Mainstay Medical Holdings, a Dublin, Ireland-based medical device company focused on commercializing an innovative implantable restorative neurostimulation system for people with disabling mechanical Chronic Low Back Pain, closed an equity financing of US$108m.
The round was co-led by new investors Ally Bridge Group and Sofinnova Partners, through its Crossover Fund, and also included a large, global medical device company. Key existing investors participating include Sofinnova Partners (Capital Fund), KCK Group and Fountain Healthcare Partners. In conjunction with the funding, Charles Chon, Partner and Managing Director at Ally Bridge Group, and Cédric Moreau, Partner at Sofinnova Partners, joined the Mainstay Medical Board of Directors.
The company intends to use the funds for the commercial launch of ReActiv8® in the U.S., continued expansion in Europe and Australia, additional post-market clinical studies and research, and general operations.
Led by Jason Hannon, CEO, Mainstay is a medical device company focused on commercializing an innovative implantable restorative neurostimulation system, ReActiv8®, for people with disabling mechanical Chronic Low Back Pain (“CLBP”).
ReActiv8 is an active implantable medical device designed to treat adults with intractable chronic low back pain associated with dysfunction of the lumbar multifidus muscle, a key stabilizing muscle of the low back, as evidenced by imaging or physiological testing in adults who have failed therapy, including pain medications and physical therapy, and are not candidates for spine surgery. ReActiv8 provides bilateral electrical stimulation of the L2 medial branch of the dorsal ramus nerve as it crosses the transverse process at L3. This nerve supplies the multifidus muscle to elicit contraction of the muscle which can lead to restoration of control over time, allowing the back to recover from CLBP.
ReActiv8 has a CE Mark allowing for commercialization in the European Economic Area and has been focused on building clinical validation in Germany in select centers ahead of wider commercial availability. ReActiv8 has also been admitted to the Australian Register of Therapeutic Goods (ARTG), enabling commercialization throughout Australia, and has been approved for inclusion on the Protheses List of reimbursed products in Australia, effective as of 1 July 2020. The Prostheses List identifies implantable devices eligible for reimbursement from all private health insurance funds in Australia. In the U.S., ReActiv8 is FDA approved and the company plans to commercially launch in early 2021.
The company also has subsidiaries operating in the United States, Australia, Germany and the Netherlands.