SonaCare Medical to Launch FDA-Cleared Sonatherm® HIFU Surgical Ablation System at American Urology Association (AUA) Annual Meeting Sonatherm is the Only Laparoscopic HIFU Device Cleared for Ablating Soft Tissue in the U.S.
CHARLOTTE, N.C., May 2, 2013 /PRNewswire/ -- SonaCare Medical, a leader in minimally invasive high intensity focused ultrasound (HIFU) technology, announced today that it will launch the FDA-Cleared Sonatherm® HIFU Surgical Ablation System at the the 108th Annual Meeting of the American Urological Association (AUA), in San Diego, May 4-8, 2013 (booth #3611).
A state-of-the-art laparoscopic HIFU surgical ablation system, Sonatherm is the only HIFU system 510(k) cleared for the laparoscopic or intraoperative ablation of soft tissue. 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 consists of a transportable console, two high frequency robotic 11mm laparoscopic probes, each equipped with multiple robotic transducers that image (6.5 MHz) and treat (4.0 MHz), along with Sonachill for water degassing and circulation. A number of published studies evaluating the ability of Sonatherm to deliver laparoscopic HIFU in soft tissues of the kidney have shown strong clinical results.
"Sonatherm overcomes the difficulties that other ablative technologies have in delivering energy into the desired target by combining ultrasound imaging and therapeutic focused ultrasound into a single unit that can be introduced through a standard 12 mm surgery access port, with an easy-to-use intuitive single screen control interface," said Mark Carol, M.D., Chief Development Officer for SonaCare Medical. "Unlike other forms of thermal ablation, Sonatherm does not require puncturing the target with a needle, which can cause bleeding. It is the only ablation system capable of using integrated ultrasound imaging for targeting and monitoring of the treatment. Sonatherm uses the same skill sets urologists have been practicing for decades and can be applied to a wide range of clinical conditions."
During the AUA, physicians will be able to plan treatments at a unique simulator workstation showcasing Sonatherm's ability to ablate a cubic centimeter of tissue per minute, with +/- 1mm precision. Attendees will also be able to see prototypes of new technology for the application of HIFU in bladder tissue, along with demonstrations of the SmartTarget software for fusing prostate MRI and real-time ultrasound images. Additionally, physicians can interact with the company's new prototype technology platform, designed to support a variety of HIFU probes for multiple urologic indications across a range of clinical settings, including hospitals, surgical centers and physician's offices.
The company will showcase the Sonablate® 500 surgical ablation system, which has been retooled to include a sleeker, more modern transportable 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. Sonablate 500 has CE Marking and is, or has been, approved for use in more than 30 countries outside the U.S. The company is currently conducting a FDA PMA clinical trial in the United States to determine the safety and efficacy of Sonablate® 450 to treat recurrent prostate cancer.
At the AUA, SonaCare Medical will conduct three HIFU advisory board meetings focused on bladder, prostate and renal, with key opinion leaders (KOLs) from top clinical centers around the United States. According to Michael Klein, CEO at SonaCare Medical, "we are very pleased with the number of top tier KOLs from a variety of urology disciplines that have agreed to participate in the advisory board meetings and look forward to sharing SonaCare Medical's urology platform vision and getting their input to help guide our clinical research and technology development priorities."
SonaCare Medical's vision is to develop HIFU surgical ablation systems for a wide range of urological indications, in addition to prostate cancer, that allow for tissue targeting techniques. Sonatherm, like Sonablate 500, is powered by the unique T3 Technology, which allows physicians to: target specific tissue using integrated ultrasound imaging and sophisticated planning tools, treat targeted tissue with pinpoint accuracy while sparing untargeted tissue; and track procedure results using real-time ultrasound imaging along with advanced tissue change monitoring software.
"Sonatherm generated significant interest at the recent European Association of Urology meeting from laparoscopic and robotic users alike and the response we've received from urologists has been extremely positive with great excitement about adding it to their practices," said Alex Gonzalez, Vice President of International Operations for SonaCare Medical. "As the only laparoscopic HIFU device cleared by the FDA for the ablation of soft tissue in the U.S., we are very excited to launch Sonatherm during the AUA."
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