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Nevro Corp. (NYSE: NVRO), headquartered in Redwood City, California, is a pioneering global medical device company dedicated to improving the lives of patients suffering from chronic pain through innovative products. The company's flagship product, the Senza® Spinal Cord Stimulation (SCS) System, is an evidence-based neuromodulation platform designed to treat chronic pain. This system features Nevro's proprietary HF10 therapy, which is known for its high-frequency, paresthesia-free stimulation, approved by the FDA in 2015, and commercially available in the U.S., Europe, and Australia.
Nevro's comprehensive product portfolio includes the HFX™ Spinal Cord Stimulation (SCS) Platform, comprising Senza®, Senza II®, Senza Omnia®, and HFX iQ™ systems. These devices offer patients a non-pharmacologic solution to manage chronic pain and painful diabetic neuropathy, providing sustainable pain relief and improved quality of life. The HFX platform also includes support services such as HFX Coach™ for patients and HFX Cloud™ for physicians, ensuring enhanced patient management and outcomes.
In November 2023, Nevro expanded its portfolio by acquiring Vyrsa Technologies, a company specializing in minimally invasive sacroiliac joint (SI joint) fusion devices. This strategic move allows Nevro to address a broader range of chronic pain conditions, particularly chronic SI joint pain. Vyrsa's innovative implants and proprietary technologies complement Nevro's existing offerings, positioning the company for significant market penetration and growth.
Financially, Nevro has shown resilience and adaptability. For the full year of 2023, the company reported worldwide revenues of $425.2 million, reflecting a 5% increase from the previous year. Despite challenges, Nevro's solid performance is attributed to its continuous focus on commercial execution, market penetration, and profitability. The company recently secured a $200 million term loan credit facility to refinance its 2025 convertible notes and ensure long-term financial stability.
Nevro's commitment to innovation is further evidenced by the recent FDA clearance of its sacroiliac joint fusion device, Nevro1, which is designed to enhance the stability and fusion of the SI joint using proprietary transfixing technology and bone-growth enhancing materials. This product, alongside the existing portfolio, reinforces Nevro's leadership in the chronic pain management market.
The company also maintains strong strategic partnerships and collaborations, ensuring that its solutions reach a wide patient base. Recent policy updates, such as the expansion of coverage for spinal cord stimulation for painful diabetic neuropathy by Carelon Healthcare, have significantly increased access to Nevro's therapies, benefiting millions of patients across the United States.
Going forward, Nevro remains dedicated to its mission of delivering life-changing solutions for chronic pain, continuously advancing its product offerings, and maintaining its commitment to improving patient outcomes globally.
Nevro Corp. (NYSE: NVRO) reported 12-month results from the SENZA-PDN trial, showing extensive pain relief and significant improvements in health-related quality of life (HRQoL) for patients with painful diabetic neuropathy (PDN) treated with 10 kHz spinal cord stimulation. Key findings include a 2.5- to 4.5-fold improvement in HRQoL metrics compared to minimal clinical importance, with over 70% of patients indicating better overall health. The data supports the product's potential for expanding market access and payer coverage, with a total addressable market of approximately $3.5 billion to $5.0 billion.
Nevro Corp. (NYSE: NVRO) announced positive results from the SENZA-PDN trial at the ADA 82nd Scientific Sessions. The 24-month follow-up demonstrated that 10 kHz spinal cord stimulation (SCS) therapy provides significant pain relief for patients with painful diabetic neuropathy (PDN). Key findings include an 84% responder rate, a 77% average reduction in pain, and 89% patient satisfaction. The study involved 216 patients across 18 U.S. centers, marking it as the largest RCT of its kind. Nevro plans to release additional data in Q4 2022 and anticipates expanding treatment options for PDN patients.
Nevro Corp. (NYSE: NVRO) announced that the SENZA Painful Diabetic Neuropathy (PDN) Randomized Controlled Trial data will be presented at the ADA's 82nd Scientific Sessions from June 3-7, 2022. The presentation will include 24-month follow-up results from the trial, which compares Nevro's 10 kHz spinal cord stimulation (SCS) therapy plus medical management to standard care. Previous results showed significant pain relief and improved quality of life. Nevro anticipates complete 24-month data availability in Q4 2022 for further presentation.
Nevro Corp. (NYSE: NVRO) reported first-quarter 2022 revenue of $87.8 million, a 1% decline from the previous year but a 7% increase compared to 2019. U.S. trial and permanent implant procedures grew by 10% and 2% respectively. The company experienced a net loss from operations of $32.8 million. For Q2 2022, Nevro expects revenues between $103 million and $106 million, and maintains full-year guidance of $415 million to $430 million. Positive payer coverage from UnitedHealthcare and Noridian could enhance access to its therapies.
Nevro Corp. (NYSE: NVRO) will report its first quarter 2022 financial results after market close on May 4, 2022. Following the report, management will host a conference call at 1:30 PM PT / 4:30 PM ET to discuss the results. Interested investors can dial (888) 330-2443 in the U.S. or +1 (240) 789-2728 internationally, using Conference ID: 3583097. The call will be accessible via a live webcast and archived on Nevro's website, www.nevro.com.
Nevro Corp. announced an update from Noridian, the Medicare Administrative Contractor, which includes two new ICD-10 codes for Painful Diabetic Neuropathy (PDN) effective retroactively from January 1, 2022. This update increases access to Nevro's 10 kHz Therapy for PDN patients, expanding coverage from approximately 25% to 43% of PDN patients in the U.S. Noridian oversees Medicare coverage in several Western states. Nevro's CEO stated that this advancement will facilitate better access and is working to ensure further coverage by other payers.
Nevro Corp. reported a 4Q 2021 revenue of $102.8 million, down 6% year-over-year and 10% from 2019. The net loss was $26.2 million, with a non-GAAP adjusted EBITDA of - $7.5 million. U.S. revenue decreased 7% to $88.4 million, while international revenue fell 5% to $14.3 million. For 2022, Nevro projects first quarter revenue of $85-$87 million and annual revenue of $415-$430 million, anticipating impacts from COVID-19. Additionally, it received FDA approval for a new therapy and a positive coverage decision from UnitedHealthcare.
Nevro Corp. (NYSE: NVRO), a leader in chronic pain treatment, announced that its Chairman and CEO, Keith Grossman, CFO Rod MacLeod, and CMO David Caraway will participate in the Wells Fargo 2022 MedTech R&D Spotlight Call Series on March 4, 2022, at 10:00 AM ET. The event will provide insights into Nevro's innovative solutions, including the proprietary 10 kHz Therapy. Investors can access a live webcast and archived recording on Nevro's website. For ongoing updates, Nevro encourages stakeholders to regularly visit their Investor Relations section.
Nevro Corp. (NYSE: NVRO) has published 12-month data from the SENZA-NSRBP randomized controlled trial in the Journal of Neurosurgery: Spine. The study highlights the effectiveness of high-frequency 10 kHz spinal cord stimulation (SCS) in treating non-surgical refractory back pain, showing that 78.2% of patients reported pain relief greater than 50%. The study involved 121 patients and demonstrated consistent safety, with a low explant rate of 2.1% and a significant 46% reduction in opioid use. Nevro is positioned uniquely with FDA approval for this therapy.
Nevro Corp. (NYSE: NVRO), a leader in chronic pain solutions, announced that its Chairman, CEO, and President, D. Keith Grossman, will present at Citi's 2022 Virtual Healthcare Conference on February 24, 2022, at 12:30 pm Eastern Time. A webcast will be available on their website. Nevro has developed the innovative 10 kHz Therapy, which has benefited over 80,000 patients globally, significantly impacting chronic pain treatment.
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