Gynesonics gets $43M to back pivotal trial of uterine fibroid ablation device

One method of vanquishing uterine fibroids, power morcellation, is under close scrutiny from the FDA and insurers. That involves the internal cutting of the uterus--and the fibroids within it--in order to conduct a hysterectomy laparoscopically but it may spread cancer throughout the body if the fibroids are cancerous.

An alternative method of treating symptomatic uterine fibroids may be about to make its way through the FDA. Gynesonics has received $43 million from investors to support the clinical development of its Sonata System, which uses radiofrequency energy to ablate fibroids under intrauterine sonography guidance in a transcervical procedure that preserves the uterus.

The FDA gave the startup the go-ahead in October to start an IDE pivotal trial for the system; it is already CE-marked and sold in Europe. The company expects that Sonata could become the primary treatment option for symptomatic uterine fibroids.

The company sees the financing as 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," said Gynesonics President and CEO Christopher Owens in a statement. "We will continue to aggressively pursue our goal of establishing the Sonata System as the preferred choice of physicians and patients worldwide."

The financing was co-led by new investor Endeavour Vision, as well as existing investor Abingworth. Also participating were HealthCrest, InterWest Partners, Advanced Technology Ventures, HBM Partners, Correlation Ventures, and Hercules Technology Growth Capital, as well as an undisclosed "multi-national medical technology company."

"Endeavour Vision's newest fund is dedicated to transformational technologies in medical devices and digital health," said Endeavour Operating Partner Robert O'Holla in a statement. "We are pleased that our first investment from our med tech 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."

He added, "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." Last September, Endeavour had a first close on a dedicated med tech fund of €89 million ($105 million).

- here is the release

Special Report: FierceMedicalDevices' 2014 Fierce 15 - Gynesonics