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NuVasive's (NUVA) Simply Cervical Artificial Disc Gets FDA Nod

·4 min read

NuVasive, Inc. NUVA recently announced the receipt of FDA approval for its Simplify Cervical Artificial Disc (“Simplify Disc”) for two-level cervical total disc replacement (“cTDR”). With this, Simplify Disc has become one of the only three FDA-approved devices for use in two-level cTDR procedures.

Per management, the latest addition in the company’s cervical offering and the expanded two-level indication offers better opportunities to bring the most clinically effective technology to more patients in the cTDR market.

The approval marks an incredible achievement for the Simplify Disc and further expands NuVasive’s C360 portfolio growth opportunities.

Simplify Disc will be featured in the upcoming International Society for the Advancement of Spine Surgery 21st Annual Conference in Miami, FL.

Simplify Disc at a Glance

NuVasive’s Simplify cervical artificial disc, part of its C360 portfolio, comprises PEEK on ceramic materials to allow enhanced visualization through MRI postoperatively when compared to alternative devices.

Simplify Disc is anatomically designed and includes 4mm, 5mm and 6mm options, while the proprietary design offers a unique articulation, which allows a variable center of rotation for each treated level to closely mimic the motion dynamics of a natural spine segment.

More in the News

In a two-level FDA Investigational Device Exemption ("IDE") study for 24 months compared to anterior cervical discectomy and fusion (“ACDF”), the Simplify Disc demonstrated an overall success rate nearly 10% higher than the ACDF. Additionally, a higher percentage of patients demonstrated success in the 15-point Neck Disability Index with no neurological deterioration components in relation to fusion.

As the field of spinal arthroplasty continues to evolve, the latest FDA approval for the Simplify Disc's two-level marks another major milestone in improving the standard of patient care in spine. Notably, the clinical superiority of Simplify Disc to ACDF, along with its unique design properties, makes it an important tool for the treatment of cervical radiculopathy by spine surgeons.

Notable Developments

In March 2021, NuVasive announced the continuation of its long-term partnership with the International Spine Study Group Foundation through the initiation of two new clinical studies focused on improving patient outcomes in adult spinal deformity surgery.

In January 2021, NuVasive’s X360 procedural approach was validated in a clinical study published in “The Spine Journal”. The study highlights that single-position spine surgery improves operative efficiency while reducing complications and length of hospital stay.

Industry Prospects

Per a report by Global Market Insights, the global artificial disc market size crossed $1.6 billion in 2019 and is projected to achieve more than 18.6% CAGR by 2026. Growing awareness among people regarding the benefits of disc replacement procedures over spinal fusion surgeries will further expand the market.

Price Performance

Shares of the company have gained 31.9% in a year’s time compared with the industry’s growth of 28.2%.

Zacks Rank and Key Picks

Currently, NuVasive carries a Zacks Rank #4 (Sell).

A few better-ranked stocks from the broader medical space are InMode Ltd. INMD, Owens & Minor, Inc. OMI and Envista Holdings Corporation NVST, each sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of Zacks #1 Rank stocks here.

InMode has a projected long-term earnings growth rate of 12.4%.

Owens & Minor has a projected long-term earnings growth rate of 15%.

Envista Holdings has an expected long-term earnings growth rate of 24%.

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