New Data Demonstrates Long-Term Improvements in Pain Intensity with Nevro's High-Frequency Spinal Cord Stimulation Therapy

Rhea-AI Summary

Nevro Corp. (NYSE: NVRO) published new data showing significant improvements in patients with painful diabetic neuropathy (PDN) and Type 2 diabetes using their 10 kHz high-frequency spinal cord stimulation therapy. The 24-month study of 144 patients demonstrated a 79.8% mean pain reduction and notable improvements in multiple health metrics. Patients with high HbA1c levels achieved reductions of up to 1.1%, while those with higher BMI experienced weight loss up to 5.4 kg. The study also showed a 65.2% improvement in sleep quality, marking the first SCS study to demonstrate long-term, significant reductions in HbA1c and weight for PDN patients.

Positive

• 79.8% mean pain reduction in study participants over 24 months
• Significant HbA1c reductions of 1.1% in high-risk patients
• Weight loss of up to 5.4 kg in patients with high BMI
• 65.2% improvement in sleep quality metrics

Negative

• Treatment not yet FDA-approved for HbA1c and weight loss benefits

Insights

Medical Research Analyst

The newly published data represents a significant breakthrough in PDN treatment. The study demonstrates 79.8% mean pain reduction and unprecedented improvements in metabolic markers. Key findings include 0.5% to 1.1% HbA1c reductions in diabetic patients and meaningful weight loss of 3.1-5.4 kg across different BMI groups.

This dual benefit of pain relief and metabolic improvement could potentially transform the PDN treatment landscape. The 24-month durability of results is particularly noteworthy, as most PDN treatments show declining efficacy over time. The study's robust design with 144 patients and clear statistical significance (p < 0.001 for pain reduction) strengthens the validity of findings.

The 65.2% improvement in sleep quality adds another valuable dimension, addressing a critical quality-of-life factor for PDN patients. These comprehensive benefits could position Nevro's 10 kHz therapy as a preferred treatment option, potentially expanding market opportunities beyond current projections.

Market Research Analyst

This data publication could significantly impact Nevro's market position in the $4+ billion global PDN treatment market. With diabetes cases quadrupling globally and PDN affecting up to 25% of diabetics, the addressable market is substantial and growing.

The demonstrated metabolic benefits create a unique competitive advantage, potentially differentiating Nevro's solution from traditional PDN treatments and other SCS devices. This could drive increased insurance coverage and adoption rates, particularly given the poor efficacy of current oral medications.

The results suggest potential for expanded indications and market opportunities, though FDA approval for metabolic benefits would be needed for direct marketing of these advantages. The comprehensive benefits shown could justify premium pricing and drive higher reimbursement rates, potentially improving profit margins.

Analysis Marks the First Study of Spinal Cord Stimulation to Demonstrate Long-term, Significant, and Clinically Meaningful Reductions in HbA1c and Weight in Study Participants with Painful Diabetic Neuropathy and Type 2 Diabetes

REDWOOD CITY, Calif., Oct. 29, 2024 /PRNewswire/ -- Nevro Corp. (NYSE: NVRO), a global medical device company that is delivering comprehensive, life-changing solutions for the treatment of chronic pain, today announced the publication of new data in the Journal of Pain Research demonstrating significant, durable pain relief and long-term and clinically meaningful reductions in hemoglobin A1c (HbA1c) and weight in study participants with painful diabetic neuropathy (PDN) and Type 2 diabetes who received 10 kHz high-frequency spinal cord stimulation (SCS) therapy.¹

Globally, the number of people with diabetes has quadrupled in the last two decades², and PDN impacts up to 25% of all people with diabetes.³ PDN can have significant impacts on the quality of life for people living with this condition, with symptoms like numbness, tingling/paresthesia, loss of protective sensation, impaired balance, and reduced response to sensory stimuli.⁴ Patients typically manage PDN with oral pain medications, but the efficacy of these medications is relatively low and can result in intolerable side effects.⁵ As a result, people with PDN suffer from significantly reduced health-related quality of life (HRQoL), impaired functionality and other comorbidities like sleep disorders, depression, and anxiety.⁶

The analysis evaluated 144 patients with Type 2 diabetes and refractory PDN who received 10 kHz SCS therapy during the SENZA-PDN randomized controlled trial (RCT), the largest RCT to evaluate SCS to treat PDN. Changes in pain intensity, HbA1c, weight, and sleep were evaluated over 24 months, with participants stratified according to preimplantation HbA1c.

At 24 months, the following benefits were noted¹:

• Significant, durable pain relief: Study participants had a mean pain reduction of 79.8% and the mean visual analog scale (VAS) score for lower limb pain decreased from 7.5 ± 0.1 cm at preimplantation to 1.5 ± 0.2 cm (p < 0.001).
• Clinically meaningful, statistically significant mean reductions in HbA1c: Participants with preimplantation HbA1c >7% and >8% achieved mean reductions of 0.5% (p = 0.031) and 1.1% (p = 0.004), respectively.
• Significant mean weight loss: Across all study participants, patients achieved a significant mean weight loss of 3.1 kg (p = 0.003). In participant subgroups with body mass indices (BMI) of ≥ 30 and ≥ 35 kg/m2, mean weight reductions were 4.1 kg (p = 0.001) and 5.4 kg (p = 0.005), respectively.
• Significant, durable reductions in pain interference with sleep: Study participants experienced a highly significant improvement in sleep quality, with pain and sleep questionnaire three-item (PSQ-3) scores decreasing by a mean of 65.2%, corresponding to a mean value of 1.9 ± 0.2 cm (p < 0.001).

"People with PDN know that this condition can extend well beyond pain – impacting sleep, sensory functions, and overall quality of life," said Dr. David Klonoff, Medical Director, Diabetes Research Institute at Mills-Peninsula Medical Center. "This is the first study of SCS to demonstrate long-term, significant and clinically meaningful reductions in HbA1c and weight in people with PDN and Type 2 diabetes – suggesting possible metabolic benefits with 10 kHz SCS for these patients."

"The SENZA-PDN RCT has already demonstrated the significant pain relief benefit when using Nevro's HFX device for the millions of people suffering from PDN around the world," said Dr. David Caraway, Nevro's Chief Medical Officer. "Now, for the first time, we've observed secondary benefits like improved HbA1c and weight loss, which exhibit potentially disease-modifying effects for people with Type 2 diabetes. I'm grateful for the dedication of the clinical investigators who supported this latest analysis and the broader SENZA-PDN RCT as we continue gathering data to support market access for more patients."

The 24-month data from the SENZA-PDN RCT were originally published in Diabetes Research and Clinical Practice in 2023. These data showed that patients who received a high-frequency 10 kHz SCS implant and conventional medical management (CMM), compared to CMM alone, experienced durable pain relief and improvements in HRQoL, neurological function, and sleep at 24 months post-implantation.

To learn more about Nevro's 10 kHz Therapy™ for PDN, visit www.nevro.com.

References

1. Nevro's high-frequency, 10 kHz spinal cord stimulation (SCS) device has not been approved or evaluated by the U.S. Food and Drug Administration (FDA) for the treatment of HbA1c and/or weight loss.
2. World Health Organization. (‎2016)‎. Global report on diabetes. World Health Organization. https://apps.who.int/iris/handle/10665/204871
3. Shillo P, et al. Painful and Painless Diabetic Neuropathies: What Is the Difference? Curr Diab Rep. 2019 May 7;19(6):32. doi: 10.1007/s11892-019-1150-5. PMID: 31065863; PMCID: PMC6505492.
4. Pop-Busui R, Ang L, Boulton AJM, Feldman EL, Marcus RL, Mizokami-Stout K, et al. Diagnosis and Treatment of Painful Diabetic Peripheral Neuropathy. Arlington (VA): American Diabetes Association; 2022.
5. Yang, M., Qian, C., & Liu, Y. (2015). Suboptimal Treatment of Diabetic Peripheral Neuropathic Pain in the United States. Pain medicine (Malden, Mass.), 16(11), 2075–2083.
6. Alleman, C. J., Westerhout, K. Y., Hensen, M., Chambers, C., Stoker, M., Long, S., & van Nooten, F. E. (2015). Humanistic and economic burden of painful diabetic peripheral neuropathy in Europe: A review of the literature. Diabetes research and clinical practice, 109(2), 215–225.

Internet Posting of Information
Nevro routinely posts information that may be important to investors in the "Investors" section of its website at www.nevro.com. The company encourages investors and potential investors to consult the Nevro website regularly for important information about Nevro.

About Nevro
Headquartered in Redwood City, California, Nevro is a global medical device company focused on delivering comprehensive, life-changing solutions that continue to set the standard for enduring patient outcomes in chronic pain treatment. The company started with a simple mission to help more patients suffering from debilitating pain and developed its proprietary 10 kHz Therapy™, an evidence-based, non-pharmacologic innovation that has impacted the lives of more than 115,000 patients globally. Nevro's comprehensive HFX™ spinal cord stimulation (SCS) platform includes the Senza^® SCS system and support services for the treatment of chronic pain of the trunk and limb and painful diabetic neuropathy.

Nevro recently added a minimally invasive treatment option for patients suffering from chronic sacroiliac joint ("SI joint") pain and now provides the most comprehensive portfolio of products in the SI joint fusion space, designed to meet the preferences of physicians and varying patient needs in order to improve outcomes and quality of life for patients.

Senza®, Senza II^®, Senza Omnia™, and HFX iQ are the only SCS systems that deliver Nevro's proprietary 10 kHz Therapy. Nevro's unique support services provide every patient with an HFX Coach™ throughout their pain relief journey and every physician with Nevrocloud™ insights for enhanced patient and practice management.

SENZA, SENZA II, SENZA OMNIA, OMNIA, HF10, the HF10 logo, 10 kHz Therapy, HFX, the HFX logo, HFX iQ, the HFX iQ logo, HFX Algorithm, HFX CONNECT, the HFX Connect logo, HFX ACCESS, the HFX Access logo, HFX COACH, the HFX Coach logo, Nevrocloud, RELIEF MULTIPLIED, HFX AdaptivAI, the X logo, NEVRO, and the NEVRO logo are trademarks or registered trademarks of Nevro Corp. Patents covering Senza HFX iQ and other Nevro products are listed at Nevro.com/patents. Bluetooth^® and the Bluetooth symbol are registered trademarks of their respective owners.

To learn more about Nevro, connect with us on LinkedIn, X, Facebook, and Instagram.

Investors and Media:
Angie McCabe
Vice President, Investor Relations & Corporate Communications
angeline.mccabe@nevro.com

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SOURCE Nevro Corp.

FAQ

What were the main results of Nevro's (NVRO) 24-month PDN study?

The study showed 79.8% mean pain reduction, HbA1c reductions up to 1.1%, weight loss up to 5.4 kg in high BMI patients, and 65.2% improvement in sleep quality.

How many patients participated in Nevro's (NVRO) SENZA-PDN trial?

144 patients with Type 2 diabetes and refractory PDN participated in the study.

What is the current FDA status of Nevro's (NVRO) 10 kHz therapy for HbA1c and weight loss?

The 10 kHz spinal cord stimulation device has not been approved or evaluated by the FDA for treating HbA1c and/or weight loss.