|May. 4, 2018|
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
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.
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."
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 email@example.com