SonaCare Medical to collaborate with Invivo on using MRI Fusion Software with Sonablate 500 System

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New fusion collaboration adds additional compatibility for magnetic resonance / Sonablate ultrasound fusion for prostate HIFU planning

Today SonaCare Medical (SCM), a world leader in minimally-invasive high intensity focused ultrasound (HIFU) technologies, announced plans to work towards a collaboration with Invivo Corporation, a worldwide leader in the development and manufacture of magnetic resonance imaging (MRI) clinical solutions, to use Invivo software to fuse a preoperative magnetic resonance imaging dataset with an intraoperative ultrasound dataset generated by SCM’s transrectal Sonablate prostate ablation system. The combination would expand the options Sonablate physicians have to use MR guidance to target precisely areas in the prostate slated for ablation.

According to Mark Carol, M.D., CEO of SonaCare, “Fusing MR images with live ultrasound images allows intraoperative identification and targeting of regions of the prostate not ordinarily seen under operative ultrasound. This process of image fusion provides an improved ability for urologists to plan and target more precisely specific regions of prostate tissue. Adding fusion technology to the ablative capabilities of Sonablate makes it easier for tissue-preserving options, such as focal therapy, to be applied to the prostate. We are pleased to have gained another top quality fusion strategic partner in Invivo in order to enhance further the treatment experience for physicians and patients.”

Studies have shown multi-parametric MRI to be an accurate method for identifying regions of abnormal prostate tissue. An annotated and segmented preoperative multi-parametric MRI dataset can be used to guide a targeted biopsy by fusing the MRI to an intraoperative ultrasound dataset generated at the time of biopsy. Adding this same fusion functionally to Sonablate allows an ablation to be targeted in a similar manner, a step considered by many urologists to be critical for the delivery of minimally invasive, tissue preserving, or focal, prostate ablations.

“We look forward to providing Sonablate customers with the best technology available for image visualization and analysis," said Thomas Tynes, Senior Director, Strategy & Business Development at Invivo Corporation. “Today, several hundred Healthcare facilities around the world are using Invivo’s integrated portfolio of Prostate Oncology Solutions to better visualize and diagnose prostate cancer early. This includes our market-leading DynaCAD advanced prostate visualization and analysis software along with our most recent addition – the UroNav Fusion Biopsy System. With the growing adoption of Invivo’s Prostate Oncology Solutions and increasing interest in prostate focal therapy, we feel that our mutual customers would benefit greatly from the use of our MRI/US fusion software with the Sonablate 500. The addition of Invivo’s fusion software is a natural next step to creating a truly integrated, MRI/US solution to better support and guide the treatment of prostate cancer.” said Mr. Tynes.

About Sonablate 500
Sonablate® 500 has CE Marking and is, or has been, approved for use to treat prostate cancer in more than 49 countries outside the U.S. and is pending De Novo submission review by the FDA.

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 49 countries outside the U.S. and is pending De Novo submission review by the FDA; and Sonatherm® laparoscopic HIFU surgical ablation system which is 510(k) cleared in the U.S., has CE Marking and is approved in more than 30 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 the Sonablate® 500 De Novo is granted or 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
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