Leadership Through Innovation Tm Nevro
Nevro: Advancing Spinal Cord Stimulation Novel Rechargeable Spinal Cord Stimulator Implantable device placed minimally invasively by Pain Specialists and Spine Surgeons Unique high-frequency waveform up to 10kHz Anatomic lead placement without paresthesia mapping The Senza® System is an investigational device in the U.S.
Company Milestones 2006 2007 2008 2009 2010 2011 2012 IDE initiated US IP issued European launch International pivotal clinical Pilot short term testing in US study Early external prototype testing Validation in additional large animal model: UC Davis Animal work: Stanford University Founded at Mayo: Initial idea generation roundtable
US Senza-RCT Study Underway Negotiated with the FDA First study to compare SCS device systems Non-inferiority study on safety and efficacy Largest randomized SCS study ever conducted Senza compared to commercially available SCS The Senza® System is an investigational device in the U.S.
Safety and Effectiveness Endpoints Primary Non-inferiority comparison: change in back pain VAS and neurological status from baseline Secondary Assessments such as % change in back pain, leg pain, function Adverse event rates Paresthesia perception Tertiary Includes sleep quality, quality of life, depression level, pain med usage The Senza® System is an investigational device in the U.S.
Pain Gaining Recognition as a Challenge
Opportunity for SCS Community Expansion Opportunity Physical therapy & conservative therapies Interventional techniques (i.e. blocks) Spine surgery Oral opioids Spinal cord stimulation Drug Pumps
Difficult Funding Environment for Innovation
Opportunity for Neuromodulation Significant opportunity for neuromodulation to improve healthcare To accomplish this, additional effort needed in: Clinical Evidence Education for HCP and Payers Patient Experience