NuVasive’s Reline Approved in Japan, iGA Launch in Focus

By Zacks Equity Research

The international business of NuVasive, Inc. NUVA, a medical device player in the global spine market, recently got a boost with the Shonin approval for its Reline posterior fixation technology in Japan. Following this regulatory clearance, the Reline launch will begin later this year in Japan and continue into 2017.

The approval also paves way for the launch of the company’s Integrated Global Alignment (iGA) platform in the largest and fastest growing international market. iGA is a platform that has advanced the historical approach of spine surgery by integrating procedural technology and tools into one platform which can lead to proper alignment.

In this regard, the company noted that the Reline portfolio is the development of posterior fixation technology within the iGA platform that can be utilized in open surgeries or with the company’s Maximum Access Surgery (MAS) procedural solutions. The competitive benefits of Reline include surgical efficiency, operative reliability and procedural versatility.

NuVasive is enthusiastic about the latest approval in Japan, a country which has demonstrated exceptional growth over the last three years showing the clear benefit of focusing the company’s market penetration efforts around its complete procedural offerings such as XLIF.

Notably, iGA has already driven NuVasive’s strong lumbar momentum in the U.S.  According to the company, the continued success of Precept posterior fixation system, augmented by the approval of Reline, may lead to more than 30% growth in the Japanese market for 2016 – a key contributor to core international growth of approximately 20% expected this year.

We note that the gradual shift in the spine market toward minimally invasive surgery and increase in international access to healthcare has provided NuVasive with a huge opportunity for accelerated growth outside the U.S. Over the last several years, NuVasive has made significant investments in key international markets and is now reaping the benefits of the same. According to the company, in 2015, its market share-acquisition strategies continued to fuel industry-leading growth in its international business especially in Western Europe and Asia Pacific, offsetting weaknesses in Latin America and the Middle East. According to management, the International region holds tremendous growth opportunity for NuVasive, given that the company currently holds a mere 4% of the total market share therein.

The stock currently carries a Zacks Rank #3 (Hold).

Key Picks from the Sector

Some top-ranked stocks in the broader medical sector are Baxter International Inc. BAX, OraSure Technologies, Inc. OSUR and Hill-Rom Holdings, Inc. HRC. All the three stocks sport a Zacks Rank #1 (Strong Buy).


Josh Sandberg

Josh Sandberg is the President and CEO of Ortho Spine Partners and sits on several company and industry related Boards. He also is the Creator and Editor of OrthoSpineNews.

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