Lungpacer Medical said it won an expedited access pathway designation from the FDA for the diaphragm pacing system it’s developing to treat patients who can’t be weaned from mechanical ventilation.

The Lungpacer DPS device is a neurostimulation system designed to exercise and strengthen the diaphragm via the temporary, transcatheter stimulation of the phrenic nerve.

The FDA’s EAP designation is for breakthrough therapies aimed at unmet clinical needs and seeks lower the cost and amount of time it takes to get the treatment to market.

“Our team is thrilled that the Lungpacer DPS was granted EAP status. This FDA action will enable our team to communicate more efficiently with the FDA to ensure the most rapid path to commercialization in order to help our patients. Mechanically ventilated patients can struggle with regaining the ability to breathe independently following extended illness, and we look forward to helping these individuals regain the ability to breathe independently faster,” Doug Evans, president & CEO of Burnaby, B.C.-based Lungpacer, said in prepared remarks.

A 1st-in-human feasibility trial of 24 patients treated with the Lungpacer DPS closed last month, according to ClinicalTrials.gov, with primary safety outcomes of successful insertion into the left subclavian vein and absence of device-related or procedure-related adverse events at 48 hours or time of discharge. The secondary outcome was phrenic nerve stimulation in sync with mechanical ventilation breaths.

In October 2015 Lungpacer said results from the 1st 5 patients enrolled in the trial were “encouraging” and in line with its pre-clinical data.