US-based women’s health medical devices manufacturer Meditrina has received the US Food and Drug Administration (FDA) 510(k) approval for the second-generation Aveta system.
The system features bipolar radiofrequency (RF) technology and a new bipolar RF device, dubbed Aveta Glo, a significant advancement in minimally invasive gynaecologic procedures.
The new-gen Aveta System builds on its older version introduced in 2019, giving physicians full control of hysteroscope procedures with integrated resection and fluid management.
It is complemented by several pathology-optimised resection devices for the treatment of soft to calcified intrauterine pathologies.
The system results in a 10-minute faster operating room turnover and faster resection time to improve the procedural and facility efficiency compared to existing modalities.
Its bipolar radiofrequency technology facilitates enhanced control and effective tissue removal with haemostasis, potentially improving patient outcomes.
In addition, the new bipolar RF device enables physicians to address fibroids with deeper myometrial wall penetration across any density tissue type and provide haemostasis.
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.”
Meditrina said that it will continue to provide complete training and support for healthcare professionals to enable easy integration of the Aveta System into clinical practices.
In addition to the regulatory approval, Meditrina has also announced the completion of the last $5m tranche of the $77m series C investment led by Deerfield, ShangBay Capital and others.
The investment includes an additional $5m debt financing by SLR Capital Partners.
Meditrina intends to be cash flow positive, and the additional funds will advance the commercialisation of its new product introduction and expansion of the sales force.
Meditrina CEO Csaba Truckai said: “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.”
