Gynesonics Raises $75M

Gynesonics, a women's healthcare company and the developer of the Sonata System and other advanced, incision-free solutions for the treatment of uterine conditions, today announced that it has completed a $75 million equity financing. The financing was led by Bain Capital Life Sciences and included all of the Company's existing investors, including Abingworth, Advanced Technology Ventures (ATV), Endeavour Vision, HealthCrest, InterWest Partners, HBM Partners, Correlation Ventures and Hercules Technology Growth Capital.

The Sonata (Sonography-Guided Transcervical Fibroid Ablation) System is intended for the diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding. The system combines a novel integrated technology – the first and only intrauterine ultrasound system – with a proprietary radiofrequency ablation device, providing a transcervical, incision-free, uterus-preserving treatment for uterine fibroids. This breakthrough technology platform provides access to a wide range of fibroid types, many of which cannot be treated with current operative hysteroscopy methods.

Concurrent with the financing, Jeffrey Schwartz, a Managing Director of Bain Capital Life Sciences, will join the Gynesonics Board of Directors. "We are impressed by the quality and promise of the Sonata System and the caliber of the Gynesonics team," said Schwartz. "We believe there is a strong clinical need for an incision-free option for women who are suffering from symptomatic fibroids. I look forward to joining the board and working closely with the team on this important platform technology as well as other advances in the company pipeline."

"The Sonata System is poised to make a significant impact in the way women are treated for this incapacitating disease," stated Ken Haas, Partner, Abingworth. "As a founding investor in Gynesonics, we are excited to help pioneer this new approach and to continue working with the management team on its path toward successful commercialization."

"We are confident that Gynesonics is well-positioned to meet the needs of women who suffer from this debilitating disease. The robust and impressive clinical data will enable the Sonata System to make a significant impact in the multi-billion worldwide market for the treatment of uterine fibroids," stated existing investor and Board Member, Mike Carusi, General Partner, Advanced Technology Ventures.
Gynesonics will use the proceeds from the financing to launch the global commercialization of the Sonata System. The Sonata System has a CE Mark for marketing in the European Union and received U.S. Food and Drug Administration (FDA) 510(k) clearance in August.

The company will also use proceeds to further develop the Sonata technology platform, and for additional clinical research initiatives to support reimbursement and market development objectives.

"On behalf of all of the stakeholders in Gynesonics, I welcome Bain Capital as a new investor and Jeff as a new member of our board," said Christopher M. Owens, President and CEO of Gynesonics. "Gynesonics has developed a breakthrough treatment option for symptomatic uterine fibroids that is designed to preserve the uterus. We are proud to offer physicians and the women under their care a new treatment choice for this disease. This financing will provide the capital to successfully commercialize the Sonata System and continue the clinical research essential to our market development objectives."

According to medical literature, about 70-80 percent of women in the U.S. will develop uterine fibroids by age 50 with a significant proportion of the fibroids causing symptoms. In addition, according to the New England Journal of Medicine, approximately 200,000 hysterectomies are performed in the U.S. each year because of uterine fibroids.

With an estimated volume of more than 1 million annual global fibroid procedures, Gynesonics projects a $3 billion-$4 billion global market opportunity for its Sonata System, including a market opportunity of more than $1 billion in the U.S. alone.

About Bain Capital Life Sciences
Bain Capital Life Sciences pursues investments in biopharmaceutical, specialty pharmaceutical, medical device, diagnostics and enabling life science technology companies globally. The team focuses on companies that both drive medical innovation across the value chain and enable that innovation to improve the lives of patients with unmet medical needs. Through its private equity business, the firm has significant experience working with companies focused on women's health issues including through its prior ownership of Warner Chilcott.

About Sonata System
The Sonata System, the next generation of Gynesonics' technology platform (the previous generation referred to as VizAblate), uses radiofrequency energy to ablate fibroids under intrauterine sonography guidance. The Sonata System, including the SMART Guide, enables the operator to target fibroids and optimize ablations within them. Sonata System's design provides a straightforward, transcervical access for a uterus preserving, incision-free fibroid treatment. This intrauterine approach is designed to treat a wide range of fibroid types while avoiding the peritoneal cavity.

About Gynesonics
Gynesonics is a women's healthcare company focused on advancing women's health, by developing minimally invasive, transcervical, uterus-preserving, incision-free technologies for diagnostic and therapeutic applications. Gynesonics has developed the Sonata System for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids. The Sonata System is CE marked. Sonata is approved for sale in the European Union and the United States. Gynesonics is a privately held company with headquarters in Redwood City, CA. For more information, go to www.gynesonics.com.