Epalinges, Switzerland – August 26, 2024 – In a significant stride towards transforming women’s healthcare, Aspivix, a leading innovator in gynecological solutions, is thrilled to announce that its pioneering device, Carevix™, has received approval from the Medicines & Healthcare products Regulatory Agency (MHRA) for use in the United Kingdom. This milestone marks a pivotal moment for the company and underscores its commitment to modernizing gynecology under its mission, “Gynecology. Now Modern.”

The MHRA approval signifies a major leap forward in the availability of advanced, pain-relieving solutions for millions of women, propelling Aspivix into the forefront of women’s healthcare innovation.

Carevix™ is designed to redefine the standards of care in gynecology, offering a more comfortable and empowering experience for patients and healthcare providers alike.

“Receiving MHRA approval is not just an achievement for Aspivix but a victory for women’s healthcare globally,” said Mathieu Horras, CEO & Co-Founder of Aspivix. “This endorsement allows us to bring Carevix™ to the UK market, further expanding our reach and impact on women’s health. With existing FDA approval for the US and CE Mark for Europe, we are poised to make significant advancements in gynecological care.”

As Aspivix continues to expand its presence in the UK market, the approval of Carevix™ by the MHRA is a testament to Aspivix’s dedication to excellence and innovation in healthcare. By focusing on minimally invasive, patient-centric solutions, Aspivix aims to ensure a positive experience for all women by alleviating the pain and bleeding associated with gynecological transcervical procedures such as coil fitting, hysteroscopies, endometrial biopsies

Over 350 patients have benefitted from the use of the Carevix™ worldwide over the last 5 months as part of our Ambassador Program across 12 centers of excellence (USA, France, Sweden, Switzerland, Germany and Austria) using Carevix™ in routine, providing women a better experience in gynecology. Now, Aspivix is excited about expanding the access to Carevix™ the healthcare professionals to improve patient outcomes by refining together the standard of care in clinical practice. For more information about Aspivix and Carevix™, please visit aspivix.com.

• Pain is the most common reason of avoidance of cost-effective and 99% efficient contraception (IUD), affecting approximately 110 million women globally every year
• Unspoken and underestimated pain leads to delays in diagnostics & treatments, resulting in 121 M unintended pregnancies globally, and 60% of them end in abortion (source: WHO).

About Aspivix

Aspivix is a pioneering leader in women’s health, dedicated to modernizing healthcare solutions for women around the world. With a focus on innovation, Aspivix is committed to developing cutting-edge medical devices, such as Carevix™, which aim to transform the gynecological experience by offering safer and less painful solutions that enhance the quality of care and empower women to take control of their health. For more information, visit aspivix.com.

About Carevix™
Carevix™ is an innovative, soft-suction cervical device designed as a modern and gentler alternative to a cervical tenaculum when stabilization of the cervix is needed, aiming to significantly reduce trauma associated with pain and bleeding. Carevix™ received FDAclearance, CE-Mark and MHRA approval, and is available for commercialization in Switzerland, other countries will be available soon.

Carevix™ has been clinically proven to be non-traumatic during transcervical procedures with compelling results from the ADVANCE Women, a multisite randomized controlled trial of Carevix™, used In IUD Procedures against the cervical tenaculum has been published in “Contraception”, the International Reproductive Health Journal in 2023.

Carevix™ has received the Design Award 2022 by the iF DESIGN AWARD, one of the most important and prestigious design awards in the world, amongst other recognitions.

For media inquiries or more information :

Please contact: Ikram Guerd – VP of Global Marketing: ikram.guerd@aspivix.com.