HeraMED Faces Regulatory Hurdles Amid Rapid Growth and Integration Efforts

Record User Growth and Platform Adoption

HeraMED Limited (ASX:HMD) has reported significant progress in the December 2024 quarter, with its HeraCARE digital maternity platform surpassing 4,100 registered mothers, including 550 active users. This milestone underscores growing adoption of HeraMED’s hybrid prenatal and postpartum care solution, which combines proprietary hardware and software to enhance maternal health outcomes.

The platform has now recorded over 140,000 maternal vital measurements, including fetal heart rate and blood pressure, building a valuable databank that supports HeraMED’s strategy to leverage data analytics and AI for early clinical intervention.

Strategic Expansion in the US Market

HeraMED’s collaboration with Broward Health, a top 10 US health system, remains a cornerstone of its US expansion. Since going live in June 2024, 389 mothers have been onboarded across nine live care plans addressing conditions such as chronic hypertension, gestational diabetes, and mental health. Notably, about half of these mothers are enrolled in postpartum care plans focused on mental health monitoring.

Integration efforts with Broward’s EPIC electronic medical record (EMR) system are underway, a critical step that will enhance interoperability and broaden HeraCARE’s utilisation within the health system. Given EPIC’s dominant global position in EMR, this integration represents a significant commercial and technological milestone for HeraMED.

Capital Raise and Financial Position

During the quarter, HeraMED successfully raised approximately $4.1 million through placements to sophisticated and institutional investors, including a leading Australian Impact Equities Fund. This capital injection substantially extends the company’s cash runway, with a closing cash balance of $3.13 million as of December 31, 2024.

The funds are earmarked to accelerate commercial deployments, pilot programs, and platform integrations across the US, Europe, and Australia, supporting HeraMED’s strategic growth initiatives.

New Partnerships and Advisory Strengthening

HeraMED executed a letter of intent with Metronomic Inc to co-develop an integrated postpartum care solution for the US market. Metronomic’s Materno platform, already deployed in 11 clinics across three states, complements HeraMED’s offering by focusing on private obstetric clinics and leveraging expanded Medicaid postpartum coverage programs.

Additionally, HeraMED is progressing a strategic partnership with Founda Health to enhance HeraCARE’s integration capabilities with electronic health records in Europe and the US.

The company also bolstered its advisory board with the appointments of Vivek Krishnan, a healthcare technology veteran, and Cheryle Royle, an experienced hospital CEO with deep expertise in maternity services and clinical governance. Their insights are expected to accelerate HeraMED’s growth and strategic execution in 2025.

Regulatory and Research Developments

HeraMED continues to engage with the Therapeutic Goods Administration (TGA) regarding the reclassification of its HeraBEAT fetal doppler device following recent regulatory changes in Australia. The company is preparing the necessary submissions to comply with the updated classification requirements.

On the research front, HeraMED’s clinical trials with Gold Coast University Hospital and a leading Dutch university hospital are in final stages of review, with results expected to further validate the clinical and economic benefits of the HeraCARE platform.

Outlook

CEO Anoushka Gungadin expressed optimism about HeraMED’s trajectory, highlighting the company’s customer-first approach, expanding evidence base, and strategic partnerships as key drivers for scaling HeraCARE globally. With ongoing discussions with major US health systems and global healthcare companies, HeraMED is positioning itself to redefine maternity care standards through digital innovation.