Aspivix Achieves New Milestone: Study Results Peer-Reviewed and Published in the International Journal of Gynecology & Obstetrics

A multicenter post-marketing study reveals safety and efficacy of carevix® in gynecological IUD insertion procedures

LOS ANGELES, Feb. 5, 2026 /PRNewswire/ -- Aspivix - a FemTech company dedicated to modernizing gynecological care - announced the results of a multicenter post-marketing study on the safety and efficacy of carevix®, a suction cervical stabilizer for IUD (intrauterine device) insertion. The results were published in the peer-reviewed International Journal of Gynecology & Obstetrics.

carevix® is the world's first clinically proven suction-based cervical stabilizer, constructed to replace the century-old tenaculum, a sharp-toothed forceps currently used in gynecology. carevix® is designed to gently grasp and hold the cervix during IUD insertion and other transcervical procedures. Tissue is then let go by the touch of a button which simply releases the vacuum.

The multicenter post-marketing study included analysis of 1,123 IUD procedures using carevix®, with data collected from 19 sites in the US, Austria, Brazil, France, Germany, Italy, Sweden, Switzerland and the UK. Operators were staff physicians and residents from private practices or university hospitals who received training in device use either on-site or via an online training program.

Participants were predominantly women between 18 - 40 years old (less than 5% below 18 and 1% above 50). Nearly half (46%) were nulliparous (never given birth to a live baby), while 47% were menstruating during the procedure.

Key highlights from the study include:

• 94% of participants were satisfied overall.
• 81% of participants would tell friends the procedure was easy/pain was manageable.
• 82% of healthcare professionals reported overall satisfaction using carevix®.
• Healthcare professionals stated ease of use, adequate visibility and a perception of low patient discomfort in at least 90% of procedures.
• 73% of participants considered the procedure less painful than expected.

"Our study results in this widely respected and peer-reviewed publication underscore the strong endorsement carevix® continues to receive from both clinicians and patients alike," said Mathieu Horras, CEO of Aspivix. "We are changing gynecological care, and the strong clinical evidence will help support our expanding commercial activities in the US and globally."

The multicenter study follows Aspivix's recent single center observational study and a randomized, single-blinded interventional study that included 113 patients at two centers in Switzerland. These controlled trials demonstrate similar results to the real-world data of the multicenter study, with high procedural completion rates and significant reductions in pain during IUD placement compared to the single-tooth tenaculum.

"Having an easy-to-use, effective device that is also more comfortable for patients is really impactful in patient care," said Alissa M. Conklin, MD and assistant professor of Clinical Obstetrics and Gynecology at Indiana University School of Medicine. "Choices and options that have the potential to decrease pain for procedures are important for the patient experience and the trust patients have in their clinician."

"For far too long, women and people with a uterus have been expected to endure pain and discomfort during routine gynecological procedures," said Ikram Guerd, general manager US at Aspivix. "Our most recent study results put a spotlight on the fact that those hardships no longer need to exist and there is a gentler and easier option in gynecological care."

To view the full results from the multicenter post-marketing study, click here.

For more information about Aspivix, visit https://www.aspivix.com/.

About Aspivix
Aspivix is a pioneering FemTech company dedicated to modernizing women's healthcare worldwide by developing innovative medical devices like carevix®, designed to transform gynecological procedures through safer and less painful solutions that enhance quality of care and empower women to take control of their health.

carevix® is Aspivix's clinically proven cervical stabilizer, featuring soft-suction technology as a modern and gentler alternative to the traditional cervical tenaculum. In a multicenter randomized controlled trial published in Contraception (2023), carevix® significantly reduced pain and bleeding during IUD placement compared to the tenaculum.

carevix® has received FDA clearance, CE-Mark, MHRA, and ANVISA approval, and is available for commercialization in Switzerland, the U.S. (Los Angeles, Orange County, New York), UK, and Benelux. The device has also earned recognition as one of TIME magazine's Best Inventions of 2024 and was honored with the iF Design Award 2022, underscoring its impact and innovative design.

For more information, visit www.aspivix.com.

To order carevix® online, visit myaspivix.us.

SOURCE Aspivix SA