Gynesonics develops minimally invasive, incision-free, uterus-preserving transcervical technologies for diagnostic and therapeutic applications, with a focus on treating symptomatic uterine fibroids. Its flagship product, the FDA-cleared Sonata System®, provides diagnostic intrauterine imaging and transcervical fibroid treatment and is CE-marked and approved for sale in the EU, UK, Switzerland, and the US. Sonata enables fibroid removal in roughly a 45-minute outpatient procedure, with most patients resuming regular activity the next day. The company is led by President and CEO Skip Baldino. Gynesonics intends to use the new funds to expand operations and broaden its business reach. Financially, the company has raised a total of $67.2M to date following the latest financing activity. Gynesonics develops minimally invasive, incision‑free, uterus‑preserving transcervical technologies; its flagship product is the Sonata System for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids. The Sonata System is FDA cleared, CE marked, and approved for sale in the United States, the European Union, and the United Kingdom. The company positions Sonata as a minimally invasive, incisionless alternative with proven clinical outcomes while noting common side effects and potential treatment risks. In early March Gynesonics appointed industry veteran Skip Baldino as President and CEO; he will also serve on the board, succeeding Christopher Owens. Gynesonics closed a $25M financing to help drive growth, accelerate adoption, and expand worldwide commercialization of the Sonata System. The company says its prior pivotal clinical trial, regulatory clearances, and initial product launch established a foundation of adoption and revenue growth to build on. Gynesonics develops minimally invasive, incision-free, uterus-preserving transcervical technologies for diagnostic and therapeutic applications in women’s health. Its core product, the Sonata System, combines real-time intrauterine ultrasound guidance with targeted radiofrequency ablation (RFA) to offer an incision-free, outpatient procedure for treating multiple uterine fibroid types. The company has secured FDA clearance for the Sonata System. The Sonata System is also CE marked and approved for sale in the European Union and the United States. Gynesonics is led by President and CEO Chris Owens. Financially, the company received a $50M senior secured term loan from Runway Growth Capital. Gynesonics develops minimally invasive, transcervical, uterus-preserving technologies, principally the Sonata System. The Sonata System combines the first intrauterine ultrasound with a proprietary radiofrequency ablation device to provide a transcervical, incision-free treatment for symptomatic uterine fibroids. Sonata enables targeting and optimizing ablations via the SMART Guide and is designed to access a wide range of fibroid types many current hysteroscopy methods cannot treat. The system has CE Mark approval for the European Union and received U.S. FDA 510(k) clearance in August. Gynesonics will use financing proceeds to launch global commercialization, further develop the Sonata technology platform, and fund additional clinical research to support reimbursement and market development. The company is headquartered in Redwood City, California and projects a $3 billion–$4 billion global market opportunity for Sonata, including more than $1 billion in the U.S. Gynesonics develops the Sonata™ System, a minimally invasive, incision‑free device that uses radiofrequency energy under intrauterine sonography guidance to ablate uterine fibroids. The Sonata system includes the SMART Targeting Guide and provides transcervical, uterus‑preserving access designed to avoid the peritoneal cavity. Sonata is CE marked and approved for sale in the European Union but is not available for sale in the United States; the company announced FDA approval of the SONATA IDE pivotal trial in October 2014. Gynesonics is privately held and headquartered in Redwood City, California. The company will use the financing to fund its strategic clinical plan, including current and future U.S. and global trials, as well as programs in operations, R&D, market adoption, and global regulatory and reimbursement efforts. The announcement cites the large, underserved market for symptomatic fibroids and the potential to reduce invasive procedures such as hysterectomy.

Total raised

$278M

Funding rounds

9

Latest round

Equity

Latest activity

Nov 2023