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SonaCare Medical Granted FDA Regulatory Clearance for Updated HIFU Prostate Tissue Ablation Device

CHARLOTTE, N.C., Jan. 11, 2017 /PRNewswire/ -- SonaCare Medical, leading developer and manufacturer of high intensity focused ultrasound (HIFU) technologies, reports receipt of 510(k) regulatory clearance to market its latest version of Sonablate® in the United States. Sonablate was the first HIFU device to receive regulatory authorization from the Food and Drug Administration (FDA) for the focused ablation of prostate tissue.

This improved version of Sonablate technology includes new and updated features such as: Tissue Change Monitoring (TCM™), a tool that quantifies RF signals for changes in tissue composition following energy delivery; altered delivery sequences that, in combination with a new and more automated planning system, reduces overall procedure time by as much as 40%; and a modernized look and feel to the software interface. 

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"We worked diligently with the FDA to provide clinical data consistent with the requirements established in the de novo authorization SonaCare Medical received for Sonablate in 2015," comments Dr. Mark Carol, Chief Executive Officer. "We are appreciative of the efforts of the FDA to continue to advance the delivery of care for men who may benefit from prostate tissue ablation. Based on the adoption rates of Sonablate in the U.S. in 2016, we expect the placements and acquisitions of our technology to grow dramatically in 2017, bringing this ground-breaking approach to a greater percentage of men in the U.S."

Since Sonablate® received FDA clearance on October 09, 2015, there have been over 40 acquisitions of Sonablate® technology, including placements at top-tier academic institutions located in California, Indiana, Maryland, New York, and Texas.  Over 43 U.S. physicians now offer HIFU prostate tissue ablation to their patients, and over 700 U.S. patients have selected this minimally-invasive alternative to surgery or radiation.

About SonaCare Medical, LLC

SonaCare Medical is a world leader in minimally invasive focused ultrasound technologies. SonaCare Medical is committed to developing focused ultrasound related technologies that support precise and innovative procedures for the treatment of a range of medical conditions. SonaCare Medical, with its subsidiary Focus Surgery, Inc., designs and manufactures medical devices, including the following: Sonablate®, which has 510(K) clearance in the U.S. under a De Novo regulatory classification; Sonablate® 500, which has CE Marking and has obtained regulatory authorization in more than 49 countries outside the U.S.; Sonatherm® laparoscopic HIFU surgical ablation system, which has 510(K) clearance in the U.S., has CE Marking and has obtained regulatory authorization in more than 30 countries outside the U.S.

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Forward Looking Statements.
The Company's forward-looking statements are based on management's current expectations and assumptions regarding the Company's business and performance, the economy and other future conditions and forecasts of future events, circumstances and results. As with any projection or forecast, forward-looking statements are inherently susceptible to uncertainty and changes in circumstances. The Company's actual results may vary materially from those expressed or implied in its forward-looking statements. Any forward-looking statement made by the Company speaks only as of the date on which it is made. The Company is under no obligation to, and expressly disclaims any obligation to, update or alter its forward-looking statements, whether as a result of new information, subsequent events or other factors.

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