HFX AdaptivAI combines insights from over
100,000 patients and more than 100 million data points¹ and
leverages artificial intelligence (AI) to deliver responsive
and personalized pain relief in real time*
REDWOOD
CITY, Calif., Sept. 24,
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 U.S. Food and Drug Administration (FDA) approval and
limited market release of HFX iQ™ with HFX AdaptivAI™ – a
responsive, personalized pain management platform powering the HFX
iQ spinal cord stimulation (SCS) system.
Building on a foundation of landmark evidence2,
clinical research and big data, HFX AdaptivAI is the only
technology with artificial intelligence (AI) to provide patients
suffering from chronic pain with an unprecedented level of
personalized, responsive pain relief.
"Nevro is further establishing its position as the leading
developer of data-driven solutions for pain management through the
launch of HFX iQ with HFX AdaptivAI," said Kevin Thornal, Nevro's CEO and president. "HFX
AdaptivAI delivers personalized pain relief, utilizing AI and
leveraging millions of data points and ten years of innovation and
patient care. We believe this new solution is a major milestone,
and it demonstrates our dedication to freeing patients from the
burden of chronic pain through evidence-based therapies that
transform patients' lives. Importantly, HFX AdaptivAI puts patients
in control of their pain relief while, at the same time, providing
physicians the ability to monitor their patient's pain journey –
closing the loop that matters."
"HFX AdaptivAI is a significant leap forward in pain
management," said Dr. Usman Latif,
MD, MBA, a Harvard-trained
interventional pain specialist at The University of Kansas Health System. "Drawing from
landmark evidence and big data, this technology has the potential
to offer patients a faster and more sustainable approach to pain
relief. HFX AdaptivAI is on the right path to make a lasting impact
on how we manage chronic pain and improve patient outcomes."
HFX AdaptivAI Offers:
- Relief and Beyond: HFX AdaptivAI is engineered to
maximize pain relief over time by continuing to optimize therapy
even when pain relief over 50% has been achieved1.
- Bipole Interlacing™: Proprietary technology creates
customized therapy programs in real-time using direct patient
input1**.
- Smart Power: Through therapy optimization, advanced
Smart Power technology allows patients to charge their device as
little as six times per year3.
- Enhanced Real-Time Insights: HFX AdaptivAI
technology gathers real-time quality of life (QoL) metrics and
device data, enabling more impactful patient-clinician
interactions. This real-time information helps patients report pain
relief in significantly less time than with traditional
programming¹.
- Advanced Proactive Remote Monitoring: With the
launch of HFX AdaptivAI, physicians will have the ability to
remotely monitor each of their patient's pain journey in real time
through Nevro's healthcare provider portal.
"Chronic pain is a dynamic, biopsychosocial human condition
unique to each individual4," said Dr. David Caraway, MD, PhD, Nevro's chief medical
officer. "To effectively treat suffering – as perceived by each
patient – therapies must be personalized based on the changing
experience of pain. Only HFX AdaptivAI seeks to engage with the
patient and personalize the SCS therapy in real time using evidence
based on algorithms and multi-dimensional metrics of pain relief,
function and satisfaction."
Nevro noted that it expects to launch its full market release of
HFX iQ with HFX AdaptivAI in the U.S. in the fourth quarter of
2024.
For more information on HFX AdaptivAI, please visit
https://nevro.com/English/us/providers/Product-HFX-AdaptivAI.
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
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
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.
*HFX AdaptivAI™ technology includes an advanced algorithm with
an ability to interlace bipoles. 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. Big data refers to Nevro's internal cloud
database.
**HFX AdaptivAI™ customized programs are pre-defined parameters
programmed by the physician.
To learn more about Nevro, please visit our website at
www.nevro.com and connect with us
on LinkedIn, Twitter, Facebook
and Instagram.
1 Data on file.
2 Kapural, L., et al. (2016). Comparison of 10-kHz
high-frequency and traditional low-frequency spinal cord
stimulation for the treatment of chronic back and leg pain:
24-month results from a multicenter, randomized, controlled pivotal
trial. Neurosurgery, 79(5), 667–677. Patel, N.P., et al. (2023).
Durable responses at 24 months with high-frequency spinal cord
stimulation for nonsurgical refractory back pain. J Neurosurg
Spine:1-11. Petersen, E., et al. (2023). Long-Term Efficacy of
High-Frequency (10 kHz) Spinal Cord Stimulation for the Treatment
of Painful Diabetic Neuropathy: 24-Month Results of a Randomized
Controlled Trial. Diabetes Research and Clinical Practice,
110865.
To learn more about Nevro's landmark publications, please visit
the company's Publications page on its website.
3 Data on file, 3% PD 10 KHz 30 μs 2.0 mA 20 secs
10mins 800 Ohms.
4 Deer T.R., Caraway D.L., Wallace M.S. 2014. A
Definition of Refractory Pain to Help Determine Suitability for
Device Implantation. Neuromodulation 2014; 17: 711–715
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 HFX AdaptivAI™ is the
future of SCS therapy and keeps Nevro firmly at the forefront of
innovation. 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 23,
2024, 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.
Investors and Media:
Angie McCabe
Vice President, Investor Relations & Corporate
Communications
angeline.mccabe@nevro.com
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SOURCE Nevro Corp.
