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SonaCare Medical, LLC reports continued growth in sales of high intensity focused ultrasound ablation devices in Europe

May 27, 2014

CHARLOTTE, N.C., May 27, 2014 /PRNewswire/ — Medical device manufacturer SonaCare Medical reports continuing strong European sales as well as a positive outlook in light of official guideline changes for prostate cancer therapy. The company has further invested in the European market by adding its newest generation high intensity focused ultrasound (“HIFU”) equipment to the HIFU center of excellence at University College of London.

Following a strong 2013 with six thermal ablation device sales outside of the U.S., SonaCare Medical has sold four Sonablate® 500 HIFU devices since the beginning of the year. Two units were sold in Mexico, one in Switzerland, and a fourth was purchased for a prestigious top tier urology center in Moscow.

In addition, a new Sonablate® 500 has been placed at University College of London Hospital with Professor Mark Emberton’s team of urologists. Professor Emberton along with Dr. Hashim Ahmed, Dr. Caroline Moore and Dr. Manit Arya lead global research in HIFU therapy for prostate cancer, having published some of the most important articles on the topic. The newest generation of Sonablate® 500 allows users to add MRI / ultrasound fusion software for treatment planning with the assistance of MRI imaging. The new fusion feature combined with the Sonablate® 500 Tissue Change Monitoring, which tracks changes in tissue, helps physicians to better ensure full tissue necrosis in targeted areas.

“While Europe has always been a strong market for our technology we have recently been experiencing a surge in volume,” states SonaCare Medical’s VP of International Operations Alex Gonzalez. “For one, the European Association of Urology (“EAU”) has included HIFU in its Guidelines for 2014, which is a huge step towards setting up reimbursement in additional European countries. Additionally, the introduction of our multi-modality platform that includes both our transrectal and laparoscopic treatment probes is impacting demand. Hospitals can now draw on the benefits of HIFU across multiple surgical disciplines, which also leads to an even better return on their investment.”

Dr. Mark Carol, MD, Chief Development Officer at SonaCare noted: “We enjoyed talking to leading physicians at the recent EAU conference in Stockholm, Sweden. The feedback clearly indicates a continuously growing adoption of what we call SonaSurgery, or sound medicine, driven by positive clinical research results, advances in our technology as well as the new EAU guidelines, which will only broaden and enhance the European HIFU market. As the technology leader we continue to work with leading research institutions to grow our HIFU probe portfolio and provide surgeons with the most powerful minimally invasive ablation tools.”

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. www.SonaCareMedical.com.

SOURCE SonaCare Medical


Source: PR Newswire



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