NuVasive, Inc. (NUVA - Free Report) received the FDA 510(k) clearance for expanded indications of the CoRoent Small Interlock system, its anterior cervical interbody fusion system. The expanded indication paves the way for on-label use of the device at various adjoining levels from C2-T1 for anterior cervical discectomy and fusion (ACDF) procedures.
Per the company, the system marks an improvement from other systems currently available in the market, which have clearance for use on only one or two levels. ACDF is a surgical procedure, which one needs to undergo to tackle cervical disc degeneration or spinal instability.
With the recent approval, NuVasive aims to strengthen foothold in the global spinal implants & devices market.
Few Words on CoRoent
The CoRoent Small Interlock is used in adult patients to treat cervical disc degeneration and/or cervical spinal instability.
Per the company, the CoRoent system is the first interfixated cervical implant to receive approval for use in more than two level procedures, among the ones currently available.
Significance of the Approval
The company believes that the clearance for multi-level use will provide surgeons with a zero-profile interbody implant. This is likely to be advantageous for surgeons as the system will enable them to avoid supplemental fixation, thus reducing the time taken for surgeries.
With the approval, Nuvasive’s Advanced Materials Science (“AMS”) product line is expected to gain a major boost. The timing of the approval got aligned with the company’s presentation on its cervical portfolio, where it hosted a workshop on ‘Cervical Spine Surgery: Why Should I Change? Featuring Advanced Materials Science’.
NuVasive commercially launched Modulus Cervical (a porous titanium interbody implant for cervical applications) in September 2019, thereby expanding the AMS portfolio. With the expansion, Porous PEEK and porous titanium offerings for ACDF techniques were included in the AMS portfolio.
Further, in August 2019, NuVasive announced the commercial launch of Modulus TLIF-A, which is a porous titanium spine implant, engineered for the transforaminal lumbar interbody fusion (TLIF) procedure. With this, the company completed its AMS portfolio for all major posterior interbody fusion techniques used in TLIF, one of the most common procedures in the spine industry.
Per a report by Grand View Research, the global spinal implants and devices market size was estimated to be $11.06 billion in 2015 and is expected to witness a CAGR of 5.8% between 2018 and 2024. Key factors driving the market are rising incidents of degenerative spine disorders and their subsequent treatments, fast-growing elderly population, advancements in medical technology, and increasing demand for minimally invasive procedures.
Given the huge potential of the spinal implants and devices market, the FDA nod has come at the right time.
The company’s shares have gained 14.2% in the past year compared with the industry’s growth of 7.6%.
Zacks Rank & Other Key Picks
Currently, NuVasive carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks from the broader medical space are Haemonetics Corporation (HAE - Free Report) , National Vision Holdings, Inc (EYE - Free Report) and ResMed Inc (RMD - Free Report) .
Haemonetics, currently flaunting a Zacks Rank #1 (Strong Buy), has a projected long-term earnings growth rate of 13.5%. You can see the complete list of today’s Zacks #1 Rank stocks here.
National Vision’s long-term earnings growth rate is estimated at 17.8%. The company currently has a Zacks Rank #2.
ResMed’s long-term earnings growth rate is estimated at 12.9%. It currently carries a Zacks Rank #2.
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