Women's health drugmaker Organon places bet on hysterectomy hardware developer Claria Medical
chale
Sun, 01/08/2023 - 20:20

Women's health drugmaker Organon places bet on hysterectomy hardware developer Claria Medical

Organon Makes Strategic Investment in Claria Medical to Support Development of Investigational Medical Device for Minimally Invasive Hysterectomy
Agreement reinforces Organon’s continued focus on pursuing new solutions in high-need areas of women’s health
January 06, 2023 14:40
JERSEY CITY, N.J.--( Business Wire / Korea Newswire ) January 06, 2023 --  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/

Organon Makes Strategic Investment in Claria Medical to Support Development of Investigational Medical Device for Minimally Inva...

Women’s health focused pharma company Organon has made a $8M strategic investment in Claria Medical, 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 in the future. “Hysterectomy is one of the most commonly performed surgeries for women, which is why it is critical…

Organon Invests $8M in Claria Medical to Support the Development of an Investigational Medical Device for Minimally Invasive Hysterectomy

Agreement reinforces Organon’s continued focus on pursuing new solutions in high-need areas of women’s health
January 05, 2023 07:30 AM Eastern Standard Time
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. Contacts

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

Author of the article:
Agreement reinforces Organon’s continued focus on pursuing new solutions in high-need areas of women’s health
We apologize, but this video has failed to load. Try refreshing your browser, or
Organon Makes Strategic Investment in Claria Medical to Support Development of Investigational Medical Device for Minimally Invasive Hysterectomy Back to video
JERSEY CITY, N.J. — 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. Advertisement 2
Article content
Financial Post Top Stories
Sign up to receive the daily top stories from the Financial Post, a division of Postmedia Network Inc.
Email Address
Sign Up
By clicking on the sign up button you consent to receive the above newsletter from Postmedia Network Inc. You may unsubscribe any time by clicking on the unsubscribe link at the bottom of our emails or any newsletter. Postmedia Network Inc. | 365 Bloor Street East, Toronto, Ontario, M4W 3L4 | 416-383-2300
Thanks for signing up! A welcome email is on its way. If you don't see it, please check your junk folder. The next issue of Financial Post Top Stories will soon be in your inbox. We encountered an issue signing you up. Please try again
Article content
“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. Advertisement 3
Article content
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. Advertisement 4
Article content
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/
Contacts

Speech Buddies

Miramar Labs

IDEO

Corporate Minority

Claria Medical is a healthcare company that develops minimally invasive surgical instruments to address unmet needs in gynecologic surgery. It uses an intelligent uterine containment and delivery system that aims to improve the hysterectomy procedure for both patients and clinicians. The company was founded in 2017 and is based in San Francisco, California.

Name	Alexey Salamini
Work History	Speech Buddies, Miramar Labs, and IDEO
Title	Founder
Status	Current

Wells Fargo Success Story

Professional Services

Platform Overview

Claria Medical

Executives

Claria Medical Management Team

1 Team Member

This profile has not been claimed.

Discover the right solution for your team