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Nevro (NVRO) Gets FDA Nod for SI Fixation Without Lateral Screw
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Nevro (NVRO - Free Report) recently announced that the FDA has given 501(k) clearance for its sacroiliac (SI) joint fusion device, Nevro1. This innovative system, developed by Vyrsa Technologies, offers a unique approach by eliminating the need of a lateral screw, NevroFix.
Nevro acquired Vyrsa Technologies in November 2023, which added a suite of innovative products, including Nevro1, that provide minimally invasive treatment options for patients suffering from chronic SI joint pain. Nevro noted that the clearance was originally received by Camber Spine and will be transferred to it for marketing and distribution.
Price Performance
Shares of the company have lost 27.3% in the past six months against the industry’s 5.7% growth. The S&P 500 has witnessed an 11.7% increase in the said time frame.
Image Source: Zacks Investment Research
Nevro1 as Flagship SI Joint Fusion Product
Nevro1 integrates transfixing technology with existing systems, immediately stabilizing the sacroiliac joint and facilitating long-term fusion. The system's self-contained, deployable titanium anchors enhance joint stability, offering superior axial and rotational support. Additionally, Nevro's proprietary instrumentation ensures optimal intra-articular SI joint preparation, a crucial step for successful joint fusion. The inclusion of a 3D-printed, bone-growth-enhancing technology further promotes bone cell growth, facilitating fusion.
The FDA clearance for Nevro1 positions the company for substantial market expansion and increased sales. By offering a standalone device that streamlines the fusion process, Nevro is set to capture a significant share of the SI joint fusion market. The company received the clearance at an optimum time, as the demand for minimally invasive treatment options for chronic SI joint pain is on the rise. With Nevro1, healthcare providers can offer patients a safer, more efficient and effective treatment option, ultimately improving health outcomes and quality of life.
The FDA clearance not only solidifies Nevro's position as a leader in chronic pain solutions but also expands its market reach. With Nevro1 as its flagship SI joint fusion product, the company now boasts one of the most comprehensive portfolios in the SI joint space. This diversification enables Nevro to cater to the preferences of different physicians and addresses varied patient needs, thereby improving overall health outcome and quality of life.
Industry Prospects
Per a report by Global Market Insights, the global SI joint fusion market was estimated to be $712 million in 2022 and is anticipated to cross $2 billion by 2032 at a CAGR of 12.1%. Factors like the advancements in surgical techniques, reduced complications and improved patient satisfaction are likely to drive the market.
Given the market potential, the latest FDA clearance is expected to significantly boost Nevro’s business.
Recent Development
This month, Nevro announced revenues for fourth-quarter and full-year 2023. Per the report, fourth-quarter 2023 worldwide revenues were $116.2 million, indicating a year-over-year increase of 2% and 1% on a reported basis and at constant exchange rate, respectively. The company reported a loss of 25 cents per share in the fourth quarter of 2023 compared with the year-ago quarter’s loss of 54 cents.
The company’s painful diabetic neuropathy (PDN) revenues represented approximately $22.4 million in revenues (up 29%) and 20% of worldwide permanent implant procedures in the fourth quarter of 2023.
Nevro recorded worldwide total revenues of $425.2 million in 2023, up 5.0% year over year. Adjusted loss per share for 2023 was $2.56 against earnings per share (EPS) of 8 cents in the previous year.
In January, Carelon Healthcare published a new interventional pain management policy that expands spinal cord stimulation (SCS) coverage for PDN. The policy is expected to go into effect on Apr 14, 2024. The latest positive coverage update is expected to strengthen Nevro’s foothold in the SCS therapy business.
Some better-ranked stocks in the broader medical space that have announced quarterly results are Cencora, Inc. (COR - Free Report) , Elevance Health, Inc. (ELV - Free Report) and Cardinal Health, Inc. (CAH - Free Report) .
Cencora, carrying a Zacks Rank of 2 (Buy) at present, reported first-quarter fiscal 2024 adjusted EPS of $3.28, which beat the Zacks Consensus Estimate by 14.7%. Revenues of $72.25 billion outpaced the consensus mark by 5%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Cencora has a long-term estimated growth rate of 8.6%. COR’s earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 6.7%.
Elevance Health reported fourth-quarter 2023 adjusted EPS of $5.62, which beat the Zacks Consensus Estimate by 1.3%. Revenues of $42.45 billion outpaced the consensus mark by 1.5%. It currently carries a Zacks Rank #2.
Elevance Health has a long-term estimated growth rate of 12%. ELV’s earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 3.1%.
Cardinal Health reported second-quarter fiscal 2024 adjusted EPS of $1.82, which beat the Zacks Consensus Estimate by 16.7%. Revenues of $57.45 billion surpassed the Zacks Consensus Estimate by 1.1%. It currently sports a Zacks Rank #1.
CAH has a long-term estimated growth rate of 15.9%. Its earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 15.6%.
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Nevro (NVRO) Gets FDA Nod for SI Fixation Without Lateral Screw
Nevro (NVRO - Free Report) recently announced that the FDA has given 501(k) clearance for its sacroiliac (SI) joint fusion device, Nevro1. This innovative system, developed by Vyrsa Technologies, offers a unique approach by eliminating the need of a lateral screw, NevroFix.
Nevro acquired Vyrsa Technologies in November 2023, which added a suite of innovative products, including Nevro1, that provide minimally invasive treatment options for patients suffering from chronic SI joint pain. Nevro noted that the clearance was originally received by Camber Spine and will be transferred to it for marketing and distribution.
Price Performance
Shares of the company have lost 27.3% in the past six months against the industry’s 5.7% growth. The S&P 500 has witnessed an 11.7% increase in the said time frame.
Image Source: Zacks Investment Research
Nevro1 as Flagship SI Joint Fusion Product
Nevro1 integrates transfixing technology with existing systems, immediately stabilizing the sacroiliac joint and facilitating long-term fusion. The system's self-contained, deployable titanium anchors enhance joint stability, offering superior axial and rotational support. Additionally, Nevro's proprietary instrumentation ensures optimal intra-articular SI joint preparation, a crucial step for successful joint fusion. The inclusion of a 3D-printed, bone-growth-enhancing technology further promotes bone cell growth, facilitating fusion.
The FDA clearance for Nevro1 positions the company for substantial market expansion and increased sales. By offering a standalone device that streamlines the fusion process, Nevro is set to capture a significant share of the SI joint fusion market. The company received the clearance at an optimum time, as the demand for minimally invasive treatment options for chronic SI joint pain is on the rise. With Nevro1, healthcare providers can offer patients a safer, more efficient and effective treatment option, ultimately improving health outcomes and quality of life.
The FDA clearance not only solidifies Nevro's position as a leader in chronic pain solutions but also expands its market reach. With Nevro1 as its flagship SI joint fusion product, the company now boasts one of the most comprehensive portfolios in the SI joint space. This diversification enables Nevro to cater to the preferences of different physicians and addresses varied patient needs, thereby improving overall health outcome and quality of life.
Industry Prospects
Per a report by Global Market Insights, the global SI joint fusion market was estimated to be $712 million in 2022 and is anticipated to cross $2 billion by 2032 at a CAGR of 12.1%. Factors like the advancements in surgical techniques, reduced complications and improved patient satisfaction are likely to drive the market.
Given the market potential, the latest FDA clearance is expected to significantly boost Nevro’s business.
Recent Development
This month, Nevro announced revenues for fourth-quarter and full-year 2023. Per the report, fourth-quarter 2023 worldwide revenues were $116.2 million, indicating a year-over-year increase of 2% and 1% on a reported basis and at constant exchange rate, respectively. The company reported a loss of 25 cents per share in the fourth quarter of 2023 compared with the year-ago quarter’s loss of 54 cents.
The company’s painful diabetic neuropathy (PDN) revenues represented approximately $22.4 million in revenues (up 29%) and 20% of worldwide permanent implant procedures in the fourth quarter of 2023.
Nevro recorded worldwide total revenues of $425.2 million in 2023, up 5.0% year over year. Adjusted loss per share for 2023 was $2.56 against earnings per share (EPS) of 8 cents in the previous year.
In January, Carelon Healthcare published a new interventional pain management policy that expands spinal cord stimulation (SCS) coverage for PDN. The policy is expected to go into effect on Apr 14, 2024. The latest positive coverage update is expected to strengthen Nevro’s foothold in the SCS therapy business.
Nevro Corp. Price, Consensus and EPS Surprise
Nevro Corp. price-consensus-eps-surprise-chart | Nevro Corp. Quote
Zacks Rank and Stocks to Consider
Nevro currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the broader medical space that have announced quarterly results are Cencora, Inc. (COR - Free Report) , Elevance Health, Inc. (ELV - Free Report) and Cardinal Health, Inc. (CAH - Free Report) .
Cencora, carrying a Zacks Rank of 2 (Buy) at present, reported first-quarter fiscal 2024 adjusted EPS of $3.28, which beat the Zacks Consensus Estimate by 14.7%. Revenues of $72.25 billion outpaced the consensus mark by 5%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Cencora has a long-term estimated growth rate of 8.6%. COR’s earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 6.7%.
Elevance Health reported fourth-quarter 2023 adjusted EPS of $5.62, which beat the Zacks Consensus Estimate by 1.3%. Revenues of $42.45 billion outpaced the consensus mark by 1.5%. It currently carries a Zacks Rank #2.
Elevance Health has a long-term estimated growth rate of 12%. ELV’s earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 3.1%.
Cardinal Health reported second-quarter fiscal 2024 adjusted EPS of $1.82, which beat the Zacks Consensus Estimate by 16.7%. Revenues of $57.45 billion surpassed the Zacks Consensus Estimate by 1.1%. It currently sports a Zacks Rank #1.
CAH has a long-term estimated growth rate of 15.9%. Its earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 15.6%.