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Meditrina Announces CE Mark Approval and First Multi-International Cases Performed

The Aveta System features the only 4.6mm fully disposable resecting hysteroscope that removes polyps and fibroids. (PRNewsfoto/Meditrina, Inc.)

News provided by

Meditrina, Inc.

May 13, 2024, 22:10 ET

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SAN JOSE, Calif., May 13, 2024 /PRNewswire/ -- Meditrina, a leading innovator in gynecologic medical devices, announces the successful receipt of UKCA Mark, and CE Mark approval in accordance with Regulation (EU) 20147/745, for its state-of-the-art Aveta Hysteroscopy System. With this significant milestone achieved, Meditrina is thrilled to enter international markets, marking a pivotal moment in the company's commitment to advancing women's health globally.

Receiving the UKCA and CE Mark approval underscores Meditrina's dedication to meeting the highest standards of quality, safety, and efficacy required for market entry in the European Union and the UK. This achievement not only validates the company's commitment to regulatory compliance but also positions Meditrina as a trusted provider of cutting-edge medical solutions.

Hysteroscopy is a crucial diagnostic and therapeutic procedure used to evaluate and treat conditions affecting the uterus. Meditrina's Aveta hysteroscopy system combines advanced technology with ergonomic design, enabling healthcare professionals to perform minimally invasive procedures with enhanced visualization and control, ultimately leading to improved patient outcomes and experiences.

"We are excited to receive UKCA and CE Mark approval for our hysteroscopy system, as it validates the exceptional quality and performance of our product," remarked Csaba Truckai, CEO of Meditrina. "Furthermore, the successful completion of our initial international procedures in Spain and Denmark signifies a significant milestone in our mission to revolutionize women's healthcare on a global scale. We are proud to collaborate with healthcare providers worldwide in delivering advanced solutions that empower women to lead healthier lives."

The appointment of Ray Gerena as the Senior Vice President of Global Sales further strengthens Meditrina's commitment to driving growth and expanding its global footprint. With Ray's extensive experience and leadership in strategic sales initiatives, Meditrina is well-positioned to capitalize on new market opportunities and forge strong partnerships with healthcare providers worldwide.

Ray remarked, "I am honored to join Meditrina at such an exciting time in its journey. The UKCA and CE Mark approval and successful international procedures represent significant milestones for the company, and I am eager to lead our global sales efforts in bringing our innovative hysteroscopy system to healthcare providers around the world. Together, we will continue to make a meaningful impact on women's health."

The inaugural international procedures conducted in Spain and Denmark exemplify the growing demand for Meditrina's groundbreaking hysteroscopy system beyond the United States. Healthcare professionals in Spain and Denmark have embraced the technology's capabilities, recognizing its potential in the diagnosis and treatment of various gynecological conditions while prioritizing patient comfort and safety.

Through ongoing innovation and collaboration, Meditrina remains steadfast in its commitment to empowering healthcare professionals and improving outcomes for women worldwide.

About Meditrina:
Founded in 2016, Meditrina, Inc. designs and develops innovative medical devices for minimally invasive gynecology. For more information, visit www.avetasystem.com.

Contact:
Abbey Taylor
Associate VP of Marketing
[email protected]
SOURCE Meditrina Inc.

Aveta® is a registered trademark of Meditrina Inc.

SOURCE Meditrina, Inc.

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