Organon touts real-world success of its Jada system for stopping postpartum hemorrhage

The women’s health company Organon has put forward the first real-world data collected from its Jada system, a device used to help stop excessive and potentially life-threatening bleeding following childbirth.

The observational study showed that Jada was able to rapidly control postpartum hemorrhage—a major cause of maternal morbidity in the U.S.—including in women who had a vaginal delivery as well as those who underwent a C-section. 

The device operates both like and unlike a balloon tamponade, which is inserted into the uterus and inflated to apply pressure to stop the bleeding. The Jada, meanwhile, relies on a gentle vacuum; instead of expanding, it gathers the uterine tissue together and compresses it to both stem the blood flow and assist the uterus in naturally contracting back toward its pre-pregnancy volume.

In cases of severe postpartum hemorrhage, or PPH, quick action is necessary to avoid complications such as admission to intensive care, the need for blood transfusions or even the need for a hysterectomy. 

The Jada system was originally developed by former Fierce Medtech Fierce 15 winner Alydia Health. That company was subsequently set up with Organon by the latter’s parent company, Merck & Co.—with the Big Pharma playing matchmaker in a $240 million acquisition deal that closed before Organon was spun out as an independent women’s health player in mid-2021

The device’s real-world study, dubbed RUBY, surveyed the records of about 800 patients, well more than the about 100 participants that enrolled in the device’s previous single-arm pivotal trial. It found that Jada was able to deliver bleeding control in 92.5% of women who had a vaginal birth, as well as 83.7% of those who had a cesarean procedure—groups of patients who had already lost medians of about 1 liter and 1.6 liters of blood, respectively, before the Jada system was deployed. 

“Severe maternal morbidity rates in the U.S. are rising, and PPH is recognized as a major cause of some of these morbidities,” study co-author Patricia Carney, M.D., of Organon’s medical affairs team, said in the company’s release. “While severe maternal morbidities occurred even at lower levels of blood loss in this study, higher rates of morbidity were associated with higher levels of blood loss prior to Jada treatment in conjunction with other interventions that may have been used.”

About half of the patients’ records noted the time it took for Jada to control the bleeding: under five minutes in 73.8% of vaginal births and 62.2% of cesarean births. Bleeding control was achieved in under one minute in 45.6% of the vaginal group and 34.4% of the cesarean group.

“These data shed light on the importance of appropriate control of blood loss, and it’s encouraging that the RUBY study reinforced the Jada pivotal study results in a real-world setting,” Carney added. The study’s results were published in Obstetrics & Gynecology, also known as The Green Journal of the American College of Obstetrics and Gynecology.