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SonaCare Medical to Introduce Two New HIFU Products at the European Association of Urology (EAU) Congress

Thu, 03/14/2013 - 2:45pm
The Associated Press

SonaCare Medical, LLC (SonaCare Medical), a leader in minimally invasive high intensity focused ultrasound (HIFU) technologies, will showcase two new HIFU products at the 28th annual European Association of Urology (EAU) Congress, in Milan, Italy, March 15-19, 2013.  (Booth: G02) SonaCare Medical, which recently changed the company's name from US HIFU as part of its' global growth strategy, experienced a record 230 percent increase in international sales in 2012 and tripled its international distributors.  To address the growing adoption of HIFU, SonaCare Medical's strategic technology vision is to provide a suite of urology devices utilizing HIFU to treat a wide range of urologic indications.

"We are seeing growing interest in our HIFU technology around the world, especially in Europe," says Michael Klein, CEO of SonaCare Medical. "Last year we achieved record breaking sales in our international division more than doubling the number of systems sold in the prior year. Today SonaCare Medical has an installed base of more than 100 systems, which have been used to treat 12,000 patients worldwide." The company's flagship product, Sonablate@ 500 has been completely retooled to include a sleeker, more modern mobile console and a redesigned software platform featuring new treatment planning and enhanced simulation capabilities that significantly reduce planning time and expands the physician's functionality for whole-gland, focal and salvage prostate treatments. The new Sonablate 500 comes with two high frequency robotic transrectal probes, each equipped with a dedicated imaging transducer (6.3 MHz) and dual split beam treatment transducers (4.0 MHz.). The new Sonablate 500 also includes an upgraded Sonachill@ unit for water degassing, circulation and cooling.

For the first time ever, SonaCare Medical will also exhibit the new Sonatherm@ HIFU Surgical Ablation System, which is 510(k) cleared in the U.S. for laparoscopic or intraoperative soft tissue ablation.

Sonatherm uses HIFU energy to ablate a wide variety of soft tissues from the ultrasound focal point back to the surface of the targeted tissue. The Sonatherm system comes with a state-of-the-art mobile console, two high frequency robotic 12mm laparoscopic probes, each equipped with multiple transducers that image (6.5 MHz) and treat (4.0 MHz) along with Sonachill for water degassing and circulation.

"One of the key drivers for the growing interest in HIFU is the shift towards minimally invasive approaches to treating prostate cancers," says Mark Carol, M.D., Chief Development Officer for SonaCare Medical.

"While research continues, clinical support for HIFU has been bolstered by a growing body of data such as the results from the UK Focal Therapy Study published in Lancet Oncology along with findings from a leading roundtable of international prostate cancer experts who reviewed both focal technologies and the latest research evaluating focal lesion diagnosis and treatment, published in the European Urological Review." "With significant research being presented here and international interest in HIFU at an all-time high, the EAU will be an important event for the company," says Alex Gonzalez, Vice President of International Operations, SonaCare Medical. "In addition to launching our two new systems, we have important meetings planned with existing European HIFU users and leading European KOL physicians along with meetings set with most of our 17 new international distributors." SonaCare Medical's vision is to develop HIFU surgical ablation systems for a wide range of urological indications, in addition to prostate cancer, that allows for tissue targeting techniques. SonaCare Medical's HIFU surgical systems are the only ablative technologies to utilize T3 TechnologyT, which enables physicians to: target selected tissue with customized planning and sophisticated localization tools; treat targeted tissue accurately and reliably with robotic precision, while sparing tissue outside the ablation zone; and track the HIFU procedure with advanced real-time ultrasound imaging and unique tissue monitoring technologies.

SonaCare Medical's proprietary HIFU systems deliver therapy that destroys targeted tissue with rapid heat elevation. HIFU concentrates high frequency ultrasound waves from a transducer (which focuses sound much like a magnifying glass focuses light) into a small ablation zone. At the ablation zone, the temperature rapidly increases causing complete cellular necrosis, destroying all targeted tissue while leaving untargeted tissue unharmed.

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.

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