Physicians across the United States are adopting Sonablate® as the preferred prostate tissue ablation device.
CHARLOTTE, N.C., January 5, 2016 -- SonaCare Medical, LLC, a pioneer in minimally invasive high intensity focused ultrasound (HIFU) technologies, and first to receive FDA regulatory authorization for the ablation of prostate tissue, reports impressive Q4 growth in 2015 since receiving a de novo grant from the Food and Drug Administration (FDA) to market and sell Sonablate® in the United States in October, 2015.
This grant created a new product class for urologic HIFU medical devices and paved the way for urologic HIFU ablation technologies to enter the U.S. market. Post grant, there have been 14 sales of Sonablate technology in the U.S. with eight systems installed to date, five of which have been used. Sonablate® already has been used to deliver 23 HIFU prostate tissue ablations in the U.S. post commercial launch, including whole gland ablations, hemi-ablations, and true focal ablations using MRI-US fused image guidance. According to Paul LaPine, V.P. Sales, "The response from the urology community since we received our grant has been extremely favorable. There is a large base of urologists in the U.S. experienced in the use of Sonablate due to their participation in our concierge medical program outside the U.S. and our clinical trials in the U.S. This has provided us with a robust sales funnel of physicians who are eager to deliver this type of care in the geographic region where they practice. In addition, academic departments have been waiting for a long time to be able to offer tissue sparing options to their patients and are looking to HIFU in general, and Sonablate specifically, to provide this ability."
Sonablate regulatory authorization in the U.S. has had a positive effect across borders as well. Since the October grant, three new international distributors have been trained and three new countries have adopted Sonablate technology. Vice President of International Operations, Alex Gonzalez, comments, "The international response for the latest Sonablate technology post FDA clearance has been significant. Sonablate® HIFU technology has made its debut in five new countries since the start of 2015 and the substantial early demand in the U.S. is indicative of the great momentum that exists at a worldwide level." In addition to Sonablate prostate ablations performed on an ongoing and regular basis at sites in Germany, England, and Switzerland, SonaCare Medical technology also was used recently in Switzerland to deliver an open kidney ablation in a patient with a single kidney for whom tissue preservation was considered essential.
"We are thrilled at the early response to our introduction of Sonablate in the U.S. and the continued interest overseas, and expect widespread worldwide dissemination of the technology over the course of 2016", states Mark Carol, SonaCare Medical CEO. "It is an exciting time in the field of whole gland and focal soft tissue ablation, and SonaCare is delighted to be at the forefront of applications of this capability in the prostate and the kidney."
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.
For additional information, visit www.SonaCareMedical.com
SonaCare Medical, LLC
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