ResMed Inc. (RMD.AX): Well-placed for a re-rate with levers in place; Buy

Research evidence excerpt

ResMed Inc. (RMD.AX): Well-placed for a re-rate with levers in place; Buy

Goldman Sachs ResMed Inc. (RMD.AX)

RMD’s addressable market to include patients with moderate-to-severe Restless Leg

Syndrome (RLS) through Noctrix’s Nidra product.

Background on Nidra

There is a large and growing population of patients with medication-refractory RLS who

do not respond well, develop tolerance or who experience adverse events when taking

first-line medications such as dopamine agonists & alpha-2-ligands.

Noctrix’s Nidra is a non-invasive, drug-free, reversible medical device which provides

tonic motor activation (TOMAC) therapy designed to reduce symptoms of

moderate-to-severe RLS and improve sleep quality in adults who have not found

sufficient relief with drug therapy. The Nidra TOMAC System delivers electrical

stimulation to the peroneal nerves via a pair of leg-worn devices.

In total for the pivotal trial and 24-week extension, 126 patients completed the Pivotal

trial and 103 patients in the extension trial. Patients who have medically refractory RLS

were not required to stop their medication during the trial but instead were given either

the Nidra device or a placebo device and were taught to self-administer a full 30-minute

Nidra therapy session whenever they experienced distressing RLS symptoms (at a

maximum of 4 sessions a day).

At weeks 4, 8 & 24 weeks (extension study), patients were examined using the primary

end point of a Clinical Global Impressions-Improvement (CGI-I) responder rate where

the clinician would score the patient’s improvement (or lack of) from using the device

through interview-based judgment. The pivotal clinical trial and later a 24-week

extension trial demonstrated both efficacy and safety benefits versus placebo for the

Nidra device.