Nevro Corp. (NYSE: NVRO), a global medical device company that is providing innovative evidence-based solutions for the treatment of chronic pain, today announced that the first commercial case has been performed in the United States under the company's May 8th, 2015 FDA approval for commercial use of the Senza® spinal cord stimulation (SCS) system, which delivers Nevro's proprietary HF10™ therapy.
"This is an exciting day for chronic pain patients and the physicians who treat them in the U.S. as they now have access to a significant advance in chronic pain management. HF10 therapy will broaden my pain practice as its superior results will allow me to treat more patients effectively. Additionally, the elimination of paresthesia is meaningful for patient quality of life as well as predictability of the operating procedure. I am excited to bring these advances to my patients," said Dr. Leonardo Kapural, lead investigator for the SENZA-RCT pivotal study from Wake Forest University Baptist Medical Center.
The Senza system delivering HF10 therapy has experienced strong adoption in Europe and Australia over the past 5 years. With this FDA approval, patients in the U.S. suffering from chronic pain will have the opportunity to experience the superior benefits of HF10 therapy. Nevro's Senza system is the only SCS therapy approved by FDA with superiority labeling, as demonstrated in the largest prospective randomized SCS study ever conducted to assess the treatment of chronic back and leg pain. The Senza system is also the only SCS therapy indicated by FDA to deliver pain relief without paresthesia (a stimulation-induced sensation, such as tingling, burning, or pricking, which is the basis of traditional SCS), and to be approved by FDA to be used without patient restrictions on motor vehicle operation while receiving therapy. Finally, the Senza system is the only implantable SCS system approved by FDA with labeling for 3T conditional MRI compatibility.
"We are pleased we are able to initiate the commercialization of HF10 therapy so quickly after FDA approval and to broaden access to U.S. patients in need of an effective chronic pain treatment," said Michael DeMane, Chairman and Chief Executive Officer of Nevro. "The Nevro team looks forward to launching the Senza system in the U.S. with a deliberate and responsible commercial rollout."
About the Senza System and HF10 Therapy
The Senza system is the only SCS system that delivers Nevro's proprietary HF10 therapy, an SCS therapy that provides electrical pulses to the spinal cord to alleviate pain. The electrical pulses are delivered by small electrodes on leads that are placed near the spinal cord and are connected to a compact, battery-powered generator implanted under the skin. HF10 therapy is the only SCS therapy indicated to provide pain relief without paresthesia (a stimulation-induced sensation, such as tingling, burning, or pricking, which is the basis of traditional SCS) and is also the first SCS therapy to demonstrate superiority to traditional SCS for back and leg pain in a comparative pivotal study. Nevro's innovations in SCS, including the Senza® system and HF10™ therapy, are covered by more than 75 issued U.S. and international patents.
Headquartered in Menlo Park, California, Nevro is a global medical device company focused on providing innovative products that improve the quality of life of patients suffering from debilitating chronic pain. Nevro has developed and commercialized the Senza spinal cord stimulation (SCS) system, an evidence-based neuromodulation platform for the treatment of chronic pain. The Senza system is the only SCS system that delivers Nevro's proprietary HF10 therapy. Senza, HF10, Nevro and the Nevro logo are trademarks of Nevro.
In addition to historical information, this press release may contain forward-looking statements with respect to our business, capital resources, strategic initiatives and growth reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including with respect to our beliefs and expectations regarding the opportunity for U.S. patients to experience significant benefits from HF10 therapy, the effects of HF10 therapy on current pain management practices, and our initiation of a responsible rollout of HF10 therapy in the U.S. 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; the timing of our U.S. commercial launch of Senza; 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; 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 with the SEC on March 18, 2015 and our Quarterly Report on Form 10-Q filed with the SEC on May 11, 2015, as well as any reports that we may file with the SEC 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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