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NuVasive (NUVA) Gets FDA 510(k) Clearance for CoRoent System
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Leading medical device company NuVasive, Inc. recently announced the receipt of U.S. FDA 510(k) clearance for its CoRoent Small Interbody System. The company’s innovation under the spine portfolio helps treat multi-level cervical disc degeneration in patients with cervical radiculopathy and myelopathy.
Cervical radiculopathy and myelopathy are common in adult patients, causing significant disability and loss of productivity. As a result, more than 200,000 cervical surgical procedures are performed in the U.S. every year.
The system therefore has been indicated for intervertebral body fusion at multiple contiguous levels in the cervical spine. This is said to be the first U.S. clearance for a cervical cage to be used up to four contiguous levels.
For the last one month, NuVasive has been underperforming the Zacks categorized Medical - Products industry in terms of price performance. The stock has gained 0.8%, lower than the 1.2% gain of the broader industry. We believe that the month-long speculation surrounding the U.S. medical device sector has affected the stock.
However, we expect the recent FDA 510(k) clearance to drive NuVasive’s price performance in the near term. Management considers the clearance as a key milestone for NuVasive as the new indication delivers the unmet need of spine surgeons.
The CoRoent Small Interbody System is an interbody cage that provides stabilization of the spinal motion segment while fusion takes place. Rows of teeth on the surface of each end of the device help grip the adjacent vertebrae to resist migration and expulsion of the device. The device consists of marker pins composed of titanium alloy or tantalum.
NuVasive is currently operating in the global spinal fusion market along with other known players such as Medtronic and Zimmer Biomet. As per a ResearchandMarkets report, the market has been forecasted to grow at a CAGR of 4.82% by 2021. Rising number of spinal disorders combined with the growing awareness toward spinal fusion procedures has resulted in growth of the Spinal Fusion market.
Therefore, management is leaving no stone unturned to tap into the opportunities in this new market. During 2016, NuVasive launched several spine products which resulted its outperformance in the spine market, delivering double-digit revenue growth for the fourth quarter in a row.
Zacks Rank & Key Picks
NuVasive currently has a Zacks Rank #3 (Hold). Better-ranked stocks in the medical product sector are Inogen, Inc. (INGN - Free Report) , Orasure Technologies, Inc. (OSUR - Free Report) and ZELTIQ Aesthetics, Inc. . While Inogen sports a Zacks Rank #1 (Strong Buy), Orasure and ZELTIQ Aesthetics carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Inogen gained 70.5% in the last one year in comparison to the S&P 500’s gain of 14.6%. The company has a stellar four-quarter positive average earnings surprise of over 49.08%.
Orasure surged 73.9% in the last one year in comparison to the S&P 500. It has a four-quarter positive average earnings surprise of 123.5%.
ZELTIQ Aesthetics gained over 100% in the past one year, better than the S&P 500 mark. It also has a trailing positive average earnings surprise of 12.03%.
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Today, you are invited to download the full list of 220 Zacks Rank #1 "Strong Buy" stocks – absolutely free of charge. Since 1988, Zacks Rank #1 stocks have nearly tripled the market, with average gains of +26% per year. Plus, you can access the list of portfolio-killing Zacks Rank #5 "Strong Sells" and other private research. See these stocks free >>
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NuVasive (NUVA) Gets FDA 510(k) Clearance for CoRoent System
Leading medical device company NuVasive, Inc. recently announced the receipt of U.S. FDA 510(k) clearance for its CoRoent Small Interbody System. The company’s innovation under the spine portfolio helps treat multi-level cervical disc degeneration in patients with cervical radiculopathy and myelopathy.
Cervical radiculopathy and myelopathy are common in adult patients, causing significant disability and loss of productivity. As a result, more than 200,000 cervical surgical procedures are performed in the U.S. every year.
The system therefore has been indicated for intervertebral body fusion at multiple contiguous levels in the cervical spine. This is said to be the first U.S. clearance for a cervical cage to be used up to four contiguous levels.
For the last one month, NuVasive has been underperforming the Zacks categorized Medical - Products industry in terms of price performance. The stock has gained 0.8%, lower than the 1.2% gain of the broader industry. We believe that the month-long speculation surrounding the U.S. medical device sector has affected the stock.
However, we expect the recent FDA 510(k) clearance to drive NuVasive’s price performance in the near term. Management considers the clearance as a key milestone for NuVasive as the new indication delivers the unmet need of spine surgeons.
The CoRoent Small Interbody System is an interbody cage that provides stabilization of the spinal motion segment while fusion takes place. Rows of teeth on the surface of each end of the device help grip the adjacent vertebrae to resist migration and expulsion of the device. The device consists of marker pins composed of titanium alloy or tantalum.
NuVasive, Inc. Price
NuVasive, Inc. Price | NuVasive, Inc. Quote
NuVasive is currently operating in the global spinal fusion market along with other known players such as Medtronic and Zimmer Biomet. As per a ResearchandMarkets report, the market has been forecasted to grow at a CAGR of 4.82% by 2021. Rising number of spinal disorders combined with the growing awareness toward spinal fusion procedures has resulted in growth of the Spinal Fusion market.
Therefore, management is leaving no stone unturned to tap into the opportunities in this new market. During 2016, NuVasive launched several spine products which resulted its outperformance in the spine market, delivering double-digit revenue growth for the fourth quarter in a row.
Zacks Rank & Key Picks
NuVasive currently has a Zacks Rank #3 (Hold). Better-ranked stocks in the medical product sector are Inogen, Inc. (INGN - Free Report) , Orasure Technologies, Inc. (OSUR - Free Report) and ZELTIQ Aesthetics, Inc. . While Inogen sports a Zacks Rank #1 (Strong Buy), Orasure and ZELTIQ Aesthetics carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Inogen gained 70.5% in the last one year in comparison to the S&P 500’s gain of 14.6%. The company has a stellar four-quarter positive average earnings surprise of over 49.08%.
Orasure surged 73.9% in the last one year in comparison to the S&P 500. It has a four-quarter positive average earnings surprise of 123.5%.
ZELTIQ Aesthetics gained over 100% in the past one year, better than the S&P 500 mark. It also has a trailing positive average earnings surprise of 12.03%.
The Best Place to Start Your Stock Search
Today, you are invited to download the full list of 220 Zacks Rank #1 "Strong Buy" stocks – absolutely free of charge. Since 1988, Zacks Rank #1 stocks have nearly tripled the market, with average gains of +26% per year. Plus, you can access the list of portfolio-killing Zacks Rank #5 "Strong Sells" and other private research. See these stocks free >>