FDA Approves Organon’s Technological Updates to Jada System

Organon (OGN) announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for technological updates to its Jada System, a medical device intended to control postpartum hemorrhage.

Shares of the multinational women’s healthcare company gained 2% to close at $33.21 on October 11 following the news. (See Organon stock charts on TipRanks)

The Jada System is designed to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage after childbirth. JADA became part of the Organon women’s health portfolio after the company acquired it in June 2021.

The product updates comprise a new kit configuration with updated packaging and an improved design to enable easier use of the device. The updated version of the Jada System is expected to be available to customers in the United States in January 2022.

Postpartum hemorrhage is one of the most common complications of childbirth, and its incidence due to uterine atony has increased massively in the United States over the past decade.

JADA marks Organon’s first acquisition and aligns with the company’s vision of a healthier every day for every woman around the world.

Organon CEO Kevin Ali commented, “More options in the area of maternal health for healthcare providers and women are urgently needed, which was what motivated Organon’s early acquisition of JADA.”

He further added, “Postpartum hemorrhage continues to be one of the most common complications of childbirth and this recent FDA clearance supports our ability to continue providing healthcare providers this important option for treating women with abnormal postpartum bleeding.”

Piper Sandler analyst David Amsellem recently initiated coverage on Organon with a Hold rating and price target of $35.00 (5.4% upside potential)

Consensus among analysts is a Moderate Buy based on 3 Buys and 2 Holds. The average Organon price target of $39 implies 17.4% upside potential to current levels.