Regulatory News:

THERACLION (ISIN: FR0010120402; Mnemo: ALTHE) (Paris:ALTHE), an innovative company developing a scalable robotic platform for non-invasive focused ultrasound therapy (HIFU), announces today the continued execution of its value creation strategy and its turnover for 2023. One of its mainstays, sale of consumables for varicose veins, is up by a substantial 61%.

Access to the US market for SONOVEIN®: progress in the pivotal study

The process of accessing the vast US market is proceeding according to plan, with more than a third of patients already treated as part of the pivotal clinical trial that began in the US in October 2023. Two other treatment sites included in this study, located in Europe, have also since opened. Treatment of patients enrolled in the clinical trial will continue during the first half of 2024. Marketing authorization in the US is envisaged for early 2026.

Strategic partnership with Furui: first milestones achieved

Theraclion SA and Furui have achieved new milestones in the context of their partnership with a view to conquering the Chinese market. The restructuring of the Theraclion China joint venture is well underway, with technical and operational collaborations already active, following an ambitious action plan. These efforts have led to the invoicing of €2,000K in license fees to Theraclion China for Echopulse® and SONOVEIN® at the end of 2023.

Turnover up 48% and sales of varicose vein consumables up 61%

Theraclion SA recorded a turnover of €1,822K in 2023 representing an increase of 48%. In addition, the inclusion of €2,000K in revenue from license fees granted to Theraclion China brings total operating revenues to €3,825K, an increase of 180% compared to 2022.

Sales of consumables, most of which are recurrent, rose by 41% overall, driven by strong growth in varicose vein indication, up 61% since 2022. In line with its strategy, Theraclion is making SONOVEIN® available to reference centers involved in development of treatment protocols while also integrating it into their commercial practices. Theraclion's performance in 2023 demonstrates these treatment centers’ positive uptake of its solutions.

Additionally, system sales were up 58%, standing at €1,204K.

Turnover in K€

2023

 

2022

 

Variation

Sale of systems

1 204

 

764

 

58%

Sale of consumables

506

 

360

 

41%

Sale of services

112

 

112

 

1%

Total turnover

1 822

 

1 235

 

48%

Including veins

1 200

 

940

 

28%

Including breast and thyroid

622

 

295

 

111%

Other operating revenue

3

 

132

 

-98%

Licenses

2 000

 

-

 

-

Operating revenue total

3 825

 

1 367

 

180%

The various intermediate objectives, both for the clinical study with a view to FDA authorization in the US, and for the partnership with Furui to penetrate the Chinese market, have so far all been achieved.

Moreover, the study led by Prof. David Brenin at the University of Virginia Cancer Center aiming at proving the efficacy of focused ultrasound in the treatment of breast cancer is continuing. This potentially offers Theraclion a very significant additional value-enhancing outlet.

About Theraclion

Theraclion is a French MedTech company committed to developing a non-invasive alternative to surgery through innovative use of focused ultrasound.

High-Intensity Focused Ultrasound (HIFU) does not require incisions or an operating theater, leaves no scars, and enables patients to return to their daily activities immediately. 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. Both of them have the potential to replace millions of surgical procedures every year.

Based in Malakoff (Paris), the Theraclion team is made up of 30 people, most of them involved in technological and clinical development.

For more information, please visit www.theraclion.com or www.echotherapy.com and follow the LinkedIn account

Theraclion is listed on Euronext Growth Paris Eligible for the PEA-PME scheme Mnemonic: ALTHE - ISIN code: FR0010120402 LEI: 9695007X7HA7A1GCYD29

Theraclion Martin Deterre Chief Executive Officer contact@theraclion.com

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