French medical technology company Theraclion has successfully arranged a reserved issuance of a convertible bond loan, aimed at bolstering its financial resources and advancing its innovative non-invasive high-intensity focused ultrasound (HIFU) therapy platform. The financing, totaling up to €6 million, is being provided by Furui and Unigestion, two key shareholders. This strategic move ensures Theraclion can focus on expanding its commercial reach, enhancing research and development efforts, and securing FDA regulatory approval for its SONOVEIN® device. The initial €3 million commitment will be disbursed in two tranches, with the potential for an additional €3 million at the investors' discretion. CEO Martin Deterre expressed gratitude for the continued support from Furui and Unigestion, highlighting the importance of this funding in driving the company's strategic priorities.
Theraclion's innovative approach to medical treatments using HIFU technology represents a significant advancement in non-invasive surgical alternatives. The company's flagship product, SONOVEIN®, offers a promising solution for varicose veins without the need for incisions or lengthy recovery periods. To further enhance its offerings, Theraclion has introduced 'SpeedPulse,' a new technology that significantly increases treatment speed. This innovation, currently undergoing clinical trials led by Professor Jaroslav Strejček in Prague, integrates advanced acoustics and optimized therapeutic ultrasound pulses. The successful implementation of SpeedPulse could lead to broader adoption by European treatment centers and accelerate revenue growth through consumable sales and machine sales in high-potential markets like the Middle East.
The convertible bond loan structure allows Furui and Unigestion to subscribe to warrants for bonds convertible into shares. Each warrant grants the right to subscribe to one OCA, which can be converted into shares between July 1, 2025, and February 15, 2030, at a conversion price set at €0.20 per share. The minimum subscription amount of €3 million extends Theraclion's cash runway until the end of the fourth quarter of 2025, ensuring sufficient funds to complete pivotal FDA studies and achieve other strategic milestones. The transaction also provides an opportunity for existing shareholders and other investors to participate under similar conditions, fostering broader investor engagement and confidence in the company's growth strategy.
In the United States, Theraclion is making strides toward FDA approval for SONOVEIN®. The pivotal study for the device is expected to reach a critical milestone in the summer of 2025, with the completion of the 12-month follow-up phase for all treated patients. This will pave the way for submitting a regulatory approval application to the FDA, marking a crucial step in expanding the company's market presence. Theraclion aims to achieve €2.5 million in revenue in 2025 and €5 million in 2026, driven by its focus on recurring revenue models and strategic market expansion. The company's leadership remains committed to generating revenue, achieving profitability, and creating value for its stakeholders.
This financial injection not only strengthens Theraclion's balance sheet but also underscores the confidence of its major shareholders in the company's long-term vision. With robust financial backing, Theraclion can continue to innovate, expand its commercial footprint, and bring life-changing medical technologies to patients worldwide. The company's dedication to advancing non-invasive treatments positions it as a leader in the MedTech industry, poised for significant growth and impact in the coming years.