We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Nevro (NVRO) Gains Following FDA Approval for Senza HFX iQ
Read MoreHide Full Article
Shares of Nevro Corp. (NVRO - Free Report) gained 5% on Oct 13, following the announcement of the FDA approval for its spinal cord stimulation (SCS) system — Senza HFX iQ — for the treatment of chronic pain. The new SCS system includes HFX iQ Implantable Pulse Generator (IPG), HFX Trial Stimulator, Charger and HFX App. The system is designed to launch algorithms specifically for treating chronic back and leg pain, including non-surgical back pain and painful diabetic neuropathy (PDN).
The Senza HFX iQ utilizes Nevro’s superior high-frequency 10 kHz Therapy platform, which has the potential to provide treatment benefits to a broader group of chronic pain indications. The company has already filed a regulatory application for approval in Europe.
The recent approval expands the company’s flagship platform, Senza — first approved in the United States in 2015. The next-generation Senza HFX iQ is the first and only system to use artificial intelligence (AI) for optimizing pain relief for each patient based on their response. The AI-based SCS system has been designed to address the variability in pain from patient to patient.
Shares of Nevro have declined 52.8% so far this year compared with the industry’s decrease of 38.4%.
Image Source: Zacks Investment Research
The digitally-enabled Senza HFX iQ system has been designed to optimize care by collecting patient data and providing a customized treatment pathway for each patient, which can be accessed through a smartphone. The company believes that the system provides several key advantages over existing SCS systems. The HFX Algorithm is most likely to be effective in achieving pain relief in patients as it has been built based on more than 20 million datapoints and 80,000 implanted patients. The system will provide a connected, digital environment that will help a patient to get customized therapy adjustments based on inputs through HFX app on a smartphone and share patient-level outcomes with treating and referring physicians. The system is also designed to allow future updates to the HFX Algorithm, as well as new features and capabilities for patients and providers.
Nevro initiated the limited launch of Senza HFX iQ in the United States in the third quarter. The company is planning a broad U.S. market launch in early 2023.
Industry Prospects
Per a report by Market Data Forecast, the global SCS market was estimated to be $1,871.6 million in 2020 and is anticipated to reach $2,827.4 million by the end of 2025 at a CAGR of 8.6%. Factors like rising cases of chronic and neuropathic pain and the growing adoption of SCS therapy are likely to drive the market.
Given the market potential, the latest positive coverages are expected to significantly boost Nevro’s business worldwide.
Notable Developments
In August, Aetna — one of the largest health plans — provided a draft proposal for including spinal cord stimulation (SCS) coverage policy to explicitly cover PDN. Nevro believes that once the proposal is finalized, it will imply that Medicare patients in all 50 states will enjoy coverage for PDN and will add approximately 17 million covered Medicare lives. However, the review of the proposed LCDs is ongoing and the final dates have not yet been confirmed.
In July, Nevro announced positive clinical data from the complete 12-month results from the SENZA-PDN Randomized Controlled Trial (RCT), including health-related quality of life outcomes in patients with PDN treated with high-frequency 10 kHz SCS.
In June, Nevro announced positive results from data presentations at the American Diabetes Association’s Scientific Sessions. The data supported the use of 10 kHz SCS therapy for patients with chronic pain, including results from the SENZA PDN RCT.
Some other top-ranked stocks in the broader medical space are ShockWave Medical, Inc. (SWAV - Free Report) , AMN Healthcare Services, Inc. (AMN - Free Report) and McKesson Corporation (MCK - Free Report) .
ShockWave Medical, sporting a Zacks Rank #1 at present, has an estimated growth rate of 33.1% for 2023. SWAV’s earnings surpassed estimates in all the trailing four quarters, the average beat being 180.1%.
AMN Healthcare, carrying a Zacks Rank #2 (Buy) at present, has an estimated long-term growth rate of 3.2%. AMN’s earnings surpassed the Zacks Consensus Estimate in all the trailing four quarters, the average beat being 15.7%.
AMN Healthcare has declined 7.3% compared with the industry’s 34.3% decrease year to date.
McKesson, carrying a Zacks Rank #2 at present, has an estimated long-term growth rate of 10.1%. MCK’s earnings surpassed estimates in three of the trailing four quarters and missed the same in one, the average beat being 13%.
McKesson has gained 42.6% against the industry’s 20% decline so far this year.
Unique Zacks Analysis of Your Chosen Ticker
Pick one free report - opportunity may be withdrawn at any time
Image: Bigstock
Nevro (NVRO) Gains Following FDA Approval for Senza HFX iQ
Shares of Nevro Corp. (NVRO - Free Report) gained 5% on Oct 13, following the announcement of the FDA approval for its spinal cord stimulation (SCS) system — Senza HFX iQ — for the treatment of chronic pain. The new SCS system includes HFX iQ Implantable Pulse Generator (IPG), HFX Trial Stimulator, Charger and HFX App. The system is designed to launch algorithms specifically for treating chronic back and leg pain, including non-surgical back pain and painful diabetic neuropathy (PDN).
The Senza HFX iQ utilizes Nevro’s superior high-frequency 10 kHz Therapy platform, which has the potential to provide treatment benefits to a broader group of chronic pain indications. The company has already filed a regulatory application for approval in Europe.
The recent approval expands the company’s flagship platform, Senza — first approved in the United States in 2015. The next-generation Senza HFX iQ is the first and only system to use artificial intelligence (AI) for optimizing pain relief for each patient based on their response. The AI-based SCS system has been designed to address the variability in pain from patient to patient.
Shares of Nevro have declined 52.8% so far this year compared with the industry’s decrease of 38.4%.
Image Source: Zacks Investment Research
The digitally-enabled Senza HFX iQ system has been designed to optimize care by collecting patient data and providing a customized treatment pathway for each patient, which can be accessed through a smartphone. The company believes that the system provides several key advantages over existing SCS systems. The HFX Algorithm is most likely to be effective in achieving pain relief in patients as it has been built based on more than 20 million datapoints and 80,000 implanted patients. The system will provide a connected, digital environment that will help a patient to get customized therapy adjustments based on inputs through HFX app on a smartphone and share patient-level outcomes with treating and referring physicians. The system is also designed to allow future updates to the HFX Algorithm, as well as new features and capabilities for patients and providers.
Nevro initiated the limited launch of Senza HFX iQ in the United States in the third quarter. The company is planning a broad U.S. market launch in early 2023.
Industry Prospects
Per a report by Market Data Forecast, the global SCS market was estimated to be $1,871.6 million in 2020 and is anticipated to reach $2,827.4 million by the end of 2025 at a CAGR of 8.6%. Factors like rising cases of chronic and neuropathic pain and the growing adoption of SCS therapy are likely to drive the market.
Given the market potential, the latest positive coverages are expected to significantly boost Nevro’s business worldwide.
Notable Developments
In August, Aetna — one of the largest health plans — provided a draft proposal for including spinal cord stimulation (SCS) coverage policy to explicitly cover PDN. Nevro believes that once the proposal is finalized, it will imply that Medicare patients in all 50 states will enjoy coverage for PDN and will add approximately 17 million covered Medicare lives. However, the review of the proposed LCDs is ongoing and the final dates have not yet been confirmed.
In July, Nevro announced positive clinical data from the complete 12-month results from the SENZA-PDN Randomized Controlled Trial (RCT), including health-related quality of life outcomes in patients with PDN treated with high-frequency 10 kHz SCS.
In June, Nevro announced positive results from data presentations at the American Diabetes Association’s Scientific Sessions. The data supported the use of 10 kHz SCS therapy for patients with chronic pain, including results from the SENZA PDN RCT.
Nevro Corp. Price
Nevro Corp. price | Nevro Corp. Quote
Zacks Rank & Other Key Picks
Currently, Nevro carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks in the broader medical space are ShockWave Medical, Inc. (SWAV - Free Report) , AMN Healthcare Services, Inc. (AMN - Free Report) and McKesson Corporation (MCK - Free Report) .
ShockWave Medical, sporting a Zacks Rank #1 at present, has an estimated growth rate of 33.1% for 2023. SWAV’s earnings surpassed estimates in all the trailing four quarters, the average beat being 180.1%.
So far this year, ShockWave Medical has gained 54.1% against the industry’s 36.8% decline. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
AMN Healthcare, carrying a Zacks Rank #2 (Buy) at present, has an estimated long-term growth rate of 3.2%. AMN’s earnings surpassed the Zacks Consensus Estimate in all the trailing four quarters, the average beat being 15.7%.
AMN Healthcare has declined 7.3% compared with the industry’s 34.3% decrease year to date.
McKesson, carrying a Zacks Rank #2 at present, has an estimated long-term growth rate of 10.1%. MCK’s earnings surpassed estimates in three of the trailing four quarters and missed the same in one, the average beat being 13%.
McKesson has gained 42.6% against the industry’s 20% decline so far this year.