Mainstay Medical sees drop in full-year operating expenses

Dublin-listed Mainstay Medical, which is targeting chronic lower back pain with an implantable device, has drawn down €10.5 million of the €15.5 million debt facility it agreed last year as it proceeds with plans to bring ReActive8 to market.

ReActiv8 is an implantable neurostimulation system developed by the company which is currently undergoing trials.

The early stage medical devices firm said in a statement that it is now preparing a b-trial for ReActiv8. It estimated that full-enrollment in the trial would take 12 to 18 months from enrolment with initial results expects some six months after this.

“We plan to ramp up enrolment in the ReActiv8-B Trial once we determine that we have sufficient financial resources to complete the Trial through data availability. A small number of subjects may be enrolled in the ReActiv8-B Trial prior to securing such financial resources,” it said.

The company said the last tranche of the debt facility, which is being provided by IPF Partners can be drawn down at its discretion up to the end of July following approval of ReActiv8 by CE Marking. Maintstay submitted an application for approval last November.

“While we await CE Marking approval for ReActiv8, we are preparing for commercialisation in Europe,” the group said.

Mainstay said operating expenses for last year fell by $2.3 million versus 2014 to $12.9 million due to one-off costs associated with its initial public offering (IPO). The company floated in Paris and Dublin in April 2014 In an IPO that valued the group at €90 million.

The company said cash on hand at the end of December was $16.6 million and operating cash outflows for 2015 were $11.6 million.

Mainstay, which is headquartered in Dublin with subsidiaries operating in Ireland, the USand Australia, also announced the issuance of two new US patents, bringing the total number in the Mainstay portfolio to seven.