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
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20230913796173/en/
“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) 43rd 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
Blood Loss Thresholds Prior to
Device Insertion
SMM Outcomes by Cumulative
Blood Loss Prior to Device Insertion1
any RBC transfusion n (%)
≥4 units of RBCs n (%)
ICU admission n (%)
Hysterectomy n (%)
≤999 mL
Vaginal (n=170)
20 (12%)
3 (2%)
3 (2%)
2 (1%)
Cesarean (n=23)
6 (26%)
0 (0)
1 (4%)
0 (0)
1,000-1999 mL
Vaginal (n=203)
63 (31%)
5 (3%)
8 (4%)
2 (1%)
Cesarean (n=142)
74 (52%)
10 (7%)
14 (10%)
2 (1%)
2,000–2999 mL
Vaginal (n=53)
40 (76%)
11 (21%)
8 (15%)
1 (2%)
Cesarean (n=58)
50 (86%)
10 (17%)
7 (12%)
2 (3%)
≥3,000 mL
Vaginal (n=5)
5 (100%)
5 (100%)
3 (60%)
2 (40%)
Cesarean (n=15)
15 (100%)
8 (53%)
7 (47%)
3 (20%)
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
birth1,13,14,15 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.
_____________________ 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
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230913796173/en/
Media Contacts: Courtney Mallon (917) 859-2409
Karissa Peer (614) 314-8094
Investor Contacts: Jennifer Halchak (201) 275-2711
Alex Arzeno (203) 550-3972
Organon (NYSE:OGN)
Historical Stock Chart
Von Apr 2024 bis Mai 2024
Organon (NYSE:OGN)
Historical Stock Chart
Von Mai 2023 bis Mai 2024