The Journey to Commercial Coverage

This episode explored the long and strategic journey to achieving commercial coverage for ReActiv8 therapy, a restorative neurostimulation treatment for mechanical chronic low back pain. Our guests Mainstay Medical CEO, Jason Hannon discussed the origins of the therapy, the challenges of navigating the U.S. payer landscape, and the 15+ year investment in clinical research, culminating in the pivotal RESTORE trial. Dr. Kiran Patel offered insight into the RESTORE trial's compelling design, outcomes, and long-term durability, which played a critical role in convincing Anthem to become the first national payer to provide coverage. Together, the guests reflect on lessons learned, the significance of the Anthem decision as a market precedent, and offer forward-looking strategies for expanding access and adoption of innovative therapies. Host, Patrick Buchanan, MD: Dr. Buchanan is double board certified in Physical Medicine and Rehabilitation and Pain Medicine. His goal is to help his patients get their life back by managing their pain and focus on things they love and enjoy. https://www.californiapaindoctors.com/patrick-buchanan-m-d/ https://www.instagram.com/patdbmd/?hl=en Host, Timothy Deer, MD: Dr. Deer is the president and CEO of the Spine and Nerve Centers of the Virginias. Dr. Deer has led a revolution in interventional spine and nerve care by teaching thousands of physicians an algorithmic approach to care including methods that are less invasive at a lower risk for complications. https://centerforpainrelief.com/about/tim-deer-md/ https://twitter.com/doctdeer?lang=en https://www.instagram.com/timdeer30a/?hl=en Guest, Jason Hannon: Jason joined Mainstay Medical as Chief Executive Officer in October 2017. He has extensive experience in the medical devices industry, particularly in the areas most critical to the future success of Mainstay: commercialization of new products, penetration of new markets, product innovation, strategic and financial planning, raising capital, regulatory and clinical management, and the building of a high-performance culture. https://www.linkedin.com/in/jason-hannon-a4072891/ Guest, Dr. Kiran Patel, MD: Dr. Patel  is board certified in pain management and anesthesiology. She completed both her Interventional Pain Medicine fellowship and Anesthesiology residency at the prestigious Columbia University Medical Center-New York Presbyterian Hospital. Dr. Patel is the Director of Neurosurgical Pain at Lenox Hill Hospital and the Pain Medicine Fellowship Program Director at the Hofstra Northwell School of Medicine. She is currently in private practice at the Spine & Pain Institute of New York. https://www.linkedin.com/in/kiran-v-patel-md/ About ASPN: ASPN was created to bring the top minds in the fields of pain and neuroscience together. ASPN has a mission to improve education, highlight scientific curiosity, establish best practice, and elevate each other in a quest to improve the field of pain and neuroscience. All initiatives of ASPN are dedicated to improving patient outcomes, education, research, and innovation. ASPN's website and social links: https://aspnpain.com https://www.youtube.com/channel/UCixMNhEtOiRm1aQmDWtzxmg https://www.instagram.com/aspn_painneuro/ https://www.facebook.com/PainNeuro https://www.linkedin.com/in/aspn/ https://twitter.com/aspn_painneuro Our sponsors: Saluda Medical: Saluda is the first to directly measure the spinal cord's physiologic response to stimulation. A 10+ year journey since the first ECAP measurement to transform the science and practice of SCS using Evoked Compound Action Potentials (ECAPs) to pioneer smart neuromodulation therapy. The Evoke® System listens and responds to each patient's neural signature.  https://www.saludamedical.com/ Spinal Simplicity: Spinal Simplicity is a medical device company dedicated to creating simple, innovative procedure solutions for our physician partners to help improve their patient's pain and quality of life. A life where pain no longer defines the day. That's the future we fight for. Chronic pain steals independence, freedom, and joy. At Spinal Simplicity, we believe patients deserve more—lasting relief, restored mobility, and renewed hope. https://spinalsimplicity.com/ Mainstay Medical: Mainstay Medical is a global medical device company offering a new therapeutic solution for people suffering from mechanical chronic low back pain (CLBP). ReActiv8 is a restorative therapy designed to address impaired neuromuscular control and multifidus dysfunction linked to CLBP. We aim to transform lives everyday by improving function and alleviating pain. https://mainstaymedical.com/ SPR: SPR is advancing pain management with the SPR® SPRINT® PNS System — a non-opioid, non-surgical, minimally invasive First-Line PNS™ treatment designed to provide significant and sustained relief. Backed by the largest body of clinical evidence in PNS, SPRINT PNS offers a clinically proven, patient-centric and non-surgical alternative to more invasive options. https://www.sprpainrelief.com/