MENLO PARK, Calif.--(BUSINESS WIRE)--Alydia Health today announced that the company has received U.S. Food and Drug Administration (FDA) 510(k) clearance of the Jada® System, an innovative device designed to rapidly control and treat postpartum hemorrhage (PPH) and abnormal postpartum uterine bleeding. The company also announced the publication of its pivotal PEARLE Study in Obstetrics & Gynecology (the Green Journal), which demonstrated that Jada is safe and highly effective in using vacuum to control postpartum bleeding – within a median of three minutes.
Abnormal postpartum uterine bleeding is a serious complication of childbirth. Mothers are treated with second-line uterotonic drugs to control bleeding in approximately 10% of births worldwide.1 The unacceptable rate of maternal complications in childbirth in the four million births taking place each year in the U.S., including the highest rate of maternal death of developed countries, has recently led to leadership action and new standards from the Joint Commission, the American College of Obstetricians and Gynecologists (ACOG), the Centers for Disease Control and Prevention (CDC) and other organizations. Women of color are disproportionately affected, experiencing three to four times more maternal deaths than white women, regardless of income or education.2
“The FDA clearance of the Jada System and the publication of this compelling clinical data are exciting milestones for Alydia, and more importantly for mothers and clinicians who have been waiting too long for innovation in maternal health,” said Rob Binney, chief executive officer of Alydia Health. “The device puts an end to this waiting with a fast, definitive and physiologic solution that enables quick and easy use before bleeding progresses too far. Speed of treatment is an essential benefit: when hemorrhage is visibly controlled in a matter of minutes, clinicians achieve peace of mind, and mothers can return their focus to bonding with their babies and treasuring this beautiful moment with their families.”
The peer-reviewed results of the PEARLE Study demonstrate that Jada was successful in controlling and treating postpartum hemorrhage and abnormal postpartum uterine bleeding in 94% of participants, achieving control of bleeding in only three minutes (median, IQR 2.0 - 5.0) from initiation of therapy. In 106 cases, performed by 99 unique investigators, Jada was rated “easy to use” 98% of the time. The authors of the study concluded that the Jada System offers “a therapeutic modality that may be considered early in the treatment of abnormal postpartum uterine bleeding and postpartum hemorrhage.”
“Given the results of the PEARLE Study, the Jada System offers an important new tool as we continue to strive to decrease rates of severe maternal morbidity and mortality from hemorrhage in the United States,” said Mary D’Alton, M.D., Chair of the Department of Obstetrics and Gynecology at Columbia University Vagelos College of Physicians and Surgeons and NewYork-Presbyterian/Columbia University Irving Medical Center and lead principal investigator for the PEARLE Study. “The Jada System is a solution that can be deployed quickly and easily. I’d like to thank my fellow investigators for their contributions to the study and for their unwavering commitment to improving outcomes for mothers. We also thank the many expectant mothers who consented to be enrolled in the study, as without their willingness to participate, we could not have completed this important clinical evaluation.”
The PEARLE IDE Study, which supported the company’s marketing submission to the FDA, was a multicenter, prospective, single-arm treatment study that evaluated the safety and effectiveness of the Jada System as a treatment for postpartum hemorrhage and abnormal postpartum uterine bleeding. 12 leading U.S. hospitals with preeminent maternal-fetal medicine and obstetric research programs participated in the study, and 106 participants were treated, with a six-week follow-up visit. The primary effectiveness endpoint of the study was met in 94% (100/106, 95% CI: 88% to 98%) of cases. Additionally, abnormal bleeding was controlled in a median of three minutes (IQR 2.0 - 5.0) after connection to vacuum. The primary safety endpoint of the study was also met, with a low rate of adverse events, all of which were resolved without serious complications. Physicians reported that the device is easy to use (98%) and would recommend it (97%). Total treatment time (includes time to control bleeding plus device in-dwelling time after bleeding control) was 3.2 hours on average, with minimal evacuation of blood from the uterus after initiation of treatment, with a median of 110mL.
“Postpartum hemorrhage is a potentially life-threatening complication of childbirth that can be challenging to manage for a number of reasons,” said Kara Rood, MD, maternal-fetal medicine physician and PEARLE principal investigator at Ohio State Wexner Medical Center, the lead enrolling site in the PEARLE study. “As an investigator in the PEARLE Study, I was able to use the system early-on to quickly and confidently control my patient’s hemorrhage. Jada fills an essential treatment need and I’m ecstatic that this easy-to-use solution will now be available to my team of health care providers and ultimately, my patients.”
About the Jada System
The Jada System treats postpartum hemorrhage and abnormal postpartum uterine bleeding using low-level vacuum to induce the normal and necessary postpartum uterine contraction that should naturally occur after childbirth. Alydia’s technology offers a mechanical alternative to uterotonic drugs, which are also intended to contract the uterus, but are limited by contraindications and side effects in certain patients. Tamponade devices, which rely on uterine distention to temporarily control bleeding, have an average treatment time of 12-24 hours. The Jada System is a thin tube with a collapsible soft loop made of medical-grade silicone – the same type of material used to make pacifiers – that is placed in the uterus. The loop has small protected pores, which gently apply suction to the uterus. The Jada System provides directly observable control of bleeding via the clear device design, continuous active suction, and in-line canister to quantify blood loss.
About Alydia Health
Alydia Health is a commercial-stage medical device company focused on preventing maternal morbidity and mortality caused by postpartum hemorrhage (PPH) or abnormal postpartum uterine bleeding – a challenging condition to manage and a growing problem in the U.S. and globally. PPH is one of the most common complications of birth, resulting in pharmacologic treatment in up to 10% of mothers and potentially resulting in emergency intervention such as hysterectomy and expensive blood transfusions, and, in some cases, maternal death.3
Founded in 2010 with a vision to make childbirth safer for all mothers, Alydia’s device, the Jada System, is designed to encourage normal contraction of the uterus to rapidly stop excessive bleeding after childbirth. Alydia received 510(k) clearance (marketing authorization) from the FDA for the Jada System in August 2020 based on results from the company’s pivotal PEARLE IDE Study. For more information, visit www.alydiahealth.com and follow the company on Twitter at @AlydiaHealth and on LinkedIn at @Alydia Health.
1 Widmer M et al. "Heat-Stable Carbetocin versus Oxytocin to Prevent Hemorrhage after Vaginal Birth." N Engl J Med 2018; 379:743-752
2 Creanga, A.A., Syverson, C., Seek, K., & Callaghan, W.M. (2017). Pregnancy-Related Mortality in the United States, 2011-2013. Obstetrics & Gynecology, 130(2), 366-373.
3 Widmer M et al. "Heat-Stable Carbetocin versus Oxytocin to Prevent Hemorrhage after Vaginal Birth." N Engl J Med 2018; 379:743-752