Alydia Health, a company based in Menlo Park, California, has developed the Jada System, a device designed to stop postpartum hemorrhage. The condition involves heavy bleeding after delivery of a baby. Affected women can experience extended hospital stays, and, unfortunately, can sometimes die. In fact, postpartum hemorrhage is a leading cause of maternal death in the US.
Current treatments for the condition are not ideal, and include medications that can be too slow to work, and an inflatable balloon that slows or stops the bleeding, but takes 12-24 hours to work and can be uncomfortable.
These issues inspired the founders of Alydia Health to design a new device that dramatically improves postpartum hemorrhage treatment. Their solution is the Jada System, a thin tube with a silicone tip that is inserted into the uterus, and which applies gentle suction to rapidly stop bleeding. The company has applied for FDA approval and hopes that the device will be available by the end of the year.
Medgadget had the opportunity to talk to Rob Binney, Alydia Health CEO, about the technology.
Conn Hastings, Medgadget: Please give us an overview of postpartum hemorrhage and the challenges it poses.
Rob Binney, Alydia Health: Childbirth complications are a major problem today. Postpartum hemorrhage (PPH), a condition causing a woman to have heavy bleeding after the delivery of a baby, is one of the most common complications of birth in the U.S. PPH, or abnormal postpartum uterine bleeding, is a challenging condition to manage and a growing problem in the United States and globally. It leads to pharmacologic treatment in up to 10% of mothers globally, emergency intervention including hysterectomy, expensive blood transfusions (1.2%) and, in some cases, maternal death.
Medgadget: Who is predominantly affected by postpartum hemorrhage and what issues does it cause?
Rob Binney: According to the Centers for Disease Control and Prevention (CDC), severe maternal mortality has been steadily increasing in the U.S. in recent years, nearly tripling between 1993 and 2014. Reasons are unclear, but changes in the overall health of the population of women giving birth may be contributing to increases in complications (e.g. increases in maternal age, obesity, preexisting chronic conditions including diabetes, and cesarean delivery).
Maternal mortality is a global issue. But it is also a significant issue here at home – women in the U.S. experience more complications and higher mortality than any other developed nation. Further, women of color in the U.S. are disproportionately affected, experiencing three to four times more maternal deaths than white women, regardless of income or education. The consequences, in addition to the health effects for the woman, are wide-ranging and include increased medical costs and longer hospitalization stays.
Medgadget: How are such hemorrhages currently treated? What are the limitations of these approaches?
Rob Binney: Current first-line therapy is uterine massage combined with a series of drugs, which can work too slowly or not at all, in addition to causing side effects. These potent drugs have contraindications that prevent many patients from receiving them.
Current non-drug device alternatives (balloon tamponade devices) are designed to exert pressure outward against the uterine walls in order to stop bleeding and encourage contraction. These devices have a good success rate, but the average treatment time is 12-24 hours, and it can be uncomfortable for the new mother to have this balloon inflated and pressing into her postpartum uterus, with the uterus contracting against the force of the balloon. The balloon can also hide the fact that a woman is still bleeding. As a result, they are underutilized in the setting of postpartum hemorrhage. In severe cases, a hysterectomy may be performed, which eliminates the possibility of future pregnancies.
Medgadget: Please give us an overview of the Jada system. How does it work to treat hemorrhage?
Rob Binney: The Jada System is simple in concept and designed for exceptional ease of use. The device is a thin tube with a collapsible soft loop that is placed in the uterus. It is made of medical-grade silicone, the same type of material used to make pacifiers. The loop, which has small protected pores, applies gentle suction to the uterus, removing blood and encouraging the uterus to contract and stop bleeding, as it should naturally do after childbirth. In a pilot study, the Jada System rapidly and effectively controlled postpartum hemorrhage within 1-2 minutes for each mom.
We are currently focused on gaining FDA clearance for the Jada System with the goal of launching in the U.S. It is also an important part of our mission as a company to develop a device specifically for the unique care environment in the developing world, where there is also a great need.
Medgadget: Is the device currently being trialed?
Rob Binney: We recently completed the pivotal PEARLE IDE study, which evaluated the safety and effectiveness of the Jada System in over 100 deliveries at leading hospitals in the U.S. and was designed to support an FDA application that is currently underway. The PEARLE study was conducted at 15 leading U.S. centers, under the leadership of Mary D’Alton MD, Chair of the Department of Obstetrics and Gynecology at Columbia University Vagelos College of Physicians and Surgeons, as lead principal investigator. Sites included The Ohio State University Wexner Medical Center, University of Utah Hospital, UPMC Magee-Women’s Hospital, and other centers with preeminent maternal-fetal medicine and obstetric research programs. The primary endpoint of the study was the avoidance of further intervention to control bleeding, and the safety analysis included a six-week follow-up visit. The data from the study have not been published yet but we look forward to sharing the results, along with the outcome of the FDA review of our application, in the coming months.
Medgadget: When do you anticipate that the device will be available?
Rob Binney: We recently submitted a 510(k) submission to the FDA for the marketing clearance of the Jada System and we anticipate bringing our device to market before year-end, pending the FDA’s review of the PEARLE study results. The centers that participated in the PEARLE study have told us that they are particularly eager to have the Jada System available for their patients again, so we will work with them first and then expand to other centers that have strong maternal safety programs in place. We anticipate a limited launch initially as we continue to grow our capabilities as a company.
Additionally, we will build out our team as we approach expanded commercialization in the future, and further, we plan to initiate clinical research on the device designed for developing countries in the next couple of years. Our world-class team is committed to making childbirth safer for all women and we are all working hard to put this device into the hands of those who need it most.
Link: Alydia Health…