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SONACARE MEDICAL ANNOUNCES THE LARGEST U.S. PUBLICATION ON FOCAL THERAPY USING SONABLATE HIFU

SONACARE MEDICAL ANNOUNCES THE LARGEST U.S. PUBLICATION ON FOCAL THERAPY USING SONABLATE HIFU

Sonablate® HIFU used in first U.S study on focal therapy since FDA clearance

Charlotte, NC (Press Release Company) [November 17, 2020] – SonaCare Medical, LLC, the leading developer and manufacturer of high intensity focused ultrasound (HIFU) technologies, is pleased to announce that the results of a recent study primarily utilizing Sonablate HIFU technology to treat prostate cancer have been published by the Journal of Urology. The manuscript was published in the October edition of the Journal of Urology and features data from both the University of Southern California and Urology Specialists of the Carolinas’ Dr. Samuel Peretsman.   

The publication entitled, High Intensity Focused Ultrasound Hemigland Ablation for Prostate Cancer: Initial Outcomes of a United States Series details the study of 100 men with biopsy-confirmed prostate cancer, 72% of which were classified with intermediate or high-risk disease. Between December 2015 and December 2019, all 100 men underwent hemi-gland ablation with HIFU as a primary treatment for prostate cancer. At two years, 91% of the participants had avoided radical treatment. Additionally, there were no major complications, and no rectal fistulas occurred. The study also found that urinary symptoms returned to near baseline questionnaire scores within 3-6 months and baseline sexual function was achieved by 12 months1.

“The outcomes in our series are consistent with those published by other Sonablate HIFU users in Europe," said Dr. Samuel Peretsman, a urological oncologist in Charlotte, NC. “We have worked in a collaborative fashion for over 13 years to refine the nuances of the diagnostic pathway. This now includes multiparametric MRI (mpMRI) and precision guided biopsy to create a fully customizable treatment (HIFU),” said Peretsman. “Our team at Urology Specialists of the Carolinas have been at the forefront of providing patients the full complement of prostate cancer treatment options. HIFU has allowed us to preserve patient defined quality of life, including uncompromised urinary continence and excellent sexual function, with adequate cancer control” he added.

“It is fantastic to see consistently good results in different jurisdictions, amongst different patient groups and with different operators.  It is a fact that with many new treatments we see considerable variability in outcome.  This does not appear to be the case using the Sonablate platform for men with prostate cancer.  These results show that men will stay continent, maintain their sexual function and obtain superior oncological outcomes in the many centers of excellence that now exist for this technology”, stated Professor of Interventional Oncology, Mark Emberton, who is Dean of Faculty at University College London and who has pioneered the use of Sonablate HIFU for focal therapy.  

Since Sonablate® received FDA clearance on October 9, 2015, many thousands of patients have had a Sonablate HIFU prostate procedure across the 60+ locations in the U.S., including top-tier academic institutions in California, Indiana, Oklahoma, Maryland, New York, Arizona and Texas. Over 70 U.S. physicians now offer HIFU prostate tissue ablation to their patients as a minimally invasive alternative to surgery or radiation.

Sonablate® has 501(K) clearance in the U.S. and is indicated for the transrectal high intensity focused ultrasound (HIFU) ablation of prostate tissue. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

1 Abreu, A.L., Peretsman, S., Iwata, A., Shakir, A., Iwata, T., Brooks, J., Tafuri, A.A., Park, D., Cacciamani, G.E., Kaneka, M., Duddalwar, V., Aron, M., Palmer, S., & Gill, I.S. (2020). High Intensity Focused Ultrasound Hemigland Ablation for Prostate Cancer: Initial Outcomes of a United States Series. The Journal of Urology, 204(4). https://doi.org/10.1097/JU.0000000000001126

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 501(K) clearance in the U.S.; Sonablate®500, which has CE Marking and has obtained regulatory authorization in more than 50 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 www.SonaCareMedical.com

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SonaCare Medical, LLC

Karen Cornett (704) 657-6278 This email address is being protected from spambots. You need JavaScript enabled to view it.

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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