Alydia Health Inc., of Menlo Park, Calif., has completed enrollment in the pivotal PEARLE investigational device exemption (IDE) study, which is assessing the safety and effectiveness of the Jada system to rapidly control and treat abnormal postpartum uterine bleeding and postpartum hemorrhage.
The company, which was founded in 2010 and formerly known as Inpress Technologies Inc., started the study to support its planned 510(k) submission for the Jada system. In this study, more than 100 women were treated with Jada after experiencing abnormal bleeding or postpartum hemorrhage. The primary endpoint is the avoidance of further intervention to control bleeding, and the safety analysis includes a six-week follow-up visit. The company expects to see the publication of results by year-end.
Fifteen U.S. hospitals participated in the PEARLE study, including the Ohio State University Wexner Medical Center, University of Utah Hospital and the University of Pittsburgh Medical Center Magee-Womens Hospital. Alydia noted that the centers have requested continued access to the system while the company continues to work toward U.S. FDA clearance.
An ongoing problem
Anne Morrissey, Alydia’s CEO, explained to BioWorld that abnormal bleeding following childbirth is a problem in the U.S.
“In the U.S., we have a high rate of complications from childbirth requiring treatment including hysterectomies and other invasive procedures, and a high rate of blood transfusions (up to 2%), which can have real short- and long-term impacts on a new mom,” she added. “We can do better for our mothers.” Currently, a series of drugs is the first-line therapy for these patients. However, they may be too slow in helping a patient – or not work at all. Side effects also could occur. “Current non-drug alternatives – balloon tamponade devices – are designed to exert pressure outward against the uterine walls in order to stop bleeding and encourage contraction,” Morrissey added. “In severe cases, a hysterectomy may be performed, which eliminates the possibility of future pregnancies and can result in early menopause.”
She added that the Jada system aims to quickly stop bleeding by encouraging the uterus to contract, naturally compressing the open blood vessels. She pointed to a pilot study that took place in Indonesia involving 10 women. The system performed well, controlling hemorrhage in all patients within two minutes.
The uterine balloon tamponade (UBT) has been available for about 40 years. With this procedure, a balloon is inserted through the cervix by catheter and inflated with water. It fills the uterus, with the aim of stopping the hemorrhage.
There were two studies published in 2013 and 2019 that put a spotlight on this technique, questioning it. But one published in 2020 in the American Journal of Obstetrics and Gynecology found the technique has saved lives.
Thomas Burke, director of the Global Health Innovation Lab in the emergency department at the Massachusetts General Hospital and an associate professor at Harvard Medical School and the Harvard T.H. Chan School of Public Health, led a team that conducted a systematic review and meta-analysis of 91 randomized control trials, nonrandomized studies, and case series, and found an overall success rate of 85.9% for UBT.
“There’s no question the device works fine. But saving a life is much more complex than just handing someone a device that’s new to their practice,” Burke said. “We need to study how to integrate the device into a health system so that good uptake, appropriate use and best practice result in quality care.”
Despite the availability of UBT, Alydia is looking to add a new option. When asked about when the company expected to go to the FDA, Morrissey said the company is focused on completing follow-up for this study and anticipates filing its application this spring.
Other markets could be on the horizon. “We believe that U.S. FDA clearance is helpful to unlock other markets, and the initial clinical experience we will gain here over the coming year will be essential to preparing for both U.S. and subsequent worldwide rollout. Globally, there are [more than] 1 million moms every year that need new treatment options for postpartum hemorrhage and abnormal uterine bleeding.”
In addition to improving patient health, the system has the potential to save in terms of cost of delivery. Morrissey pointed to a report from Premier Inc, titled “The Added Cost of Complications During and After Delivery: Analyzing the Prevalence of Preventable Complications, their Pre-Existing Risk Factors and the Correlation to Cost,” part of its Bundle of Joy: Maternal & Infant Health Trends Series. Specifically, the report found that, on average, hemorrhage increases the cost of delivery by 45%. “In the case of severe maternal morbidity, costs can more than double,” she added. Those cost drivers include length of stay, acuity of care, as well as transfusions and additional pharmacy and lab expenses.
“While our team is still in the process of evaluating the health economics, we expect that the Jada system will contribute to shorter hospital stays and reduced costs to the health care system,” Morrissey added.
Looking to the next year to 18 months, the company plans to roll out the PEARLE ACCESS IDE study as a follow on to the current trial and provide treatment to eligible women with the system while the FDA evaluates its marketing application. “Our primary focus for the next 12 to 18 months is to support our planned marketing application, present the data from the PEARLE study, and begin commercializing in the U.S. and begin our work toward impact.”