GHENT, Belgium, May 25, 2022 /PRNewswire/ -- ASPIVIX SA, a developer of medical technologies to advance gynecological care, today announced positive results from its ADVANCE Women (Atraumatic Device using VAcuum Technology for CErvical Procedures in Women) study. The data confirm the usability, efficacy and safety of Carevix™, an innovative, soft-suction cervical device designed as a modern and gentler alternative to a tenaculum to stabilize the cervix for the insertion of an Intrauterine Device (IUD) for contraception.
ADVANCE Women is a single-blinded, randomized, comparative study of 100 women who underwent IUD insertion with either the Carevix device or a tenaculum, the forceps-like, standard-of-care surgical instrument. Results from the study, conducted at Geneva University Hospitals (HUG) and Lausanne University Hospital (CHUV), were shared at the 16th Congress of the European Society of Contraception and Reproductive Health:
- Women in the Carevix study arm reported significantly lower pain scores at all relevant points of the IUD procedure. Pain scores were 52% lower with the Carevix device during cervix grasping, 53% lower during cervix stabilization (traction), 30% lower during IUD insertion, and 33% lower during cervix release, compared to tenaculum use.
- Women who had not given birth (nulliparous), experienced the greatest benefits from Carevix. During IUD insertion, twice as many nulliparous women in the Carevix group were free of pain compared to those in the tenaculum group, and they reported an 88% lower rate of severe pain.
- Bleeding rates were 78% lower with Carevix vs. the tenaculum.
"The IUD is 99% effective in preventing pregnancies and is considered the most cost-effective birth control method available, but many women experience pain and bleeding during IUD placement, leading to the use of less effective methods out of fear of procedural pain," said Dr. Michal Yaron, ADVANCE Women investigator and Head of Outpatient Gynecology Consultations, Department of Woman, Child & Adolescent, Geneva University Hospitals. "The highly compelling results from the ADVANCE Women study demonstrate that Carevix is a promising and important alternative technology that has the potential to dramatically improve the IUD placement experience for women around the world."
"We are thrilled that the ADVANCE Women trial results affirm what ASPIVIX has envisioned since the company began – that we could re-imagine the IUD procedure by delivering a gentler approach to a century-old gynecological tool," said Mathieu Horras, Chief Executive Officer of ASPIVIX. "We are eager to partner with gynecology centers of excellence to transform IUD placement with Carevix for the estimated 90 million women worldwide who experience pain and bleeding due to the cervical tenaculum."
Carevix is limited to investigational use and not yet available commercially anywhere in the world. ASPIVIX plans to pursue regulatory approval and commercialization of its advanced-design Carevix device in Europe and the United States.
Carevix is an innovative, soft-suction cervical device designed as a modern and gentler alternative to a cervical tenaculum when stabilization of the cervix is needed. By leveraging suction technology to gently stabilize the cervix, Carevix delivers cervical engagement without the need to perforate the tissue. A semi-circular, anatomical pad is applied onto the delicate tissue during gynecological procedures, reducing trauma associated with pain and bleeding. Carevix is not approved for commercial use anywhere in the world.
ASPIVIX SA is a privately held medical device company based in Renens, Switzerland, dedicated to developing modern and gentle gynecological solutions that advance women's healthcare. The Company's innovative technology, development and clinical program are supported by 4FO Venture Partners and Zürcher Kantonalbank (ZKB), HEMEX, Launchpad, Innosuisse, Le Service de la Promotion Économique et de l'Innovation, the European Union research and innovation program Horizon 2020, and visionary angel investors.
1 Lopez LM, Bernholc A, Zeng Y, Allen RH, Bartz D, O'Brien PA, Hubacher D. Interventions for pain with intrauterine device insertion. Cochrane Database Syst Rev. 2015 Jul 29;(7):CD007373. doi: 10.1002/14651858.CD007373.pub3. PMID: 26222246.
SOURCE ASPIVIX SA