ResMed Steps Up PAP Innovation With New Amalfi vs. CLA11 Sleep Apnea Study

Resmed Inc (RMD) announced an update on their ongoing clinical study.

ResMed’s new trial, “External Evaluation of PAP Systems,” aims to compare different positive airway pressure (PAP) machines, masks, and tubing used to treat obstructive sleep apnea. The study will test how well these systems work in real home use and how easy they are for patients to use, which matters for long term adherence and future product launches.

The trial tests two device setups: PAP System A with the new Amalfi platform and PAP System B with the CLA11 platform. Both are designed to deliver nightly breathing support, but the goal is to see which option delivers better comfort and usability so ResMed can refine its next wave of PAP hardware and accessories.

The study is an interventional trial that randomly assigns participants to use the systems in different orders. It uses a crossover design, so each person tries both systems at home for a week each, with single masking for participants to limit bias, and the main aim is to improve treatment tools rather than test a drug.

The trial was first submitted on 16 August 2024, marking the start of formal planning and regulatory review. The latest update was filed on 22 April 2026, signaling that ResMed is actively moving toward recruitment and product validation, though primary and final completion dates have not yet been reported.

For investors, this update points to a focused pre market push in ResMed’s core sleep apnea franchise, with Amalfi and CLA11 likely feeding into future premium devices and accessories. Positive usability and performance data could support pricing power and share gains versus Philips and other PAP players, while delays or weak results could temper sentiment around RMD’s medium term growth story.

The study remains in the not yet recruiting phase but has been recently updated, with further details available on the ClinicalTrials portal.