SonaCare Medical Announces Significant Publication of Focal Therapy Comparison to Radical Therapy
CHARLOTTE, NC, UNITED STATES, January 28, 2021 /EINPresswire.com/ -- SonaCare Medical, LLC, the leading developer and manufacturer of high intensity focused ultrasound (HIFU) technologies, is pleased to report the publication of Focal Therapy Compared to Radical Prostatectomy for Non-Metastatic Prostate Cancer: A Propensity Score-Matched Study(1) just released in Nature. In this analysis, focal therapy and radical prostatectomy were compared using 1-to-1 propensity score-matched for treatment year, age, PSA, Gleason, T-Stage, cancer core length and neoadjuvant hormone use. At 3, 5 and 8 years Failure Free Survival (FFS) for radical prostatectomy was 86%, 82% and 79% compared to 91%, 86% and 83% FFS for focal therapy at the same time intervals. Also, of note the secondary treatment rates were approximately 16% for radical prostatectomy and approximately 17% for focal therapy.
Karen Cornett, Vice President of Clinical Operations, for SonaCare Medical, said, “This propensity matched study comparing radical surgery versus focal therapy, the majority which were treated with Sonablate HIFU, is significant due to how it compared both treatment options. This comparison clearly demonstrates the advantages of the minimally invasive, outpatient, focal therapy over radical surgery. The fact that HIFU patients are only in the medical facility for a few hours and require only a minimal presence of personnel in the operating room make it ideal especially now as we are in the midst of the COVID pandemic.”
The study lead, Professor Hashim Ahmed, one of the world’s most authoritative prostate cancer experts, said, “We know that about 1 in 3 patients who have radical surgery for prostate cancer regret their decision afterwards. Often this is due to not being fully informed of options that carry fewer side-effects. Our study has shown that focal therapy carries up to 10-fold reductions in urine leak and sexual problems. Importantly, for the first time we have shown that it has similar cancer control at 5-8 years after treatment to radical prostatectomy.” He added, “Whilst focal therapy is not suitable for all patients, there are thousands every year who are suitable and they should be fully informed about it.”
(1) Shah, T., Reddy, D., et al. Focal therapy compared to radical prostatectomy for non-metastatic prostate cancer: a propensity score-matched study. Nature. 2021. https://doi.org/10.1038/s41391-020-00315-y
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.
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
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.
Karen Cornett, Vice President of Clinical Operations, for SonaCare Medical, said, “This propensity matched study comparing radical surgery versus focal therapy, the majority which were treated with Sonablate HIFU, is significant due to how it compared both treatment options. This comparison clearly demonstrates the advantages of the minimally invasive, outpatient, focal therapy over radical surgery. The fact that HIFU patients are only in the medical facility for a few hours and require only a minimal presence of personnel in the operating room make it ideal especially now as we are in the midst of the COVID pandemic.”
The study lead, Professor Hashim Ahmed, one of the world’s most authoritative prostate cancer experts, said, “We know that about 1 in 3 patients who have radical surgery for prostate cancer regret their decision afterwards. Often this is due to not being fully informed of options that carry fewer side-effects. Our study has shown that focal therapy carries up to 10-fold reductions in urine leak and sexual problems. Importantly, for the first time we have shown that it has similar cancer control at 5-8 years after treatment to radical prostatectomy.” He added, “Whilst focal therapy is not suitable for all patients, there are thousands every year who are suitable and they should be fully informed about it.”
(1) Shah, T., Reddy, D., et al. Focal therapy compared to radical prostatectomy for non-metastatic prostate cancer: a propensity score-matched study. Nature. 2021. https://doi.org/10.1038/s41391-020-00315-y
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.
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
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.
Karen Cornett
SonaCare Medical
+1 704-805-1885
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