SonaCare Medical Announces Acceptance of Medicare C-Code application for HIFU Prostate Ablation

Tuesday, May 23, 2017 General News
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C-code goes into effect on July 1, 2017, affording greater opportunity to prostate patients in the United States

CHARLOTTE, N.C., May 23, 2017 /PRNewswire/ -- SonaCare Medical, leading developer and manufacturer of high intensity

focused ultrasound (HIFU) technologies, announces the imminent reimbursement for HIFU prostate tissue ablation with a newly approved C-code.

As the first company to introduce and gain FDA authorization for sale of HIFU prostate tissue ablation in the United States in October of 2015, SonaCare Medical has worked extensively with its partners to obtain a reimbursement code for this minimally-invasive procedure. The Centers for Medicare and Medicaid Services (CMS) recently accepted the application for a HIFU C-code, which will go into effect on July 1st of this year.

This HCPCS code C9747, under the ambulatory payment classification (APC) 5376, is specific to the ablation of prostate tissue using transrectally delivered high intensity focused ultrasound (HIFU), and includes image guidance. It will be applicable to procedures performed using SonablateŽ, including but not limited to primary whole gland ablation, sub-total ablation, and salvage ablation. This C-code is applicable to procedures performed in hospitals and ASC facilities under the Medicare Hospital Outpatient Prospective Payment System (OPPS) and may also be applied to claims from other providers in the future.

"The patient is our top priority and we are thrilled that this C-code will make HIFU a more accessible option for men seeking a minimally-invasive, targeted prostate procedure," comments SonaCare Medical CEO, Mark Carol. "The issuance of this C-code represents a notable breakthrough for HIFU in the United States, legitimizing the important role this technology plays in modern-day prostate care. Additionally, SonaCare Medical extends our gratitude to the reimbursement strategy team at Medical Technology Partners, with whom we will continue to work as we strive to enhance reimbursement coverage of HIFU procedures in the United States."

Since SonablateŽ received FDA clearance on October 09, 2015, more than 1,000 patients have had a Sonablate HIFU prostate procedure across the 40+ locations in the U.S., including placements at top-tier academic institutions in California, Indiana, Oklahoma, Maryland, New York, Arizona, and Texas. 

About SonaCare Medical, LLCSonaCare Medical is a world leader in minimally invasive focused ultrasound 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: SonablateŽ, which has 510(K) clearance in the U.S.; SonablateŽ 500, which has CE Marking and has obtained regulatory authorization in more than 50 countries outside the U.S.; SonathermŽ 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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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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SOURCE SonaCare Medical


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