Global Launch Generates Strong Support for SonaCare Medical's Urology Platform Technology to Provide HIFU Surgical Ablation Systems for a Wide Range
Medical Devices & Technology
Update: Thursday, 04 April 2013
CHARLOTTE, N.C., April 4, 2013 - SonaCare Medical, a leader in minimally invasive high intensity focused ultrasound (HIFU) technology, successfully launched two new products at the recent European Association of Urology (EAU) Congress in Milan, Italy.
Generating significant interest in its platform technology to provide HIFU surgical ablation for a wide range of urological indications, SonaCare Medical showcased the updated Sonablate® 500 with a redesigned software interface featuring new treatment planning and enhanced simulation capabilities along with the new FDA 510(k) cleared laparoscopic soft tissue ablation device, Sonatherm® HIFU Surgical Ablation System. SonaCare Medical experienced record attendance at its EAU booth where physicians were able to plan simulated treatments using Sonatherm's new high frequency simulator showcasing the technology's ability to treat a cubic centimeter of tissue per minute with +/- 1mm precision.
"Sonatherm's ability to be introduced via a standard laparoscopic port, in conjunction with its easy-to-use intuitive single screen control interface, drew significant attention from laparoscopic and robotic users alike. The number of physicians without prior HIFU experience who came by to examine the system also was impressive," says Alex Gonzalez, Vice President of International Operations for SonaCare Medical. "Featured alongside our flagship product, the new Sonablate® 500, Sonatherm was well received and will continue to build the installed base for the company. With FDA clearance in the U.S. for laparoscopic or intraoperative soft tissue ablation, we have immediate ability to take orders and deliver Sonatherm."
Hosting dozens of European key opinion leaders (KOLs) from multiple urology disciplines at its international HIFU users group meetings, the company reviewed its HIFU platform technology vision to develop HIFU surgical ablation systems for a wide range of urological indications.
Participating in one of the clinical advisory panel meetings focusing on potential new indications, Dr. Arnulf Stenzl, Professor and Chairman, Dept. of Urology, University Medical Clinic Tuebingen and Director, Scientific Office European Association of Urology said, "I was impressed with SonaCare Medical's leadership in bringing together a variety of leading European urologists, engineers and scientists in the meetings to discuss the future of HIFU and how it can be applied to a variety of clinical indications. With the ability to implement tissue conserving therapy with focused HIFU, the SonaCare Medical technology could be transformative for the treatment of bladder cancer."
SonaCare Medical's vision is to develop HIFU surgical ablation systems for a wide range of urological indications, in addition to prostate cancer, that allows for tissue targeting techniques. SonaCare Medical's HIFU surgical systems are the only ablative technologies to utilize T3 Technology™, which enables physicians to: target selected tissue with customized planning and sophisticated localization tools; treat targeted tissue accurately and reliably with robotic precision, while sparing tissue outside the ablation zone; and track the HIFU procedure with advanced real-time ultrasound imaging and unique tissue monitoring technologies.
Thermal ablation has significant advantages over standard "cut and remove" surgical approaches including reduced bleeding, reduced patient treatment time, reduced collateral damage, and potentially real-time imaging, but its use has been limited due to difficulties in delivering the ablative energy to the desired target.
"Sonatherm represents a major advance in this respect," said Mark Carol, M.D., Chief Development Officer for SonaCare Medical. "It combines ultrasound imaging and therapeutic focused ultrasound delivery capabilities into a package that is delivered in a sterile manner through a standard 12 mm robotic surgery access port. Unlike other forms of thermal ablation, such as radiofrequency, microwave, and cryo, Sonatherm does not require puncturing the target with a needle, which can cause bleeding, and its use of on-board US imaging for targeting and monitoring of the treatment is a capability not present in these other forms of ablation.
"Unlike any other HIFU technology available currently, Sonatherm allows urologists to add HIFU to their surgical practice with only a minimal learning curve. Easily understood by urologists with an extensive range of potential indications, the response we've received from urologists has been extremely positive with great excitement about adding it to their practices," Dr. Carol added.
"During our extensive meetings with European users and key opinion leaders throughout the EAU, we saw significant interest in HIFU and the development of a common technology platform designed to support multiple HIFU probes for a wide variety of urological indications," said Mike Klein, CEO for SonaCare Medical. "Built on the foundation of our proven HIFU technologies that have been used to treat more than 12,000 patients worldwide, the SonaCare Medical urology platform will enable us to deploy new applications regardless of which system users currently have. This not only offers customers the ability to rapidly expand their clinical capabilities, but also offers significant economic efficiencies and practice development opportunities by enabling multiple physicians within a group to implement treatment services on a wider array of clinical applications."
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. Additional information may be found at www.SonaCareMedical.com.
Chris K. Joseph