Fresh off earning an updated FDA clearance for its flagship neuromodulation device, Mainstay Medical has closed an equity financing round to help expand the device’s global presence.
The Irish company took in a total of $125 million from the round, which CEO Jason Hannon said in a release this week will go toward “continuing our rapid commercial growth and building on our insurance coverage” of the ReActiv8 implant in the U.S., Europe and Australia.
In addition, Hannon said in the announcement, the money will help support “the generation of additional clinical and health economic data to further demonstrate that ReActiv8’s purpose-built, restorative approach to the treatment of mechanical chronic low back pain is superior to competitive therapies originally designed for other indications, as well as the continued development and enforcement of our dominant intellectual property portfolio.”
Gilde Healthcare and Viking Global Investors, both new investors in the company, led the financing, and Gilde sent partner Geoff Pardo to join Mainstay’s board of directors. Several existing backers also chipped in, including Ally Bridge Group, Sofinnova Partners’ Crossover Fund, Fountain Healthcare Partners and Perceptive Advisors.
The ReActiv8 technology is specifically indicated to treat intractable chronic low back pain associated with multifidus muscle dysfunction, an often-overlooked cause of back pain that may not be effectively treated with medications or physical therapy.
The device is implanted under the skin of the lower back, from which it can send out electrical stimulation to the nerves of the multifidus muscle via a pair of leads, with an aim of disrupting the pain signals that travel along those nerves. The system is designed to be used in 30-minute therapy sessions twice a day which the company describes as feeling “like a deep tissue massage.”
According to Mainstay, after three years, more than 77% of participants in a clinical trial reported at least a 50% reduction in their pain on the visual analog scale—with two-thirds achieving resolution of their chronic low back pain, per VAS ratings—while 63% experienced at least a 20-point improvement on the 100-point Oswestry Disability Index. Additionally, more than 70% of participants were able to voluntarily reduce or completely stop using opioids for pain management while undergoing treatment with the ReActiv8 system.
Mainstay’s technology earned CE mark clearance in Europe in 2016, followed by an Australian green light in 2019 and FDA approval in 2020—which paved the way for the device to begin rolling out in the U.S. in 2021.
Earlier this year, the company tacked on another stateside nod, as the FDA signed off on an expanded label allowing people implanted with the ReActiv8 device to undergo 1.5T full-body MRI scans.