Shots: 

• Mainstay Medical recently raised $125M in the company’s largest funding round. The financing is intended to accelerate the commercial growth of the company’s ReActiv8, a restorative Neurostimulation therapy in the US, Europe, and Australia 

• Today, at PharmaShots, we had Jason Hannon, CEO of Mainstay Medical, who talked in great length about the ReActiv8 Restorative Neuromodulation System developed for the treatment of Chronic Low Back Pain (CLBP) associated with Multifidus Muscle Dysfunction 

• Jason says, Mainstay currently focuses on ReActiv8 and continues following ReActiv8-B patients 

Saurabh: Our audiences would like to know more about the funding raised by the company in equity financing. Can you walk us through this? 

Jason: We recently announced our largest financing round, raising $125 million in gross proceeds. The funding will be allocated towards accelerating the commercial growth of our ReActiv8 Restorative Neurostimulation therapy in key markets, such as the U.S., Europe, and Australia, as well as supporting additional clinical studies, research activities, and general operations. We were excited to have the two prominent funds, Gilde Healthcare and Viking Global Investors, participate alongside our previous existing investors. This infusion of capital will enable Mainstay to further advance its mission of revolutionizing the treatment of mechanical low back pain and further establish the superiority of ReActiv8 therapy.  

Saurabh: Can you shed some light onto the company’s ReActive8 Restorative Neuromodulation System developed for the treatment of Chronic Low Back Pain (CLBP) associated with Multifidus Muscle Dysfunction? 

Jason: Multifidus muscle dysfunction occurs when the multifidus muscles located along the spine become impaired due to injuries, degenerative conditions, or habits resulting in mechanical lower back pain. These muscles are crucial for spinal stability, alignment and overall quality of life. ReActiv8 is a restorative therapy that stimulates the nerves of the muscle directly responsible for stabilizing your lumbar spine. Patients conduct their own at-home therapy twice daily for 30 minutes per session. On average, people with CLBP who were treated with ReActiv8 Restorative Neurostimulation therapy had substantial reductions in pain, and improvements in disability and quality of life after one year.  

Saurabh: As you mentioned, the funds will be used by the company to help ReActiv8 expand commercially. How does the company intend to approach the commercialization of ReActiv8? 

Jason: We will continue to work with our physician customers in each of our target markets to select appropriate patients that will result in positive outcomes. We will also increase the numbers of physician customers by sharing our positive results. In the U.S. specifically, we expect our growing body of clinical and other evidence to compel payers to cover ReActiv8. 

Saurabh: With the funds raised, what post-market clinical studies and research operations does the company plan to pursue next? 

Jason: We will continue following ReActiv8-B patients, our RESTORE results comparing ReActiv8 to standard of care will be published in the second half of this year, and we continue to generate and publish data in real-world settings and related to the health economic benefits of the therapy. 

Saurabh: How does ReActiv8 fulfill the limitation of treatment options available for CLBP and how does it stand out from the conventional treatment options available? 

Jason: ReActiv8 offers restorative neurostimulation, as demonstrated in our recent Economic Impact study. Unlike traditional approaches (spinal surgeries, medications, PT), ReActiv8’s electrical stimulation to the medial branches of the spinal nerves overrides the major drivers of CLBP, including high-impact pain that significantly restricts daily activities and leads to substantial healthcare costs. The therapy not only clinically treats CLBP, but also has a positive economic impact by reducing healthcare utilization and costs, thereby fulfilling a critical need for effective and cost-efficient long-term management of CLBP. 

Saurabh: What are your plans to further enhance the treatment of mechanical low back pain with ReActiv8 Restorative Neurostimulation? Are there any other medical devices lined under your pipeline targeting the same therapy area? 

Jason: Our full focus is currently on ReActiv8. We will continue following ReActiv8-B patients, our RESTORE results comparing ReActiv8 to standard of care will be published in the second half of this year, and we continue to generate and publish data in real-world settings and related to the health economic benefits of the therapy. 

Image Source: Canva 

About the Author: 

Jason Hannon 

Jason Hannon joined Mainstay Medical, a global medical device company that developed and is commercializing ReActiv8, a restorative therapy for chronic low back pain, as Chief Executive Officer in October 2017. Mr. Hannon has extensive experience in the medical devices industry, including in the 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. He previously served as President and Chief Operating Officer of NuVasive (NASDAQ:NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions. Mr. Hannon helped grow NuVasive from a small U.S.-centric business with a handful of products into the third largest spine company in the world. During his 12 years at the company, and prior to becoming COO, Mr. Hannon led the international business, was responsible for business development and strategy, and also served as general counsel. During his tenure, the company’s commercial presence was expanded globally to more than 40 countries, revenue grew from $61M to almost $1 billion, and the product portfolio expanded to over 100 products. 

Mr. Hannon has a JD degree from Stanford University Law School and a BA degree from the University of California, Berkeley. 

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