Meditrina has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its Gen 2 bipolar radio-frequency (RF) hysteroscopy system and Aveta Glo bipolar RF device.
This clearance marks a significant milestone in the advancement of minimally invasive gynecologic procedures.
The Gen 2 bipolar RF hysteroscopy system comprises bipolar RF technology and the Aveta Glo device.
An evolution of the first-generation system launched in 2019, the Aveta System 2.0 provides physicians with integrated resection and fluid management directly from the hysteroscope handle.
The system is designed to improve operating room turnover by approximately ten minutes and offers faster resection times, enhancing procedural and facility efficiency compared to current modalities.
The bipolar RF technology of the new system enables more controlled tissue removal with hemostasis, which may lead to better patient outcomes.
Furthermore, the Aveta Glo device's versatility allows for a broader range of diagnostic and therapeutic procedures, including the treatment of fibroids with deeper penetration into the myometrial wall and provision of hemostasis across various tissue densities.
Meditrina CEO Csaba Truckai said: “The clearance of our Gen 2 system marks a significant milestone for Meditrina and underscores our commitment to advancing women's health through innovative medical technologies.
“We are dedicated to providing healthcare professionals with the tools they need to deliver the highest standard of care, and our new system exemplifies this mission by offering unparalleled performance.”
The company has also completed the final $5m tranche of its $77m Series C investment, led by ShangBay Capital and Deerfield Management Company, with additional insiders participating.
The investment is complemented by a $5m SLR Capital Partners’ debt financing.
Meditrina plans to use the new funds to expedite product launches and expand the sales force.
Truckai added: “This financing not only validates our strategic direction but also provides the necessary resources to scale our operations and bring our innovative solutions to a global market. We are poised for substantial growth and are confident in our ability to achieve cash flow positivity soon.”
Recently, Meditrina secured CE Mark approval for its Aveta hysteroscopy system.
