Alydia Health Completes Enrollment in Pivotal PEARLE IDE Study

Alydia Health, a clinical-stage medical device company dedicated to making childbirth safer for all mothers, has completed enrollment in the pivotal PEARLE IDE Study. The PEARLE Study is investigating the safety and effectiveness of the Jada System, a technology designed to rapidly control and treat abnormal postpartum uterine bleeding and postpartum hemorrhage (PPH).
 
Excessive bleeding after delivering a baby (postpartum hemorrhage) is one of the most common maternal complications of birth,¹ and can lead to emergency interventions such as hysterectomy and blood transfusions, and in some cases, maternal death. The Jada System was developed to achieve rapid cessation of bleeding by encouraging the uterus to contract quickly, naturally compressing the open blood vessels. In a pilot study published in Obstetrics & Gynecology, the device rapidly and effectively controlled postpartum bleeding, with hemorrhage controlled within two minutes for each mother.²
 
Alydia initiated the PEARLE Study to support the company’s planned 510(k) submission to the U.S. Food and Drug Administration (FDA) for marketing clearance of the Jada System. In this study, over 100 women enrolled and were treated with Jada after experiencing abnormal bleeding or PPH. The primary endpoint of the study is the avoidance of further intervention to control bleeding, and the safety analysis includes a six-week follow-up visit. Results are expected to be published by year-end.
 
“Postpartum hemorrhage is a persistent and potentially life-threatening complication of childbirth that can be challenging to manage for a number of reasons,” said Mary D’Alton, M.D., chair of the Department of Obstetrics and Gynecology at Columbia University Vagelos College of Physicians and Surgeons, chair of the Foundation for the Society for Maternal and Fetal Medicine, and lead principal investigator for the PEARLE Study. “New methods for managing postpartum hemorrhage are very much needed and could significantly reduce the morbidity and mortality that we see from uncontrolled blood loss in mothers all over the world. I, along with the other study investigators, eagerly await the results of the PEARLE Study and the promise of a new option to protect the health of moms during childbirth.”
 
Fifteen U.S. hospitals participated in the PEARLE study, including The Ohio State University Wexner Medical Center, University of Utah Hospital, UPMC Magee-Womens Hospital, and other centers with preeminent maternal-fetal medicine and obstetric research programs. These centers have also requested continued access to the Jada System while the company continues to work toward FDA clearance. The FDA approved the PEARLE ACCESS IDE Study, which will allow the clinical trial sites to continue to enroll and treat eligible women with the Jada System until marketing authorization is obtained.
 
“Alydia Health is thrilled to complete this milestone towards our mission of making childbirth safer for all moms, especially given the urgency of addressing maternal morbidity in the United States where up to approximately 2 percent of moms receive transfusions after childbirth,”³ said Anne Morrissey, CEO of Alydia Health. “This tremendous group of physicians are leaders in the field and we are humbled by their passion for improving outcomes for new moms. We are grateful to the entire Labor & Delivery team at each clinical trial site for their incredible commitment to enroll this important study. Finally, we extend our deepest thanks to the women who chose to participate in the study. These mothers were willing to enroll amidst all the emotion and anxiety of bringing a baby into the world, and in doing so, they made an important contribution towards understanding the Jada System.”
 
Immediately following childbirth, the uterus should contract to stop the normal bleeding associated with delivery. A mother with risk factors such as a long or challenging delivery might find that her uterus is unable to contract on its own, causing uncontrolled bleeding known as postpartum hemorrhage (PPH). PPH is one of the most common complications of birth, resulting in emergency intervention such as hysterectomy and expensive blood transfusions, and, in some cases, maternal death. According to the Centers for Disease Control and Prevention (CDC), severe maternal morbidity has been steadily increasing in recent years, nearly tripling between 1993 and 2014.¹ Despite the unacceptably high rate of complications from childbirth requiring treatment, there remains a significant need for effective therapies.

References 
¹ https://www.cdc.gov/vitalsigns/maternal-deaths/index.html
² Purwosunu Y, et al. “Control of Postpartum Hemorrhage Using Vacuum-Induced Uterine Tamponade.” Obstetrics & Gynecology. Vol. 128, No. 1, July 2016.
³ Marshall AL, et al. “The impact of postpartum hemorrhage on hospital length of stay and inpatient mortality: a National Inpatient Sample-based analysis.” Am J Obstet Gynecol. 2017 Sep;217(3):344.; Goffman DE et al. “Quality of administrative data in measuring hemorrhage-related morbidity.” SMFM Abstract 2019.