Regulatory Filings • Oct 15, 2020
Regulatory Filings
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Malakoff, October 15, 2020 - THERACLION (ISIN: FR0010120402; Mnemo: ALTHE, PEA-PME eligible), an innovative company specialized in echotherapy treatment (using High Intensity Focused Ultrasound or HIFU), has obtained CE Mark for the second generation of SONOVEIN®, it's HIFU treatment solution for varicose veins. It has also signed a strategic supplier partnership with SuperSonic Imaging (part of Hologic Inc.). Theraclion's ambition is to give all patients access to non-invasive varicose vein treatments.
Theraclion's SONOVEIN, launched in 2019, is a revolution in the field of varicose vein treatment allowing treatment from outside the body without the need of an operating theatre. SONOVEIN's first generation was intentionally rolled-out to a limited number of centres and hospitals only and is currently installed in 5 countries. The commercial roll-out can now be accelerated thanks to the CE marking of the second-generation system.
The new technology, called SONOVEIN S, remains the only non-invasive option, without scars and without incisions. It now integrates 16 times faster beam pulses streamlining the treatment procedure and improving patient experience. This substantially advanced technological solution could reduce the treatment duration by up to 2 to 3 times and it eliminates the need for tumescence or local anaesthesia. Importantly, the new device is designed to integrate future upgrades on "plug-and-play" basis.
A strategic partnership agreement with SuperSonic Imaging has been signed. SuperSonic Imagine is a pioneer in the field of innovative ultrasound imaging. Its parent Hologic Inc. is a leading global innovator in women's health.
The incorporation of improved imaging could assist doctors in further improving treatment times in the future.
Varicose veins affect an estimated 30% of the world's adult population and requires about 5 million medical procedures annually. This second-generation disruptive technology is supported by Key Opinion Leaders and represents a significant milestone in Theraclion's ambition to revolutionize varicose vein treatments.
Theraclion has developed an innovative high-tech 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 over years by Theraclion 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 a 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 Millenium research Varicose Vein Device Market Study 2015. Theraclion's technological solutions are based on high-tech ultrasound medical imaging 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
David Caumartin Chief Executive Officer Tél : + 33 (0)1 55 48 90 70 [email protected] Anja Kleber VP Marketing, Market Access & Sales Francophonia [email protected]
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