CHARLOTTE, N.C., May 2, 2013 /PRNewswire/ -- SonaCare Medical, a global leader in minimally invasive HIFU technologies, announced today that it has partnered with University College London (UCL) to create a HIFU Center of Excellence. The Center of Excellence will provide physician training and proctoring along with clinical studies, patient satisfaction research and advanced technology development associated with two innovative HIFU systems: the Sonatherm® laparoscopic HIFU surgical ablation system and the Sonablate® 500 transrectal HIFU surgical ablation system.
According to Mark Emberton , MD, Director of the Division of Surgery and Interventional Science, University College London, "Our collaboration with SonaCare Medical's innovative technology provides a great platform for us to help expand the use of HIFU in a responsible and effective way. Tissue preserving strategies have been used successfully in other solid organ cancers, such as kidney cancer with great results. Published results from our practice continue to demonstrate that focal therapy delivers good cancer control along with a significant reduction in treatment side effects, which suggests a new option in a spectrum of prostate cancer care that, based on risk profile, can effectively balance clinical benefits and quality of life.
"The highly precise Sonablate 500 HIFU transrectal system has already proven an effective way to transition from treating the entire prostate to treating only the known prostate cancer and the addition of the Sonatherm® laparoscopic system allows us to offer an important new minimally invasive option for certain tumors," added Dr. Emberton.
UCL researchers presented multiple abstracts highlighting the ability of HIFU to balance disease control and quality of life at the recent European Association of Urology (EAU) Congress, including ongoing results from the UK Focal Therapy Study published in Lancet Oncology (DOI:10.1016/S1470-2045(12)70121-3). In this study "Focal Therapy Targeted to the Index Lesion in Multifocal Prostate Cancer: a Prospective Development Study," UCL researchers evaluated the outcomes in men with multi-focal disease in which patients received focal HIFU therapy delivered to clinically significant cancer lesions using the Sonablate 500, developed by SonaCare Medical. Results showed that no biopsy evidence of cancer was identified in the treated regions in 60 percent of men and 83 percent were free of clinically significant cancer. The trifecta rate, which was defined as pad-free leak-free continence, erections sufficient for intercourse, and absence of clinically significant disease at 12 months, was achieved by 87 percent of men who completed the study.
"Europe has a long history of using HIFU to treat a range of clinical conditions. SonaCare Medical is extending the reach of HIFU for multiple urologic indications, including laparoscopic ablation of the kidney, transrectal ablation of the prostate and transurethral ablation of the bladder," said Mark Carol , M.D., Chief Development Officer for SonaCare Medical. "We look forward to working with UCL to validate these approaches and to introduce them into the European markets."
UCL previously reported on the use of HIFU to treat the entire half of the prostate where cancer was found. That study also showed similar reduction in side-effects and encouraging early cancer control. In the focal HIFU study, researchers wanted to evaluate whether damage to healthy tissue could be further reduced by treating only the specific cancer sites in one or both sides. Results suggest that after focal therapy men have a 9 in 10 chance of achieving excellent clinical results at 12 months with no urine leakage, good erections and no imaging evidence of disease.
"SonaCare Medical has partnered with UCL for many years to provide physician training and to support UCL's ground-breaking research in the field of HIFU. We have tremendous respect for the clinical and academic leadership Dr. Mark Emberton and his team at UCL has brought to the field of HIFU and the diagnosis and minimally invasive treatment techniques for prostate cancer. We are proud to formalize this long-term relationship through the creation of this important HIFU Center of Excellence designed to support further clinical and technical advances," said Michael Klein , CEO for SonaCare Medical.
About SonaCare Medical
SonaCare Medical, a privately held, venture-backed healthcare company is a world leader in minimally invasive high intensity focused ultrasound (HIFU) technologies. SonaCare Medical is committed to developing technologies for urological indications that offer precise and innovative procedures that can control cancer and reduce potential quality of life altering side effects. SonaCare Medical, with its subsidiary Focus Surgery, Inc., designs and manufactures high intensity focused ultrasound (HIFU) medical devices, including the following: Sonablate® 450 which is investigational in the U.S. and being studied in a pivotal FDA clinical trial as a possible treatment for recurrent prostate cancer in patients treated previously with external beam radiation therapy; Sonablate® 500 which has CE Marking and is, or has been, approved for use to treat prostate cancer in more than 30 countries outside the U.S.; and Sonatherm® laparoscopic HIFU surgical ablation system which is 510(k) cleared in the U.S. The FDA has made no decision as to the safety or efficacy of Sonablate® 450 or 500. In the event Sonablate® 450 is approved by the FDA for use in the U.S., there is no assurance that instructions for use or the specifications of the device will be the same for treatment approved or authorized in other countries outside of the U.S.
SonaCare Medical was founded in 2004 and is headquartered in Charlotte, N.C. Additional information may be found at www.SonaCareMedical.com.
|SOURCE SonaCare Medical|
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