Organon Makes Strategic Investment in Claria Medical to Support Development of Investigational Medical Device for Minimally Invasive Hysterectomy

Rhea-AI Summary

Organon (NYSE: OGN) has announced an $8 million strategic investment in Claria Medical, a company developing a medical device aimed at enhancing laparoscopic hysterectomy procedures. This investment includes an option for Organon to acquire Claria Medical. The Claria System is designed to improve safety and efficiency in hysterectomy surgeries and has been accepted into the FDA’s Safer Technologies Program. This move underscores Organon’s commitment to innovation in women’s healthcare.

Positive

• Strategic investment of $8 million signals commitment to women's health innovation.
• The Claria System is included in the FDA’s Safer Technologies Program, potentially expediting market approval.

Negative

• The $8 million upfront payment will be recorded as an in-process R&D expense in 2023, impacting short-term financials.

Agreement reinforces Organon’s continued focus on pursuing new solutions in high-need areas of women’s health

JERSEY CITY, N.J.--(BUSINESS WIRE)-- Organon (NYSE: OGN), a global women’s healthcare company, today announced a strategic investment in Claria Medical, Inc. a privately-held company developing an investigational medical device being studied for use during minimally invasive laparoscopic hysterectomy. The agreement also grants Organon the option to acquire Claria Medical.

“Hysterectomy is one of the most commonly performed surgeries for women,^[1] which is why it is critical to invest in new technology with the goal of providing safer, simpler and faster procedures,” said Kevin Ali, Organon’s CEO. “Collaborations such as our agreement with Claria Medical are integral to our business development approach. We search across the entire horizon for potential solutions—be they medicines, devices, or other technologies— that can improve the health of women. This agreement builds on our experience in devices and aligns with our focus on advancing urgently needed innovations.”

Claria’s initial investigational device, the Claria System, uses an intelligent uterine containment and extraction system that aims to improve the hysterectomy procedure for both patients and physicians. The device was selected for inclusion in the U.S. Food and Drug Administration’s Safer Technologies Program (STeP), which is a collaborative program intended to help reduce the time it takes to obtain marketing authorization for eligible devices.

Alexey Salamini, Claria Medical’s CEO, commented, “Our team is excited to enter this strategic agreement with Organon, who brings extensive knowledge in women’s health. Organon’s investment reinforces the potential of our technology to help improve outcomes for women. We look forward to continuing our clinical program for the Claria System and obtaining clearance from the U.S. Food and Drug Administration.”

Under the terms of the agreement, Organon will pay $8 million upfront and have the option to acquire Claria Medical for pre-defined terms. The $8 million upfront payment will be classified as an in-process research & development expense in 2023.

About Claria Medical
Claria Medical is passionate about developing best-in-class treatments to address unmet needs in women’s healthcare. Claria is a pre-commercial medical device start-up developing minimally invasive surgical tools. Early accomplishments have resulted in a “Safer Technologies Designation” from the U.S. Food and Drug Administration. In addition to private financing, Claria Medical has been awarded prestigious National Science Foundation and National Institute of Health grants to develop products to improve hysterectomy, myomectomy and other surgical procedures.

About Organon
Organon is a global healthcare company with a focus on improving the health of women throughout their lives. Organon has a portfolio of more than 60 medicines and products across a range of therapeutic areas. Led by the women’s 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 innovation and future growth opportunities in women’s health. 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 and Instagram.

Cautionary Note Regarding Forward-Looking Statements

Except for historical information herein, this press 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 Organon’s strategic investment in Claria Medical and the potential benefits of Organon’s exclusive option to acquire Claria Medical, Organon’s expectation regarding the safety and effectiveness of the Claria System, and expectations regarding the clinical program for the Claria System, including the pivotal clinical trial planned for 2023. 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 execute on our business development strategy or realize the benefits of our planned acquisitions; general economic factors, including 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; the 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).

^[1] Jacoby VL, Fujimoto VY, Giudice LC, Kuppermann M, Washington AE. Racial and ethnic disparities in benign gynecologic conditions and associated surgeries. Am J Obstet Gynecol. 2010 Jun;202(6):514-21. doi: 10.1016/j.ajog.2010.02.039.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230105005090/en/

Media Contacts:

Karissa Peer

(614) 314-8094



Kate Vossen

(732) 675-8448



Investor Contacts:

Jennifer Halchak

(201) 275-2711

Source: Organon & Co.

FAQ

What is Organon's recent investment in Claria Medical about?

Organon announced an $8 million strategic investment in Claria Medical for an investigational medical device aimed at improving laparoscopic hysterectomy procedures.

What financial implications does Organon's investment in Claria Medical have?

The $8 million upfront payment will be classified as an in-process research & development expense in 2023, impacting Organon's short-term financials.

What is the significance of the Claria System in women's health?

The Claria System aims to provide safer, simpler, and faster hysterectomy procedures and has been accepted into the FDA's Safer Technologies Program.

Is there an option for Organon to acquire Claria Medical?

Yes, Organon holds an option to acquire Claria Medical based on pre-defined terms as part of their investment agreement.