SonaCare Granted Broad CE Mark for Sonatherm and Sonablate HIFU Device

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New certification allows SonaCare to market the world’s first and only focused ultrasound ablation system platform

SonaCare Medical, a leader in minimally invasive high intensity focused ultrasound (HIFU) technology, announced today that it has received new broad CE Mark Certification for both its Sonatherm and Sonablate High Intensity Focused Ultrasound (HIFU) devices. The new CE Mark is for the design and manufacture of imaging and therapeutic ultrasound devices for imaging, planning, energy delivery and ablation tracking in support of soft tissue ablation. According to Dave Hernon, Director of Quality Assurance & Regulatory Affairs at SonaCare, “The new CE Mark represents an important regulatory expansion compared to the Company’s current regulatory approval and further differentiates SonaCare as the only HIFU manufacturer with this broad degree of certification.”

Mark Carol, M.D., Chief Executive Officer for SonaCare Medical, is very excited about this news. “Although we may need clinical evaluations to help validate the use of our devices for any given indication, the new CE Mark allows physicians to explore using Sonablate and Sonatherm to ablate any benign or malignant tissue they deem clinically appropriate, such as skin, breast, thyroid, prostate, pancreas, liver, kidney, via whatever path they deem desirable, including transrectal, invasive, transoral, and extracorporeal. Over the past couple of years we have seen a growing number of customers who want to see our HIFU technology used not just in urology, where it has had its first clinical use, but throughout the hospital. We believe this certificate gives us the green light to begin and/or advance these discussions.”

SonaCare’s HIFU platform consists of the Sonasource transportable console, the Sonachill water degassing/circulation unit, and two attachable probes, Sonatherm and Sonablate. The Sonatherm laparoscopic probe uses HIFU energy to ablate from the ultrasound focal point back to the surface of the targeted tissue. The 11mm probe is equipped with a robotic transducer that can both image using ultrasound and treat using ultrasound and is introduced through a standard 12 mm surgery access port. An easy-to-use intuitive single screen control interface is used to plan and monitor imaging and therapy. Unlike many other forms of thermal ablation, Sonatherm does not require puncturing the target with a needle which can cause bleeding. A number of published studies evaluating the ability of Sonatherm to deliver laparoscopic HIFU in the treatment of kidney cancer have shown strong clinical results. Sonatherm is the only HIFU system that is FDA 510(k) cleared for the laparoscopic or intraoperative ablation of soft tissue.

Sonablate received CE Marking in 2001 for the transrectal treatment of prostate cancer and has been used in more than 30 countries outside the U.S. for treatment of primary, salvage and focal prostate cancer. More than 100 systems have been installed worldwide and doctors have treated over 12,000 patients with Sonablate. Similar to Sonatherm, Sonablate uses a robotic driven transducer equipped with dedicated imaging and treatment capabilities. Each Sonablate HIFU beam treats a precisely defined portion of the targeted tissue. As each acoustic wave propagates through the tissue it is absorbed and converted to heat causing desired tissue damage. The entire target is treated by the robotic movement of the transducer according to a protocol designed by the physician.

“What’s unique about Sonablate is its ability to ablate precisely only the targeted area while sparing both intervening and surrounding tissue,” said Dr. Carol. “This means Sonablate can ablate across the skin surface (extracorporeal) or from outside an organ though a natural orifices. Additionally, Sonablate can ablate either a small foci of tissue or an entire region of interest. By combining the elegance and versatility of Sonablate with the speed and power of Sonatherm, SonaCare has developed a true platform capability with the potential to become an institution-wide system of care that will significantly impact not just a single surgical division, such as urology, but the entire surgical services branch of a hospital.”

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 48 countries outside the U.S.; and Sonatherm® laparoscopic HIFU surgical ablation system which is 510(k) cleared in the U.S., has CE Marking and is approved in 31 countries outside 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.

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Sandra Stein
@SonaCareMedical
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