JERSEY CITY, N.J. -- Organon (NYSE: OGN), a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day, announced 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.