Organon expands into medtech with Jada System for postpartum haemorrhage

Organon has secured TGA approval for its first women’s health medical device in Australia, the Jada System, to treat abnormal postpartum uterine haemorrhage (PPH). This marks a strategic expansion of the company’s product portfolio from pharmaceuticals into medical technology.

Postpartum haemorrhage remains one of the leading causes of maternal morbidity and mortality in Australia, affecting 5–15% of births annually. Most cases occur without identifiable clinical or historical risk factors, making early intervention critical.

“As a serious and potentially life-threatening obstetric emergency it [PPH] requires timely, swift intervention,” said Associate Professor Stefan Kane, maternal fetal medicine subspecialist obstetrician based in Melbourne.

The Jada System was originally developed by Alydia Health, which was acquired by MSD in a US$240 million deal ahead of Organon’s spin-out in 2021 as an independent women’s health company.

The medical device uses a low-level vacuum to stimulate uterine contractions and control postpartum bleeding. Designed for insertion within 24 hours of delivery, it is intended for use by trained obstetric healthcare professionals and can remain in place for up to 24 hours.

“At Organon we are dedicated to creating a healthier every day for every woman including during childbirth,” said Bilal Somra, Managing Director, Organon ANZ. “Jada now being on the ARTG is another step towards achieving our vision of making a better and healthier every day for every woman.”

The RUBY post-market registry study provides the first real-world data on the Jada System’s efficacy and safety profile. Treatment success was observed in 95.8% of vaginal births and 88.2% of caesarean births. Among the 49% of patients with documented time to bleeding control, haemostasis was achieved in ≤5 minutes for 73.8% of vaginal and 62.2% of caesarean deliveries.

Further insights are expected from A/Professor Kane, who has been approached to comment on where the Jada System fits within the current PPH treatment paradigm, how its efficacy and safety profile compares to existing pharmacological agents such as Duratocin, and whether Australia’s clinical guidelines should evolve to incorporate this medtech option.

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