Organon’s JADA® System (JADA) is now included on the Australian Register of Therapeutic Goods (ARTG) as a medical device to control and treat abnormal postpartum uterine bleeding or haemorrhage

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July 28, 2025 2:54 pm EDT

JADA is an intrauterine vacuum-induced haemorrhage control device now included on the ARTG.1

JADA is used to control and treat abnormal postpartum uterine bleeding or haemorrhage, due to suspected atony, where conservative management is warranted.1

In Australia, PPH remains a major cause of maternal mortality and morbidity occurring in between 5 – 15% of all births.[i]

Sydney, Australia, 25 JULY 2025 – Organon’s JADA is now included on the ARTG (475806) as a medical device to control and treat abnormal postpartum uterine bleeding or haemorrhage, due to suspected atony, where conservative management is warranted.1

PPH is a form of obstetric haemorrhage that occurs during childbirth where there is excess blood loss of 500mL.[1] While there are known causes of PPH, including loss of uterine tone, retained products of conception, trauma to the cervix, vagina, uterus, and blood clotting disorders, most women who experience PPH have no identifiable clinical or historical risk factors, making it unpredictable.3, [2], [3]

Associate Professor Stefan Kane, maternal fetal medicine subspecialist obstetrician, based in Melbourne, says “post-partum haemorrhage remains a major cause of maternal mortality and morbidity for Australian women, impacting between 5 – 15% of all births every year. As a serious and potentially life-threatening obstetric emergency it requires timely, swift intervention”.

JADA is a medical device that applies a low-level vacuum to the uterus, inducing muscle contraction to control and treat PPH.[4],[5] JADA is intended to be inserted within the first 24 hours of delivery and is intended for use by healthcare professionals trained and experienced in obstetrics only. JADA may be used for a maximum of 24 hours.[6]

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

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Please refer to the JADA System Instructions for Use (IFU) for the indications, contraindications, warnings, precautions, and other important information available from Organon available at: https://organonpro.com/en-au/wp-content/uploads/sites/2/2025/03/Jada-system-instructions-for-use.pdf or accompanying the JADA System pack. JADA should not be used in the following conditions: Ongoing pregnancy inside the uterus, an untreated tear in the uterus, untreated uterine inversion, existing cancer of the cervix, known abnormality in the uterus, ongoing infection in the vagina, cervix or uterus, for C-sections the cervix is less than 3 cm open before use of JADA.

A/Prof. Kane has been involved in Advisory Boards for Organon, for which they were remunerated. In relation to this Organon media announcement, no compensation was provided to A/Prof. Kane, and the opinions expressed are their own.

About Organon

Organon is a global healthcare company with a focus on improving the health of women throughout their lives. Organon has a portfolio of more than 60 medicines and products across a range of therapeutic areas. Led by the women’s health portfolio coupled with an expanding biosimilars business and stable franchise of established medicines, Organon’s products produce strong cash flows that will support investments in innovation and future growth opportunities in women’s health. In addition, Organon is pursuing opportunities to collaborate with biopharmaceutical innovators looking to commercialise their products by leveraging its scale and presence in fast growing international markets.

Organon has a global footprint with significant scale and geographic reach, world-class commercial capabilities, and approximately 9,300 employees with headquarters located in Jersey City, New Jersey.

© (2025) Organon group of companies.  All rights reserved. Organon and the Organon logo are trademarks of the Organon group of companies. JADA® is the registered trademark of Alydia Health, Inc.

Organon ANZ, Level 5, 66 King St, Sydney, NSW 2000. AU-JDA-110046. First issued June 2025.

For more information, visit www.organon.com/australia or connect with us on LinkedIn at @OrganonANZ.

References

[1] Australian Institute of Health and Welfare. Primary postpartum haemorrhage. Available at: brief_8_per-82.pdf. Last accessed May 2025.  

[2] Mayo Clinica. Obstetrics and Gynecology. Postpartum hemorrhage, risks and current management. Available at: Postpartum hemorrhage, risks and current management – Mayo Clinic. Last accessed May 2025.  

[3] WHO recommendations for the prevention and treatment of postpartum haemorrhage. Who.int. Published January 1, 2012. Available at: https://www.who.int/publications/i/item/9789241548502. Last accessed May 2025.

[4] D’Alton ME, Rood KM, Smid MC, et al. Intrauterine vacuum-induced hemorrhage-control device for rapid treatment of postpartum hemorrhage. Obstet Gynecol 2020;136(5):882-891. This study was funded by Alydia Health, Inc.

[5] D’Alton M, Rood K, Simhan H, et al. Profile of the Jada® System: the vacuum-induced hemorrhage control device for treating abnormal postpartum uterine bleeding and postpartum hemorrhage. Expert Rev Med Devices 2021;18(9):849-853.

[6] JADA System Instructions for Use. Available at: https://organonpro.com/en-au/wp-content/uploads/sites/2/2025/03/Jada-system-instructions-for-use.pdf. Last accessed June 2025.