First Randomized Controlled Trial Specifically Powered to Assess Restoration of Neurological Function in Patients with Intractable Painful Diabetic Neuropathy
Breakthrough Device Designation Provides Expedited Review for Marketing Application to Expand Nevro’s FDA Labeling
REDWOOD CITY, Calif., April 24, 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 enrolled the first patient in its Painful Diabetic Neuropathy (PDN) Sensory Study, which is the first prospective randomized controlled trial (RCT) to assess restoration of neurological function as a primary objective in patients with intractable PDN. The study will enroll up to 236 patients at multiple sites across the U.S. Patients will be randomized to conventional medical management or 10 kHz Therapy™ plus conventional medical management, with optional crossover to the other treatment arm at 6 months if those criteria are met.
The FDA has granted Breakthrough Device Designation for the PDN Sensory Study and this potential device indication. This designation by the FDA provides for an expedited review for a marketing application to expand Nevro’s FDA labeling and provide patients and health care providers with timely access to critical medical devices that offer more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
“This PDN Sensory Study affords a path forward to building clinical evidence for slowing the progression of or improving sensory loss of the lower limbs in patients with chronic intractable pain and builds on the significant outcomes seen in the landmark SENZA-PDN RCT,” said Mitchell Engle, MD, PhD, Institute of Precision Pain Medicine in Corpus Christi, Texas. “It also offers a unique opportunity for patients with refractory painful diabetic neuropathy to participate in a research study utilizing 10 kHz SCS, a proven minimally invasive, completely reversible technology, with powered study endpoints targeting the disease modifying benefits of improved neurological function and pain relief.”
“The observed neurological improvements we saw in the SENZA-PDN study are unique to 10 kHz Therapy and have not been reported for any other competitive SCS modality,” said Kevin Thornal, CEO and President of Nevro. “Not only do we anticipate that this study will provide additional confirmatory evidence of the benefits of Nevro’s proprietary 10 kHz Therapy in these PDN patients, but we also believe that the additional Level 1 data generated will be very helpful as we continue to work with payers to expand PDN coverage generally and professional societies to update PDN clinical treatment guidelines.”
Diabetes and peripheral neuropathy pose a staggering socioeconomic burden, and there is no available disease modifying treatment option available for patients with PDN. In fact, every 20 seconds in the US there is a diabetes-related amputation according to the American Limb Preservation Society, and many of these amputations are preventable. Insensate or numb feet contribute to unrecognized injuries and foot ulcers as patients lack protective sensation. Foot ulcer treatment and associated amputation surgeries are costly, both economically and psychosocially. 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.
For more information on Nevro’s PDN Sensory Study, please visit the ClinicalTrials.gov website.
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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.
*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.
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.
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SOURCE Nevro Corp.