CHARLOTTE, NC (PRWEB) October 03, 2014
FRIDAY, OCTOBER 3, 2014 SonaCare Medical, LLC, a leader in minimally invasive high intensity focused ultrasound (HIFU) technology, announced that the Gastroenterology and Urology Device Panel met on Wednesday October 1st with representatives from the FDA and SonaCare Medical to review and vote on recommendations for the interim analysis of SonaCare Medical’s Sonablate® 450’s safety, efficacy, and risk/benefits ratio for the treatment of 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.
This interim review took place after half of the planned 200 patients treated in the company’s trial had achieved at least one-year follow-up. Although the FDA is not obligated to follow the recommendations of a panel, the FDA does use panel meetings to garner clinical insight into the issues raised by a PMA submission and to receive guidance on current patterns of care and trends in treatment germane to the submission under consideration.
At this panel meeting, although a favorable verdict did not result on the indication for use as submitted, guidance was provided to the FDA by the Panel regarding the potential value of the Sonablate technology in a subset of patients, namely those with radiorecurrent prostate cancer who have a Gleason score greater than six. Several panel members suggested that for this more specific indication for use, the efficacy, safety profile, and benefit-risk ratio for the device may provide the basis for a more favorable recommendation.
According to Mark Carol, M.D., Chief Development Officer, “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 Executive Officer Michael Klein noted his disappointment that the panel was unable to approve the interim study at this stage but highlighted SonaCare‘s commitment to working closely with the FDA and its review team to identify the best path for making Sonablate available in the U.S.
SonaCare Medical would like to thank the FDA, members of the advisory panel, community supporters, investigators and patients, employees and investors for their hard work and continuous support and the company looks forward to helping patients by continuing the PMA trial in the U.S. as well as making products and services available to customers abroad.
About SonaCare Medical SonaCare Medical, a privately held, venture-backed healthcare company, is a world leader in minimally-invasive high intensity focused ultrasound (HIFU) technologies. SonaCare Medical is committed to developing technologies for urological indications that offer precise and innovative procedures that can control cancer and reduce potential quality of life altering side effects. SonaCare Medical, with its subsidiary Focus Surgery, Inc., designs and manufactures high intensity focused ultrasound (HIFU) medical devices, including the following: Sonablate® 450 which is investigational in the U.S. and being studied in a pivotal FDA clinical trial as a possible treatment for recurrent prostate cancer in patients treated previously with external beam radiation therapy; Sonablate® 500, which has CE Marking and is, or has been, approved for use to treat prostate cancer in more than 30 countries outside the U.S.; and Sonatherm® laparoscopic HIFU surgical ablation system which is 510(k) cleared in the U.S. The FDA has made no decision as to the safety or efficacy of Sonablate® 450 or 500. In the event Sonablate® 450 is approved by the FDA for use in the U.S., there is no assurance that instructions for use or the specifications of the device will be the same for treatment approved or authorized in other countries outside of the U.S. SonaCare Medical was founded in 2004 and is headquartered in Charlotte, N.C.
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