Nevro Responds to Competitor's Announcement of FDA Approval for Painful Diabetic Neuropathy

Rhea-AI Summary

Nevro Corp. has responded to Medtronic's FDA approval for painful diabetic neuropathy (PDN), highlighting the significant market potential for this condition. The company asserts its SENZA-PDN trial is the largest and most comprehensive for spinal cord stimulation therapy, yielding superior outcomes compared to Medtronic's studies. Nevro claims its proprietary 10 kHz Therapy offers advantages in pain relief, treatment success rates, and neurological improvement. The company expresses concern over Medtronic's reliance on older studies for FDA approval, emphasizing the robust data from their SENZA-PDN trial.

Positive

• SENZA-PDN trial is the first FDA-approved spinal cord stimulation system for PDN, demonstrating significant pain relief (75% at 18 months).
• 10 kHz Therapy offers superior pain relief and higher treatment success rates compared to competitor devices.
• Nevro's comprehensive approach includes ongoing support for patients and clinicians through HFX Coach and HFX Cloud.

Negative

• Medtronic's FDA approval is based on smaller, older studies, which Nevro claims lack clinical relevance.

REDWOOD CITY, Calif., Jan. 25, 2022 /PRNewswire/ -- Nevro Corp. (NYSE: NVRO), a global medical device company that is delivering comprehensive, life-changing solutions for the treatment of chronic pain, today responded to Medtronic's announcement of FDA approval for painful diabetic neuropathy (PDN).

"PDN represents a very large potential market, and having another competitor validate this large opportunity speaks to its attractiveness," stated D. Keith Grossman, Chairman, CEO and President of Nevro.  "We are very proud of our SENZA-PDN study, the largest, prospective SCS trial conducted for this patient population, generating Level 1 clinical data that we believe has moved the field and the therapy forward.  The trials presented by our competitor to support its FDA submission makes especially clear that our proprietary, paresthesia-free 10 kHz Therapy is uniquely suited to treat PDN patients.  In fact, a recent review of spinal cord stimulation evidence for painful diabetic neuropathy concluded, 'High-frequency 10 kHz SCS offers several advantages over low frequency SCS, including greater pain relief, a higher proportion of patients achieving treatment success, paresthesia-independence, and evidence of improved neurological function. Neuromodulation with SCS, especially with 10 kHz SCS, offers a pathway forward for improving the lives of PDN patients.'"¹

Dr. David Caraway, Nevro's Chief Medical Officer added, "Instead of the large clinical trial it has been promising to the Pain and Diabetes clinical communities for these patients, Medtronic has simply reintroduced two small European studies from 2014.^2,3  One of these studies was actually sponsored by another competitor and did not even use Medtronic's products.²  Both of these low-frequency, SCS trials required paresthesia delivery and demonstrated results that were dramatically inferior to the outcomes generated in our landmark SENZA-PDN trial, a fact widely recognized by our clinicians since the publication of the SENZA-PDN trial results.  Unfortunately, these much smaller trials provide no new evidence to further advance the field, drive adoption or expand payer coverage.  We believe the significant, durable outcomes from our SENZA-PDN randomized, controlled trial speak for themselves, and we are disappointed in the disparity of standards supporting these two FDA approvals." 

Nevro's landmark SENZA-PDN randomized, controlled trial (RCT), using 10 kHz high frequency, is the first spinal cord stimulation system approved by the FDA with a specific indication to treat PDN and has demonstrated significant benefits for SCS therapy to treat PDN patients.^4,5  The 2014 Slangen study submitted by Medtronic to support their FDA submission is the only published RCT using Medtronic devices. Differences in this and the Senza-PDN include:

• The SENZA-PDN study randomized 216 patients with 113 patients assigned to the SCS arm and 154 implanted after crossover.  In the Medtronic sponsored Slangen study, 36 patients were randomized and only 22 were assigned to the SCS group.  In total, 17 patients received permanent SCS device implants and only 16 completed the RCT with 15 available for 24-month follow-up;⁶  
• Medtronic's press release on 1/24/22 stated, "70% of patients receiving treatment with SCS experienced relief of their pain symptoms."  However, the intention to treat (ITT) pain responder rate (using the 50% pain relief industry standard) at the end of the 6-month RCT was reported in the Medtronic sponsored study as 9/22 (41%) for daytime pain and only 8/22 (36%) for night time pain.  In the SENZA-PDN RCT, 75/104 (72%) of patients were overall pain responders. Using the same comparator, this two-fold difference leads to a number needed to treat (NNT) of 2.4 and 3.4 (day and night, respectively), for the Medtronic device as compared to only 1.5 for 10 kHz SCS;
• SENZA-PDN demonstrated average pain relief of 75% at 18 months vs. 46% at 24 months in the Slangen study;⁶  10 kHz Therapy is the only device to demonstrate improvement in neurological function, with two-thirds of 10 kHz patients reporting improvement, including restoration of sensation.  There was no evidence of neurological improvement reported in the Slangen study;
• SENZA-PDN RCT demonstrated a clinically and statistically significant improvement in Health-Related Quality of Life (HRQoL).  The Medtronic device showed no improvement in HRQoL or EQ5D measures in the Slangen study;
• In the Senza-PDN study, there were no explants due to loss of efficacy or battery depletion.  In the Slangen study, 33% of devices required replacement due to battery depletion at 5 years.  

For additional information on Nevro's HFX^TM for PDN, a Senza spinal cord stimulation system that uses 10 kHz Therapy to treat pain from diabetic neuropathy, visit https://www.hfxforpdn.com/why-hfx/overview/.

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 80,000 patients globally. Nevro's comprehensive HFX™ spinal cord stimulation (SCS) platform includes a Senza SCS system and support services for the treatment of chronic trunk and limb pain and painful diabetic neuropathy. 

Senza®, Senza II®, and Senza Omnia™ 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, HFX, HXF Coach, HFX Cloud, HFX Connect, Nevro and the Nevro logo are trademarks of Nevro Corp.

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

References

¹ Strand N, Burkey A.  Neuromodulation in the Treatment of Painful Diabetic Neuropathy: A Review of Evidence for Spinal Cord Stimulation. Journal of Diabetes Science and Technology. November 2021; https://doi.org/10.1177/19322968211060075.

² de Vos CC, Meier K, Zaalberg PB, et al. Spinal cord stimulation in patients with painful diabetic neuropathy: a multicentre randomized clinical trial. Pain. 2014 Nov;155(11):2426-31.

³ Slangen R, Schaper N, Faber C, et al. Spinal Cord Stimulation and Pain Relief in Painful Diabetic Peripheral Neuropathy: A Prospective Two-Center Randomized Controlled Trial. Diabetes Care. 2014;37:3016-3024.

⁴ Petersen E, Stauss T, Scowcroft J, et al.  Effect of High-frequency (10-kHz) Spinal Cord Stimulation in Patients With Painful Diabetic Neuropathy: A Randomized Clinical Trial. JAMA Neurol. 2021;78(6):687-698. https://doi:10.1001/jamaneurol.2021.0538.

⁵ Petersen E, Stauss T, Scowcroft J, et al.  Durability of High-Frequency 10-kHz Spinal Cord Stimulation for Patients With Painful Diabetic Neuropathy Refractory to Conventional Treatments: 12-Month Results From a Randomized Controlled Trial. Diabetes Care. 2022;45:e1–e4; https://doi.org/10.2337/dc21-1813.

⁶ van Beek M, Slangen R, Schaper N, et al.  Sustained Treatment Effect of Spinal Cord Stimulation in Painful Diabetic Peripheral Neuropathy: 24-Month Follow-up of a Prospective Two-Center Randomized Controlled Trial. Diabetes Care. 2015;38:e132–e134.

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 PDN represents a very large potential market, and having another competitor validate this large opportunity speaks to its attractiveness; our belief that neuromodulation with SCS, especially with 10 kHz SCS, offers a pathway forward for improving the lives of PDN patients; and our belief that our 10 kHz Therapy is uniquely suited to treat PDN patients.  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 Quarterly Report on Form 10-Q filed on November 8, 2021, 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 

 

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SOURCE Nevro Corp.

FAQ

What does Nevro's SENZA-PDN trial demonstrate for painful diabetic neuropathy?

The SENZA-PDN trial shows a 75% pain relief rate at 18 months, making it the first FDA-approved spinal cord stimulation system for PDN.

How does Nevro's 10 kHz Therapy compare to Medtronic's devices?

Nevro's 10 kHz Therapy offers better pain relief and higher rates of treatment success compared to Medtronic's low-frequency devices.

What concerns does Nevro have regarding Medtronic's FDA approval?

Nevro is concerned that Medtronic's FDA approval relies on older, smaller clinical studies that do not demonstrate significant advancements or results.

What support does Nevro offer to patients using its spinal cord stimulation system?

Nevro provides ongoing support through its HFX Coach program, ensuring patients receive assistance throughout their pain relief journey.