Yoqneam, Israel (ots/PRNewswire) - Sofwave Medical Ltd., an emerging
aesthetic device company, announced that it has received 510(k)
clearance from the U.S. Food and Drug Administration (FDA) for its
Sofwave system. The Sofwave device is indicated for use as a
non-invasive aesthetic treatment to improve facial lines and
The 510(k) clearance was supported by a blinded study of 59 subjects,
demonstrating the safety and performance of the Sofwave System for
non-invasive treatment to improve facial lines and wrinkles. The
trial was led by Principal Investigators Dr. Roy Geronemus, New York
and Dr. Arielle Kauvar, New York.
According to investigators' evaluation, 86% of the subjects
demonstrated improvement in wrinkle appearance of at least one
Elastosis Score (-1ES), while the blinded reviewers identified
correctly the pre- and post-treatment photographs for 78% of the
Dr. Roy Geronemus stated, "The Sofwave technology represents the
next-generation in aesthetic devices and is exactly what my patients
are looking for - non-invasive, minimal downtime, and with favorable
results. The Sofwave device has great potential to fill this void".
Dr. Kauvar added, "Our patients were surprised they could achieve
such obvious results after only one treatment. The Sofwave procedure
is tolerated very well and it appears that the treatment depth is
ideal for improving aging skin".
Dr. Shimon Eckhouse, Sofwave Medical's Chairman of the Board, stated,
"Our patented, low-divergence fractional ultrasound technology is a
simple solution based on sophisticated science with proven efficacy
to treat facial lines and wrinkles. He added, "I am excited to once
again bring innovative aesthetic devices to the market."
Louis Scafuri, Sofwave Medical's CEO said, "Receiving FDA clearance
for the Sofwave technology is an important milestone for the company
as it opens our product to the large market in the United States. Our
breakthrough non-invasive ultrasound technology targets a growing
customer base of patients who are looking to reduce their wrinkles
and facial lines, but did not wish to consider surgery. We believe
that our device addresses this demand across broad demographics"
Following FDA clearance, the company will launch marketing and sales
activities in the United States. For this purpose, the company has
already established an office in the US, which will be the base for
all sales, marketing, clinical and customer support activities for
the US market.
About SofWave Medical Ltd.
SofWave Medical Ltd. implements a novel approach to wrinkle reduction
using proprietary Fractional Ultrasound. SofWave Medical's
breakthrough technology brings a new option to non-invasive aesthetic
treatments, providing physicians with smart yet simple, effective and
safe aesthetic solutions for their patients.
The company was founded in 2015 by a multidisciplinary team of
engineers, physicists and experienced professionals in the aesthetics
market. The corporate, R&D, and manufacturing headquarters for
SofWave Medical are located in Israel. The company also has offices
in California, U.S.A.
Mrs. Dafna Katz,
Chief Marketing Officer,
Digital press kit: http://www.ots.at/pressemappe/PR136192/aom
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