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US HIFU Announces Name Change To SonaCare Medical

Thu, 02/21/2013 - 5:04pm
The Associated Press

USHIFU, LLC (US HIFU), a global leader in minimally invasive high intensity focused ultrasound (HIFU) technologies, announced today that it has changed the company's name to SonaCare Medical, LLC (SonaCare Medical).

Effective immediately, US HIFU will function as SonaCare Medical and all subsidiaries and operating units, including International HIFU and Focus Surgery, will be rebranded to reflect their relationship to SonaCare Medical.

"The company was renamed SonaCare Medical to better align with our strategic vision of expanding our current HIFU technology to treat a range of urological indications that, like our prostate cancer application, balances both treatment effectiveness and quality of life," said Michael Klein, CEO of SonaCare Medical.  "This also enables us to streamline our global operations and focus our development and regulatory efforts to expand the application of our suite of HIFU technologies, which have been used to treat more than 12,000 patients worldwide." 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.

"The field of urologic oncology has embraced the concept of tissue-sparing approaches to cancer treatment, provided therapeutic efficacy is not compromised," says Mark Schoenberg, MD, Chief Medical Officer at SonaCare Medical. "A critical feature of image-guided surgery is the ability to localize and verify ablation of the therapeutic target in real-time.  The HIFU systems from SonaCare Medical combine three capabilities into one single operating platform; integrated imaging, precision ablation and real-time tissue change validation." 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 raises causing complete cellular necrosis, destroying all targeted tissue while leaving untargeted tissue unharmed.

"Our approach to the thermal ablation market is very unique," says Mark Carol, M.D., Chief Development Officer for SonaCare Medical. "The result is a family of HIFU ablation systems that combine the best aspects of minimally invasive robotic surgery and the treatment planning elements of image guided radiation therapy." SonaCare Medical, through its subsidiary Focus Surgery, Inc., manufactures the HIFU systems. Sonatherm@ laparoscopic HIFU surgical ablation system is 510(k) cleared in the United States. Sonablate@ 450 is approved for investigational use within the U.S. and is being studied in a clinical trial as a possible treatment for recurrent prostate cancer in patients treated previously with external beam radiation therapy.  Sonablate@ 500 has CE Marking, has an installed base of more than 130 systems and is, or has been, approved for use in more than 30 countries outside the U.S. for the treatment of prostate cancer.

"To help fund the continued development of SonaCare Medical's HIFU surgical ablation systems, the completion of our FDA filings and to prepare for the commercialization of new products, the company completed financings totaling $17 million in 2012," Klein added.

"This further validates our market leadership and puts the company in a strong position to achieve our goals of expanding our technology to a wide range of urological indications." 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; Sonablate@500 which has CE Marking and is, or has been, approved for use in more than 30 countries outside the U.S.; and Sonatherm@ which is 510(k) cleared. 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 SonaCareMedical.com.

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