First Real-World Observational Study of the JADA® System, a Medical Device to Control Postpartum Hemorrhage (PPH), Published in ACOG’s Obstetrics & Gynecology

JADA Rapidly and Effectively Controlled Bleeding Due to PPH,¹ Reinforcing Pivotal Study Results¹

PPH is a Significant Cause of Maternal Morbidities in the U.S.^2,3,4,5

New Exploratory Post-Hoc Analysis Examined the Relationship Between Reported Severe Maternal Morbidity (SMM) Outcomes and Cumulative Blood Loss Prior to JADA Insertion¹

Organon (NYSE: OGN), a global healthcare company focused on improving women’s health, today announced that Obstetrics & Gynecology (“The Green Journal”), the peer-reviewed journal of the American College of Obstetrics and Gynecology (ACOG), published the results of the RUBY study (NCT04995887) which reached its primary effectiveness outcome of successfully treating abnormal postpartum uterine bleeding and postpartum hemorrhage (PPH) with the JADA^® System.¹ JADA is an intrauterine vacuum-induced hemorrhage control device intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted.¹

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“PPH is a potentially life-threatening obstetric emergency that can occur after childbirth and requires timely medical intervention.^1,6 Appropriate management of abnormal postpartum uterine bleeding is critical to minimize the potential clinical consequences of PPH⁷ and its associated severe maternal morbidities, such as the need for blood transfusions, ICU admission or hysterectomy,”^1,8,9 said lead author Dena Goffman, M.D., a maternal-fetal medicine subspecialist, and professor and vice chair for quality and patient safety in the Department of Obstetrics and Gynecology at Columbia University Irving Medical Center in New York. “The new study, which included a larger population than the pivotal trial, showed how the device is being used outside of a controlled clinical trial environment. The results indicate that the intrauterine vacuum-induced hemorrhage control device is an important tool for PPH management.”^1,3

Study Design and Results

The RUBY (Treating Abnormal Postpartum Uterine Bleeding or Postpartum Hemorrhage with the JADA^® System) observational, post-market, registry review study assessed records of 800 patients across 16 U.S. hospitals from October 2020 through March 2022 and evaluated JADA treatment of abnormal postpartum uterine bleeding and PPH in real-world settings.¹ Treatment success was defined as bleeding control after insertion with no treatment escalation or bleeding recurrence.¹ JADA achieved treatment success in both the vaginal (92.5%) and cesarean birth (83.7%) groups, regardless of the cause of the abnormal postpartum uterine bleeding.¹

The primary study outcomes were presented at Society for Maternal-Fetal Medicine’s (SMFM) 43^rd Annual Pregnancy Meeting in February 2023. Secondary outcome measures, including time to bleeding control, in-dwelling time, total blood loss and red blood cell transfusions, were also presented.

New Post-hoc Analysis Supports Appropriate Control of Blood Loss

In an exploratory post-hoc analysis, red blood cell (RBC) transfusion and severe maternal morbidities (SMM) outcomes were summarized by blood loss at time of device insertion.¹ ACOG defines PPH as cumulative blood loss of ≥1,000 mL and recommends women are carefully and thoroughly evaluated once they have lost 500 mL post-vaginal delivery and 1,000 mL post-cesarean delivery.^2,10 In RUBY, median post-delivery blood loss prior to device insertion was 1,050 mL in the vaginal group and 1,600 mL in the cesarean group.¹

When reviewing patient cases that received standard PPH interventions plus the JADA^® System, lower blood loss prior to device insertion was associated with lower severe maternal morbidity.¹

ICU, intensive care unit, RBC, red blood cell; SMM, severe maternal morbidity.

“Severe maternal morbidity rates in the U.S. are rising, and PPH is recognized as a major cause of some of these morbidities,”^1,7,8,13,15 said Patricia Carney, M.D., FACOG, Organon Medical Affairs. “While severe maternal morbidities occurred even at lower levels of blood loss in this study,¹ higher rates of morbidity were associated with higher levels of blood loss prior to JADA treatment in conjunction with other interventions that may have been used.¹ These data shed light on the importance of appropriate control of blood loss, and it’s encouraging that the RUBY study reinforced the JADA pivotal study results in a real-world setting.”¹

Adverse events in RUBY were consistent with the pivotal study PEARLE (NCT02883673) and what would be expected when managing an obstetric emergency.¹ Three serious adverse device events were deemed possibly related to the device or procedure [2 (0.4%) vaginal, 1 (0.4%) cesarean], all of which resolved with treatment.¹

About RUBY

The RUBY study was an observational, post-market registry chart review conducted at 16 U.S. hospitals from October 2020 through March 2022.¹ The study evaluated real-world use experience with JADA among 800 patients (n=530 vaginal, n=270 cesarean),¹ 94.3% of whom had uterine atony¹ (the uterus not contracting well to prevent blood loss after childbirth), a principal cause of postpartum hemorrhage.^1,11 The primary effectiveness endpoint was treatment success, defined as bleeding control after insertion with no treatment escalation or bleeding recurrence.¹ Safety data was collected from time of device insertion through hospital discharge¹ and included rates of procedure- and device-related adverse events.¹ The secondary outcome measures were: rate of non-surgical or surgical procedures other than JADA for atony-related bleeding after JADA was used; rate of blood transfusions; device in-dwelling time; time spent in care settings (e.g., labor and delivery, operating room, delivery room, postpartum room, ICU, other) from JADA treatment through discharge; and length of stay from delivery to discharge.^1,12

The study successfully met its primary measure.¹ Additionally, secondary outcome measures were met,¹ including the following which expanded upon JADA clinical findings:

• Time to bleeding control (available in 49% of patients) was achieved within five minutes in 73.8% of vaginal births (n=178) and 62.2% of cesarean births (n=94) after JADA insertion and within one minute for 45.6% of the vaginal group (n=110) and 34.4% (n=52) of the cesarean group.¹
• Treatment duration was short from insertion to removal, known as in-dwelling time, with a median of 3.1 hours for vaginal births and 4.6 hours for cesarean.¹
• As blood loss volume prior to JADA insertion increased, so did rates of blood transfusion, and all women who lost ≥3,000 mL of blood prior to JADA insertion (100%) received a blood transfusion.¹ Red blood cell transfusions of ≥4 units (a measure of severe maternal morbidity) were required for 4.5% (n=24) of those with vaginal births and 12.6% (n=34) of those with cesarean births.¹

Blood loss volume was collected per participating institutions’ protocols and included a mix of estimated and quantitative reporting.¹

About Postpartum Hemorrhage

Postpartum hemorrhage (PPH), or abnormal postpartum uterine bleeding,¹ is one of the most common complications of birth^1,13,14,15 and may result in potential emergency intervention, such as hysterectomy or red blood cell transfusion.^2,13 In some cases, it may even result in maternal death.^2,13 PPH causes 70,000 maternal deaths globally every year, and 12% of maternal deaths in the U.S. (2017-2019).^{1,4,6,14,15,16} Severe maternal morbidity (SMM) rates have increased in the U.S., with PPH as the most common cause (2.7% in 2000, 4.3% in 2019).^1,8,13

PPH is severe blood loss following childbirth⁶ that can result in heart rate or blood pressure changes.¹⁷ PPH is typically treated with pharmacologic agents and a uterine balloon.² Consequences of PPH can lead to extended time in the hospital, blood transfusions and more serious complications.^18,19,20

About JADA^®

JADA is designed to apply low-level vacuum to encourage physiologic (consistent with normal functioning) contraction of the uterus to provide control and treatment of abnormal uterine bleeding or hemorrhage after childbirth.^1,3 JADA was first cleared by the FDA in August 2020 based on results from the pivotal PEARLE IDE Study.^1,3 The study showed that JADA helped provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted with an acceptably demonstrated safety profile.^1,7

Please refer to the JADA^® System Instructions for Use for indications, warnings, precautions and contraindications at tinyurl.com/JADAIFU2.

About Organon

Organon is a global healthcare company formed to focus on improving the health of women throughout their lives. Organon offers more than 60 medicines and products in women’s health in addition to a growing biosimilars business and a large franchise of established medicines across a range of therapeutic areas. Organon’s existing products produce strong cash flows that support investments in innovation and future growth opportunities in women’s health and biosimilars. In addition, Organon is pursuing opportunities to collaborate with biopharmaceutical innovators looking to commercialize their products by leveraging its scale and presence in fast growing international markets.

Organon has a global footprint with significant scale and geographic reach, world-class commercial capabilities, and approximately 10,000 employees with headquarters located in Jersey City, New Jersey.

For more information, visit http://www.organon.com and connect with us on LinkedIn, Instagram, Twitter and Facebook.

Forward-Looking Statements

Except for historical information herein, this news release includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about Organon management’s expectations about the RUBY study, which may not be indicative of future outcomes. Forward-looking statements may be identified by words such as “expects,” “intends,” “anticipates,” “plans,” “believes,” “seeks,” “estimates,” “will” or words of similar meaning. These statements are based upon the current beliefs and expectations of Organon’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include, but are not limited to, an inability to fully execute on our product development and commercialization plans within the United States or internationally; changes in tax laws or other tax guidance which could adversely affect our cash tax liability, effective tax rates, and results of operations and lead to greater audit scrutiny; an inability to execute on our business development strategy or realize the benefits of our planned acquisitions; efficacy, safety, or other quality concerns with respect to marketed products, including market actions such as recalls, withdrawals, or declining sales; political and social pressures, or regulatory developments, that adversely impact demand for, availability of, or patient access to contraception or fertility products; general economic factors, including recessionary pressures, interest rate and currency exchange rate fluctuations; general industry conditions and competition; the impact of the ongoing COVID-19 pandemic and emergence of variant strains; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances; new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Organon’s ability to accurately predict its future financial results and performance; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; difficulties developing and sustaining relationships with commercial counterparties; dependence on the effectiveness of Organon’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

Organon undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Organon’s filings with the Securities and Exchange Commission (SEC), including Organon’s Annual Report on Form 10-K for the year ended December 31, 2021 and subsequent SEC filings, available at the SEC’s Internet site (www.sec.gov).

References and links to websites have been provided for convenience, and the information contained on any such website is not a part of, or incorporated by reference into, this press release. Organon is not responsible for the contents of third-party websites.

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¹ Goffman D, Rood K. Real-world utilization of an intrauterine vacuum-induced hemorrhage-control device. Obstetrics & Gynecology. Online publication date September 14, 2023. Available from: https://journals.lww.com/greenjournal/fulltext/9900/real_world_utilization_of_an_intrauterine,.902.aspx

² Postpartum Hemorrhage. www.acog.org. Published October 2017. https://www.acog.org/clinical/clinical-guidance/practice-bulletin/articles/2017/10/postpartum-hemorrhage. Accessed July 31, 2023.

³ D'Alton ME, Rood KM, Smid MC, et al. Intrauterine vacuum-induced hemorrhage-control device for rapid treatment of postpartum hemorrhage. Obstet Gynecol. 2020;136(5):882-891. doi:10.1097/AOG.0000000000004138

⁴ Corbetta-Rastelli CM, Friedman AM, Sobhani NC, Arditi B, Goffman D, Wen T. Postpartum hemorrhage trends and outcomes in the United States, 2000-2019. Obstet Gynecol. 2023;141:152–61.doi:10.1097/AOG.0000000000004972.

⁵ Creanga AA, Berg CJ, Ko JY, et. al. Maternal mortality and morbidity in the United States: where are we now? J Womens Health. 2014;23(1):3-9. doi:10.1089/jwh.2013.4617

⁶ World Health Organisation. (2022). WHO postpartum haemorrhage (PPH) summit. https://www.who.int/publications/m/item/who-postpartum-haemorrhage-(pph)-summit

⁷ D’Alton M, Rood K, Simhan H, Goffman D. Profile of the Jada® System: the vacuum-induced hemorrhage control device for treating abnormal postpartum uterine bleeding and postpartum hemorrhage. Expert Rev Med Devices. 2021;18:849–53. doi: 10.1080/17434440.2021.1962288

⁸ Severe Maternal Morbidity in the United States. Updated July 3, 2023. https://www.cdc.gov/reproductivehealth/maternalinfanthealth/severematernalmorbidity.html#print. Accessed July 27, 2023

⁹ ACOG Obstetric Care Consensus number 5: severe maternal morbidity: screening and review. Obstet Gynecol. 2016;128(3):e54-e60. doi: 10.1097/AOG.0000000000001642

¹⁰ ACOG Safe Motherhood Initiative. Obstetric Hemorrhage Checklist. Accessed April 2023. smi-ob-hemorrhage-bundle-hemorrhage-checklist.pdf (acog.org)

¹¹ Gill P, Patel A, Van Hook JW. Uterine atony. StatPearls. NCBI Bookshelf. Updated February 6, 2023. https://www.ncbi.nlm.nih.gov/books/NBK493238/. Accessed July 31, 2023.

¹² RUBY Post-Market Registry on the JADA® System - Full text view - ClinicalTrials.gov. (n.d.). https://classic.clinicaltrials.gov/ct2/show/NCT04995887

¹³ Callaghan WM, Creanga AA, Kuklina EV. Severe maternal morbidity among delivery and postpartum hospitalizations in the United States. Obstet Gynecol. 2012;120(5):1029-1036. doi: 10.1097/aog.0b013e31826d60c5.

¹⁴ Pregnancy mortality surveillance system. Centers for Disease Control and Prevention. March 23, 2023. Accessed July 31, 2023. https://www.cdc.gov/reproductivehealth/maternal-mortality/pregnancy-mortality-surveillance-system.htm

¹⁵ Ahmadzia HK, Grotegut CA, James AH. A national update on rates of postpartum haemorrhage and related interventions. Blood Transfus. 2020;18:247-53. Doi: 10.2450/2020.0319-19.

¹⁶ Wolfson C, Qian J, Chin P, et al. Findings from severe maternal morbidity surveillance and review in Maryland. JAMA Netw Open. 2022;5(11):e2244077. doi:10.1001/jamanetworkopen.2022.44077.

¹⁷ Borovac-Pinheiro A, Cecatti JG, de Carvalho Pacagnella R. Ability of shock index and heart rate to predict the percentage of body blood volume lost after vaginal delivery as an indicator of severity: results from a prospective cohort study. J Glob Health. 2019;9(2):020432. doi.10.7189/jogh.09.020432.

¹⁸ Evidence-based practice center systematic review protocol project title: management of postpartum hemorrhage. Agency for Healthcare Research and Quality. June 11, 2014. Accessed July 31, 2023. https://effectivehealthcare.ahrq.gov/sites/default/files/pdf/hemorrhage-postpartum_research-protocol.pdf

¹⁹ McLintock C, James AH. Obstetric hemorrhage. J Thromb Haemost. 2011;9(8):1441-1451. doi: 10.1111/j.1538-7836.2011.04398.x

²⁰ Zelop CM. Postpartum hemorrhage: becoming more evidence-based. Obstet Gynecol. 2011;117(1):3-5. doi: 10.1097/AOG.0b013e318202ec9a

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