News Release

March 28, 2024

Organon Canada Receives Health Canada Medical Device Licence (MDL) Approval for the JADA^TM System Intended to Control and Treat Abnormal Postpartum Uterine Bleeding or Hemorrhage

Postpartum hemorrhage is one of the most serious complications of childbirth¹

KIRKLAND, QC — March 28, 2024 – Organon Canada, a subsidiary of Organon (NYSE: OGN), a global healthcare company with a focus on women’s health, is announcing the approval by Health Canada of the JADA^TM System, intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted.² The incidence of postpartum hemorrhage (PPH) continues to be an important contributor to maternal morbidity and mortality worldwide.³ In Canada alone, PPH increased by 22% from 2003 to 2010.⁴

“Postpartum hemorrhage can be a life-threatening complication of childbirth and requires rapid and effective medical intervention⁵,” said Michael Casia, President and Managing Director, Organon Canada. “At Organon, we are happy to deliver a new solution for this important health need in obstetrics.”

The JADA^TM System became part of the Organon women’s health portfolio in June 2021, as part of the company’s first acquisition, continuing to build upon our leadership in women’s health. The JADA^TM System represents the company’s first medical device approval in Canada and is expected to be launched by the end of Q3.

About the JADA^TM System

JADA is designed to apply low level vacuum to encourage normal contraction of the uterus to provide control and treatment of abnormal uterine bleeding or hemorrhage after childbirth. Please refer to the Jada System Instructions for Use for indications, warnings, precautions, and contraindications at https://www.organon.com/canada-en/jada-instructions-for-use.

About Organon

Organon is a global healthcare company formed to focus on improving the health of women throughout their lives. Organon offers more than 60 medicines and products in women’s health in addition to a growing biosimilars business and a large franchise of established medicines across a range of therapeutic areas. Organon’s existing products produce strong cash flows that support investments in innovation and future growth opportunities in women’s health and biosimilars. In addition, Organon is pursuing opportunities to collaborate with biopharmaceutical innovators looking to commercialize 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 10,000 employees with headquarters located in Jersey City, New Jersey.

For more information, connect with us on LinkedIn.

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References: 1. NCBI, May 8, 2023. Kelly C. Wormer; Radia T. Jamil; Suzanne B. Bryant. Acute Postpartum Hemorrhage, available online: https://www.ncbi.nlm.nih.gov/books/NBK499988/#:~:text=Obstetric%20hemorrhage%20is%20the%20most%20common%20and%20dangerous,mL%20estimated%20blood%20loss%20associated%20with%20cesarean%20delivery. 2. Organon Canada, JADA SYSTEM Instructions for Use. March 2024 3. SOGC Guidelines 431 Postpartum Hemorrhage and Hemorrhagic Shock, December 2022, p. 1296 4. Alberta Health Services. Provincial Clinical Knowledge Topic Post-Partum Hemorrhage, Adult – Inpatient Maternal & Child Health V 1.2, p.4 5. WHO, 2023. WHO issues global plan to tackle leading cause of death in childbirth, available online: WHO issues global plan to tackle leading cause of death in childbirth

^TM Alydia Health, Inc. Used under license.
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