New Data Demonstrates Long-Term Improvements in Pain Intensity with Nevro's High-Frequency Spinal Cord Stimulation Therapy
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.
Nevro Corp. (NYSE: NVRO) ha pubblicato nuovi dati che mostrano miglioramenti significativi nei pazienti con neuropatia diabetica dolorosa (PDN) e diabete di tipo 2, utilizzando la loro terapia di stimolazione del midollo spinale ad alta frequenza di 10 kHz. Lo studio di 24 mesi su 144 pazienti ha dimostrato una riduzione media del dolore del 79,8% e notevoli miglioramenti in diversi parametri di salute. I pazienti con alti livelli di HbA1c hanno ottenuto riduzioni fino all'1,1%, mentre coloro con un BMI maggiore hanno visto una perdita di peso fino a 5,4 kg. Lo studio ha anche mostrato un miglioramento del 65,2% nella qualità del sonno, segnando il primo studio SCS a dimostrare riduzioni significative e a lungo termine in HbA1c e peso per i pazienti con PDN.
Nevro Corp. (NYSE: NVRO) publicó nuevos datos que muestran mejoras significativas en pacientes con neuropatía diabética dolorosa (PDN) y diabetes tipo 2 utilizando su terapia de estimulación de la médula espinal de alta frecuencia de 10 kHz. El estudio de 24 meses con 144 pacientes demostró una reducción media del dolor del 79,8% y mejoras notables en múltiples métricas de salud. Los pacientes con altos niveles de HbA1c lograron reducciones de hasta el 1,1%, mientras que aquellos con mayor IMC experimentaron una pérdida de peso de hasta 5,4 kg. El estudio también mostró una mejora del 65,2% en la calidad del sueño, marcando el primer estudio SCS en demostrar reducciones significativas y a largo plazo en HbA1c y peso para pacientes con PDN.
네브로사 (NASDAQ: NVRO)는 10kHz 고주파 척수 자극 치료를 사용하여 통증 있는 당뇨병성 신경병증(PDN) 및 제2형 당뇨병 환자에서 유의미한 개선을 보이는 새로운 데이터를 발표했습니다. 144명의 환자를 대상으로 한 24개월 연구에서는 79.8%의 평균 통증 감소와 여러 건강 지표에서 두드러진 개선을 보였습니다. HbA1c 수치가 높은 환자는 최대 1.1%의 감소를 달성했으며, BMI가 높은 환자들은 최대 5.4kg의 체중 감소를 경험했습니다. 이 연구는 또한 수면 질이 65.2% 개선되었음을 보여주었으며, PDN 환자의 HbA1c와 체중에 대한 장기적이고 유의미한 감소를 입증한 첫 번째 SCS 연구로 기록되었습니다.
Nevro Corp. (NYSE: NVRO) a publié de nouvelles données montrant des améliorations significatives chez les patients souffrant de neuropathie diabétique douloureuse (PDN) et de diabète de type 2 grâce à leur thérapie de stimulation de la moelle épinière à haute fréquence de 10 kHz. L'étude de 24 mois portant sur 144 patients a démontré une réduction moyenne de la douleur de 79,8% ainsi que des améliorations notables dans plusieurs indicateurs de santé. Les patients ayant des niveaux élevés de HbA1c ont obtenu des réductions allant jusqu'à 1,1%, tandis que ceux ayant un IMC plus élevé ont connu une perte de poids allant jusqu'à 5,4 kg. L'étude a également montré une amélioration de 65,2% de la qualité du sommeil, ce qui constitue la première étude SCS à démontrer des réductions significatives et durables de l'HbA1c et du poids chez les patients atteints de PDN.
Nevro Corp. (NYSE: NVRO) hat neue Daten veröffentlicht, die signifikante Verbesserungen bei Patienten mit schmerzhafter diabetischer Neuropathie (PDN) und Typ-2-Diabetes zeigen, die ihre 10-kHz-Hochfrequenz- spinalen Stimulations Therapie nutzen. Die 24-monatige Studie mit 144 Patienten zeigte eine durchschnittliche Schmerzlinderung von 79,8% und bemerkenswerte Verbesserungen in verschiedenen Gesundheitskennzahlen. Patienten mit hohen HbA1c-Werten erreichten Reduzierungen von bis zu 1,1%, während Patienten mit höherem BMI bis zu 5,4 kg Gewicht verloren. Die Studie zeigte auch eine Verbesserung der Schlafqualität um 65,2%, was die erste SCS-Studie darstellt, die langfristige, signifikante Reduzierungen bei HbA1c und Gewicht für PDN-Patienten nachweist.
- 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
- Treatment not yet FDA-approved for HbA1c and weight loss benefits
Insights
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
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.
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
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
Globally, the number of people with diabetes has quadrupled in the last two decades2, and PDN impacts up to
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 of0.5% (p = 0.031) and1.1% (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
- 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. - World Health Organization. (2016). Global report on diabetes. World Health Organization. https://apps.who.int/iris/handle/10665/204871
- 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.
- 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. - 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. - 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
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.
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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?
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