Women’s health devices maker Halt Medical announced a U.S. regulatory win for its game-changing uterine fibroid treatment, providing an alternative for women who refuse hysterectomy.
"Acessa is the 1st product cleared anywhere in the world that can be used by gynecologists to treat all fibroid symptoms and types," Halt CEO Jeffrey Cohen said in prepared remarks.
The technology represents a major shift in treatment of uterine fibroids, the company noted. Fibroids are the leading global cause of hysterectomy procedures, according to the Centers for Disease Control & Prevention.
"It’s estimated that 97% of women with fibroids choose to suffer with their symptoms rather than having their uterus removed. We’re about to change all that," Cohen added. "Finally, gynecologists will have an alternative to hysterectomy for their fibroid patients."
The Las Vegas, Nev.-based company’s Acessa system, which is already on the market in Canada and Europe, allows physicians to deliver radiofrequency energy to uterine fibroids through a minimally invasive procedure.
In traditional fibroid surgery a physician generally must either cut through healthy tissue to access the tumor or remove the uterus entirely, according to Halt Medical.
A patient treated with Acessa can typically leave the hospital the same day resume regular activities in 5 days or less, according to a press release. The destroyed fibroid is re-absorbed by surrounding tissue.
The company has been expanding ts San Francisco manufacturing efforts in order to prepare to meet new demand, according to a press release.
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