RENENS, Switzerland, Dec. 10, 2020 /PRNewswire/ -- ASPIVIX SA, a developer of medical technologies to advance gynecological care, today announced completion of and interim analysis results from its Phase I first-in-women trial. The ADVANCE Women (Atraumatic Device using VAcuum Technology for CErvical Procedures in WOMEN) Phase I trial was conducted at Lausanne University Hospital (CHUV) by Prof. Patrice Mathevet, an expert in innovative gynecological surgical approaches, and his team.
The two-phase ADVANCE Women trial is assessing the usability, efficacy and safety of the investigational 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. CAREVIX is limited to investigational use and not yet available commercially anywhere in the world.
"The IUD is considered the most cost-effective, reversible contraceptive solution, but many women experience pain, bleeding and tissue tear during IUD placement related to the tenaculum, a forceps-like surgical instrument used in the procedure," said Prof. Mathevet, M.D., Ph.D., head of the department of Gynecology at CHUV and ADVANCE Women trial principal investigator. "The innovative CAREVIX device is easy-to-use, and I am encouraged by its potential to enhance women's overall experience with an interest in IUD placement."
Ten women eligible for an IUD with CAREVIX in a single-arm, non-comparative Phase I study reported the following preliminary results, to be confirmed in a Phase II study:
- Lower procedural pain compared to published literature from IUD procedures using a tenaculum; and
- No procedural bleeding or tissue tear related to the CAREVIX device
"We are pleased to gather positive initial physician and patient experience using the CAREVIX device, which we believe has the potential to transform how IUD procedures are performed and motivate more women to consider this safe and effective contraception option," said Mathieu Horras, chief executive officer of ASPIVIX. "We look forward to conducting the ADVANCE Women Phase II trial, a randomized, multi-centre study comparing pain scores and other complication rates among women receiving an IUD with CAREVIX versus procedures using a tenaculum."
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 investors 4FO Venture Partners and Zürcher Kantonalbank (ZKB), European Union research and innovation program Horizon 2020, and visionary angel investors.
SOURCE ASPIVIX SA