SonaCare Medical Launches Remote Monitoring Platform During Live HIFU Procedures

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SonaCare Medical achieves a successful pilot using the Company’s new remote monitoring software, Sonalink™

Sonablate trans-rectal HIFU probe
"...Emphasis on training and customer support during the early phases of the learning curve provides the greatest likelihood of superior patient outcomes..." - Dr. Mark Carol

SonaCare Medical, LLC reports the introduction of a highly anticipated expansion to their comprehensive training and support program, Sonalink™ remote monitoring. The inaugural launch of this new technology occurred over the course of two Sonablate® HIFU procedures performed on Friday, February 5th, connecting Dr. Samuel Peretsman to a HIFU technical expert at SonaCare Medical headquarters.

Sonalink allows the complete procedure, ranging from device setup to active computer-controlled HIFU delivery, to be remotely monitored by experienced support personnel. These specialists have the ability to interact with the physician and OR staff in real-time to answer questions and provide ongoing training and guidance in the use of the device. Sonalink is included on all Sonablate systems, and provided at no extra charge to all domestic users of Sonablate technology.

Along with the support of HIFU Prostate Services (HPS), Dr. Peretsman, an experienced HIFU physician who performed his first US-based Sonablate procedure earlier this year, volunteered to participate in this introductory Sonalink case. He comments, “Ranging from a novice to an experienced Sonablate user, Sonalink provides cutting edge technical support during a HIFU procedure. This service is a highly valuable remote training or support tool, as I was linked seamlessly with SonaCare headquarters. It is very reassuring to know we have continuous technical support throughout a procedure.”

According to Dr. Mark Carol, CEO of SonaCare, “As is the case with any new technology, emphasis on training and customer support during the early phases of the learning curve provides the greatest likelihood of superior patient outcomes which in turn leads to the long-term viability of the technology. Oftentimes it is physically impossible to have experienced support personnel on site for cases. Sonalink provides an efficient and cost effective means of quality assurance, making sure that the physician and OR support staff can always elect to have a second pair of experienced “eyes” watching a case.”

Sonablate® is the first device to receive regulatory authorization from the FDA for the focused ultrasound ablation of prostate tissue. Since its introduction over 15 years ago, Sonablate® technology has been used around the world on nearly 15,000 patients in over 30 countries, including approximately 4,000 U.S. men who have had this procedure performed outside the U.S.

About SonaCare Medical, LLC
SonaCare Medical is a world leader in minimally invasive focused ultrasound (HIFU) technologies. SonaCare Medical is committed to developing focused ultrasound related technologies that support precise and innovative procedures for the treatment of a range of medical conditions. SonaCare Medical, with its subsidiary Focus Surgery, Inc., designs and manufactures medical devices, including the following: Sonablate®, which has 510(K) clearance in the U.S. under a De Novo regulatory classification; Sonablate® 500, which has CE Marking and has obtained regulatory authorization in more than 49 countries outside the U.S.; Sonatherm® laparoscopic HIFU surgical ablation system, which has 510(K) clearance in the U.S., has CE Marking and has obtained regulatory authorization in more than 30 countries outside the U.S.

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SonaCare Medical, LLC
Erica Griffith (704) 936-1834, EricaGriffith(at)SonaCareMedical(dot)com

Forward Looking Statements.
The Company's forward-looking statements are based on management's current expectations and assumptions regarding the Company's business and performance, the economy and other future conditions and forecasts of future events, circumstances and results. As with any projection or forecast, forward-looking statements are inherently susceptible to uncertainty and changes in circumstances. The Company's actual results may vary materially from those expressed or implied in its forward-looking statements. Any forward-looking statement made by the Company speaks only as of the date on which it is made. The Company is under no obligation to, and expressly disclaims any obligation to, update or alter its forward-looking statements, whether as a result of new information, subsequent events or other factors.

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Erica Griffith
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