California’s Gynesonics reported raising $3 million in a new debt offering as it pursues development of its VizAblate fibroid treatment device.
The Redwood City-based company, which disclosed the April 9 offering in a recent regulatory filing, is running a clinical trial for VizAblate. The device is a minimally-invasive radiofrequency ablation system designed to both image and treat fibroids within the walls of the uterus without using incisions.
Last October Gynesonics won an investigational device exemption from the FDA to start the Sonata pivotal trial to evaluate the safety and effectiveness of VizAblate as a treatment for heavy menstrual bleeding relating to symptomatic uterine fibroids. Sonata is expected to expand to as many as 22 sites and enroll up to 147 patients.
Gynesonics raised $6.3 million from 16 unnamed investors in July 2014. A $21 million Series D financing came through in February 2013, led by HBM Partners and including Correlation Ventures, Abingworth, Advanced Technology Partners and InterWest Partners.
VizAblate already has CE Mark approval in the European Union.
DeviceTalks Minnesota's leadership track is designed to provide attendees with insights on topics such as:
Use code SAVE15 to save 15%!