North Carolina-based SonaCare Medical is getting a day with the FDA, but the company’s prospects are murky given that it’s going before an advisory panel that just rejected a technology similar to SonaCare’s Sonablate 450 prostate cancer therapy.
SonaCare is scheduled to appear on October 1, 2014, before the FDA’s Gastroenterology & Urology Devices Panel to review the SonaCare device, which uses high intensity focused ultrasound (HIFU) to treat prostate cancer. The company’s looking for indication to treat patients that have already undergone treatment with external beam radiation therapy.
The FDA expert panel recently rejected a similar technology, Edap’s (NSDQ:Edap) Ablatherm system, after ruling unanimously that the device was no effective. Ablatherm is a computer-controlled HIFU device that ablates the entire prostate gland in order to destroy cancerous tissue. That device may still get FDA approval if regulators disagree with the advisory panel.
SonaCare has been testing the Sonablate system in its STAR clinical trial, which has yet to post results on ClinicalTrials.gov.
"We are pleased that the date for the FDA advisory panel meeting has been set and look forward to the opportunity to present our findings from the Sonablate 450 clinical trial," SonaCare CEO Michael Klein said in prepared remarks. "If approved, Sonablate 450 will provide U.S. physicians and patients with the only therapeutic option approved by the FDA specifically for the treatment of recurrent prostate cancer. If approved, Sonablate 450 will provide a new therapeutic option to a patient population that has few alternatives."