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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) announced FDA approval for its manufacturing operations in Costa Rica, aimed at producing its spinal cord stimulation systems, including the HFX platform for chronic pain treatment. This facility, located in the Coyol Free Trade Zone, will enhance production efficiency and quality control. With a $21 million investment by year-end 2022 and approximately 100 employees, Nevro plans to start shipping products by October 2022, anticipating gross margin expansion from the high 60s% to mid-70s% within three to five years.
Nevro Corp. (NYSE: NVRO) announced that its HFX 10 kHz Therapy is the only spinal cord stimulation (SCS) method referenced in the American Association of Clinical Endocrinology's 2022 Diabetes Clinical Practice Guideline for treating painful diabetic neuropathy (PDN). This therapy is a nonpharmacological option for patients who have not responded to traditional medications. The guideline underscores the significant need for effective treatments in managing PDN, which affects a substantial number of diabetic patients, representing a market opportunity of $3.5 to $5 billion annually.
Nevro Corp. announced that Aetna has updated its spinal cord stimulation (SCS) coverage to include painful diabetic neuropathy (PDN), effective August 29, 2022. This policy change benefits approximately 22 million commercial lives. Additionally, proposed local coverage determinations from Novitas and First Coast could expand Medicare coverage for PDN, affecting around 17 million Medicare beneficiaries. Overall, this could increase coverage for PDN patients in the U.S. from 54% to approximately 66% if finalized. These advancements enhance access to Nevro's proprietary 10 kHz Therapy for chronic pain treatment.
Nevro Corp. (NYSE: NVRO), based in Redwood City, California, announced its participation in two upcoming investor conferences. On September 9, 2022, CFO Rod MacLeod will present at the Wells Fargo Healthcare Conference at 9:10 am ET in Boston, MA. The following week, on September 12, 2022, he will present at the Morgan Stanley 20th Annual Global Healthcare Conference at 9:55 am ET in New York, NY. Webcasts of both events will be available on Nevro's website. Nevro specializes in innovative solutions for chronic pain, with its proprietary 10 kHz Therapy benefiting over 80,000 patients globally.
Nevro Corp. (NVRO) reported Q2 2022 revenue of $104.2 million, marking a 2% increase year-over-year. The company experienced notable 14% growth in U.S. trial procedures. Painful Diabetic Neuropathy (PDN) contributed $11 million in revenue. However, the net loss from operations was $23.8 million, up from $15.8 million a year earlier. Nevro issued Q3 revenue guidance of $97 million to $101 million, and updated full-year guidance to $400 million to $410 million. The company reached a settlement with Boston Scientific, receiving $85 million in cash.
Nevro Corp. and Boston Scientific Corp. have resolved their intellectual property litigation through a settlement. This agreement allows Boston Scientific to operate with its current products utilizing features below 1,500 Hz while granting Nevro similar freedoms. Nevro will license paresthesia-free therapy technology to Boston Scientific, and vice versa. The settlement also includes a net payment of $85 million from Boston Scientific to Nevro, concluding all ongoing litigations between the two parties.
Nevro Corp. (NYSE: NVRO), a medical device company based in Redwood City, California, will have CFO Rod MacLeod present at the Canaccord Genuity 42nd Annual Growth Conference. The event is scheduled for August 10, 2022, at 2:30 pm Eastern Time, in Boston, MA. Investors can access a live webcast and subsequent recording on Nevro's website. Nevro specializes in innovative solutions for chronic pain, including the proprietary 10 kHz Therapy, which has benefited over 80,000 patients worldwide. For more details, visit www.nevro.com.
Nevro Corp. (NVRO), a global medical device company, will report its financial results for Q2 2022 after market close on August 3, 2022. A conference call to discuss the results will take place at 1:30 pm PT / 4:30 pm ET. Investors can tune in by calling (888) 330-2443 or +1 (240) 789-2728 with Conference ID: 3583097. Nevro specializes in innovative solutions for chronic pain, including its proprietary 10 kHz Therapy, impacting over 80,000 patients globally. For further updates, visit Nevro's website.
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.
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