Channel Medsystems said today it won FDA investigational device exemption trial approval to run a pivotal trial of its Cerene cryotherapy device designed for endometrial ablation.
The multicenter pivotal trial aims to examine the safety and effectiveness of the Emeryville, Calif.-based company’s Cerene device in endometrial ablation procedures for women with heavy menstrual bleeding who are finished with childbearing.
“We expect that the Clarity study will confirm that the Cerene device can support a comfortable procedure without the need for IV sedation or narcotic pain medication. This is the first endometrial ablation technology that was designed to deliver reproducible, successful outcomes in the comfort of the physician’s office — a lower-cost setting of care that both women and gynecologists prefer,” CEO Ric Cote said in a press release.
The trial will also examine outcomes across parameters of comfort, recovery time and uterine healing, the company said. The trial is slated to include sites across the U.S., Mexico and Canada.
“Cerene is different from other endometrial ablation technologies I routinely use. Unlike current heat-based ablation devices, my patients actually relaxed once the two-and-a-half-minute treatment was initiated. This was a completely different treatment experience for me, my patients, and my staff,” lead investigator Dr. Jose Leal of Monterrey, Mexico’s Universidad Autónoma de Nuevo León said in a prepared statement.
Last July, Channel Medsystems said it raised $23.8 million in a new equity financing round seeking $29.5 million, according to an SEC filing.
Channel Medsystems found 23 unnamed investors for this equity financing round, according to the filing. No information on what the funds will be used for has been released.