CHARLOTTE, NC. Friday, March 20, 2015 -- Today SonaCare Medical announced that the Company has filed with the FDA a submission for a De Novo grant of its Sonablate® 500 HIFU system for the transrectal ablation of prostatic tissue. This submission is in addition to the Company's Pre-Market Approval ("PMA") application and study which it is continuing to pursue. The De Novo process was first introduced in 1997, with the implementation of the FDA's Modernization Act (FDAMA), as a means to reclassify novel medical devices of low to moderate risk profiles that were automatically deemed Class III because no substantially equivalent devices existed to merit a successful 510(k) submission.

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

CHARLOTTE, NC. Monday, March 16, 2015 -- 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."

University of Southern California's Keck Hospital first to perform renal HIFU ablation in outpatient setting

SonaCare Medical announces that doctors at the University of Southern California (USC) have successfully used the new Sonatherm robotic High Intensity Focused Ultrasound (HIFU) technology to ablate renal cancer at Keck Hospital of USC. Dr. Inderbir Gill, MD, MCh founding executive director, USC Institute of Urology, and Chairman and Professor, Catherine and Joseph Aresty Department of Urology at the Keck School of Medicine of USC, performed this HIFU procedure, which was the first in the world in an outpatient setting.

SonaCare Medical Board of Directors to Include Members with Extensive Health Care and Executive Business Management Experience

CHARLOTTE, NC -- SonaCare Medical, a leading manufacturer of medical High Intensity Focused Ultrasound (HIFU) devices, announced today that five new members have been selected to serve on the company's Board of Directors. The new members bring additional health care industry experience to the Board and include a physician and hospital CEO, a president of multiple medical companies, two founders of investment firms, and SonaCare Medical's newly appointed CEO. The new Board members are Evan Bakst, Dr. Mark Carol, David Koslosky, Dr. Bruce Murphy, and Dr. John Wilkerson. They join the Chairman of the Board, Thomas Mendell, along with Co-Founder and Board Member, Stephen Puckett, Sr.

Sonatherm® Laparoscopic HIFU device used to demonstrate thermal ablation at hands-on lab

CHARLOTTE, NC -- SonaCare Medical, a leading manufacturer of medical High Intensity Focused Ultrasound (HIFU) devices, recently participated in the American Urology Association's (AUA) surgical summit "Small Renal Mass 360°." Key opinion leaders in urology presented on the latest diagnostic and therapeutic advances related to small renal masses while attendees had the opportunity to evaluate and learn about different ablative technologies in hands-on labs. Attendees at the Los Angeles, CA lab, under direction of course director Inderbir Gill, MD, successfully used the Sonatherm® (HIFU) device to laparoscopically ablate porcine kidney tissue as well as the bladder wall. Dr. Gill had previously performed the first outpatient renal ablation with Sonatherm®.

Dr. David Schulsinger spearheads pilot study for ablation of renal cell carcinoma with SonaCare Medical's Sonatherm®Laparoscopic Soft Tissue HIFU Surgical Ablation Device

Charlotte, NC. October 28, 2014 -- SonaCare Medical, manufacturer of High Intensity Focused Ultrasound (HIFU) ablative devices, announces ongoing progress at Stony Brook University in Stony Brook, NY where Dr. David Schulsinger and his team are conducting the first North American Institutional Review Board (IRB) approved treat and resect study of kidney cancer in humans with SonaCare's Sonatherm® laparoscopic soft tissue HIFU Surgical Ablation Device.

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