ASPIVIX SA is a privately held medical device company based in Switzerland, dedicated to developing modern and gentle gynecological solutions that advance women's healthcare. The company's flagship product, Carevix, is an innovative, soft-suction cervical device designed as a gentler alternative to the cervical tenaculum for stabilizing the cervix during transcervical procedures such as Intrauterine Device (IUD) insertions or fertility treatments.
Carevix leverages suction technology to gently stabilize the cervix without perforating the tissue. A semi-circular, anatomical pad is applied onto the delicate tissue, reducing trauma associated with pain and bleeding. The ADVANCE Women study, a single-blinded, randomized, comparative trial involving 100 women, demonstrated the device's clinical effectiveness. Compared to the tenaculum, Carevix resulted in up to 73% reduction in pain scores, 78% reduction in bleeding occurrences, and higher rates of pain-free IUD insertions, particularly among nulliparous women.
Carevix received 510(k) clearance from the US FDA in February 2023 and CE Mark approval in December 2023, allowing its commercialization in the US and European markets. The device is the result of ASPIVIX's commitment to modernizing gynecology and addressing the unmet need for less painful transcervical procedures, which impact millions of women globally.
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