Nevro Announces U.S. Full Market Launch of Revolutionary HFX iQ™ Spinal Cord Stimulation System to Personalize Treatment of Chronic Pain

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03/07/2023 - 07:00 AM

Senza® HFX iQ™ is the First and Only SCS System that Uses Artificial Intelligence to Optimize and Maintain Pain Relief Using Each Patient's Response

REDWOOD CITY, Calif., March 7, 2023 /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 that it has now initiated the U.S. full market launch of its HFX iQ spinal cord stimulation (SCS) system, following the completion of a successful limited market release.

"This is an exciting time in spinal cord stimulation -- better waveforms, more conditions we can treat, and a massive treasure trove of patient data," said Dr. Usman Latif, MD, MBA, a Harvard-trained interventional pain specialist who practices at the University of Kansas Medical Center. "The way forward in this field is precision medicine powered by big data and artificial intelligence. Our limitations are human in nature. What if we could take all the programming experience and clinical outcomes of tens of thousands of patients across the country, including what programs worked and what didn't, and bring the power of all that knowledge into the palm of our patient's hand -- with them 24/7, monitoring them, and offering them the best program for their exact situation with a tap on the screen. HFX iQ is the future of medicine, where expanded data holds the promise of new capabilities and improved care."

HFX iQ starts patients on the program most likely to provide pain relief, based on the HFX Algorithm™, which was built from more than 20 million datapoints and 80,000 implanted patients.¹ HFX iQ combines clinical inputs, such as pain relief and pain score, along with Quality of Life inputs, such as pain medication and activity level changes, to provide an individualized program setting for each patient.² It offers both low frequency and the company's proprietary high-frequency 10 kHz Therapy™, which represents the widest range of frequencies of any SCS system on the market. The superior Senza® high-frequency 10 kHz Therapy has been validated in both clinical and real-world outcomes and offers unique AI-driven iQ modes specifically for treating painful diabetic neuropathy (PDN) and chronic back and leg pain, including non-surgical back pain (NSBP).

"We are continuing to lead the way with the first big data-backed, AI-powered SCS system that gets smarter over time, learning from patient responses to deliver personalized relief to patients," said D. Keith Grossman, Chairman, CEO and President of Nevro. "With over 10 years of innovation and now over 100,000 patients served, Nevro brings the next big advancement to SCS therapy with HFX iQ, a system that will apply the big data we have collected over the last decade to help patients find pain relief faster, and maintain that relief over time. We believe that what we're doing with HFX iQ is the future of SCS therapy, and keeps Nevro firmly at the forefront of innovation, as we continue to work with our clinicians to bring new technology, new data and new indications to their patients."

The Senza HFX iQ system is comprised of the HFX iQ Implantable Pulse Generator (IPG), HFX Trial Stimulator, and HFX App. With a new Bluetooth®-enabled IPG that is upgradeable and connects directly to the HFX App, each patient can input assessments into their smartphone and then receive programming adjustments in real time.

In addition to the U.S. approval for Senza HFX iQ, Nevro has submitted for approval in Europe and Australia.

For more information on HFX iQ, please visit www.NevroHFX.com/HFXiQ and https://nevro.com/English/us/providers/Product-HFX-iQ.

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 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. Bluetooth® and the Bluetooth symbol are registered trademarks of their respective owners.

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

¹ Patients used a Senza, Senza II, or Omnia device offering 10 kHz.

² 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 HFX iQ 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 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.

Investors and Media:
Julie Dewey, IRC
Nevro Corp.
Chief Corp Communications and Investor Relations Officer
650-433-3247 | julie.dewey@nevro.com