The agreement reinforces Organon’s continued focus on seeking new solutions in areas of high need for women’s health
Jersey City, NJ, January 05, 2023– (working wire) — Organon (NYSE: OGN), a global women’s healthcare company, today announced a strategic investment in Claria Medical, Inc. , a privately owned company developing an investigational medical device that is being studied for use during laparoscopic hysterectomy. The agreement also gives Organon the option to acquire Claria Medical.
Hysterectomy is one of the most common surgeries for women.[1] Kevin Ali, CEO of Organon, said it was critical to invest in new technology with the goal of providing safer, simpler and faster procedures. “Collaborations such as our agreement with Claria Medical are an integral part of the approach to developing our business. We search across the entire horizon for potential solutions – be it drugs, devices or other technologies – that can improve women’s health. This agreement builds on our expertise in the device field and is in line with our focus to develop 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 clinicians. The device has been selected for inclusion in the FDA’s Safer Technologies Program (STeP), a collaborative program intended to help reduce the time it takes to obtain marketing authorization for eligible devices.
Alexi Salamini, CEO of Claria Medical, commented: “Our team is excited to enter into this strategic agreement with Organon, which brings extensive knowledge to women’s health. Organon’s investment enhances the potential of our technology to help improve outcomes for women. We look forward to continuing our Claria System clinical program and obtain authorization from the US Food and Drug Administration.”
Under the terms of the agreement, Organon will pay $8 million up front and have the option to acquire Claria Medical for predetermined terms. The advance payment of $8 million will be classified as R&D expenses in operation in 2023.
About Claria Medical
Claria Medical is passionate about developing best-in-class treatments to address the unmet needs of women’s healthcare. Claria is a pre-commercial medical device startup developing minimally invasive surgical instruments. Early achievements resulted in a “safer technologies designation” from the US Food and Drug Administration. In addition to private funding, Claria Medical has been awarded prestigious grants from the National Science Foundation and the National Institutes of Health to develop products to improve hysterectomy, myomectomy, and other surgical procedures.
About Organon
Organon is a global healthcare company focused on improving women’s health throughout their lives. Organon has a portfolio of more than 60 medicines and products in a range of therapeutic areas. Led by a women’s health portfolio along with expanding biosimilars businesses and a stable franchise of well-established medicines, Organon products are generating strong cash flow that will support investments in innovation and future growth opportunities in the women’s health space. In addition, Organon is pursuing opportunities to collaborate with biopharmaceutical innovators looking to commercialize their products by leveraging its scale and presence in rapidly growing international markets.
Organon has a global footprint with significant geographic reach and reach, world-class business capabilities, and approximately 10,000 employees and is headquartered in Jersey City, New Jersey.
For more information visit http://www.organon.com Contact us on linkedin And the Instagram.
Cautionary note regarding forward-looking statements
Except for the historical information herein, this press release includes “forward-looking statements” within the meaning of the safe harbor provisions of the US 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 choice to acquire Claria Medical, Organon’s expectations regarding the safety and efficacy of the Claria System, and expectations regarding the Claria System clinical program, including the pivotal clinical trial planned for 2023. Forward-research data may be identified by words such as “expects” or “intends,” “expects,” “plans,” “believes,” “seeks,” “estimates,” “will,” or words of a similar meaning. These statements are based on the current beliefs and expectations of Organon management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results could differ materially from those set forth in the forward-looking statements.
Risks and uncertainties include, but are not limited to, the inability to execute our business development strategy or realize the benefits of planned acquisitions; general economic factors, including fluctuations in interest rates and currency exchange rates; general industry and competition terms; the impact of the ongoing COVID-19 pandemic and the emergence of different strains; the impact of drug industry regulation and healthcare legislation in the United States and internationally; global trends toward containing healthcare costs; technological developments; new products and patents obtained by competitors; the challenges inherent in new product development, including obtaining regulatory approval; Organon’s ability to accurately predict future financial results and its performance; manufacturing difficulties or delays; financial instability of international economies and sovereign risks; difficulties in developing and sustaining relationships with business counterparties; Reliance on the effectiveness of Organon’s patents and other protections for innovative products; and exposure to litigation, including patent litigation, and/or regulatory action.
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 on the SEC’s website (www.sec.gov).
[1] Jacoby FL, Fujimoto VA, Giudice LC, Cooperman M, Washington AE. Racial and ethnic disparities in benign gynecological diseases and associated surgeries. I am J Obstet Gynecol. 2010 Jun; 202 (6): 514-21. doi: 10.1016/j.ajog.2010.02.039.
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