Klinik für Prostata established as German demonstration center

JULY 9th 2015. CHARLOTTE, NC -- SonaCare Medical, global leader in high-intensity focused ultrasound (HIFU) ablation devices, announced today the purchase of a newest generation Sonasource with Sonablate® prostate ablation probes by Klinik für Prostata Therapie (Clinic for Prostate Therapy) in Heidelberg, Germany. SonaCare's Germany-based distribution partner Dr. Sennewald Medizintechnik GmbH facilitated the purchase and will collaborate with the clinic and SonaCare to form a German HIFU and Focal Therapy demonstration center in Heidelberg.

Image fusion and targeted ablation programs garner high interest inside and out of the science & industry hall

CHARLOTTE June 4th, 2015 -- The recent 110th Annual Meeting of the American Urological Association in New Orleans, LA, featured a wealth of events and exhibits focusing on less invasive, more targeted treatment of urological cancers. SonaCare Medical, a world-wide leader in the design and manufacture of high intensity focused ultrasound (HIFU) devices, delivered a meeting program that highlighted innovations in image-guided focal ablation including a multi-modal HIFU console Sonasource and associated probes Sonablate® and Sonatherm®.

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

CHARLOTTE, N.C., May 19, 2015 -- 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,

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.

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