Artrya Limited (ASX: AYA) has secured in-principle agreement from Dignity Health Arizona to participate in the Artrya SAPPHIRE Study Expansion, subject to final documentation and ethics approval. Dignity Health operates as one of the largest nonprofit health systems in the United States, with more than 40 hospitals and 400 care centres across 21 states. The participation brings high-volume cardiovascular data to Artrya’s upcoming retrospective, multi-centre real-world study, scheduled to launch in 2026.
Dignity Health (part of CommonSpirit Health) maintains 48 dedicated physicians in their cardiovascular medical and surgical team. Their cardiovascular program has completed over 30,000 interventional cardiology procedures, 250,000 cardiac catheterisations, 120,000 open heart procedures, and 1,600 heart transplants. This scale positions the health system as a significant contributor to the SAPPHIRE Study’s statistical power and commercial credibility ahead of the company’s planned U.S. market entry.
The Artrya SAPPHIRE Study Expansion will assess the clinical and prognostic value of the Salix® Plaque Analysis platform and its proprietary Plaque Dispersion Score, aiming to identify patients at elevated risk of cardiovascular events. Access to Dignity Health’s patient data strengthens the study’s real-world evidence base, which may support future reimbursement discussions and commercial adoption across major U.S. health systems.
CEO Commentary
“We are pleased by Dignity Health Arizona’s interest in the SAPPHIRE Study. As one of the largest health systems in the United States, with operations across 21 states, their participation has the potential to significantly expand the scale and impact of the study, supported by their strong leadership in cardiovascular care and research,” said John Konstantopoulos, Co-Founder and CEO of Artrya.
Why diagnosing heart disease in women requires a different approach
Coronary artery disease remains the leading cause of death among women globally, yet conventional diagnostic methods frequently fail to identify high-risk female patients. Women often present as asymptomatic despite having coronary artery disease, whereas men typically display more recognisable symptoms such as chest pain. This diagnostic gap creates missed opportunities for early intervention and treatment.
Key diagnostic challenges for women with coronary artery disease include:
- Frequent absence of typical symptoms despite disease presence
- Conventional risk stratification methods that fail to identify high-risk women with non-obstructive coronary artery disease
- Higher rates of asymptomatic presentation compared to male patients
- Limited early intervention opportunities due to undetected disease progression
These challenges position Artrya’s focus on female cardiovascular health as addressing a significant unmet clinical need. The underdiagnosis of coronary artery disease in women represents a large underserved market segment, with potential for differentiated clinical evidence that could support regulatory pathways and commercial positioning.
SAPPHIRE-WIN targets improved outcomes for female patients
The company has launched SAPPHIRE-WIN as a dedicated female cohort within the broader SAPPHIRE Study. This women-only patient cohort will use the Salix® platform to assess a diverse range of women with non-obstructive coronary artery disease. The objective is to better predict the risk of major adverse coronary events and improve treatment outcomes for this population.
SAPPHIRE-WIN focuses specifically on women with non-obstructive coronary artery disease, a group that conventional assessment tools often overlook despite elevated cardiovascular risk. The study’s sex-specific clinical evidence may create a competitive advantage and address regulatory interest in gender-differentiated medical research, potentially opening pathways for targeted marketing authorisations and reimbursement discussions.
“We are also pleased to expand the SAPPHIRE Study to include the assessment of female patients at risk of coronary artery disease, a population that is frequently asymptomatic despite the condition remaining the leading cause of death among women. Through this expansion, we aim to enhance the understanding, diagnosis and treatment of cardiovascular disease in women using Salix® and our proprietary Plaque Dispersion Score,” Konstantopoulos added.
What SAPPHIRE Study validation could mean for Artrya’s U.S. pathway
The SAPPHIRE Study is a retrospective, multi-centre, real-world study set to launch in 2026. It will assess the clinical and prognostic value of Artrya’s Salix® Plaque Analysis and its proprietary Plaque Dispersion Score across multiple U.S. cardiology groups. Dignity Health Arizona joins other participating U.S. cardiovascular centres already committed to the study, adding scale and geographical diversity to the patient cohort.
Real-world evidence from high-volume health systems serves as a critical component of U.S. commercial adoption strategies. Payers and health systems increasingly require clinical validation beyond regulatory approval before implementing new diagnostic technologies. The SAPPHIRE Study’s multi-centre design positions Artrya to generate this evidence across diverse patient populations and clinical settings.
| Cardiovascular Metric | Volume |
|---|---|
| Interventional cardiology procedures | 30,000+ |
| Cardiac catheterisations | 250,000+ |
| Open heart procedures | 120,000+ |
| Heart transplants | 1,600+ |
Dignity Health’s participation remains subject to final documentation and ethics committee approval. The health system’s in-principle agreement represents a strategic validation point for Artrya’s technology from a major U.S. cardiovascular care provider. This positions the company for commercial conversations with health systems and potential reimbursement pathway development following study completion.
Strategic milestones on the horizon
Key upcoming milestones for the Artrya SAPPHIRE Study Expansion include:
- Finalisation of documentation and ethics approval with Dignity Health Arizona
- SAPPHIRE Study launch targeted for 2026
- SAPPHIRE-WIN female cohort patient enrolment and data collection
- Real-world evidence generation across multiple U.S. cardiology centres
- Publication of study results to support commercial and regulatory activities
The 2026 launch timeline positions the SAPPHIRE Study as a near-term catalyst for investors monitoring Artrya’s U.S. market entry strategy. The combination of a major health system partner and dedicated female cohort study creates multiple validation pathways for the Salix® platform across different patient populations and clinical scenarios.
Artrya’s broader regulatory and commercial activities continue across international markets, with the SAPPHIRE Study representing a strategic component of the company’s U.S. commercialisation pathway. The study’s retrospective design allows for efficient data collection from existing patient records, potentially accelerating the timeline for evidence generation compared to prospective trial designs.
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