Organon Completes Divestiture of JADA® System to Laborie
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postpartum uterine bleedingmedical
Postpartum uterine bleeding is the discharge of blood and tissue from a woman’s uterus after childbirth; a normal amount is part of recovery, but excessive or prolonged bleeding can be dangerous. For investors, it matters because severe cases drive demand for drugs, devices, blood products and hospital care, affect clinical trial safety and regulatory decisions, and can materially change treatment costs and utilization—like a faucet that should slow after use but sometimes keeps running.
postpartum hemorrhagemedical
A heavy, uncontrolled loss of blood after childbirth that can endanger the mother’s life if not treated quickly; think of it as a faucet that won’t stop leaking after a major event. It matters to investors because the size of the medical need, available treatments, regulatory approvals, and hospital practices drive demand for drugs, devices, and services that prevent or stop the bleeding, affecting market opportunity, revenue forecasts, and liability risk.
uterine rupturemedical
A uterine rupture is a severe tear in the wall of the uterus that can occur during pregnancy or labor, causing heavy bleeding and putting both mother and baby at immediate risk; imagine a balloon developing a large tear under pressure. For investors, it matters because such events can affect clinical trial safety assessments, prompt regulatory scrutiny, drive product recalls or legal claims, and influence hospital costs and demand for safer treatments or devices.
uterine inversionmedical
Uterine inversion is a rare but serious childbirth complication in which the uterus folds inward and may protrude through the birth canal, like a glove turned inside out. It matters to investors because it is a medical emergency that drives urgent hospital care, blood transfusions, surgery and specialized devices or drugs; its frequency, treatment costs, and any new prevention or repair products can affect healthcare spending, device makers’ markets, liability exposure and reimbursement dynamics.
air embolismmedical
An air embolism is a dangerous medical event where one or more air bubbles enter the bloodstream and block blood flow to organs, like a small balloon clogging a pipe. For investors, it matters because such events can trigger safety investigations, regulatory action, product recalls or liability claims for healthcare companies, potentially affecting clinical trial outcomes, sales, reputation and a company’s stock value.
JERSEY CITY, N.J.--(BUSINESS WIRE)--
Organon (NYSE: OGN), a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day, announced today the successful closing of the sale of its JADA® System to Laborie Medical Technologies Corp. Please see our prior announcement for a summary of the transaction terms.
Indications for Use
The JADA® System is intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted.
Contraindications
Ongoing intrauterine pregnancy
Untreated uterine rupture
Unresolved uterine inversion
Current cervical cancer
Known uterine anomaly
Current purulent infection of vagina, cervix, or uterus
For C-sections: Cervix <3 cm dilated before use of JADA
Warnings
Avoid excessive force when inserting JADA into the uterus or trauma to uterine wall may occur, including perforation.
The safety and effectiveness of the JADA System in delivery at a gestational age <34 weeks or, if multiples, uterus judged <34 weeks size, have not been established. With smaller uterine size, there is potential for increased risk of perforation and expulsion.
Signs of patient deterioration or failure to improve indicate the need for reassessment and possibly more aggressive treatment and management of postpartum hemorrhage (PPH)/abnormal postpartum uterine bleeding.
JADA is not a substitute for surgical management and fluid resuscitation of life-threatening PPH/abnormal postpartum uterine bleeding.
Remove air from Cervical Seal prior to device use to minimize risk of air embolism if Cervical Seal bursts.
Always fill the Cervical Seal with sterile fluid. Never inflate with air, carbon dioxide, or any other gas to minimize risk of air embolism if Cervical Seal bursts.
To report an adverse event or product quality complaint for JADA, please call 844-JADAMOM.
Please read the Instructions for Use for important information prior to using JADA.
About Organon
Organon (NYSE: OGN) is a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day. With a portfolio of over 70 products across Women’s Health and General Medicines, which includes biosimilars, Organon focuses on addressing health needs that uniquely, disproportionately or differently affect women, while expanding access to essential treatments in over 140 markets.
Headquartered in Jersey City, New Jersey, Organon is committed to advancing access, affordability, and innovation in healthcare. Learn more at www.organon.com and follow us on LinkedIn, Instagram, X, YouTube, TikTok and Facebook.
Except for historical information, this press release includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about the payment of up to $25 million subject to the achievement of certain 2026 revenue targets and other statements about future beliefs, goals, plans or prospects for Organon. Forward-looking statements may be identified by words such as “goals,” “potential,” “will,” “expects,” “believes,” “future,” or words of similar meaning. These statements are based upon the current beliefs and expectations of Organon’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate, or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Organon undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Organon’s filings with the SEC, including Organon’s most recent Annual Report on Form 10-K, Current Reports on Form 8-K, and subsequent SEC filings, available at the SEC’s Internet site (www.sec.gov).
