RS01X takes the Plastiape RS01, the world's most popular single-dose dry-powder inhaler, and builds Respiro in: dose capture, inhalation profile and connectivity, without changing how it's used. If you already develop with the RS01, this is that same smart dry-powder inhaler, now connected.
RS01X keeps the proven RS01 mechanism (a passive, breath-actuated capsule inhaler) exactly as it is, and adds a sensing band that reads each dose and the inhalation behind it. The connected upgrade is invisible to the patient: same routine, data where there was none before.
Patients inhale through RS01X exactly as they would the inhaler they already know. No new technique to learn.
The proven RS01 dose mechanism: the same one Plastiape ships at commercial scale for inhaled therapies worldwide.
Captures every actuation and the inhalation profile behind it: dose and technique, not just a button-press log.
Syncs wirelessly to the Respiro app on its own: nothing to pair, nothing to charge (the battery is built in). Inhalation data is encrypted on the device.
RS01X isn't a prototype looking for a factory. It's built on the RS01 (Plastiape's capsule-based dry-powder inhaler), marketed under multiple brands by multiple pharma companies and chosen across independent inhaled-drug development programmes, so the connected device inherits manufacturing maturity and a regulatory track record that's already at commercial scale.
Breath-actuated and single-dose: just ten components, no battery and no propellant. Each pre-metered size-3 capsule is pierced and spins on inhalation to release the dose.
The RS01 platform carries a Type III DMF on file with the FDA, regulatory groundwork your own submissions can reference, on a device made at commercial scale.
Extensively characterised in peer-reviewed respiratory literature: across asthma, COPD, cystic fibrosis, bronchiectasis and pulmonary-hypertension research.
Device facts describe the RS01 platform (Plastiape). Marketed products and development programmes referenced are independent third parties using the RS01 device, not Amiko partnerships.
RS01X keeps the RS01's drug-delivery geometry exactly as characterised, building the sensing around the air path rather than into it, so airflow resistance and aerodynamic performance are unaffected. It changes what you can measure, not what the patient inhales, so your formulation behaves exactly as it always has.
Made by Plastiape in ISO 7 (Class 10,000) clean rooms.
Airflow-resistance options to match your target inspiratory profile.
Compatible with various hard-gelatin and HPMC capsule sizes.
Internal flow geometry tuned for full, consistent powder outflow.
Small, simple and cost-effective at commercial scale.
Most "connected" inhalers log that something happened. RS01X reads how it happened (the dose, the inhalation and the moment) and turns it into evidence the rest of the Respiro platform can act on.
Every actuation, time-stamped: adherence is measured, not self-reported. The foundation of a complete treatment record.
Each inhalation measured as duration, volume and peak inspiratory flow: the basis for technique scoring, and the signal that separates a real dose from a missed one.
Data flows into the Respiro app and the regulated core automatically, feeding the breathing-risk forecast, the clinician view and pharma evidence alike.
An independent clinical study put RS01X's sensing against a laboratory reference instrument. Its on-device readings of duration, volume and peak inspiratory flow agreed closely with the reference, so what RS01X reports can be trusted as data, not estimates. And the platform behind it is already in the field: Respiro has been used across clinical studies and 40+ commercial programmes.
Chamaon D, Sportel E, Elferink ECM, van der Palen J. Validation of an AI-Powered Smart Dry Powder Inhaler (RS01X) for Asthma and COPD in a Clinical Setting. Int J Chron Obstruct Pulmon Dis. 2025;20:811–819. doi:10.2147/COPD.S490684. Further RS01X analysis: Respiratory Therapy with Digital Inhalers: Insights from Multimodal Experimental and In Vitro Analysis. J Aerosol Med Pulm Drug Deliv. 2025;38(3):127–135. doi:10.1089/jamp.2024.0042. These studies validated measurement accuracy and characterised device performance; they are not a claim of treatment efficacy or individual outcomes.
RS01X is a connected inhaler, but it's never just a device. The inhaler itself is designed, engineered, manufactured and distributed by Plastiape, a global inhaler manufacturer that already ships the RS01 at commercial scale, so RS01X inherits that supply chain and quality system intact. The sensing and connectivity inside are ours, as Respiro Connect, and the data they capture is what becomes evidence for pharma partners.
RS01X is the integrated-inhaler option within Respiro Connect: the connectivity and integration layer. Prefer an add-on? The same sensing is available as a clip-on module for existing devices.
See the platform stack The evidence it powers Respiro for PharmaDevice-linked adherence and inhalation-technique data: the real-world evidence competitors can't pull from claims, supporting development, market access and outcomes-based deals.
How pharma uses Respiro For clinical trials Trial-grade dataThe RS01 is already a clinical-development workhorse. RS01X adds objective dose, technique and inhalation data: digital endpoints and eCOA-ready measures for connected, decentralised trials.
Connected inhalers for trialsWhether you embed RS01X or start with an add-on sensor, Respiro is the fastest route from a standard inhaler to device-linked, real-world evidence, at commercial scale.