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ASPIVIX Reports Positive First-in-Women Results Using Novel Suction-based Cervical Device in IUD Procedures
"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:
"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.
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