5-year Outcomes Following a HIFU Focal Therapy Study Demonstrate Impressive Disease Control & Low Side Effect Profiles For Prostate Cancer Patients In The U.K.

Charlotte, NC (PR Newswire) July 05, 2018 – SonaCare Medical, the leading developer and manufacturer of high intensity focused ultrasound (HIFU) technologies, is pleased to report 5-year outcomes from a multicenter study following focal therapy treatment with its Sonablate technology of 625 medium to high-risk clinically significant nonmetastatic prostate cancer patients.

With a median five-year follow-up, failure free survival at one, three, and five years was 99%, 92%, and 88% respectively, equivalent to that achieved with surgery. Metastasis-free, cancer-specific, and overall survival at five years was 98%, 100%, and 99% respectively. The study additionally reports that 98% of men maintained pad-free urinary continence after their procedure and 85% maintained erectile function, both material improvements over that seen with surgery and radiation therapy.1

The study concluded that failure free survival with HIFU can be equivalent to that of surgery but with a side effect profile far more beneficial to the patient’s quality of life post-procedure. A recent report from the U.K. on 1,000 patients who underwent a radical prostatectomy found maintenance of pad-free continence at only 65%.2 This suggests that focal HIFU therapy can result in a 97% reduction in the number of men who require pads post-procedure when compared to surgery; ancillary data suggests a similar magnitude reduction in erectile dysfunction with focal HIFU compared to surgery.

"Focal HIFU is a major shift in treating men with early prostate cancer. Our study shows that cancer control in the medium term is very good and importantly, men can expect a low-risk of side effects such as incontinence and erection problems,” states Prof. Hashim Ahmed, Chair of Urology at Imperial College London and contributing author to this study. “All men who are suitable for focal HIFU should be told about this treatment option so they might consider it as an alternative to radical prostatectomy or radiotherapy."

“This is a landmark study in the treatment of medium to high-risk prostate cancer authored by one of the leading clinical research groups in the field,” adds Dr. Mark Carol, CEO of SonaCare Medical. “It encompasses the largest focal treatment patient population to date followed for the longest period of time. Until now, otherwise healthy men with prostate cancer faced the prospect of leaving the hospital after treatment with their cancer treated but with a compromised quality of life. This study shows it is possible to achieve whole-gland equivalent cancer control rates without the concomitant side effect profile of whole gland treatments. Now, otherwise healthy men with prostate cancer can leave the hospital post focal HIFU treatment with their cancer under control yet still healthy. They can even return back to work and activities of daily living the very next day instead of having to wait the weeks required with surgery. This represents a remarkable achievement and a treatment option that should be made available to all men with prostate cancer!”

Since Sonablate® received FDA clearance on October 09, 2015, more than 1,800 patients have had a Sonablate HIFU prostate procedure across the 40+ 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 510(K) clearance in the U.S. and is indicated for the transrectal high intensity focused ultrasound (HIFU) ablation of prostatic tissue. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

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.; 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

COMPANY CONTACT:

SonaCare Medical, LLC

Erica Griffith (704) 936-1834, 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.

1Guillaumier S, et al. A Multicentre Study of 5-year Outcomes Following Focal Therapy in Treating Clinically Significant Nonmetastatic Prostate Cancer. Eur Urol (2018), https://doi.org/10.1016/j.eururo.2018.06.006

2Protopapa E, et al. Truenth UK Post Surgery - Urinary Function in the 1st Post-Operative Year in a 1000 Man Contemporary Radical Prostatectomy Cohort. The Journal of Urology (2018), https://doi.org/10.1016/j.juro.2018.02.1755

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