FDA Approval for Pivotal Varicose Veins Study With Theraclion’s SONOVEIN®
17 Aprile 2023 - 6:30PM
Business Wire
Regulatory News:
THERACLION (ISIN: FR0010120402; Mnemo: ALTHE) (Paris:ALTHE),
an innovative company developing a scalable robotic platform for
non-invasive ultrasound therapy, announces today that the US
Food&Drug Administration (FDA) has approved its Investigational
Device Exemption (IDE) application to initiate the multi-center
pivotal study VEINRESET for the treatment of primary insufficiency
of great saphenous veins with SONOVEIN®.
Theraclion’s most significant clinical trial to date
“We are pleased to announce this major milestone”, stated Michel
Nuta, MD, Chief Medical Officer and Vice President Veins at
Theraclion, “and want to formally thank our physician advisors and
our regulatory team for their leadership and contributions to this
landmark study.”
“We believe that this key study will confirm the positive
findings of the FDA feasibility study, completed just two months
ago, and will ultimately allow us to commercially address the US
market”, stated Yann Duchesne, Executive Chairman of
Theraclion.
The pivotal study will be conducted in four scientifically
prominent centers in the United Stated and in Europe. Principal US
investigator, Steven Elias, MD, is the director of the Center for
Vein Disease at Englewood Hospital, New Jersey, and a Fellow of the
American Board of Venous and Lymphatic Medicine and of the American
College of Surgeons. Patients treatments are planned to start later
this year.
Paving the way to the biggest varicose vein market in the
world and beyond
The technology has been endorsed by major key opinion leaders in
both the US and Europe and its results have been presented in
numerous scientific congresses.
This clinical trial approval is a key development in
Theraclion’s commercial strategy, as the North American market
represents more than 45% of the global market, driven by the US.
Compared to Europe, the US is a higher price market and allows for
more homogenous market access strategy, and therefore a faster
market penetration. In addition, accessing the US market is a major
milestone and driver for global sales uptake.
Addressable annual varicose veins procedures globally are
expected to rise up to 4.3M in 2033 representing a potential $2.1B
medical device market for Theraclion.
About Theraclion
Theraclion is a French MedTech company committed to developing a
non-invasive alternative to surgery through the innovative use of
focused ultrasound.
High Intensity Focused Ultrasound (HIFU) does not require
incisions or an operating room, leaves no scars, and allows
patients an immediate return to their daily activities.
Echotherapy, as the HIFU treatment method is called, concentrates
therapeutic ultrasounds to an internal focal point from outside of
the body.
Theraclion has developed two CE-marked robotic platforms
delivering echotherapy: SONOVEIN® for varicose veins and ECHOPULSE®
for breast fibroadenoma and thyroid nodules. Each represents the
potential to replace millions of surgical procedures every
year.
Based in Malakoff (Paris), Theraclion’s team of 30 people is
mostly made up of engineers and researchers. Designing and
manufacturing the products, they also support a limited number of
reference centers, where treatment protocols are defined, paving
the way for the clinical trial required to obtain US market
access.
For more information, please visit www.theraclion.com or
www.echotherapy.com and follow the account on LinkedIn.
Theraclion is listed on Euronext Growth Paris Eligible for the
PEA-PME scheme Mnemonic: ALTHE - ISIN code: FR0010120402 LEI:
9695007X7HA7A1GCYD29
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version on businesswire.com: https://www.businesswire.com/news/home/20230417005642/en/
Theraclion contact David AUREGAN Chief Operating Officer
david.auregan@theraclion.com
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