2014 Fierce 15 company Gynesonics has unveiled long-term follow-up data, spanning more than five years, that tracks the durability of its incisionless ablation treatment for uterine fibroids.
The study showed that no surgical reinterventions were needed in the first 3.4 years following treatment with the company’s Sonata system, with an annualized reintervention rate of 2.2%. Cumulatively—over the study’s average follow-up of 5.4 years in 17 patients—the reintervention rate reached 11.8%.
In addition, scores of symptom severity and quality of life improved by an average of 37 points and 49 points, respectively. The full results were published in the Journal of Gynecologic Surgery.
Gynesonics’ Sonata system—the next generation of its VizAblate platform—combines a unique intrauterine ultrasound guidance and imaging system with a radiofrequency ablation device. The system received 510(k) approval from the FDA last August for the transcervical treatment of symptomatic uterine fibroids, also known as leiomyomas, including those associated with heavy menstrual bleeding.
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“Such lasting results are even more impressive considering the low risk and quick recovery our patients experienced with the Sonata procedure, especially when compared to other fibroid treatment alternatives,” said study author Jose Gerardo Garza-Leal, M.D., of the Universidad Autonoma de Nuevo Leon in Monterrey, Mexico.
Previously, methods such as power morcellation were used to cut up fibroids and uterine wall tissue, but these practices could end up dispersing undetected cancer cells that had been hidden within some fibroids and causing the disease to spread.
According to the company, the Sonata platform also allows physicians access to a wide range of fibroid types, as well as those that cannot be treated with current hysteroscopy methods.
In early January, Gynesonics secured $75 million in equity financing, led by Bain Capital Life Sciences. The company’s previous investors also returned to back the company, including Abingworth, Advanced Technology Ventures, Endeavour Vision, HealthCrest, InterWest Partners, HBM Partners, Correlation Ventures and Hercules Technology Growth Capital.
Gynesonics said it plans to use the proceeds to help launch global commercialization efforts for its Sonata system, which has also received a CE mark.
The company projects a global market opportunity ranging between $3 billion and $4 billion, with more than $1 billion coming from the U.S. alone—with estimates of about 200,000 hysterectomies being performed in the U.S. annually, and more than 1 million fibroid procedures being performed globally each year.