SonaCare Medical said it will reposition its Sonablate prostate cancer device to treat a more aggressive stage of the disease after an FDA panel last week failed to recommend approval for the device.
The FDA’s Gastroenterology & Urology Devices panel voted 7-3 with 1 abstention that the SonaCare device is not safe for the proposed indication to treat "biopsy proven recurrent prostate cancer, stage T1c – T2, in patients who have failed primary External Beam Radiation Therapy and have a PSA ≤ 10 ng/mL. The panel voted 9-2 with no abstentions that the device is effective and 10-0 with 1 abstention that its benefits outweigh its risks.
The company said several panel members suggested the potential value of the Sonablate technology in treating a subset of patients with radiorecurrent prostate cancer who have a Gleason score greater than 6, a more aggressive stage of the condition.
"SonaCare Medical has already begun an assessment of the results in the subset of trial patients that meet the panel’s recommended target population who would be appropriate for treatment with Sonablate. Although this assessment is very preliminary and premature, it does look favorable. We are in the process of reaching out to the FDA to request an opportunity to discuss this possible path forward, and the our additional preliminary results, with them," chief development officer Dr. Mark Carol said in prepared remarks.
Charlotte, N.C.-based SonaCare Medical has been conducting clinical trials in the U.S. and Canada for the Sonablate 450, which uses high-intensity focused ultrasound to treat prostate cancer. The agency is not bound by its advisory panels’ decisions, but often heeds their advice.
Previously known as USHIFU, SonaCare has not reported raising capital since 2012, when it secured $17 million. Current investors include Stamford, Conn.-based Galen Partners and CEO Michael Klein, who previously was president of the radiology oncology division of CIVCO Medical Solutions.
Shares in EDAP (NSDQ:EDAP), which also is developing a HIFU platform to treat cancer, plunged last month after the same FDA advisory panel also recommended against approval of its Ablatherm device. Shareholders later sued EDAP accusing its leadership of misleading investors about the company’s prospects.