US Sale of ASPIVIX Carevix greenlighted

Carevix is an atraumatic cervical stabilizer that utilizes a gentle approach to reduce pain and bleeding in multiple transcervical procedures, such as, Intrauterine Device insertions. In ASPIVIX' comparative study of 100 women who underwent an IUD insertion with either the Carevix device or a traditional cervical tenaculum, women reported statistically significant results with up to 73% reduction of pain scores and 78% reduction of bleeding occurrences in favor of the Carevix device.

In the Summer of 2021, ASPIVIX SA obtained an FDA clearance for the first version of its device, produced with 3D-printing and developed mainly for clinical trials. The new 510(k) clearance applies to the final version of the product.  As CEO and Founder Mathieu Horras explained to Startupticker.ch: “The second device is manufactured with a scaled-up plastic injection production process reducing significantly the production costs and turning it into a viable business case.”

Carevix is the result of ASPIVIX constant commitment to make gynecology, now modern.Mathieu Horras commented: “With the 510(k) clearance of Carevix, a design-award winning device, we will provide our U.S. customers with an innovative and easy-to-use system that brings a gentler alternative to a century-old gynecological tool. Extensive research was incorporated into the development of Carevix so we know the unique and differentiating features it demonstrates with significant less pain and bleeding that has the potential to dramatically improve the IUD adoption and placement experience for millions of American women.”

(PR ES)