RS01X takes the Plastiape RS01 capsule dry-powder inhaler and builds Respiro in: time-stamped inhaler use, inhalation profiles and wireless connectivity in a familiar format. The RS01 you know, now with Respiro inside.
RS01X combines the RS01 capsule inhaler with an integrated sensing module. It records when the inhaler is used and the inhalation behind it, bringing everyday use into view.
Designed around the familiar RS01 inhalation routine, with connected sensing built into the device.
The RS01 capsule mechanism, made by Plastiape for inhaled therapies.
Records inhaler use and the inhalation profile behind it: duration, volume and peak inspiratory flow.
Connects wirelessly to the Respiro app and platform, bringing recorded use and inhalation profiles into one place.
RS01X builds on Plastiape's established RS01 capsule-inhaler platform, used across marketed therapies and drug-development programmes. It brings connected sensing to a familiar device, backed by the RS01's manufacturing heritage.
The RS01 drug-delivery mechanism is passive and breath-actuated, with no propellant. A pierced, pre-metered capsule spins on inhalation to release the powder.
The RS01 platform holds a Certificate of Compliance with the Medical Device Regulation (EU) 2017/745 and a Type III DMF on file with the FDA. These are RS01-platform references for a device already in volume production.
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.
Connected sensing builds on the RS01's capsule-based design and resistance options. Device and formulation testing establishes performance for each programme.
Made by Plastiape in ISO 7 (Class 10,000) clean rooms.
Airflow-resistance options to optimise the device–formulation fit for your target patient population.
Compatible with various hard-gelatin and HPMC capsule sizes.
Internal flow geometry tuned for full, consistent powder outflow.
Small, simple and cost-effective at volume.
RS01X records when the inhaler is used and how the inhalation unfolds. Duration, volume and peak inspiratory flow add technique information to the treatment record.
Time-stamped inhaler use is recorded automatically, giving patients and study teams a treatment history without manual entries.
Duration, volume and peak inspiratory flow show how the inhaler was used. These three measurements were evaluated in the published RS01X validation study.
Data flows into the Respiro app and core automatically, feeding the patient app, Respiro Hub and pharma evidence.
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. The platform behind it is already in the field: Respiro has been used across 40+ research and 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 is never just a device. Plastiape engineers, manufactures and distributes the RS01 at commercial scale; the sensing and connectivity inside are ours as Respiro Connect, and the data they capture becomes evidence for pharma partners.
RS01X is the integrated-inhaler option within Respiro Connect: the connectivity and integration layer. Add-on sensors bring Respiro sensing to compatible existing inhalers.
See the platform stack The evidence it powers Respiro for PharmaEmbedded sensing provides device-linked data on inhaler use and technique for development, market access and outcomes-based programmes.
How pharma uses Respiro For clinical trials Objective data for clinical trialsTime-stamped inhaler use and technique measurements complement eCOA and ePRO, connecting patient-reported experience with device data between study visits.
Connected inhalers for trialsIf your programme already runs on the RS01, bring connected sensing and device-linked, real-world evidence into it with RS01X.