FDA Approves the 1st Trial with Theraclion's Vein Therapy in the US
September 21 2021 - 3:00AM
Business Wire
Regulatory News:
THERACLION (ISIN: FR0010120402; Mnemo: ALTHE, PEA-PME
eligible) (Paris:ALTHE), an innovative company specialized in
echotherapy treatment (using High Intensity Focused Ultrasound or
HIFU), announces FDA (Food & Drug Administration) approval
for the first trial with SONOVEIN in the United States (US). After
this clinical trial, a full pivotal study will be conducted for FDA
review for market authorisation.
The study will be initiated as soon as possible and conducted in
a well-known New Jersey Center by Steve Elias MD FACS DABVLM, an
internationally recognized vein specialist with more than 30 years
experience in the treatment of venous disease. The study will be
conducted in collaboration with Dr Nicos Labropoulos and Dr
Antonios Gasparis both internationally recognized vein specialists
with more than 30 years experienced too.. “We are excited to be the
first in the US to assess this breakthrough technology which takes
superficial vein treatment to the next level: completely
non-invasive and transcutaneous. It will be great for patients”
said Dr Steve Elias, MD FACS DABVLM.
“We are proud that SONOVEIN, our technology, was chosen to be
assessed by renowned experts in vein treatments. We are hoping to
have soon the first US patients treated with our extra corporeal
system for their varicose veins. Our qualitative pre-clinical
studies, the CE marking since 2019 and our clinical data from our
European centers should support a fast approval for our pivotal
study” said Michel Nuta, MD, Chief Medical Officer, Vice-President
Veins Theraclion SA.
It is a crucial milestone for Theraclion to access the largest
market for varicose veins with an estimated 2,3 million procedures
representing healthcare spending of $ 5 Billion. It has
historically been under penetrated but will expand with the
development of painless and non-invasive technologies such as
SONOVEIN.
SONOVEIN is the only non-invasive option, without scars and
without incisions. The advanced technological solution allows
optimal treatment procedure in a reduced duration and improves
patient experience.
About Theraclion Theraclion has developed an innovative
echotherapy solution using High Intensity Focused Ultrasound for
the treatment of varicose veins, SONOVEIN®. The treatment solution,
which obtained CE marking in April 2019, is based on the
leading-edge echotherapy treatment expertise developed by
Theraclion over years for non-invasive ablation of breast
fibroadenomas and thyroid nodules using its ECHOPULSE® solution.
Further improvements to the ECHOPULSE technology are the foundation
for SONOVEIN to provide the only non-invasive ablation therapy for
varicose veins. This procedure allows for treatment without a
catheter, chemical injection, or incision. An operating room is not
necessary, and the treatment can be performed at a doctor’s offices
or in clinics, as well as in hospitals. Venous pathology is
widespread worldwide and generates around 5 million treatment
procedures per year, according to Millennium research Varicose Vein
Device Market Study 2015. Theraclion's technological solutions are
based on high-tech ultrasound medical devices that are precise and
easy to use for practitioners. Located in Malakoff, near Paris,
Theraclion brings together a team of 25 people, more than half of
whom are dedicated to R&D and clinical trials.
For more information, please visit the Theraclion website:
www.theraclion.com and the patient site:
https://echotherapie.com/echotherapy/
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/20210921005470/en/
Theraclion David Caumartin Chief Executive Officer
david.caumartin@theraclion.com Tel : + 33 (0)1 55 48 90 70
Anja Kleber VP Marketing, Market Access & Sales Francophonia
anja.kleber@theraclion.com
Theraclion (EU:ALTHE)
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