Key Points
- Since we last profiled Theraclion, their SONOVEIN® device has received the CE Mark in Europe for the treatment of varicose veins.
- The company is now exploring the use of focused ultrasound to treat breast cancer and planning a strategic global expansion.
Theraclion is a French company committed to developing a noninvasive alternative to surgery through the innovative use of high-intensity focused ultrasound (HIFU). Their Echopulse® platform was first approved to treat thyroid nodules and breast fibroadenomas. Since we last profiled the company in 2018, their SONOVEIN® device also received the CE Mark – or regulatory approval in Europe – for the treatment of varicose veins. Theraclion is now exploring the use of HIFU to treat breast cancer and planning a strategic global expansion.
We spoke with CEO Martin Deterre about what is next for this innovative company now in its 20th year.
To start, can you share a brief history of the company and its products?
Theraclion developed its expertise in HIFU over a period of a few years before commercializing its first robotic platform, Echopulse®, starting in 2014. For the first time, thyroid nodules and benign breast tumors called fibroadenomas could be treated from outside the body, without incision, scarring, and outside of an operating room. This was a true revolution!
Theraclion then shifted its focus to a larger market: varicose veins, a symptom of chronic venous insufficiency (CVI), addressed with its product called SONOVEIN®. The CE marking allowing for commercialization within the EU was first obtained in 2019. Several generations of SONOVEIN® have already been developed in the startup mindset of our team of around thirty individuals in Malakoff, in the Paris area. Today, over 2,500 veins have been treated with SONOVEIN® technology, in around fifteen centers worldwide, demonstrating the maturity of our product.
Tell us a little about yourself.
I have been the chief executive officer of Theraclion since May 2023, following three years in the company as the director of Engineering and Development. After earning an engineering degree from the Ecole Polytechnique in France, I obtained a master of science at MIT in the United States, and I then completed a PhD in physics focusing on micro/nanotechnologies applied to cardiac implants. In total, I have worked in the medical device sector for nearly 15 years, primarily in startups, focusing on cardiac, ophthalmological, and now, venous indications.
In general, what is the current status of your company?
Since obtaining the CE mark in 2019, Theraclion has focused its efforts on developing SONOVEIN®, our robotic platform using HIFU to treat varicose veins from outside of the body. Approximately 2,500 patients have now been treated in around 15 centers, mainly in Europe.
Our next step for SONOVEIN® will be accessing markets in the United States and China. In the United States, following the successful completion of a feasibility study in 2022, a pivotal study was initiated at the end of 2023. The treatment phase concluded in June 2024, and results will be shared next year after a 12-month follow-up period. In China, our strategic partnership with historic shareholders Furui since May 2023 has enabled us to get started on our production capabilities for this market.
What are some of the technical challenges your group has to overcome to develop a fully noninvasive system?
Our main challenge has been combining robotic, electronic, acoustic, thermal, and software technologies into a simple and intuitive platform. Today, 149 patents protect our expertise. Our platform is primarily composed of a robotic arm, at the end of which are an ultrasound imaging probe and a transducer, producing therapeutic acoustic waves. These waves pass harmlessly through the skin and focus on a specific point inside the tissues, heating them to high temperatures. By moving and treating point-by-point, the device gradually destroys the incompetent vein (in the treatment of varicose veins) or the tumor (in the case of treating the breast and thyroid), all without surgery. An ergonomic touchscreen interface, displaying ultrasound imaging among other things, allows the physician to monitor and control therapy parameters in real time.
What is next for the company?
Our primary development focus lies in accessing the vast market of varicose vein treatment, particularly in the United States. A multicenter pivotal study is already underway following a promising feasibility study that was conducted in 2022. We hope the pivotal study will enable us to apply to the US food and Drug Administration (FDA) for approval in 2026.
Additionally, we are entering the Chinese market through a joint venture with Furui, a Chinese medical devices group and one of our shareholders. Their expertise has already facilitated successful expansion in China of other Paris-based MedTech companies.
In Europe, our clients continue to treat increasing numbers of patients each year. We also maintain close collaborations with partner centers, led by some of the foremost opinion leaders in the vascular field, to further enhance our product.
Our research and development efforts continue, with a focus on significant robotic and technological enhancements for SONOVEIN. We have begun integrating artificial intelligence (AI) for data and image collection and to provide aid to physicians in decision-making, streamline procedures, and reduce the learning curve.
Furthermore, a clinical trial on breast cancer combining our technology with traditional treatment methods, such as immunotherapy and chemotherapy, is underway at the University of Virginia in the United States. If successful, it could potentially cure numerous women and open up a vast new market for Theraclion.
To support these ambitious technological and commercial endeavors, we are always open to welcoming new investors. Theraclion is listed on Euronext Growth, making shares accessible to those interested in participating in our growth. All the essential conditions for our investors’ financial success are in place: a clear strategy, a highly efficient and focused team, and a unique and innovative product operating in a very promising market.
Tell us about your clinical studies and the results.
A number of clinical studies on varicose veins were conducted in Europe prior to getting the CE mark for SONOVEIN® in 2019. One of the most recent studies (conducted in 2023) is the FDA-approved, US-based feasibility study that showed a 100% success rate in the primary end point and 95% abolition of venous reflux. In the pivotal study that is currently ongoing, the treatment phase was concluded in June 2024, and final results are expected by the end of 2025.
We have also partnered with the University of Virginia Cancer Center, since 2017, on breast cancer research with our Echopulse® system. The latest protocol aims at evaluating the combined effect of HIFU with low-dose chemotherapy in patients with early breast cancer.
What are the benefits of your technology over companies?
Our treatment is currently the only noninvasive option for treating incompetent veins. Without incisions, there are no scars or risks of post-operative complications. To date, we have experienced no serious adverse events, whereas traditional techniques (surgery, laser, radiofrequency) unfortunately sometimes do.
Moreover, patients no longer need to reserve their day and can resume their daily activities immediately after treatment. One patient from Madrid even got married just 2 days after her SONOVEIN® treatment! This would be entirely unthinkable after undergoing surgery.
For healthcare facilities, our technology bypasses the requirements for surgical treatment – including a sterile operating room, a surgeon, an anesthesiologist, etc. – and their significant peripheral costs. With only one operator, HIFU treatment represents a time-saving and substantial organizational optimization for physicians and healthcare establishments.
Our technology also opens up a new treatment opportunity for cases of CVI for which there is currently no satisfactory therapeutic response, such as ulcers and particularly tortuous varicose veins.
Another major advantage of SONOVEIN® that keeps us at the forefront of innovation is its ability to collect treatment data, thus enabling the development of treatment automation through AI, notably by integrating robotics with real-time ultrasound image processing. Our product also stands out for its significant potential for further improvements, which are entirely unthinkable with other solutions.
Have you learned any lessons from watching the experience of the other companies?
Of course, we’re always looking to learn from the experiences of others, especially US market entries of other MedTech companies (particularly those based in Europe). We approach this with humility, understanding that every company’s journey offers valuable insights. For example, bringing a highly disruptive medical device to market, securing reimbursement, and deploying it to address as many patients as possible is a complex process filled with challenges. Learning from others in the field is crucial to navigating these obstacles effectively and fast.
Is your system approved for commercial use in any markets? If so, how is it being used in these markets?
Yes, SONOVEIN® received CE marking in 2019. Successful generations of the device, including the latest version, SONOVEIN® HD, have been increasingly used in Europe since then. The product has also been allowed into some Middle Eastern markets, such as the United Arab Emirates and some Asian countries (Hong Kong, Singapore mainly).