Nevro Receives FDA 510(k) Clearance to Use SI Fixation System Without Need to Include Lateral Screw

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Feb 28, 2024, 16:10 ET

Nevro1™ Proven to Immediately Transfix Sacroiliac (SI) Joint to Allow for Long-term SI Joint Fusion

REDWOOD CITY, Calif., Feb. 28, 2024 /PRNewswire/ -- Nevro Corp. (NYSE: NVRO), a global medical device company delivering comprehensive, life-changing solutions for the treatment of chronic pain, today announced that the U.S. Food and Drug Administration (FDA) cleared its sacroiliac joint fusion device, which will be marketed as Nevro1, without the need to include the screw ("NevroFix™").

Nevro1, an integrated transfixing technology, is proven to immediately transfix the SI joint to allow the opportunity for long-term fusion. Self-contained, deployable titanium anchors transfix the sacrum and ilium to enhance axial and rotational stability of the joint. In addition, Nevro's proprietary instrumentation allows for optimal intra-articular SI joint preparation which is critical to achieve joint fusion. Nevro1 comes with 3D-printed, bone-growth enhancing technology which helps promote bone cell growth and, as a result, fusion.

"Nevro1 as a standalone device represents the most significant advancement in SI fusion in years. In my experience, it is the safest and most efficient and effective true fusion implant available," said Gregory Bailey, M.D., an orthopedic surgeon in State College, Pennsylvania.

"Nevro1 will be our flagship SI joint fusion product as there is no other device like it on the market," said Kevin Thornal, Nevro's CEO and president. "We now offer one of the most comprehensive portfolios of products in the SI joint space, and we can meet the preferences of different physicians and varying patient needs – ultimately helping to improve health outcomes and quality of life for patients."

This is the first regulatory clearance since Nevro acquired Vyrsa™ Technologies, with its suite of innovative products that provide minimally invasive treatment options for patients suffering from chronic SI joint pain, in November 2023. The company noted that the clearance was originally received by Camber Spine and will be transferred to Nevro for marketing and distribution.

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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 the Senza® SCS system and support services for the treatment of chronic pain of the trunk and limb and painful diabetic neuropathy.

Nevro recently added a minimally invasive treatment option for patients suffering from chronic sacroiliac joint ("SI joint") pain and now provides the most comprehensive portfolio of products in the SI joint fusion space, designed to meet the preferences of physicians and varying patient needs in order to improve outcomes and quality of life for patients.

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 HFX Coach™ support throughout their pain relief journey and every physician with HFX Cloud™ insights for enhanced patient and practice management.

Senza, Senza II, Senza Omnia , Omnia, 10 kHz Therapy, HFX, HFX iQ, HFX Coach, HFX Cloud, NevroFix, NevroPro, Nevro1, 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.

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Investors and Media:

Angie McCabe
Vice President, Investor Relations & Corporate Communications
[email protected]

SOURCE Nevro Corp.