Gynesonics said today it raised $43 million in a new round of equity financing, with funds slated to aid the company’s operations and support its Sonata radiofrequency ablation device used to treat intrauterine fibroids.
The Sonata system is minimally invasive and incision-free, using radiofrequency ablation guided by sonography and preserving the uterus, unlike hysterectomies which are often performed to treat symptomatic fibroids, the company said.
The round was co-led by newly invested Swiss group Endeavour Vision and returning investor Abingworth, the Redwood City, Calif.-based company said. Other firms joining the round were HealthCrest, InterWest Partners, Advanced Technology Ventures, HBM Partners, Correlation Ventures and Hercules Technology Growth Capital.
“Endeavour Vision’s newest fund is dedicated to transformational technologies in medical devices and digital health. We are pleased that our 1st investment from our medtech growth fund will support a company with the potential to make a significant improvement in the lives of millions of women globally who suffer from symptomatic uterine fibroids. Sonata’s potential to reduce the need for the large number of invasive procedures, such as hysterectomy, currently used to treat fibroids was compelling, especially as studies suggest women are increasingly looking for uterine-preserving, incision-free treatment options,” Endeavour Vision operating partner Robert O’Holla said in a press release.
Proceeds are slated to fund Gynesonics strategic clinical plan, including international and U.S. trials, research & development, market adoption of its Sonata device and regulatory clearances, the company said.
“This investment from such a broad and accomplished group of international firms represents a significant endorsement of our technology and our team. It is also an acknowledgement of the large, underserved women’s healthcare market and the significant unmet need for a safe and effective uterus-preserving, incision-free option for the treatment of symptomatic uterine fibroids. We will continue to aggressively pursue our goal of establishing the Sonata System as the preferred choice of physicians and patients worldwide,” Gynesonics CEO Christopher Owens said in prepared remarks.
In April, Gynesonics raised $3 million in a debt offering, slated to pursue development of its fibroid treatment device.
Last October Gynesonics won an investigational device exemption from the FDA to start the Sonata pivotal trial to evaluate the safety and effectiveness of radiofrequency ablation 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.