SonaCare Medical Files De Novo Grant for Focused Ultrasound Device

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De Novo grant filed for SonaCare Medical's Sonablate® 500 HIFU system for the transrectal ablation of prostatic tissue.

Today SonaCare Medical announced that the Company has filed with the FDA a submission for a De Novo grant of its Sonablate® 500 HIFU system for the transrectal ablation of prostatic tissue. This submission is in addition to the Company’s Pre-Market Approval ("PMA") application and study which it is continuing to pursue. The De Novo process was first introduced in 1997, with the implementation of the FDA’s Modernization Act (FDAMA), as a means to reclassify novel medical devices of low to moderate risk profiles that were automatically deemed Class III because no substantially equivalent devices existed to merit a successful 510(k) submission.

Sonablate® is a transrectally delivered probe that uses ultrasound to target MRI-defined regions of interest in the prostate, uses high intensity focused ultrasound (HIFU) to treat the targeted tissue while sparing intervening tissue, and uses ultrasound to track the degree of ablation resulting from the treatment.

According to Dr. Mark Carol, SonaCare CEO, "Sonablate has been in use around the world for more than a decade for the treatment of benign prostatic hypertrophy (BPH) and prostate cancer. While we will continue to pursue the PMA pathway for the specific claim of the treatment of recurrent prostate cancer post failed radiation therapy, a De Novo submission and subsequent grant will allow us to accelerate getting this technology in the hands of American urologists for use in ablation of prostate tissue. We look forward to our continued interaction with the FDA as we pursue both the De Novo and PMA paths simultaneously.“

About Sonablate
The Sonablate® 450 is currently undergoing FDA review for the treatment of localized, recurrent prostate cancer after failed radiation therapy. Sonablate® 500 has CE marking and is approved in 48 countries worldwide.

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 48 countries outside the U.S.; and Sonatherm® laparoscopic HIFU surgical ablation system which is 510(k) cleared in the U.S., has CE Marking and is approved in 31 countries outside the U.S. The FDA has made no decision as to the safety or efficacy of Sonablate® 450 or 500. In the event the Sonablate® 500 De Novo is granted or 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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Sandra Stein
@SonaCareMedical
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