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Korean FDA cleared DirexGroup’s Renova for ED Treatment

May. 4, 2018

DirexGroup, a global medical device company focused on the field of urology with a strong emphasis on product development and innovation, announced today that it has received approval from the Korean Food & Drug Administration (KFDA) for Erectile Dysfunction treatment by Renova.

Renova applies Linear Low Intensity Shockwaves (LLISW) which promotes angiogenesis - a natural process of new blood vessel formation. The process restores blood supply on a micro-vascular level, thus improving erectile function in men experiencing vascular  erectile weakness.

Renova is the only device offering coverage of penis and crura linear segments due to a unique Linear applicator. Consequently, Renova offers the shortest protocol of four weekly sessions - 20 minutes per session. Efficacy of up to 80% success rate is documented by worldwide KOL's at http://www.direxgroup.com/files/27ecc736cbdc73c24213b7ede15a4b62.pdf

 "I am pleased and excited about receiving Renova approval from KFDA which treats Erectile Dysfunction" says Byung Ki Kim, Manager of Direx Korea. "Success in the international markets ensure great business for this treatment in Korea. Renova treatment is painless, does not require anesthesia and has no known side effects. The unique Linear  technology of Renova treatment, has quickly become the preferred choice of treatment for healthcare professionals and patients seeking a spontaneous and satisfactory sexual life"

KFDA approval in Korea is the most recent of regulatory clearances for Renova, adding to its existing regulatory approvals which include CE, ANVISA, CFDA, RZN, SFDA, MOH and HAS.

"As we expand to new markets globally," says Dr. Moshe Ein-Gal of DirexGroup, "we will continue to invest in research and development, intellectual property and clinical studies that will help us expand our applications and create innovative products and technologies. South Korea is a very important market and I expect continued global regulatory approvals this year."

About DirexGroup
DirexGroup specializes in providing innovative devices for urologists in all worldwide markets. Established 35 years ago, DirexGroup has continuously extended its worldwide presence in numerous countries and markets. The Group has put its emphasis on the field of urology and offers urologists and medical centers various equipment and service solutions to their clinical and economic needs. The products are reliable, modular and transportable, as well as offering cost effectiveness and ease of use. Support and maintenance is provided by a worldwide network of committed and competent service centers.

Contact DirexGroup at info@direxgroup.com

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