Shots: 

• Amy Taneja, in a stimulating conversation with PharmaShots, shares the highlights of the Jada system, a vacuum-induced hemorrhage control device  

• Amy describes how the Jada system differs from traditional methods of controlling PPH while explaining how the system works  

• JADA, which is now being shipped to Chile, Hong Kong, Puerto Rico, New Zealand, and Singapore outside the USA, is also anticipated to be launched in Brazil  

Saurabh: Can you provide an overview of the Jada System and its significance in the field of obstetrics and gynecology? 

Amy: In a space where there has been very little innovation in decades, JADA, a vacuum-induced hemorrhage control device, is an important tool to manage abnormal postpartum uterine bleeding and postpartum hemorrhage (PPH). 

PPH is an obstetric emergency that can occur after childbirth and requires timely medical intervention. Appropriate management of abnormal postpartum uterine bleeding is critical to minimize the potential clinical consequences of PPH and its associated severe maternal morbidities, such as the need for blood transfusions, ICU admission or hysterectomy. 

Saurabh: Tell us what specific technologies or mechanisms the Jada System employs to control postpartum hemorrhage and what sets it apart from traditional methods of PPH control.  

Amy: There are a variety of ways healthcare providers manage abnormal postpartum bleeding, including uterine massage and the use of a class of medications called uterotonics which help the uterus contract. If bleeding does not stop, additional measures such as uterine tamponade techniques or performing procedures to block blood flow to the uterus may be used. JADA is an additional tool for the management of bleeding. It is intended to provide control and treatment of abnormal postpartum uterine bleeding and PPH when conservative management is warranted. JADA works by using a low-level vacuum to encourage normal contraction of the uterus to provide fast control of bleeding. 

Saurabh: According to you, what specific challenges in postpartum hemorrhage management does the Jada System address?  

Amy: In the pivotal PEARLE study, JADA was effective in managing abnormal postpartum bleeding and hemorrhage. Now we know that it works in real-world settings outside of a clinical trial environment. 

Appropriate management of abnormal postpartum uterine bleeding is critical to minimize the potential clinical consequences of PPH and its associated severe maternal morbidities, such as the need for blood transfusions, ICU admission or hysterectomy. 

Saurabh: Organon mentioned the real-world observational study of the Jada System. Could you elaborate about the study design and on the key findings and insights from this study?  

Amy: It was important to assess JADA in real-world settings, where there can be so many variables in patient care and situations, and it was very reassuring to see how consistent the RUBY results were compared to the pivotal study. It works in vaginal and cesarean births and across various blood loss categories. RUBY, a large observational real-world study of 800 cases, underscores the importance of JADA as an important tool for managing PPH. 

Additionally, in the exploratory post-hoc analysis, red blood cell transfusion and severe maternal morbidity outcomes were summarized by blood loss at the time of device insertion. When reviewing patient cases that received standard PPH interventions plus the JADA, lower blood loss prior to device insertion was associated with lower severe maternal morbidity. The analysis supports appropriate control of blood loss when managing PPH. 

Saurabh: How accessible is the Jada System, and what steps are being taken to ensure that it is widely available to healthcare providers around the globe?  

Amy: PPH has a disproportional impact in low-resource settings, and Organon is committed to helping to address this. We are continuing to pursue pathways to make JADA technology accessible to more women around the world. 

Outside the U.S., we are now shipping JADA to Chile, Hong Kong, Puerto Rico, New Zealand, and Singapore, and we expect to launch in Brazil in the fourth quarter where we recently received approval. We are expecting additional regulatory milestones this year across Asia, Latin America, and the Middle East. Our plan is to move quickly to make JADA available to healthcare professionals upon finalization of our regulatory approval.  

Saurabh: Could you discuss any future developments or innovations in medical devices or technologies related to women's health that Organon is working on?  

Amy: The area of Women’s Health has been historically underfunded, and we are committed to identifying and bringing forward innovations where there is an unmet need. One of the ways we’re doing that is by focusing on emerging science in Women’s Health. A critical element of this strategy is ongoing dialogue across the innovation landscape with researchers, entrepreneurs and investors to foster an ecosystem of development across every stage of development from pre-clinical to on the market. Our four Therapeutic Cornerstones – contraception (male and female), fertility (male and female), maternal and peripartum conditions and disorders unique to women as well as a fifth area focusing on diseases that are more prevalent in women – guide our work. Our recent announcement with Cirqle Biomedical on an exclusive licensing agreement and research collaboration is a prime example of this strategy. We will support Cirqle’s work in designing and monitoring the pre-clinical studies needed to confirm the desired target product profile and determine further aspects of the future clinical development program. 

Image Source: Canva 

About the Author: 

Amy Taneja 

Amy Taneja, MD is a board-certified OB/GYN and a Director of Medical Affairs at Organon. She graduated from Wright State University Boonshoft School of Medicine and has over twenty years of experience as a physician, specializing in women’s health.

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