Leadership Through Innovation TM 1 Nevro Leadership Through Innovation TM Leadership Through Innovation TM LEADERSHIP THROUGH INNOVATION TM Nevro
Dec 26, 2015
Leadership Through Innovation TM 1Nevro
Leadership Through Innovation TM
Leadership Through Innovation TM
LEADERSHIP THROUGH INNOVATION TM
Nevro
Leadership Through Innovation TM 2Nevro
Leadership Through Innovation TM
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.
Leadership Through Innovation TM 3Nevro
Leadership Through Innovation TM
Company Milestones
2006
Founded at Mayo: Initial idea generation roundtable
Founded at Mayo: Initial idea generation roundtable
Validation in additional large animal model: UC Davis
Validation in additional large animal model: UC Davis
Animal work: Stanford University
Animal work: Stanford University
Early external prototype testing
Early external prototype testing
Pilot short term testing in US study
Pilot short term testing in US study
International pivotal clinical
International pivotal clinical
European launchEuropean launch
IDE initiatedIDE initiated
2007 2008 2009 2010 2011 2012
US IP issuedUS IP issued
Leadership Through Innovation TM 4Nevro
Leadership Through Innovation TM
US Senza-RCT Study Underway
Non-inferiority study on safety and efficacy
Senza compared to commercially available SCS
Negotiated with the FDA
Largest randomized SCS study ever conducted
First study to compare SCS device systems
The Senza® System is an investigational device in the U.S.
Leadership Through Innovation TM 5Nevro
Leadership Through Innovation TM
Safety and Effectiveness Endpoints
Primary
Secondary
Tertiary
Non-inferiority comparison: change in back pain VAS and neurological status from baseline
• Assessments such as
• % change in back pain, leg pain, function
• Adverse event rates
• Paresthesia perception
• Includes sleep quality, quality of life, depression level, pain med usage
The Senza® System is an investigational device in the U.S.
Leadership Through Innovation TM 6Nevro
Leadership Through Innovation TM
Pain Gaining Recognition as a Challenge
Leadership Through Innovation TM 7Nevro
Leadership Through Innovation TM
Interventional techniques (i.e. blocks)
Physical therapy &
conservative therapies
Spinesurgery
Oralopioids
Spinal cord stimulation
DrugPumps
SCSExpansion
Opportunity
Opportunity for SCS Community
Leadership Through Innovation TM 8Nevro
Leadership Through Innovation TM
Difficult Funding Environment for Innovation