CHARLOTTE, N.C. (PRWEB) July 21, 2020
SonaCare Medical, LLC, the leading developer and manufacturer of high intensity focused ultrasound (HIFU) technologies, is pleased to announce that on July 8, 2020 it received regulatory approval from the National Medical Products Administration (NMPA), formerly known as the Chinese FDA, for the Sonablate® HIFU device for use in the treatment of prostate cancer and benign prostatic hypertrophy (BPH). Along with NMPA approval, Sonablate was chosen as one of the top one hundred imported technologies/innovations the NMPA has approved in the past twenty years and will be part of a permanent display at the NMPA Medical Device Evaluation Center.
Chinese regulatory approval represents a significant step in ensuring all men have access to Sonablate HIFU technology and opens a significant market for SonaCare Medical. Dr. Mark Carol, SonaCare Medical CEO and President, said, “China is the largest medical market in the world and has a growing need for advanced treatment modalities for prostate cancer and BPH. Sonablate, the first HIFU technology to be approved in China for the treatment of these indications, has been shown in multiple studies to control prostate cancer while minimizing the occurrence of the side effects that typically are a part of prostate cancer treatment. Achieving NMPA authorization has been a multiyear long process that has involved a multitude of people. We are extremely honored and excited to have achieved this milestone.”
As Chief Commercialization Officer for SonaCare Medical, Alex Gonzalez will be leading the sales effort in China alongside SonaCare Medical Board Member and President of the Asian Master Distribution arm for SonaCare, Mr. Richard Yang. Mr. Gonzalez said, “The interest in our Sonablate technology expressed by China’s top tier universities and hospitals has been remarkable. The physicians already enrolled in our training program represent the best in urologic care in the country, and our Sonablate technology will be a perfect complement to the world class facilities that will be the first to adopt our device in China. Our sales and support teams in China, which are overseen by Mr. Yang, are ready for this great challenge and look forward to providing the industry leading training and support that has become synonymous with SonaCare Medical around the world.”
Tom Mendell, SonaCare Medical Chairman of the Board, believes that being the only transrectal HIFU device with NMPA authorization shows the value and utility of the Sonablate device. Mr. Mendell said, “NMPA authorization represents a very significant development in the history of SonaCare Medical. With approval, our minimally invasive transrectal device enables our Chinese physician partners to now offer prostate cancer patients the same excellent cancer control, with significantly lesser side effects than standard treatments, as we provide currently to patients in Europe and America. We are also confident that over time Sonablate HIFU will become the preferred minimally invasive treatment option of Chinese physician and patients for BPH.”
Since Sonablate® received FDA clearance on October 9, 2015, many thousands of patients have had a Sonablate HIFU prostate procedure across the 60+ locations in the U.S., including top-tier academic institutions in California, Indiana, Oklahoma, Maryland, New York, Arizona and Texas. Over 70 U.S. physicians now offer HIFU prostate tissue ablation to their patients as a minimally invasive alternative to surgery or radiation.
Sonablate® has 501(K) clearance in the U.S. and is indicated for the transrectal high intensity focused ultrasound (HIFU) ablation of prostate tissue. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
ABOUT SONACARE MEDICAL, LLC
SonaCare 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: Sonablate®, which has 501(K) clearance in the U.S.; Sonablate® 500, which has CE Marking and has obtained regulatory authorization in more than 50 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
SonaCare Medical, LLC
Karen Cornett (704) 805-1885 KarenCornett@SonaCareMedical.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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