SonaCare Medical Reports the Sale of 33 Sonablate® High Intensity Focused Ultrasound (HIFU) Prostate Ablation Systems since FDA Clearance
Charlotte, NC (PRWEB) April 06, 2016 -- SonaCare Medical, LLC, the pioneer in minimally invasive high intensity focused ultrasound technologies and the first company to receive FDA 510K clearance for transrectal high intensity focused ultrasound (HIFU) ablation of prostatic tissue, announced today that it has sold 28 Sonablate® HIFU Systems in the U.S., and 33 overall, since obtaining FDA clearance in October, 2015.
“The 33 Sonablate systems we have sold since FDA clearance is a remarkable testament to the pent up demand for alternatives to the traditional ways of targeting prostate tissue, such as radiation therapy and surgery. SonaCare Medical continues to advance the field of focal ablation by now partnering with four leading image-guided fusion companies, and is continuing to develop additional probes for use with our FDA cleared Sonasource™ console that address other indications for use for HIFU, such as our FDA cleared Sonatherm™. These and other endeavors are positioning the Company ideally for rapid growth and value creation,” commented Mark Carol, M.D, Chief Executive Officer.
SonaCare Medical most recently promoted its technology at the European Association of Urology (EAU) Annual Conference on March 11th, in Munich, Germany. “It’s very encouraging to see the impact FDA clearance has had on our international market” comments Alex Gonzalez, SonaCare Medical’s VP of International Operations. “Our exhibit at EAU was the busiest it’s ever been. We had promising conversations with hundreds of physicians and dozens of international distributors. I believe the Sonablate sales we have recorded in 5 different countries outside of the U.S. since FDA clearance emphasizes our position as the recognized leader in prostate tissue ablation.”
In May, SonaCare Medical will be attending the annual American Urology Association (AUA) meeting being held this year in San Diego, California. The Company will be highlighting its newly FDA cleared Sonablate, its redesigned FDA cleared Sonatherm laparoscopic ablation probe, and Sonalink™, its tele-monitoring support system. It also will be holding the first ever “HIFU Insiders Social,” a cocktail and dessert event where physicians and institutions can learn about the myriad of options for gaining access to a Sonablate system for prostate tissue ablation.
About SonaCare Medical, LLC
SonaCare Medical is a world leader in minimally invasive high intensity 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.
For additional information, visit http://www.SonaCareMedical.com
COMPANY CONTACT: 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.
Erica Griffith, SonaCare Medical, http://www.sonacaremedical.com, +1 7049361834, [email protected]
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