HeraMED has secured pivotal US commercial agreements and achieved a key Australian regulatory milestone, positioning itself for scalable growth in digital maternity care.
- Signed major US commercial agreements with Philips and Lee Health
- Achieved TGA Class IIb approval for HeraBEAT in Australia
- Reduced operating cash outflow to $690k, lowest since 2020
- Raised $3.2 million in January 2026 to fund US expansion
- Appointed Dr Mandy Khaira as Chief Clinical Transformation & Medical Officer
US Market Breakthrough
HeraMED Limited has marked a significant turning point in its commercial journey with two major agreements in the United States, the company’s primary strategic focus. The partnership with Philips, a global leader in health technology, will see HeraMED’s HeraCARE digital maternity platform integrated with Philips’ clinical-grade monitoring devices and logistics infrastructure. This collaboration aims to offer a scalable, enterprise-ready solution to US hospitals and health systems, leveraging Philips’ extensive distribution network.
Complementing this, a pilot deployment with Lee Health, a large not-for-profit health system in Florida, is underway. This pilot will test HeraCARE’s capabilities across prenatal and postpartum care pathways, including remote monitoring, virtual engagement, and integration with Epic’s electronic medical records system. The pilot’s success metrics will inform a broader commercial rollout, providing critical validation of clinical workflows and reimbursement pathways.
Regulatory and Clinical Advances in Australia
On the regulatory front, HeraMED achieved a milestone with the Therapeutic Goods Administration (TGA) granting Class IIb medical device approval for its HeraBEAT fetal heart rate monitor. This upgrade positions HeraBEAT as the only remote home-use fetal heart rate monitor approved in Australia, enhancing its hospital-grade credentials and commercial appeal. This regulatory endorsement strengthens HeraMED’s foothold in its home market and supports ongoing clinical collaborations with private clinics such as Simply Women and Melbourne Mothers.
Financial Discipline and Leadership Strengthening
Operationally, HeraMED has successfully reduced its quarterly cash outflow to $690,000, the lowest since mid-2020, reflecting over 18 months of restructuring and cost optimisation. The company’s strategic shift to a capital-light commercialisation model is further supported by a $3.2 million capital raise announced in January 2026, aimed at funding near-term US deployments and commercial execution.
Leadership enhancements include the appointment of Dr Mandy Khaira as Chief Clinical Transformation and Chief Medical Officer. Dr Khaira brings extensive healthcare leadership experience, particularly in integrating artificial intelligence and value-based care models, which aligns with HeraMED’s ambitions to embed AI and data-driven insights into its platform for scalable enterprise adoption.
Looking Ahead
With over 4,400 mothers registered on the HeraCARE platform and nearly 167,000 maternal vital measurements recorded, HeraMED is building a valuable clinical dataset that underpins its “data as an asset” strategy. Meanwhile, commercial discussions continue in Europe, hinting at potential expansion beyond the US and Australia. The company’s focus in 2026 will be on validating clinical outcomes and operational scalability in the US market, leveraging its strengthened balance sheet and leadership team.
Bottom Line?
HeraMED’s strategic US partnerships and regulatory progress set the stage for a critical growth phase, but execution risks remain as pilot programs scale.
Questions in the middle?
- How quickly will HeraMED transition from pilot deployments to broader US commercial rollouts?
- What impact will the TGA Class IIb approval have on HeraBEAT’s market penetration in Australia?
- How effectively can HeraMED leverage its new capital and leadership to accelerate AI-driven platform adoption?