Patents Offer Additional International Protection for Proprietary, HF10(TM) Spinal Cord Stimulation Therapy
Nevro Corp., a medical device company that has developed and commercialized an innovative, evidence based neuromodulation platform for the treatment of chronic pain, is pleased to announce the issuance of European and Australian patents related to the company’s Senza(R) spinal cord stimulation system and HF10(TM) therapy.
European Patent No. EP 2630984 B1, titled Multi-Frequency Neural Treatments and Associated Systems, and Australian Patent No. AU 2013263724 B2, titled Selective High Frequency Spinal Cord Modulation for Inhibiting Pain with Reduced Side Effects and Associated Systems and Methods, pertain to systems for treating chronic pain by applying Nevro’s proprietary HF10 therapy to a patient’s spinal region. Further patent applications covering other aspects of Nevro’s proprietary technology are pending in Europe and Australia.
Nevro’s Senza system is currently available for sale in Europe and Australia, and is supported by a European clinical study recently published in the journal Pain Medicine. The clinical study evaluated the long term safety and efficacy of Nevro’s HF10 therapy in patients with difficult-to-treat chronic, retractable back and leg pain. The two-year follow up of the open label, prospective study was conducted at two sites in Belgium and the United Kingdom. 82 chronic pain patients completed the therapy evaluation phase, or trial phase, for HF10 therapy and 72 were permanently implanted as a result of successful evaluation phase. 65 of these patients were followed to two years. Key results at two year follow-up included a reduction of the mean baseline back pain score from 8.4 out of 10.0 to 3.3 (P < 0.001) and a reduction of leg pain score from 5.4 out of 10.0 to 2.3 (P < 0.001). Furthermore, the mean dosage of oral morphine equivalents per patient decreased from 84 mg/day to 27 mg/day (P < 0.001) and disability and sleep disturbances were also significantly reduced. The results were achieved while demonstrating a safety profile for HF10 therapy that was comparable to traditional spinal cord stimulation (SCS) in terms of type and rates of complications.
“We are encouraged by the clinical results and patient outcomes achieved by HF10 therapy, and we are pleased to announce the addition of these patents to our growing intellectual property portfolio,” said Nevro’s CEO Michael DeMane.
About the Senza system and HF10 therapy
The Senza system is the only SCS system that delivers Nevro’s proprietary HF10 therapy, an advanced SCS therapy that provides electrical pulses to the spinal cord at a rate up to 10,000 per second (10 kHz), as compared to traditional SCS, which utilizes low frequency stimulation, typically between 40 Hz and 60 Hz. HF10 therapy also differs from traditional SCS in that it provides back and leg pain relief without paresthesia, a constant tingling sensation that is the basis of traditional SCS therapy. 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. The Senza system utilizes a rechargeable battery and has at least 10 year battery life as indicated in its CE label.
In the United States, the Senza system is limited by federal law to investigational use only, and is presently the subject of the SENZA-RCT pivotal study, a prospective randomized controlled pivotal study.
About Nevro Corp.
Headquartered in Menlo Park, Calif., privately held Nevro Corp. is a medical device company that has developed an innovative, evidence based neuromodulation platform for the treatment of chronic pain. Nevro’s investors include Johnson & Johnson Development Corporation, NEA, Bay City Capital, Three Arch Partners, Novo, Aberdare Ventures, MPM Capital, Covidien and Accuitive Medical Ventures. For more information visit http://www.nevro.com.