ASPIVIX SA
Renens, Switzerland, March 16, 2023 (Reuters) /PRNewswire/
ASPIVIX SA, a medical technology company focused on improving gynecological and reproductive healthcare, announced today the publication of the results of the ADVANCE Women study (Atraumatic Device using VAcuum Technology for CErvical Procedures in WOMEN) in the international reproductive healthcare journal Contraception, announced. The randomized controlled Study evaluated Carevix™, ASPIVIX’s novel non-traumatic cervical stabilizer.
ADVANCE Women was a single-blind, randomized study evaluating the use of Carevix™ versus the standard Tenakulum cervical stabilization instrument, the cervical forceps, in 100 women undergoing IUD or intrauterine device (IUD) placement. Carevix™ uses a non-traumatic, gentle approach to reduce pain and bleeding in multiple transcervical procedures, including IUD insertions. The results of the study, carried out at the University Hospitals of Geneva (HUG) and the University Hospital of Lausanne (CHUV), show that:
- Women in the Carevix group reported statistically and clinically significantly lower pain scores at all relevant time points during IUD placement, with pain scores 30-53% lower using Carevix™ than using cervical forceps.
- Carevix™ was particularly beneficial for nullipara women, with 88% fewer nullipara women reporting severe pain during IUD insertion in the Carevix group compared to the cervical forceps group.
- Carevix™ resulted in a 78% reduction in the frequency of cervical bleeding compared to cervical forceps.
“The intrauterine device (the IUD) is the most cost-effective method of contraception, with more than 99% effectiveness in preventing pregnancy, but because of the pain and bleeding many women experience during insertion, less effective methods are chosen for fear of procedural pain.” said Dr. Michal Yaron, investigator of the ADVANCE Women study and head of outpatient gynecological consultations at the University Hospitals of Geneva. “The extremely compelling results of the study show that Carevix represents a promising and important alternative technology that has the potential to dramatically improve the intrauterine device (IUD) placement experience for women worldwide.”
“The publication of the ADVANCE study in Contraception affirms our commitment to providing women with clinically proven gentle solutions to gynecological and fertility needs. This release, along with FDA approval for Carevix™, brings us one step closer to revolutionizing age-old gynecological tools and procedures,” said Mathieu Horras, CEO of ASPIVIX. “Our mission remains steadfast: to bring innovative technologies that prioritize women’s health and improve their lives.”
information to the Carevix™
Carevix is an innovative suction cervical stabilizer developed as a modern and gentler alternative to the tenaculum. By using suction technology to gently stabilize the cervix, Carevix™ provides cervical anchorage without the need to perforate the tissue. A semi-circular, anatomical pad is applied to sensitive tissue during gynecologic procedures, significantly reducing trauma associated with pain and bleeding.
Information about ASPIVIX
ASPIVIX SA is a privately held, Swiss-based medical technology company dedicated to the development of modern and gentle gynecological solutions that advance women’s healthcare.
visit www.aspivix.com or stay up to date at www.aspivix.com/stay-informed/.
Media contact:
Mathieu Horras
[email protected] +41 79 103 22 06
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