mr. Lucier joined the board in 2013 and became chair and CEO in 2015. He left his role as CEO in November 2018 after growing the company's net sales to more than $1 billion.

9. NuVasive acquired Simplify Medical and its Simplify Disc for spinal arthroplasty in a $150 million deal in February. The Simplify Disc is one of three artificial discs approved for two-level cervical total disc replacement.

10. NuVasive is participating in two clinical trials focusing on improving outcomes in adult spinal deformity surgery in partnership with the International Spine Study Group Foundation. One study is assessing the treatment of complex adult spinal deformity from a minimally invasive approach, and the other is a prospective analysis of the safety profile, clinical and radiographic outcomes, and performance of the VersaTie posterior fixation system.

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