Medical device company Mainstay Medical Holdings has secured $108m in equity financing for its ReActiv8 implantable restorative neurostimulation system.

Ally Bridge Group and Sofinnova Partners, which are the new investors, co-led the financing round and participated by existing investors, including Sofinnova Partners (Capital Fund), KCK Group and Fountain Healthcare Partners. Also, a major global medical device company has participated in the funding round.

The company will use the funding for the commercial launch of ReActiv8 in the US and support its expansion in Europe and Australia.

The funding will also help the company to conduct additional post-market clinical studies and research, as well as manage general operations.

ReActiv8 is an active implantable medical device developed for the treatment of adults with intractable chronic low back pain (CLBP) associated with dysfunction of the lumbar multifidus muscle.

The device delivers bilateral electrical stimulation to the L2 medial branch of the dorsal ramus nerve when it crosses the transverse process at L3.

The ramus nerve is said to supply the multifidus muscle to evoke contraction of the muscle which may help restore control over time and recover from CLBP.

Mainstay Medical already secured CE mark for the ReActiv8 device to commercialise in the European Economic Area. It is also focusing on building clinical validation in select centres of Germany before its wider commercial availability.

In June last year, the company also secured approval from the US Food and Drug Administration (FDA) for the ReActiv8 device.

Mainstay CEO Jason Hannon said: “A financing of this magnitude, supported by such a quality global investor group, is testament to the confidence in the commercial opportunity for ReActiv8.

“We are now strongly capitalised to execute on our corporate objectives in 2021 and beyond, including the launch of ReActiv8 in the U.S. market and acceleration of our commercialisation efforts in Europe and Australia.”