July 22, 2015

Fierce Medical Devices

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.

Read more: http://www.fiercemedicaldevices.com/story/gynesonics-gets-43m-back-pivotal-trial-uterine-fibroid-ablation-device/2015-07-22

By Stacy Lawrence