Evidence Published in Diabetes Research and
Clinical Practice Shows 10 kHz Therapy Yields Lasting Pain Relief
and Enhances Health-Related Quality of Life and Sleep
REDWOOD
CITY, Calif., Aug. 16,
2023 /PRNewswire/ -- Nevro Corp. (NYSE: NVRO), a
global medical device company delivering comprehensive,
life-changing solutions for the treatment of chronic pain, today
announced the publication of 24-month data from the SENZA Painful
Diabetic Neuropathy (PDN) Randomized Controlled Trial (RCT), the
largest RCT to evaluate spinal cord stimulation (SCS) to treat PDN,
in Diabetes Research and Clinical Practice.
Globally, the number of people with diabetes has quadrupled in
the last two decades1, and PDN is one of its most common
complications, affecting up to 25 percent of all people with
diabetes. PDN symptoms can have a significant impact on quality of
life. These symptoms include numbness, tingling/paresthesia, loss
of protective sensation, impaired balance, and reduced response to
sensory stimuli.2 Patients typically manage this
complication with oral pain medications, but the efficacy of these
medications is relatively low and can result in intolerable side
effects for patients.3 As a result, people with PDN
suffer significantly-reduced health-related quality of life
(HRQoL), impaired functionality, and other comorbidities like sleep
disorders, depression, and anxiety.4
Published 24-month data from the SENZA-PDN RCT evaluated the
long-term efficacy of high-frequency 10 kHz SCS to treat refractory
PDN. The data show 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 significant
improvements in both HRQoL and sleep at 24 months
post-implantation.
Furthermore, most participants experienced neurological symptom
improvements, including those in motor, sensory, and reflex
function. The long-term data further supports that 10 kHz SCS is a
safe and highly effective therapy for PDN, as well as a therapy
that demonstrates durable quality of life improvements.
"The 24-month data from the SENZA-PDN RCT show us high-frequency
SCS is a viable, long-term relief solution for people with PDN,
which is particularly encouraging for a condition that naturally
worsens over time," said lead Principal Investigator Dr.
Erika Petersen, Professor of
Neurosurgery and Director of Functional and Restorative
Neurosurgery at the University of
Arkansas for Medical Sciences. "These results further
validate not only the efficacy of high-frequency 10 kHz SCS for
pain relief, but also show profound improvements in quality of
life, sleep, and neurological function."
The SENZA-PDN RCT 24-month data demonstrated the following
benefits of 10 kHz SCS Therapy:
Durable Pain Relief
- At 24 months, 10 kHz SCS reduced pain by a mean of 79.9%
compared to baseline, with 90.1% of participants experiencing ≥50%
pain relief.
- A DN4 score ≥4 is consistent with clinically confirmed PDN. In
the 10 kHz SCS recipients, the proportion with a DN4 score <4
increased significantly from 3.9% at preimplantation to 48.9% at 24
months. (P < .001).
Neurological Improvements:
- Investigators assessed neurological function versus study
baseline in all implanted patients. At 24 months, 65.7% of
implanted patients exhibited clinically meaningful improvements
over study baseline in sensory, motor, or reflex function without
worsening in any category. A majority of these neurological
improvements were in sensory function, which may have implications
in restoring protective sensation.
- No other SCS treatment for PDN has exhibited the potentially
disease-modifying effects demonstrated by Nevro HFX™ in improving
neurological function.
HRQoL:
- HRQoL significantly improved with 10 kHz SCS, based on the
EuroQol 5-Dimensional 5-Level (EQ-5D-5L) questionnaire.
- Among all implanted patients, the mean EQ-5D-5L index value
increased by 0.146 from preimplantation to 24 months, which is 2.9
to 4.9 times the minimally important difference for people with
type 2 diabetes.
Pain Interference with Sleep:
- Baseline sleep quality was poor among all study participants,
as shown by a mean score on the Pain and Sleep Questionnaire 3-Item
Index (PSQ-3; 0-10 cm scale) of 6.5 cm at preimplantation.
- Treatment with 10 kHz SCS significantly reduced pain
interference with sleep in the group of all implanted patients over
24 months, as demonstrated by a 65.5% decrease in the mean PSQ-3
score, from 6.5 at preimplantation to 1.9 at 24 months.
Safety:
- The incidence and type of procedure-related complications were
comparable to those reported in the SCS literature for all patient
populations. Five (3.2%) SCS systems were explanted due to
infection, and no devices were explanted due to lack of
efficacy.
Consistent Outcomes:
- Comparable to the 6- and 12-month SENZA-PDN study outcomes, the
24-month results confirm robust and long-lasting beneficial effects
of 10 kHz SCS in PDN patients. These are important findings, given
the severe, chronic, and debilitating nature of PDN and the lack of
effective treatment options for this patient population.
"We're encouraged by the latest data demonstrating the long-term
efficacy of Nevro HFX to treat the millions of people suffering
from PDN worldwide," said Dr. David
Caraway, Nevro's Chief Medical Officer. "Compared to
previous studies evaluating traditional low-frequency systems for
these patients, high-frequency 10 kHz SCS demonstrated greater pain
reduction and higher responder rates over time.5 As we
continue gathering data, we expect these results to be used in
physician referral decisions and continue to support market access
for high-frequency SCS for PDN patients."
Nevro's SENZA-PDN trial is the largest RCT conducted to date
studying SCS therapy for PDN patients, enrolling 216 patients with
refractory PDN. In total, 142 patients implanted with Nevro's
high-frequency (10 kHz) SCS system, Nevro HFX, were followed for 24
months, including 84 initial 10 kHz SCS+CMM recipients and 58
crossovers from CMM alone.
This study aimed to provide high-level evidence to aid clinical
decision-making, albeit with some limitations, including risks of
biased outcomes and potential placebo effects, the potential impact
of missed follow-up visits on study results, and limitations
related to interpreting the observed neurological improvements.
About Painful Diabetic Neuropathy (PDN)
The World
Health Organization estimates 422 million adults live with diabetes
worldwide and its prevalence (8.5%) has nearly doubled over four
decades.1 Diabetes may cause systemic damage with a
profound impact on health-related quality of life and is
potentially life-threatening. Diabetic peripheral neuropathy is a
common complication presenting as pain and other dysesthesias,
including numbness, burning, or tingling. Approximately 20% of
patients with diabetes will develop PDN, a progressive, potentially
debilitating chronic neuropathic pain condition.6 In the
U.S., it is estimated that there are approximately 140,000 to
200,000 PDN patients each year that are refractory to conventional
medical management, representing an annual total addressable market
opportunity of approximately $3.5
billion to $5.0
billion.7,8
Internet Posting of Information
Nevro routinely posts
information that may be important to investors in the "Investor
Relations" 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 100,000 patients globally. Nevro's comprehensive
HFX™ spinal cord stimulation (SCS) platform includes a Senza SCS
system and support services for the treatment of chronic pain of
the trunk and limb, with and without surgery, and painful diabetic
neuropathy.
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 HFX
Cloud™ 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, HFX CLOUD, the HFX Cloud logo,
RELIEF MULTIPLIED, 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.
To learn more about Nevro, connect with us
on LinkedIn, Twitter, Facebook and Instagram.
*Senza HFX iQ™ uses a fixed set of instructions to provide
optimized treatment recommendations that utilize direct patient
input from assessments on pain and quality of life measures.
Forward-Looking Statements
In addition to historical
information, this press release contains forward-looking statements
reflecting the company's current beliefs and expectations of
management made pursuant to the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995, including: our
belief that that this study will provide additional confirmatory
evidence of the benefits of Nevro's proprietary 10 kHz Therapy in
these PDN patients; our belief that, by restoring sensation in the
feet, 10 kHz Therapy may alleviate this tremendous disease burden,
prevent amputations, and enable patients to be more active, all of
which would improve overall health and quality of life and of
course reduce healthcare costs; and our belief that this study will
provide additional confirmatory evidence of the benefits of Nevro's
proprietary 10 kHz Therapy in PDN patients, and the additional
Level 1 data generated will be very helpful as we work to expand
PDN coverage generally and update PDN clinical treatment
guidelines. These forward-looking statements are based upon
information that is currently available to us or our current
expectations, speak only as of the date hereof, and are subject to
numerous risks and uncertainties, including our ability to
successfully commercialize our products; our ability to manufacture
our products to meet demand; the level and availability of
third-party payor reimbursement for our products; our ability to
effectively manage our anticipated growth and the costs and
expenses of operating our business; our ability to protect our
intellectual property rights and proprietary technologies; our
ability to operate our business without infringing the intellectual
property rights and proprietary technology of third parties;
competition in our industry; additional capital and credit
availability; our ability to attract and retain qualified
personnel; and product liability claims. These factors, together
with those that are described in greater detail in our Annual
Report on Form 10-K filed on February 21,
2023, as well as any reports that we may file with the
Securities and Exchange Commission in the future, may cause our
actual results, performance or achievements to differ materially
and adversely from those anticipated or implied by our
forward-looking statements. We expressly disclaim any obligation,
except as required by law, or undertaking to update or revise any
such forward-looking statements.
1 World Health Organization.
(2016). Global report on diabetes. World Health
Organization. https://apps.who.int/iris/handle/10665/204871
2 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.
3 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.
4 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.
5 van Beek, M., Geurts, J. W., Slangen, R.,
Schaper, N. C., Faber, C. G., Joosten, E. A., Dirksen, C. D., van
Dongen, R. T., van Kuijk, S. M.
J., & van Kleef, M. (2018). Severity of Neuropathy Is
Associated With Long-term Spinal Cord Stimulation Outcome in
Painful Diabetic Peripheral Neuropathy: Five-Year Follow-up of a
Prospective Two-Center Clinical Trial. Diabetes
care, 41(1), 32–38.
6 Schmader K. E. (2002). Epidemiology and impact on
quality of life of postherpetic neuralgia and painful diabetic
neuropathy. The Clinical journal of pain, 18(6),
350–354.
7 CDC National Diabetes Statistics Report 2020.
8 Trinity Partners Market Research 2017.
Investors and Media:
Nevro
Corp.
ir@nevro.com
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