‘JADA system’ for postpartum bleeding control recognized as new medical tech

Organon Korea said its intrauterine negative pressure hemostasis using the “JADA system,” a medical device that controls and treats postpartum bleeding, won recognition as a safe and effective new medical technology from the National Evidence-based Healthcare Collaborating Agency (NECA) on June 27.

JADA is a new type of negative pressure-induced bleeding control device that can quickly control and treat abnormal postpartum bleeding. Before the latest medical technology evaluation, JADA was approved by the Ministry of Food and Drug Safety in March as a device to control and treat abnormal postpartum bleeding in cases requiring conservative management of the uterus.

In the existing intrauterine balloon dilatation compression method, hemostasis was achieved by applying direct pressure to the uterine lining for 12 to 24 hours. In contrast, JADA puts the uterus under negative pressure within minutes and applies pressure (up to 90 mmHg) to induce physiological contractions, the company said.

According to Organon Korea, JADA was shown to help control abnormal postpartum bleeding in the PEARLE clinical study. The PEARLE study was a multicenter, prospective, single-arm study of 106 women 18 years and older who gave birth after 34 weeks gestation and had a normal uterus and placenta but had uterine atony. The primary endpoint was the share of patients successfully treated with JADA, and secondary endpoints included time to bleeding control and the need for further treatment.

The results showed that postpartum hemorrhage was controlled without further treatment in 94 percent of patients who used ZEIDA, and the median time to control bleeding was three minutes.

JADA was also clinically effective in real-world use in the RUBY study, a post-marketing investigation using a medical record review of 800 patients from October 2020 to March 2022 in 16 U.S. hospitals. In the study, bleeding was successfully controlled in 92.5 percent of vaginal birth patients and 83.7 percent of cesarean section patients.

"Postpartum hemorrhage is a common complication of childbirth, and early and rapid treatment is critical as excessive blood loss can lead to hysterectomy, severe maternal illness, and maternal death," Organon Korea Managing Director Kim So-eun said. "The recognition of intrauterine negative pressure hemostasis using JADA as a new medical technology opens up new treatment opportunities for Korean mothers to control postpartum hemorrhage quickly and accurately.”

Kim continued, "JADA is the first fruit of Organon Korea's ongoing commitment to delivering new treatment options for unmet needs in women's health since its launch. We will continue to lead the way in providing a range of innovative medicines and solutions for women's health issues across the lifecycle."