Organon Receives FDA Clearance for Technological Updates to the Jada® System, a Medical Device Intended to Control Postpartum Hemorrhage

Rhea-AI Summary

Organon (NYSE: OGN) announced FDA clearance for its updated Jada® System, designed to treat abnormal postpartum uterine bleeding effectively. Postpartum hemorrhage cases have risen significantly in the U.S. The updated system features a new kit configuration and improved ease of use, enhancing treatment options in maternal health. The reconfigured Jada system is set to be available in January 2022. This strategic move follows Organon's acquisition of Alydia Health, reinforcing its commitment to women's health.

Positive

• FDA clearance of updated Jada® System enhances treatment options for postpartum hemorrhage.
• Improved kit configuration and design to streamline use.
• Availability of updated Jada System expected in January 2022.
• Strengthens Organon’s portfolio in women’s health following the acquisition of Alydia Health.

Negative

• None.

Postpartum hemorrhage is one of the most common complications of birthⁱ

JERSEY CITY, N.J.--(BUSINESS WIRE)-- Organon (NYSE: OGN), a global women’s health company, today announced clearance by the U.S. Food and Drug Administration (FDA) of the Special 510(k) for technological updates to the Jada® System, intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted. The incidence of postpartum hemorrhage due to uterine atony has increased significantly in the United States during the past decade.ⁱⁱ The product updates include a new kit configuration with updated packaging, as well as a streamlined design to help improve the device’s ease of use.

“More options in the area of maternal health for healthcare providers and women are urgently needed, which was what motivated Organon’s early acquisition of JADA,” said Kevin Ali, Chief Executive Officer, Organon. “Postpartum hemorrhage continues to be one of the most common complications of childbirth and this recent FDA clearance supports our ability to continue providing healthcare providers this important option for treating women with abnormal postpartum bleeding.”

JADA became part of the Organon women’s health portfolio in June 2021, as part of the company’s first acquisition, continuing to build upon the company’s vision of a better and healthier every day for every woman around the world. Organon estimates this updated version of the Jada System should be available to customers in the United States in January 2022.

About the Jada® System

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

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

About Organon

Organon (NYSE: OGN) is a global healthcare company formed through a spin-off from Merck, (NYSE: MRK) known as MSD outside of the United States and Canada, to focus on improving the health of women throughout their lives. Here for her health, the company has a portfolio of more than 60 medicines and products across a range of therapeutic areas. Led by the reproductive health portfolio coupled with an expanding biosimilars business and stable franchise of established medicines, Organon’s products produce strong cash flows that will support investments in future growth opportunities in women’s health, including business development like recently acquired Alydia Health, a medical device company focused on postpartum hemorrhage. 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 9,000 employees with headquarters located in Jersey City, New Jersey.

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

Forward-Looking Statement of Organon

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 management’s expectations about the Jada® System and the recent technical updates, Organon’s acquisition of Alydia Health, and Organon’s business prospects. 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 the company’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, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; 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; the company’s ability to accurately predict its future financial results and performance; the company’s ability to accurately predict future market conditions; 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 the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company 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 the company’s filings with the Securities and Exchange Commission (SEC), including its registration statement on Form 10, available at the SEC’s Internet site (www.sec.gov).

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ⁱ Widmer M et al. "Heat-Stable Carbetocin versus Oxytocin to Prevent Hemorrhage after Vaginal Birth." N Engl J Med 2018; 379:743-752
ⁱⁱ Bateman, Brian T et al. “Patterns of Second-Line Uterotonic Use in a Large Sample of Hospitalizations for Childbirth in the United States: 2007–2011.”Anesthesia & Analgesia. 119(6):1344-1349, December 2014
ⁱⁱⁱ D'Alton ME,et al.. National Library of Medicine. (September 17, 2017-March 25, 2020). Safety and Effectiveness of the Jada System in Treating Primary Postpartum Hemorrhage (PEARLE). Identifier: NCT02883673. https://clinicaltrials.gov/ct2/show/NCT02883673

View source version on businesswire.com: https://www.businesswire.com/news/home/20211011005040/en/

Media:

Karissa Peer

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Kim Hamilton

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Source: Organon & Co.

FAQ

What is the significance of the FDA clearance for Organon's Jada® System?

The FDA clearance allows Organon to provide an updated Jada® System that improves treatment for abnormal postpartum uterine bleeding, addressing a significant health need.

When will the updated Jada® System be available in the U.S.?

The updated Jada® System is expected to be available to customers in January 2022.

How does the Jada® System contribute to maternal health?

The Jada® System applies low-level vacuum to help control and treat abnormal uterine bleeding or hemorrhage after childbirth.

What was the impact of acquiring Alydia Health on Organon's business?

The acquisition of Alydia Health strengthens Organon's focus on women's health, particularly in addressing postpartum hemorrhage.

How has the trend of postpartum hemorrhage changed in recent years?

The incidence of postpartum hemorrhage due to uterine atony has significantly increased in the United States over the past decade.