Theraclion Delivers Its 2023 Strategic Objectives
14 Dicembre 2023 - 6:30PM
Business Wire
Regulatory News:
THERACLION (ISIN: FR0010120402; Mnemo: ALTHE), an innovative
company developing a scalable robotic platform for non-invasive
ultrasound therapy, is now taking stock of its achievements
over 2023.
Martin Deterre is appointed Managing Director to accelerate the
deployment of the 3-pronged strategy:
- Access to the US market;
- Access to the Chinese market and development of industrial
capacity in China;
- Continued product development (artificial intelligence,
robotics, improved treatment protocols).
"I am delighted with the major advances achieved in 2023. The
start of the pivotal vein study in the United States, the
partnership established with the Chinese group Furui, the
acceleration in the number of treatments and the achievement of
major technological developments all contribute to securing
Theraclion's commercial success," said Martin Deterre.
Launch of pivotal study: the United States in sight
The process of gaining access to the colossal US market is
proceeding according to plan. The first treatments in the pivotal
study took place in the United States in October. Since then, new
cases have been treated in Europe. Treatment will continue in the
first half of 2024, and results will be known after 12 months'
follow-up, in accordance with the protocol approved by the FDA
(Food and Drug Administration). Market authorization in the US is
envisaged after the FDA's statutory review period, by early
2026.
Partnership with Furui: a new start for the Chinese
market
Furui has already invested €6 million in Theraclion by June
2023. Further investments of €4 million are planned: €1 million via
exercise of ABSAs and €3 million via licensing rights. A first ABSA
exercise for 0.5 M€ was recorded following the launch of the
pivotal study in the United States. Theraclion and Furui have also
made significant progress over the last 3 months in structuring
their joint venture, which will enable access to the high-potential
Chinese market and extend production capacity in China.
Innovations in Artificial Intelligence (AI) and
robotics
Significant new hardware and software enhancements to the system
are deployed in the field as part of the ongoing clinical study and
have received excellent feedback from the investigating physicians.
Advances made in integrating the latest-generation robotics and AI
will facilitate the adoption of the system and improve patient
care. These developments will enhance the product's competitiveness
and commercial potential, contributing to a considerable
appreciation in the company's value.
A new milestone: 2,000 veins treated with SONOVEIN®.
Following on from the 1,000 veins treated in 2022, this year
Theraclion has treated 2,000 veins with its SONOVEIN® robotic
platform. No severe adverse events have been reported, confirming
the technology's excellent safety profile. Such acceleration
demonstrates the method's capacity for adoption by centers and its
relevance for patients and doctors alike.
Exploring potential in breast cancer treatment
In the first half of the year, the Cancer Center at the
University of Virginia in the United States acquired the latest
generation SONOVEIN® HD for the launch of a new clinical trial,
approved by the FDA. The aim is to assess the combined effects of
High Intensity Focused Ultrasound (HIFU) and chemotherapy in
patients with early-stage breast cancer. This study could pave the
way to a new market with considerable global potential.
Funding secured for 2024
The company has stepped up its efforts to ensure sound financial
management, in particular by controlling its expenditure. As budget
forecasts currently stand, 2024 should be fully covered
financially.
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), the Theraclion team is made up of 30
people, mainly in technological and clinical development.
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/20231214478206/en/
Theraclion contact
Martin Deterre Chief Executive Officer
contact@theraclion.com
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