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NuVasive (NUVA) Wins MHLW Approval for XLIF Device Suite
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Leading medical device company NuVasive, Inc. recently announced the receipt of approval from the Japanese Ministry of Health, Labour and Welfare (MHLW), for instruments used in the eXtreme Lateral Interbody Fusion (XLIF) procedure. These devices fall under the company’s global minimally invasive surgical (MIS) product line for spine surgery.
XLIF is a MIS procedure performed through the side of the body. The procedure requires proprietary neuromonitoring and an integrated portfolio of instruments and specialized implants for treating a range of spinal pathologies. Several studies have validated the positive outcome and benefits of a lateral approach to the spine compared to traditional posterior and anterior approaches.
Meanwhile, NuVasive witnessed robust share price movement as compared to the Zacks classified Medical-Products industry in the past six months. Even though the company posted disappointing third-quarter results, the stock gained 13.6%, way better than the industry’s decline of 7.2%. The company has also recorded a 5-year CAGR revenue of 10.7%, reflecting its strong fundamentals.
Meanwhile, in its latest guidelines, MHLW has stated that dilators and associated components utilized in lateral access spine surgical procedures are to be categorized as Class III medical devices in Japan. NuVasive's dilator, which is used in XLIF procedures, was originally approved in Japan as a Class II device in Aug 2011 with additional sizes gaining approval in Jan 2014. NuVasive had earlier submitted its dilator and associated components for reclassification as Class III medical devices while surgeons had temporarily stopped performing XLIF procedures in Japan while the reclassification was pending.
With this approval, XLIF procedures in Japan will recommence in the first quarter of 2017. In connection with the approval, NuVasive has agreed to provide additional training to surgeons with limited experience in XLIF and ensure that procedures are conducted at approved hospitals.
As per a recent MarketsandMarkets research, the global MIS instruments market is projected to reach a worth of $21.47 billion by 2021 from $13.89 billion in 2016, at a CAGR of 9.1%. The gradual shift in the spine market toward MIS and the increase in international access to healthcare have opened up scope for 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. In the last reported quarter, the company’s international business grew a strong 23% at constant exchange rate. Growth was significantly driven by strong contributions from core direct markets, including Japan. Thus, we expect the MHLW’s approval to reflect positively in the company’s forthcoming quarterly reports.
Zacks Rank & Key Picks
NuVasive carries a Zacks Rank #4 (Sell). Better-ranked medical stocks are NxStage Medical Inc. , Align Technology, Inc. (ALGN - Free Report) and Haemonetics Corporation (HAE - Free Report) . NxStage Medical and Align Technology sport a Zacks Rank #1 (Strong Buy) while Haemonetics carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
NxStage Medical gained 19.4% over the last one year compared with the S&P 500’s 10.1%. The company has a four-quarter average positive earnings surprise of 46.3%.
Align Technology rallied 47.2% year to date, way better than the S&P 500’s 10.1%. It has a trailing four-quarter average positive earnings surprise of 23%.
Haemonetics recorded a 23.9% gain year to date, better than the S&P 500. It has a trailing four-quarter average positive earnings surprise of 0.82%.
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NuVasive (NUVA) Wins MHLW Approval for XLIF Device Suite
Leading medical device company NuVasive, Inc. recently announced the receipt of approval from the Japanese Ministry of Health, Labour and Welfare (MHLW), for instruments used in the eXtreme Lateral Interbody Fusion (XLIF) procedure. These devices fall under the company’s global minimally invasive surgical (MIS) product line for spine surgery.
XLIF is a MIS procedure performed through the side of the body. The procedure requires proprietary neuromonitoring and an integrated portfolio of instruments and specialized implants for treating a range of spinal pathologies. Several studies have validated the positive outcome and benefits of a lateral approach to the spine compared to traditional posterior and anterior approaches.
Meanwhile, NuVasive witnessed robust share price movement as compared to the Zacks classified Medical-Products industry in the past six months. Even though the company posted disappointing third-quarter results, the stock gained 13.6%, way better than the industry’s decline of 7.2%. The company has also recorded a 5-year CAGR revenue of 10.7%, reflecting its strong fundamentals.
Meanwhile, in its latest guidelines, MHLW has stated that dilators and associated components utilized in lateral access spine surgical procedures are to be categorized as Class III medical devices in Japan. NuVasive's dilator, which is used in XLIF procedures, was originally approved in Japan as a Class II device in Aug 2011 with additional sizes gaining approval in Jan 2014. NuVasive had earlier submitted its dilator and associated components for reclassification as Class III medical devices while surgeons had temporarily stopped performing XLIF procedures in Japan while the reclassification was pending.
NUVASIVE INC Price
NUVASIVE INC Price | NUVASIVE INC Quote
With this approval, XLIF procedures in Japan will recommence in the first quarter of 2017. In connection with the approval, NuVasive has agreed to provide additional training to surgeons with limited experience in XLIF and ensure that procedures are conducted at approved hospitals.
As per a recent MarketsandMarkets research, the global MIS instruments market is projected to reach a worth of $21.47 billion by 2021 from $13.89 billion in 2016, at a CAGR of 9.1%. The gradual shift in the spine market toward MIS and the increase in international access to healthcare have opened up scope for 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. In the last reported quarter, the company’s international business grew a strong 23% at constant exchange rate. Growth was significantly driven by strong contributions from core direct markets, including Japan. Thus, we expect the MHLW’s approval to reflect positively in the company’s forthcoming quarterly reports.
Zacks Rank & Key Picks
NuVasive carries a Zacks Rank #4 (Sell). Better-ranked medical stocks are NxStage Medical Inc. , Align Technology, Inc. (ALGN - Free Report) and Haemonetics Corporation (HAE - Free Report) . NxStage Medical and Align Technology sport a Zacks Rank #1 (Strong Buy) while Haemonetics carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
NxStage Medical gained 19.4% over the last one year compared with the S&P 500’s 10.1%. The company has a four-quarter average positive earnings surprise of 46.3%.
Align Technology rallied 47.2% year to date, way better than the S&P 500’s 10.1%. It has a trailing four-quarter average positive earnings surprise of 23%.
Haemonetics recorded a 23.9% gain year to date, better than the S&P 500. It has a trailing four-quarter average positive earnings surprise of 0.82%.
Zacks’ Best Private Investment Ideas
In addition to the recommendations that are available to the public on our website, how would you like to follow all Zacks' private buys and sells in real time?
Our experts cover all kinds of trades… from value to momentum . . . from stocks under $10 to ETF and option moves . . . from stocks that corporate insiders are buying up to companies that are about to report positive earnings surprises. You can even look inside exclusive portfolios that are normally closed to new investors. Starting today, for the next month, you can have unrestricted access. Click here for Zacks' private trades >>