FDA Clears Meditrina’s Gen 2 Bipolar RF Hysteroscopy System

Meditrina Inc. has gained U.S. Food and Drug Administration 510(k) clearance of its Gen 2 bipolar RF hysteroscopy system, which features bipolar radiofrequency technology and a new bipolar RF device called the Aveta Glo.

The Aveta System 2.0 builds on the success of its first-generation system, introduced in 2019, allowing physicians full control of procedures from the hysteroscope handle with integrated resection and fluid management. The system is complimented by several pathology-optimized resection devices to treat soft to calcified intrauterine pathologies resulting in faster operating room turnover (by 10-minutes¹) and significantly faster resection time improving the procedural and facility efficiency compared to existing modalities. The new System’s bipolar radiofrequency technology allows for more controlled and efficient tissue removal with hemostasis, potentially improving patient outcomes. Additionally, the new bipolar RF device offers enhanced versatility, enabling physicians to perform a wider range of diagnostic and therapeutic procedures including the ability to address fibroids with deeper myometrial wall penetration across any density tissue type and provide hemostasis, when needed, expanding Meditrina’s market opportunity an additional $1.5 billion.

“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,” Meditrina CEO Csaba Truckai said. “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.”

In tandem with the FDA clearance, Meditrina also has completed the last $5 million tranche of the $77 million series C investment led by Deerfield Management Company, ShangBay Capital, and other insiders. The investment is combined with an additional $5 million debt financing by SLR Capital Partners. The company is approaching a cash flow positive state, and the additional funds will accelerate new product introduction and sales force expansion. This successful financing effort underscores strong investor confidence in the company’s vision and growth trajectory.

“We are immensely grateful for the continued support of our investors,” Truckai added. “This financing not only validates our strategic direction but also provides the necessary resources to scale our operations and bring our solutions to a global market. We are poised for substantial growth and are confident in our ability to achieve cash flow positivity soon.”

Meditrina will continue striving to better women’s health, with a focus on delivering cutting-edge medical devices that enhance the quality of care for patients worldwide. 

Founded in 2016, Meditrina Inc. designs and develops medical devices for minimally invasive gynecology. 

Reference
¹ Data on file at Meditrina inc.; survey conducted Oct 2019-Aug 2020 of n56 OB/GYN users and n38 Nurse users.