ASPIVIX has announced a strategic partnership with AGHealth to launch Carevix, its MHRA-approved non-traumatic suction cervical stabilizer, in the United Kingdom. This development represents a significant advancement in women's healthcare, providing a clinically validated alternative to traditional cervical tenaculum forceps for intrauterine procedures.
Clinical Evidence Demonstrates Substantial Pain Reduction
The ADVANCE Women Study, a single-blinded, randomized, multicenter comparative trial, demonstrated that Carevix achieved a 73% reduction in pain and 78% reduction in bleeding during IUD placement compared to standard tenaculum procedures. These results position the device as a potential game-changer for improving patient experience during gynecological procedures.
Fear of pain during IUD insertion remains a major barrier to contraceptive adoption, affecting 30% to 45% of women globally—an estimated 120 million women each year. This barrier is primarily attributed to the use of traditional cervical tenaculum forceps, which are known to cause discomfort, fear, and sometimes trauma for patients.
Real-World Validation Through Ambassador Program
Peterborough City Hospital, part of the North West Anglia NHS Foundation Trust, became the first hospital in the UK to adopt Carevix in 2024 through the Carevix Ambassador Program. This initiative brought together 21 centers of excellence across 9 countries to evaluate the device in real-world clinical settings.
Results from the Ambassador Program showed high satisfaction rates among both clinicians and patients, with 96% of clinicians finding Carevix easy to use and 94% overall patient satisfaction according to the Carevix Ambassador Program Report 2024-2025.
Strategic Partnership for UK Market Entry
AGHealth, a UK specialist distributor in women's health known for introducing evidence-based innovations to NHS and private sector providers, will serve as the distribution partner for Carevix in the UK market.
"At AGHealth, we focus on delivering forward-thinking, evidence-based solutions to clinicians. Carevix represents exactly the kind of innovation the UK market needs—offering a more dignified, pain-conscious option for gynaecological procedures that women undergo every day," said Charlotte Barker, Director of AGHealth.
Device Design and Regulatory Approval
Carevix has been designed to minimize pain and reduce bleeding during intrauterine procedures such as coil-fitting and endometrial biopsies. The device received approval from the UK's Medicines and Healthcare products Regulatory Agency (MHRA), enabling its use in clinical practice across the country.
"We are proud to bring Carevix to the UK in partnership with AGHealth, a company that shares our commitment to advancing women's health through innovation. With MHRA approval and strong clinical results, Carevix provides a game-changing solution that improves both patient comfort and clinical confidence," said Mathieu Horras, ASPIVIX CEO & Co-Founder.
The launch of Carevix in the UK represents ASPIVIX's continued expansion efforts while strengthening its mission to modernize gynecology and provide women with better healthcare choices. The device offers healthcare providers a modern alternative to traditional tenaculum forceps, potentially improving both patient outcomes and clinical workflow efficiency.
