Theraclion Announces Results of First US Trial
January 30 2023 - 12:30PM
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 the results of the first SONOVEIN® trial in the United
States, a major milestone towards receiving FDA approval and
accessing the US varicose veins market.
100% success rate in the primary end point and 95% abolition
of venous reflux
The definitive results show a 100% feasibility result, the
primary end point of the trial. Patients did not experience any
serious adverse event. Abolition of venous reflux, as measured by
duplex ultrasound, was achieved in 95% of cases.
The study compliance was 100%, meaning all 80 visits were
completed and timely, none lost to follow-up or missed visits.
A total of 20 patients were enrolled in this clinical trial
approved by the FDA (Food & Drug Administration) in early 2022.
Internationally recognized KOLs Dr Steve Elias, Dr Antonios
Gasparis and Dr Nicos Labropoulos conducted this first trial in New
Jersey, United States.
Dr Steve Elias declared: “I am happy to have finished the first
FDA-approved trial with SONOVEIN in the United States. More
importantly, the results are as good - if not a little bit better -
than some of the results with the more traditional
technologies. 95% of patients had a successful healing of the
abnormal vein. We treat people who have abnormal veins, and not
just the veins. Most important, all patients felt better. SONOVEIN
really is the next evolution of a completely non-invasive,
transcutaneous way of treating vein diseases. We look forward to
being able to offer this to our patients.”
Theraclion’s Chief Medical Officer and Veins Vice President Dr
Michel Nuta said: “These very robust results generated by first
class KOLs are the launchpad for our pivot multi-center FDA study,
which will start shortly. The USA patients are needing the access
to an extra corporeal incision-free varicose veins treatment,
without catheters or foreign chemical products insertion.”
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 nor 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 representing 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/20230130005517/en/
Theraclion contact
David AUREGAN Chief Operating Officer
david.auregan@theraclion.com
Theraclion (EU:ALTHE)
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