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.
Cautionary Note Regarding Forward-Looking Statements
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).
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