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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), based in Redwood City, California, has received FDA approval for expanded labeling of its Senza® Spinal Cord Stimulation (SCS) System to treat Non-Surgical Refractory Back Pain (NSRBP), marking it the only SCS system specifically indicated for this condition. This approval highlights Nevro's proprietary 10 kHz Therapy. Clinical trials indicate significant improvements in pain relief and quality of life for patients after 12 months of treatment. Nevro aims to enhance market access and payer coverage based on these results.
Nevro Corp. announced significant outcomes from its clinical trials presented at the 2022 North American Neuromodulation Society Annual Meeting. The SENZA-PDN trial demonstrated durable efficacy for 10 kHz spinal cord stimulation in painful diabetic neuropathy at 18 months, with no explants due to loss of efficacy. The SENZA-NSRBP trial showed profound pain relief and improved quality of life in patients at 12 months, supported by cost-effectiveness data for the treatment. Nevro aims to be the only SCS company with an on-label indication for treating non-surgical refractory back pain upon FDA approval.
Nevro Corp. (NYSE: NVRO) reported preliminary unaudited revenue results for Q4 and full-year 2021, expecting Q4 revenue of approximately $102.5 million, down from $109.7 million YoY. Full-year revenue is expected at $386.6 million, up from $362.0 million in 2020. Despite Q4 declines, U.S. trial procedures rose 3%, with painful diabetic neuropathy (PDN) trials growing 92% sequentially. Nevro anticipates exceeding its adjusted EBITDA guidance of negative $10 million to negative $13 million. The company plans to report full financial results on February 23, 2022.
Nevro Corp. (NYSE: NVRO) announced that UnitedHealthcare will provide coverage for its high-frequency 10 kHz Therapy for Painful Diabetic Neuropathy (PDN), effective March 1, 2022. This decision is seen as a major milestone in facilitating access to Nevro's FDA-approved spinal cord stimulation therapy. UnitedHealthcare’s policy considers this treatment medically necessary under specific criteria. Nevro believes this coverage will enhance its market position and lead to further endorsements from additional health plans, supported by extensive clinical data.
Nevro Corp. (NYSE: NVRO) announced a settlement of its patent lawsuit against Nalu Medical regarding high-frequency spinal cord stimulation (SCS) technology. Initially filed in February 2020, Nevro accused Nalu of patent infringement, but the lawsuit concluded with both parties agreeing to avoid further litigation costs. Nevro's General Counsel, Kashif Rashid, emphasized the importance of protecting intellectual property. Nevro remains the sole provider of FDA-approved high-frequency SCS therapy for painful diabetic neuropathy, allowing them to focus on developing solutions for chronic pain.
Nevro Corp. (NYSE: NVRO) announced that three abstracts related to Painful Diabetic Neuropathy (PDN) and Non-Surgical Refractory Back Pain (NSRBP) have been accepted for podium presentations at the NANS 2022 Annual Meeting on January 15, 2022. The presentations will showcase critical results from the largest randomized controlled trial of spinal cord stimulation for PDN, involving 216 subjects, and 12-month outcomes from a similar trial for NSRBP with 159 participants. A focus will also be on the cost-effectiveness of their 10 kHz spinal cord stimulation.
Nevro Corp. (NYSE: NVRO), a leader in innovative medical devices for chronic pain, announced its participation in the 40th Annual J.P. Morgan Healthcare Conference. D. Keith Grossman, Chairman, CEO, and President, will present on January 10, 2022, at 7:30 am PT in San Francisco, CA. A live webcast will be accessible on Nevro's website. The company focuses on the Senza spinal cord stimulation system, which offers evidence-based, non-pharmacologic pain management solutions.
Nevro Corp. (NYSE: NVRO) announced two poster presentations at ISPOR Europe 2021, focusing on health economic results from the SENZA-PDN trial. The first study showed a trend towards reduced hospitalization rates and shorter stays for patients receiving 10 kHz spinal cord stimulation (SCS) combined with conventional medical management compared to those on conventional management alone. The second study revealed that patients receiving SCS therapy earlier incurred nearly €8,000 less in costs than those starting therapy later. Both studies aim to enhance physician referral decisions and expand payer coverage for diabetic neuropathy treatments.
Nevro Corp. (NYSE: NVRO) announced three significant clinical publications for treating Painful Diabetic Neuropathy (PDN) with 10 kHz Therapy, including 12-month results from the SENZA-PDN Randomized Controlled Trial. Published findings highlight the effectiveness of high-frequency spinal cord stimulation (SCS) in providing significant pain relief and neurological improvements. Notably, 86% of participants reported over 50% pain relief at 12 months. Nevro's 10 kHz SCS is currently the only FDA-approved device for PDN, aiming to expand payer coverage policies for broader access.
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