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NuVasive (NUVA) Gets FDA Nod for Attrax Putty Expanded Use

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NuVasive, Inc. recently announced the receipt of the FDA 510(k) approval for expanded indications of use for Attrax Putty, with its wide-ranging thoracolumbar interbody portfolio for spine surgery. For investors’ note, Attrax Putty is the first and only synthetic biologic to receive 510(k) indications for utilization in interbody fusions of the thoracolumbar spine.

The 510(k) clearance reflects on NuVasive's commitment to accelerate the standard of spine care, while providing better economic value to its customers.

The recent approval is likely to strengthen NuVasive’s spine surgery product line.

Few Words on Attrax Putty

Attrax Putty is a synthetic, bioactive and osteoconductive bone void filler developed to facilitate bone fusion. It features a surface microarchitecture, which offers an improved environment for bone formation without added cells or growth factors.

Interestingly, Attrax Putty is one of only a few bone grafting devices that is supported by a level I randomized controlled trial as a bone graft substitute in posterolateral spinal fusions.

Significance of the Approval

With the FDA 510(k) clearance, Attrax Putty can now be used with NuVasive's procedurally integrated thoracolumbar interbody portfolio. The portfolio includes the Advanced Materials Science (AMS) technologies of Modulus porous titanium and Cohere Porous PEEK.

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Attrax Putty’s expanded indications along with thoracolumbar implants aid NuVasive’s clinical efficacy and emphasize on the comparative clinical advantage over other biologic offerings in the market.

Per personnel, patients treated with optimized porous titanium cages like Modulus XLIF together with Attrax Putty have demonstrated remarkable radiographic and clinical success. This implant combination for spinal fusion led to cost-savings while continuing to offer clinical value to the patients.

Industry Prospects

Per a report by Fortune Business Insights, the global spinal fusion devices market size was $6.37 billion in 2018 and is projected to reach $8.45 billion by 2026 at a CAGR of 3.6%. Increasing numbers of spinal disorders and the growing geriatric population are the major factors driving the market. Hence, this approval comes at an opportune time for NuVasive.

Other Notable Developments

In October 2021, NuVasive made a significant advancement in the high-potential surgical spine procedures space. The company launched the Cohere TLIF-O implant and also revealed its plans to launch the Cohere TLIF-A implant later in the fourth quarter. These new additions are going to broaden the company’s AMS portfolio.

In September 2021, NuVasive announced the expansion of opportunities to train more surgeons and change more patient lives with the opening of its East Coast Experience Center in the New York metropolitan area. The East Coast Experience Center compliments NuVasive's flagship experience center in San Diego headquarters. The latest investment continues to play a vital role in the implementation of NuVasive's spine procedures and technologies, especially with the integration of the Pulse platform into the procedural offering.

Price Performance

Shares of the company have lost 8.4% in a year compared with the industry's decline of 8.6%.

Zacks Rank and Key Picks

NuVasive currently carries a Zacks Rank #5 (Strong Sell). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.

A few better-ranked stocks in the broader medical space that investors can consider are AMN Healthcare Services, Inc. (AMN - Free Report) , Apollo Endosurgery, Inc. and Laboratory Corporation of America Holdings (LH - Free Report) .

AMN Healthcare, carrying a Zacks Rank #1, has a long-term earnings growth rate of 16.2%. The company surpassed earnings estimates in the trailing four quarters, delivering a surprise of 19.5%, on average.

AMN Healthcare has outperformed its industry in the past year. AMN has gained 65.9% versus the 56.9% industry decline.

Apollo Endosurgery, carrying a Zacks Rank #2 (Buy), has a long-term earnings growth rate of 7%. The company‘s earnings surpassed estimates in the trailing four quarters, delivering a surprise of 25.6%, on average.

Apollo Endosurgery has outperformed its industry in the past year. APEN has gained 109.2% against the industry’s 2.7% fall.

Laboratory Corporation surpassed earnings estimates in each of the trailing four quarters, the average surprise being 25.7%. The company currently sports a Zacks Rank #1.

Laboratory Corporation’s long-term earnings growth rate is estimated at 10.6%. The company’s earnings yield of 9.4% compares favorably with the industry’s 3.4%.


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