Halt Medical, Inc. Lands FDA Nod for Game-Changing Uterine Fibroid Treatment
11/7/2012 6:20:32 AM
LAS VEGAS, Nov. 6, 2012 /PRNewswire/ -- Halt Medical, Inc. announced today at the opening session of the AAGL Global Congress on Minimally Invasive Gynecology that the FDA has cleared Acessa, a revolutionary new medical technology for treating millions of women suffering from uterine fibroids. "At last, a fibroid treatment that patients and physicians have been waiting for," said Dr. David Levine, former Board Member of the American Association of Gynecological Laparoscopists (AAGL).
"Acessa is the first product cleared anywhere in the world that can be used by gynecologists to treat all fibroid symptoms and types," said Jeffrey Cohen, Halt Medical's Chief Executive Officer.
According to the Centers for Disease Control (CDC), fibroids are the leading cause for hysterectomy procedures worldwide. "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," said Mr. Cohen. "Finally, gynecologists will have an alternative to hysterectomy for their fibroid patients."
Acessa is used in a minimally invasive same-day surgery procedure where a slender handpiece is used to deliver radiofrequency (RF) energy to the fibroid. After treatment, the fibroid is re-absorbed by the surrounding tissue.
In traditional fibroid surgery, layers of healthy tissue are cut through to gain access to the tumor or to remove the uterus entirely. This can lead to complications, significant pain, and long recovery times. Acessa treats just the fibroids, preserving the normal function of the uterus. Patients typically go home the same day with little pain and are back to regular activities in 5 days or less. According to Mr. Cohen, "The high patient satisfaction and low re-intervention rates seen in our clinical studies provides the opportunity for the healthcare system to replace radical surgery and save billions of dollars."
Acessa is already being used to treat women at medical centers in Canada and Europe. "With compelling results from three clinical studies, we have been anticipating this clearance from the FDA," said Russ DeLonzor, Halt's President and Chief Operating Officer. "We've been expanding our manufacturing operations near San Francisco and are ready to meet the increased demand for Acessa from doctors in the U.S. and abroad."
Two surgeons, Dr. Bruce Lee and Dr. Gordon Epstein, led the team of engineers at Halt Medical to develop Acessa to be the ideal treatment for uterine fibroids. "The FDA clearance means we can now put this imperative new medical technology in the hands of gynecologists in the U.S., a major milestone for our company," said Mr. Cohen.
For information about Acessa, please visit www.haltmedical.com.
SOURCE Halt Medical, Inc.