Press Releases

Multiple Articles Highlight the Benefits of Partial Gland Prostate Ablation Using Sonablate

Charlotte, NC Nov 07, 2019 – SonaCare Medical, the leading developer and manufacturer of high intensity focused ultrasound (HIFU) technologies, is pleased to report the publication of multiple articles highlighting the benefits of its technology when used in the partial ablation of the prostate. 

Three articles have appeared in press within the past 18 months, based on clinical trials undertaken in the U.K., that highlight the medium to long-term durability of Sonablate treatments in the control of prostate cancer when used in the partial gland ablation setting.1,2,3  Across the three articles and a total of more than 1,800 men, salvage free survival (no need for a whole gland or systemic treatment) was greater than 90% out as far as 60 months.  This excellent disease control was accompanied by a pad-free incontinence rate of greater than 98% and maintenance of erectile function in more than 80% of men. An additional article based on Canadian experience produced roughly similar results. 14

“While few will continue to question the benefit of partial gland ablation with HIFU over more conventional treatments such as surgery and radiation therapy when it comes to side effect profile, these studies, authored by leaders in the field, continue to put to rest the concern that partial gland HIFU ablation in general is not a durable procedure,” writes Dr. Mark Carol, CEO of SonaCare Medical.  “Studies featuring Sonablate continue to produce the best disease control and side effect profiles of any prostate ablation technology. Internal reports indicate that these same excellent outcomes are being experienced among men treated in the U.S., with a number of short-term studies by U.S. clinicians being prepared for publication.  Each of these studies demonstrate definitively that 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

Gwen Ross (704) 805-1887, 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

2Stabile et al. “Medium -term oncological outcomes in a large cohort of men treated with either focal or hemi-ablation using high-intensity focused ultrasonography for primary localized prostate cancer”. BJU 12 Feb 2019
https://www.ncbi.nlm.nih.gov/pubmed/30753756/

3Johnston MJ et al. Urology. 2019 Aug 23 (19)30730-7. Focal High-intensity Focused Ultrasound Partial Gland Ablation for the Treatment of Localised Prostate Cancer: A Report of Medium-term Outcomes From a Single-center in the United Kingdom.”

4Bass et al. Oncologic and Functional Outcomes of Partial Gland Ablation with High Intensity Focused Ultrasound for Localized Prostate Cancer. 2019; 201:113-119
https://www.ncbi.nlm.nih.gov/pubmed/30577402

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