Organon to invest in investigational device for ‘minimally invasive’ hysterectomy

The women’s healthcare company Organon has announced a US$8m investment to support the development of a medical device for women undergoing hysterectomy.

Organon has made the “strategic” investment in the US start-up Claria Medical to bring to market a medical device being studied for use during minimally invasive laparoscopic hysterectomy.

The investigational device developed by Claria 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 US Food and Drug Administration’s Safer Technologies Program (STeP), a collaborative programme intended to help reduce the time it takes to obtain marketing authorisation for eligible devices.

“Hysterectomy is one of the most commonly performed surgeries for women, 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 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.”

Alexey Salamini, Claria Medical CEO, said: “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 US Food and Drug Administration.”

Radical hysterectomy removes the uterus, cervix and upper part of the vagina and is a major operation with a long recovery time. It is only considered after less invasive treatments have been tried.

Approximately 600,000 hysterectomies are performed annually in the US. By the age of 60, more than one-third of all women have had a hysterectomy.

Due to the invasiveness of the procedure, the National Women’s Health Network advises women to search for hysterectomy alternatives and explore nonsurgical options before resorting to life-changing operations.