Theraclion Reaches Major Milestones in 2022, Paving the Way for the Commercial Deployment of SONOVEIN®
16 Janvier 2023 - 7:00PM
Business Wire
Regulatory News:
THERACLION (ISIN: FR0010120402; Mnemo: ALTHE) (Paris:ALTHE),
an innovative company developing a scalable robotic platform for
non-invasive ultrasound therapy, shares its 2022 annual report,
marked by accelerated technological development and activity of the
reference centers, and:
- 1,264 SONOVEIN® treatments performed as of December
31st, 2022;
- Preliminary results similar to the standards of invasive
treatments (95% reflux free after one week in the first
clinical study in the US);
- A clinical study on early-stage breast cancer at the
University of Virginia: a possible opening to a new market.
The driving force of value creation: R&D
In accordance with the strategy established by Yann Duchesne,
Executive President of Theraclion since January 2022, the focus is
on improving technological performance and clinical benefits to
access the US vein market.
The launch of the latest robotic platform for the treatment of
varicose veins in May marked a real turning point for the
ultrasound technology. Integrating a very high performance imager,
this model makes it easier to identify the vein to be treated,
resulting in a faster and more effective treatment, and paving the
way for automated treatment support through the integration of
algorithms.
SONOVEIN® successfully implemented and adopted in the US and
in Europe
The particularly enthusiastic reception from the medical
profession quickly led to the deployment of this new generation in
the main reference centers. The presence of SONOVEIN®, all models
combined, extends in Europe to 9 centers in 7 different countries.
The threshold of 1,000 treatments of varicose veins with SONOVEIN®
was crossed in April. In the United States, the University of
Virginia Cancer Center, which has partnered with Theraclion on
breast cancer research since 2017, wanted to acquire this new
version to open up new research opportunities. The success of this
study could open up the breast cancer treatment market for
Theraclion.
Promising preliminary results for the first clinical trial on
varicose veins in the US
A feasibility trial was conducted at the Venous Disease Center
at Englewood Hospital, New Jersey, by vascular surgeons Dr. Steven
Elias, Dr. Antonios Gasparis and Prof. Nicos Labropoulos between
May and October. While awaiting definitive results, Dr Steven Elias
has already presented encouraging preliminary results at the
American Vein & Lymphatic Society (AVLS) annual meeting in
October: 95% of treated cases (19/20) showed no reflux after a
week. This first clinical trial in veins is a major step in the
process leading to FDA (Food and Drug Administration) approval and
thus gaining access to the US varicose vein treatment market, the
biggest in the world, which is Theraclion's development
priority.
KOL (Key Opinion Leader) treatment protocols formalization
and intensification of the reference centers’ activity
In Europe, the focus has been on formalising treatment protocols
with the help of KOL (Key Opinion Leaders) to ensure the success of
the future multi-centre trial required to obtain FDA marketing
authorization in the US. Theraclion plans to file its trial
application with the FDA in the second semester of 2023.
The clarification and precision of the treatment protocols has
led to an increase in the number of doctors trained in the
technology in the various reference centers in Europe and Asia.
This productivity of the partner centers has enabled doubling
consumables sales for varicose veins treatments.
Strategic partnership under negotiation
Negotiations with a potential strategic partner being well
underway at the end of the year, their successful conclusion’s
announcement is to be expected in the coming months. This new
financial contribution will extend the financial visibility to the
whole year 2023. At 31 December 2022, the available cash amounted
to €2,490k, in line with 31 December 2021. Taking into account the
expected sales receipts and expenses, Theraclion should be able to
meet its cash needs until the end of May 2023.
2022 turnover
Theraclion SA achieved a turnover of €1,235K in 2022, a decrease
of 17% compared to 2021.
System sales, at €764k, were down 28%. Theraclion sold one
refurbished Echopulse® and one SONOVEIN® in 2022, in the Persian
Gulf, compared to 4 refurbished Echopulse® and one SONOVEIN® in
2021. The sale of the latest generation device ordered by the
University of Virginia will be recorded in 2023.
Sales of consumables increased by 80%, driven by a doubling of
sales in the varicose vein indication. Theraclion has chosen to
make SONOVEIN® available to 8 reference centres in Europe to
develop treatment protocols. These centres have the possibility to
use SONOVEIN® in their commercial practice as well, which is a
revenue generator for Theraclion.
Turnover /K€
2022
2021
Variation
Systems sales
764
1,059
-28%
Consummables sales
360
200
+80%
Services sales
112
222
-50%
Theraclion SA sales
1,235
1,481
-17%
Including breast & thyroid
295
937
-69%
Including veins
940
530
+77%
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/20230116005484/en/
Theraclion contact David AUREGAN Chief Operating Officer
david.auregan@theraclion.com
Theraclion (EU:ALTHE)
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