For 40 percent of women in their 30s, uterine fibroids directly impact their daily lives. The growths can expand enough to cause distended bellies and cause women to lose bladder control. The treatment? A hysterectomy.
But Redwood City-based Gynesonics has developed a device that can blast the fibroids without undergoing the rigorous and permanent process of a hysterectomy.
“These women are in the prime of their lives and feel like they have to hide,” said Gynesonics Chief Operations Officer, Jordan Bajor.
For years, hysterectomies were the only treatment, forcing women into a debilitating three-week recovery period and no possibility of having children. But women chose to undergo the procedure to rid themselves of the fibroids that could cause embarrassing and uncomfortable behavior like bleeding, loss of bowel movement control, and fatigue.
“This is for the silent sufferers,” Bajor said of the women who opted not to have a hysterectomy. “They would have to wait till menopause when the fibroids would shrink.”
The Gynesonics disposable device, VizAblate, employs a minimally invasive procedure that occurs during conscious sedation. Patients can be in and out of the office in as little as 20 minutes, or up to an hour, without any surgery.
Doctors use ultrasound technology to locate the fibroids, which appear as a different shade of gray on the screen.
Using the same device, doctors then deploy a high frequency current from seven separate spokes that heats the tissue and “cooks it,” Bajor said.
Bajor said that he had worked at many different biotech start-ups in his career, but "this one has the impact to be the most life-changing."
Changing Women’s Lives
In 2005, gynecologist Jessica Grossman was fed up with the choices available to women with uterine fibroids and started to combine off the shelf technologies, according to Bajor.
“No one had done this before,” Bajor said.
Grossman onboarded Bajor and took the development of the device to a prominent physician in Mexico.
After treating hundreds of women in Mexico, the Netherlands and the United Kingdom, the company has received its CE mark in Europe. This certification deems that the procedure is safe and allows the company to treat patients. To achieve the same approval from the Food and Drug Administration (FDA,) Gynesonics needs to prove that the procedure is not only safe, but effective.
Studies have shown that not only are the symptoms like heavy bleeding reduced, but women also rate their quality of life as magnitudes higher.
“The data is exquisite,” Bajor said of the evidence supporting the effectiveness of their technology.
Bajor estimated that the FDA approval could happen in three years. Until then, the company has raised three rounds of funding for a total of $40 million from venture capital firms.
Bajor added that the Redwood City location was ideal because of the burgeoning start-up culture. The area is also close to Sand Hill Road in Menlo Park, where funding companies are located.
“I love this area,” Bajor said. “It was just a great space that opened up for us.”