Clinical Development
Evidence first. Claims second.
ONYX is advancing through a deliberate, staged program of investigational studies. Every step is designed to generate evidence before any clinical role is considered.
Regulatory status
ONYX devices and software are investigational and intended for research use only. They have not been cleared or approved by the U.S. Food and Drug Administration or any other regulatory authority, and are not intended to diagnose, treat, cure, or prevent any disease.
01Investigational studies
A staged study pipeline.
- Study 01
Benchtop technical characterization
Quantify accuracy, repeatability, and range of ONYX airflow measurements under controlled conditions.
Laboratory evaluation against reference flow sources
In progress - Study 02
Usability & human factors
Assess whether participants can perform valid maneuvers with the device and companion app.
Small-cohort observational study under IRB oversight
Planned - Study 03
Comparative measurement study
Compare ONYX measurements with established clinical spirometry in the same participants.
Paired-measurement, cross-sectional design
Planned - Study 04
Longitudinal multimodal pilot
Collect consented multimodal data to support AsthmaNET research and estimate feasibility.
Prospective observational cohort
Planned
02Research objectives
What the program is designed to answer.
- O1
Establish the measurement performance of the ONYX device against recognized references.
- O2
Characterize adherence and data quality in home-use conditions.
- O3
Generate consented, de-identified datasets for multimodal research.
- O4
Define the evidence required for any future regulatory pathway.
03Development milestones
Where ONYX stands today.
- 01Verified
Concept & first prototype
Research question formed and initial device built.
- 02Verified
Connected system
Device, mobile sync, and data platform integrated.
- 03Verified
AsthmaNET architecture
Multimodal fusion framework designed and implemented.
- 04In progress
Peer-review submissions
Manuscripts in progress for IEEE JBHI, CHEST, and Nature BME.
- 05In progress
Technical characterization
Benchtop evaluation of measurement performance.
- 06Planned
IRB-approved human studies
Usability and comparative measurement studies.
- 07Planned
Regulatory strategy
Assessment of applicable regulatory pathways with expert advisors.
04Ethics & governance
Principles we do not compromise.
Participant safety
Studies are designed with ethics review and informed consent.
Data protection
Encryption, de-identification, and access controls by default.
Honest claims
We describe what has been shown — never more.
Clinical partnership
Study design developed with clinicians and researchers.
Partner on the studies that matter.
We are seeking clinical sites, principal investigators, and advisors for upcoming investigational studies.