New Data, iCARE Study: Hailie® Smartinhaler® Powers Unprecedented Medication Adherence in Patients with COPD and Asthma

Highlights:

• Up to 235% increase in real-world adherence compared to published norms (20–40%), across ~850 chronic obstructive pulmonary disease (COPD) and asthma patients.
• >60% patients achieved an average two-week baseline adherence with ~4 in 10 patients reaching the critical threshold of >80% adherence, a level associated with 50% fewer exacerbations and lower hospitalisations.
• Sustained engagement of 12+ months with 54% persistence even in high-risk, elderly patients, far above typical digital health benchmarks (30–45%).
• Clinically meaningful reductions in admissions, readmissions, and overall care costs, directly aligned with payer and health system value-based care priorities.
• Clear multi-billion-dollar commercial opportunity, positioning Adherium's Hailie® Smartinhaler® as a scalable, defensible platform for U.S. and global expansion.

MELBOURNE, Australia, Sept. 15, 2025 /PRNewswire/ -- Adherium Limited (ASX: ADR), a global leader in connected respiratory health solutions, has today announced preliminary results from the groundbreaking iCARE study, a real-world study conducted in partnership Intermountain Health, a leading nonprofit US health provider, and CareCentra, an AI-driven prevention-as-a-service remote monitoring platform.

The iCARE study ('the Study') has resulted in significant positive clinical outcomes, including record adherence rates and consistent patient engagement for patients with COPD and asthma. The Study included the supply of 4,000 Halie® Smartinhalers®, supporting up to 2,500 COPD and asthma patients across five Intermountain Health facilities over two years.

Adherium Chief Executive Officer, Dawn Bitz, said: "By generating actionable patient data, including biometrics from Adherium's Smartinhaler technology, the iCARE study demonstrates breakthrough adherence, unprecedented patient persistence, reduced hospitalisations, and significant potential cost savings. This data lays strong foundations for a scalable, value-based care model with global commercial relevance. We are now on track to close one of the largest historical gaps in respiratory management, unlocking value for patients, providers, payers, and investors alike."

Analysis of the ~850 Intermountain Health patients enrolled in the Study revealed compelling clinical results. Adherence was evaluated in a subset of patients with connected controller inhalers and at least 30 days of inhalation data. Across this group, patients used their inhalers on average nearly two-thirds of the time, far higher than the roughly one-in-five times typically reported in these populations, marking one of the strongest independent, real-world adherence outcomes recorded in chronic respiratory care. Average two-week baseline adherence was 62%, with ~4 in 10 patients reaching the critical threshold of greater than 80% adherence, a level long associated with nearly 50% fewer respiratory attacks.

Separately, analysis of nearly 700 patients demonstrated clinically meaningful improvements across multiple dimensions of respiratory care including reductions in inpatient admissions, 30-day readmissions, average length of stay and lower reliance on rescue medications; resulting in decreases in overall cost of care.

The iCARE study also demonstrated strong persistence ("stickiness") of the CareCentra remote monitoring platform, with more than half active users staying engaged for over a year, far outpacing expectations typically reported in behaviour -change program. Engagement was the highest in elderly, high-risk patients, including those with depression, proving that technology-enabled support can make a lasting difference even for the hardest to reach patients, and those least likely to adopt or sustain digital health interventions. These patients also represent the highest-cost segment of the healthcare system, requiring the most hospitalisations and readmissions. 

Adherium Chief Executive Officer, Dawn Bitz, said: "These interim results prove that digital health can deliver both measurable patient impact and health system value at scale. By combining innovative connected inhaler technology with CareCentra's AI-driven behavioural engagement, we are not only improving adherence but also validating a sustainable, value-based care model.

"At the same time, outpatient encounters are increasing, reflecting earlier, proactive interventions that prevent costly crisis-level exacerbations. Together, these shifts demonstrate iCARE's potential to fundamentally bend the cost curve in respiratory disease management—an outcome highly aligned with payer priorities in both U.S. and Australian markets."

Intermountain Health Research Director for Respiratory Care Clinical Services, Kim Bennion, said: "For patients living with chronic respiratory disease, what happens between clinic visits often determines whether their condition stabilises or escalates. Through the iCARE program with continuous respiratory monitoring and nudging technology, we are giving our patients the tools and support to stay on therapy, avoid hospitalisations, and maintain a higher quality of life. These early results affirm the power of technology-enabled care to extend our reach beyond the hospital and clinic walls."

The Study also presents opportunities for deeper analysis by condition type (COPD vs. asthma), patient severity (e.g., prior hospitalisations, GINA or GOLD classifications), environmental and weather-related factors, and socioeconomic influences on participation and outcomes, said Bennion.

A statistically more comprehensive dataset with detailed breakdowns will be released later but these results already serve as a leading indicator of iCARE's ability to sustain engagement over time, and to deliver enduring value for patients, payers, and health systems.

Commerical Significance

• Adherium considers these preliminary results to be material under Listing Rule 3.1 because they demonstrate the scalability of the Hailie® platform in a leading U.S. health system, providing clinical validation that supports commercial expansion opportunities and payer engagement.
• These results are preliminary in nature and further data and analysis will be required before final conclusions can be drawn. Accordingly, while the findings are encouraging, they should not be taken as guarantees of future outcomes.
• Whilst the Study is currently being delivered in a research framework, these positive results position Adherium for new contracts, expanded sales and reimbursement.
• The iCARE study is the largest real-world respiratory monitoring care program for chronic obstructive pulmonary disease (COPD) and asthma patients. The Study included the supply of 4,000 Hailie® sensors, supporting up to 2,500 chronic obstructive pulmonary disease (COPD) and asthma patients, across five Intermountain facilities over a two-year period, underscoring both the scale of the program and the commercial adoption of Adherium's technology.

Background

• Pressing global challenge: Asthma and COPD affect 40M in the U.S. and over 700M worldwide, with poor adherence the biggest barrier to better outcomes.
• Closing the adherence gap: Real-world adherence is often just 20–40%. In iCARE, adherence improved by up to 235%.
• Gold standard achieved: One third of patients-maintained adherence levels of > 80% during the entirety of the study, compared to single-digit rates in earlier studies.
• Scale and persistence: Nearly 1,000 patients, with two-thirds of doses taken as prescribed and more than 9 in 10 remain active after a year. Results unmatched by other digital health programs.
• Engaging the hardest to reach: Over half of patients remained engaged for a year, with the strongest persistence among elderly, high-risk patients including those aged 70 to 80.
• Engine of iCARE: Powered by Adherium's Hailie® Smartinhaler® technology, which captures use, identifies technique errors, and enables real-time intervention, turning data into action for patients and providers.
• System-level impact: Early results show fewer hospital admissions, fewer readmissions, shorter stays, and less reliance on rescue medications, translating to better patient lives and lower system costs.
• Economic relevance: COPD drives over $31B in U.S. healthcare costs annually. Adherium's technology directly addresses payer and provider priorities in value-based care.
• Investor significance: Adherium is the data engine behind iCARE and owns the insight pipeline, positioning the company for a multi-billion-dollar global opportunity.

Forward-Looking Statements: This announcement may contain forward-looking statements. These statements are based on current expectations, assumptions and uncertainties, and actual results may differ materially from those expressed or implied. Adherium undertakes no obligation to update or revise forward-looking statements except as required by law.

Learn more at adherium.com

This ASX announcement was approved and authorised for release by the Board of Adherium.

Investor EnquiriesAdherium Limitedinvestors@adherium.com

About Adherium (ASX:ADR)

Adherium is a provider of integrated digital health solutions and a worldwide leader in connected respiratory medical devices, with more than 180,000 sold globally. Adherium's Hailie® platform solution provides clinicians, healthcare providers and patients access to remotely monitor medication usage parameters and adherence, supporting reimbursement for qualifying patient management. The Hailie® solution includes a suite of integration tools to enable the capture and sharing of health data via mobile and desktop apps, Software Development Kit (SDK) and Application Programming Interface (API) integration tools, and Adherium's own broad range of sensors connected to respiratory medications. Adherium's Hailie® solution is designed to provide visibility to healthcare providers of medication use history to better understand patterns in patient respiratory disease. Learn more at adherium.com

About CareCentra, Inc

CareCentra, Inc. is a patient behavior-shaping company based in the U.S. that enables value-based care through an AI-driven, prevention-as-a-service remote monitoring platform. The CareCentra platform for continuous connected care

leverages advanced decision science, nudge theory, behavior science and personal technologies to enable remote monitoring and coordinate care for patients across the entire spectrum of chronic and acute conditions. CareCentra's AI-driven platform was proven to better patient outcomes and lower healthcare costs in

Randomized Clinical Trials and is now used at several U.S. health systems to reduce admission/readmission while increasing patient engagement and improving care plan adherence.

About Intermountain Health

Headquartered in Utah with locations in six Western states, Intermountain Health is a nonprofit health system comprising 34 hospitals, approximately 385 clinics, and medical groups with some 3,900 employed physicians and advanced care providers, as well as a health plan division called SelectHealth—serving more than one million members. Helping people live the healthiest lives possible, Intermountain is committed to improving community health and is widely recognized for transforming healthcare by using evidence-based best practices to deliver high-quality outcomes at sustainable costs.