Breakthrough US Launch and Validation for Aspivix

After years of progress, securing FDA clearance, being named one of TIME magazine’s Best Inventions of 2024, and partnering with leading U.S. institutions such as Indiana University Health, Columbia University, and Tia Health, Aspivix, Swiss FemTech company dedicated to modernizing gynecological care, has officially launched its breakthrough device, carevix, to healthcare professionals in Southern California and New York State.

This milestone delivers an innovative, less painful alternative to the century-old tenaculum for intrauterine device (IUD) placement and other transcervical procedures. It is the first step toward a nationwide rollout.

A Modern Alternative to a Century-Old Tool

carevix is the world’s first clinically proven suction-based cervical stabilizer, designed to replace the century-old tenaculum, a sharp-toothed forceps still widely used in gynecology. Clinical studies demonstrate that the gentle suction technology reduces pain during IUD insertions by more than 70% and bleeding by over 80% compared to the use of a traditional tenaculum. Beyond IUDs, this new suction device is designed for a broad range of gynecological and fertility procedures, including hysteroscopies, embryo transfers, intrauterine inseminations (IUI), fallopian tube patency assessments, and endometrial biopsies. “As we launch in Los Angeles, Orange County, and New York, we are not just introducing a new device – we are in essence redefining the standard of gynecological care,” Mathieu Horras, CEO of Aspivix.

The Right Device, at the Right Time

This launch aligns with recent CDC and ACOG recommendations that call for better pain management in gynecological procedures, particularly IUD placement. carevix offers clinicians a timely, evidence-based alternative. carevix is backed by robust global clinical data and patient experience, thanks to a comprehensive real-world evidence campaign conducted across nine countries, involving 21 reference sites and more than 1,250 patients prior to launch.

This international initiative enabled Aspivix to collect valuable real-life data that demonstrates carevix®’s effectiveness and safety in diverse clinical settings, providing clinicians and patients with confidence in its use. “My previous IUD insertion was 10/10 painful, worse than when I broke my ankle. I’d been fearful of getting a new one. But this time was so easy. I’d always choose an IUD if it’s this easy,” a patient from Tia Health said.

Immediate Access for Physicians, Pathway to Patients

Healthcare professionals in Los Angeles, Orange County, and New York can order carevix directly through the new U.S. portal: myaspivix.us.

This physician-first launch provides immediate access for OB-GYNs and women’s health clinics, with patient benefits following as clinics introduce the device into routine care. Patients are encouraged to ask their providers about carevix or visit the website for a list of participating clinics

“With carevix, we are giving women and people with a uterus access to a gentler, more respectful experience, because gynecological pain can be reduced, and it should never be dismissed as ‘just a pinch,’” Ikram Guerd, general manager US of Aspivix.

From selected pilots to commercial availability

Contacted by Startupticker.ch, Mathieu Horras, CEO of Aspivix tells us what the latest milestone means for the company based in Lausanne: “This launch marks our move from selected pilots, with unpaid evaluation sites generating real-world evidence, publication data (e.g., FIGO Cape Town presentation covering 1,178 carevix® use cases; a recent publication reporting 72 cases), and product–market-fit insights, to commercial availability in two anchor regions: Southern California and New York. Concretely, we now have a dedicated US field & training cadence (we’ve hired a Clinical Sales Specialist in Los Angeles and are recruiting for NYC), local inventory and fulfilment, and targeted digital marketing for both B2B and D2C. We are writing our sales playbook and testing several combinations of sales methods before releasing carevix on a larger scale in the US.”

Since late 2023, through pilots at IU Health (Indianapolis), Columbia (NYC), and several Tia clinics, Aspivix has seen strong interest from clinics focused on gentler IUD insertion and other intrauterine procedures. Opening sales in Southern California and NYC now enables the hundreds of HCPs who previously expressed interest to order, train, and integrate carevix into their workflows. The company is also rolling out a digital campaign modelled on the programme that performed well in Switzerland.

Remaining flexible to grow in the US

Regarding US Tariffs, today, carevix components are sourced and assembled in Malaysia, explains the CEO, adding: “While recent tariff changes introduce potential impacts, we pre-positioned US inventory ahead of the new rates (filling up our inventory in preparation of the launch) and are monitoring developments closely. We have several supply-chain options ready, pending the outcome of the supreme court’s decision expected in November/December, to preserve cost stability, and uninterrupted supply.”

(PR – ES)