Dr. Lepor becomes first urologist in the Northeast to perform the newly authorized Sonablate prostate tissue ablation procedure.
CHARLOTTE, N.C., JANUARY 26, 2016 -- SonaCare Medical, LLC announces that Drs. Herbert Lepor and James Wysock performed a HIFU Sonablate prostate tissue ablation procedure in New York City last week, making them the first physicians to use the device in the Northeast since Sonablate® received FDA clearance in October 2015.
The outpatient procedure was performed on Thursday, January 21st, and utilized Sonablate's innovative fusion software that enables a physician to merge ultrasound imaging with biopsy MRI annotations for a more precise ablation plan.
Dr. Herbert Lepor is a notable professor and Urology Chief based in New York, New York, and is the co-developer of the nerve sparing radical prostatectomy. Dr. Wysock was one of the pioneers developing MRI/Ultrasound fusion biopsy, which facilitates identifying the optimal candidates for focal HIFU ablation. Both physicians have been longtime supporters of focal therapy in general and HIFU specifically. Dr. Lepor has a long history as an advisor to the company.
Dr. Lepor comments, "Today, both the urologist and the patient have essentially two options for prostate care: active surveillance, which is 'wait and see,' or total removal or destruction of the entire prostate gland. As a surgeon who has performed almost 5,000 radical prostatectomies, there is no doubt that focal HIFU ablation will find an important niche in prostate health. It was satisfying to see our first patient leave our out-patient facility in the afternoon with plans to enjoy dinner with his wife that night."
According to Dr. Carol, SonaCare Medical CEO, "Dr. Lepor has been one of the strongest advocates in the U.S. for image-guided approaches to the prostate. We are absolutely delighted to have him as the first user of our technology in the greater northeast, and look forward to working closely with him to support our training and educational efforts."
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. A total of 16 systems have been sold in the U.S. for prostate tissue ablation since Sonablate received FDA regulatory authorization in October of 2015.
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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