|A model of a procedure that treats uterine fibroids using the VizAblate--Courtesy of Gynesonics|
Gynesonics has raised an additional $6 million in its march toward raising a total round of $35.5 million in equity and debt, according to an SEC filing. That brings this financing total to more than $28 million, from the roughly $22 million it had raised last February that included a Series D venture round.
The additional cash is timely, coming on the heels of its receipt of a European CE mark for and treatment of the first patient with its next-generation VizAblate System in June. If approved in the U.S., the system could provide a minimally invasive alternative to the controversial power morcellators, which are the subject of an FDA panel review this week after concerns were raised about a potential increased cancer risk associated with their use.
VizAblate is a transcervical treatment of symptomatic uterine fibroids guided by intrauterine ultrasound. It is a handheld device for radio-frequency ablation and works on larger and deeper fibroids than other transcervical methods, according to the company.
About 70% to 80% of U.S. women will develop uterine fibroids by age 50, with about 200,000 hysterectomies performed annually because of symptomatic fibroids.
Investors may be preparing down the road for an M&A exit. In April, Gynesonics appointed Christopher Owens as president and CEO; he previously held those titles with medical device company IDEV Technologies, which was acquired by Abbott Laboratories ($ABT) for $310 million in 2013.
Venture investors in Gynesonics include HBM Partners, which led the Series D round, as well as Abingworth, ATV Capital, Correlation Partners and InterWest Partners.
- here is the SEC filing