SonaCare Medical's Sonablate® HIFU Used in First Academic U.S. Location at the University of Southern California

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Sonablate® continues to gain momentum as the preferred prostate tissue ablation device in the United States

Sonablate trans-rectal HIFU probe
"FDA clearance of HIFU represents a tremendous milestone for the urology community." - Dr. Inderbir Gill

SonaCare Medical, LLC announces that Dr. Inderbir Gill performed two Sonablate® prostate tissue ablation procedures yesterday, December 10th, at Keck Medicine of USC. With the launch of University of Southern California’s urologic HIFU program, Keck Medicine of USC becomes the first academic medical center in the United States to provide this pioneering technology since the FDA granted Sonablate® de novo clearance this past October for the ablation of prostate tissue.

Dr. Inderbir S. Gill, Chairman and Professor for the Catherine and Joseph Aresty Department of Urology, is the Founding Executive Director of the University of Southern California’s Institute of Urology and Associate Dean for Clinical Innovation. An internationally recognized leader in the field of robotic surgery for urologic cancers, his team has one of the world’s largest experiences in the use of minimally invasive excisional and ablative therapies for the treatment of prostate and kidney cancer. Dr. Inderbir Gill comments, “FDA clearance of HIFU represents a tremendous milestone for the urology community. We are delighted to be the first academic department in the U.S. to treat patients on a routine basis with the Sonablate® device. We look forward to helping appropriate patients by using this groundbreaking technology, and seek to advance the field and open new horizons for focal prostate ablation procedures.”

Focal ablation is an emerging technique where only a small volume of prostate tissue is targeted for ablation, rather than half or the entire prostate gland. By targeting and ablating a limited amount of tissue within the prostate gland, a patient’s likelihood of experiencing adverse events is decreased, thereby preserving their quality of life. Sonablate® has a range of tools, including image fusion, automatic margin based planning, dual focal depth transducers, and Tissue Change Monitoring (TCM), that make it suited ideally for this form of ablation.

According to Dr. Mark Carol, CEO of SonaCare Medical, “Dr. Gill is recognized around the world as one of the pioneers in ablative therapy. His interest in focal ablation of the prostate and other urologic organs, along with the capabilities of the Sonasource™ system, upon which Sonablate® is based, should provide fertile ground for the development of novel ways to deliver and apply ablative therapy in urology. It is an honor for SonaCare Medical to have Dr. Gill be the first academic surgeon since our de novo grant to use our technology.”

Sonablate® is 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 nearly 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 high intensity 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.

For additional information, visit http://www.SonaCareMedical.com

COMPANY CONTACT:
SonaCare Medical, LLC
Erica Griffith (704) 936-1834, EricaGriffith(at)SonaCareMedical.com

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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Erica Griffith
@SonaCareMedical
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