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SonaCare Medical Paves the Way with the First HIFU Device Cleared by the FDA for Prostate Tissue Ablation - A Year in Review

Charlotte, NC (PR Newswire) Oct 5th, 2016,  SonaCare Medical, leading developer and manufacturer of High Intensity Focused Ultrasound (HIFU) Technologies, reports over 40 acquisitions of Sonablate® technology since the device received FDA clearance on October 09, 2015.

This Sunday marks the 1-year anniversary of the Food and Drug Administration's decision to clear Sonablate for sale and use inthe United States for the ablation of prostate tissue. Within its first year in the U.S. market, 43 physicians have started offering Sonablate as an alternative to surgery or radiation, and 10 more doctors are in the process of completing their training.

As a core strategic initiative, SonaCare Medical has established a significant presence among top-tier academic institutions across the United States including respected universities located in California, Indiana, Maryland, New York, and Texas. Their adoption of Sonablate for tissue ablation has not only validated the utility of Sonablate technology in addressing the prostate but has also created a unique teaching and training environment for the next generation of urologists.

"Urologists at these institutions have done their research and clearly appreciate the versatility of the technology and the international studies, demonstrating successful clinical outcomes for over 10 years," comments Kevin Alverson, Vice President of Sales. "Our dominant presence in the U.S. HIFU prostate ablation market, and notably at academic centers within the United States, speaks a great deal to the caliber of physicians at these institutions. We are proud to work with doctors who clearly value patient safety, quality of life, and clinical outcomes."

SonaCare Medical attributes much of its success in the prostate tissue ablation market to several unique Sonablate software features, including the use of MRI/US fusion to precisely target regions slated for ablation. In addition, Sonablate provides the feedback data required by the physician to assess how the prostate is responding to energy deposition, and the tools required to modify that energy to achieve complete ablation. These multiple and unique features all play a role in providing the accuracy, consistency, and safety required for the delivery of focused ultrasound energy into the prostate.

Sonablate was the first device to receive regulatory authorization from the FDA for the focused ultrasound ablation of prostate tissue. Since its introduction over 15 years ago, Sonablate technology has been used around the world on 15,000 patients in over 30 countries, including approximately 4,000 U.S. men who have had this procedure performed outside the U.S.

About SonaCare Medical, LLC

SonaCare Medical is a world leader in minimally invasive focused ultrasound (HIFU) 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.


SonaCare Medical, LLC

Erica Griffith (704) 936-1834, This email address is being protected from spambots. You need JavaScript enabled to view it.

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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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