RSNA. Non-Invasive Treatment for Benign Tumors

French echotherapy specialist Theraclion presented its flagship Echopulse device at this year’s RSNA. It combines an ultrasound imaging system with high-intensity focused ultrasound (HIFU) therapy. The latter destroys benign breast and thyroid tumors non-invasively, painlessly and with precision. The next step will be to treat cancerous tumors. Theraclion CEO David Caumartin told us more.

MedicalExpo e-magazine: Echopulse was created in 2004. Why has it taken so long to develop this technology?

David Caumartin: We responded to a request by Saint-Louis Hospital in Paris for a way to use focused ultrasound as an alternative to head and neck surgery. Following CE certification for thyroid and breast treatment, we sold the first Echopulse in Germany in 2013. It took a while to develop such complex technology because it requires complicated studies and takes time to reach the market. Introducing a non-surgical alternative to surgery runs into a lot of resistance. Today, we have 36 systems in use around the world, half of them in Germany. We also have four clinical research systems in the United States.

At this year’s RSNA, a University of Virginia (UVA) team was invited to present data from the preliminary feasibility study. They used Echopulse on 20 patients, and followed them for 12 months. After the study, Theraclion approached the Food and Drug Administration to begin a pivotal study in the US to evaluate the safety and efficacy of Echopulse. UVA is managing the study and recruitment is already at nearly 50%. In the trials, 100 patients will be followed for 12 months. The goal is to enter the American market in a year and a half.

ME e-mag: How does the system work?

David Caumartin: The robotic system positions a treatment echograph over the lesion. It then performs thermal ablation by sending heat generated by high-intensity ultrasound waves through the skin and healthy tissue to the tumor.

The patient receives a local anesthetic and the treatment head is positioned precisely over the center of the tumor via the user interface controls. The robot automatically makes a 3D map of the tumor, enabling the operator to determine tumor volume from several cross-sections. The system then locates target zones on the cross-sections and destroys the tumor one point at a time. The doctor simply makes sure the treatment is proceeding properly. The system is designed to operate automatically.

The heat destroys the DNA of the tumor cells. This cellular destruction incites the immune system to clean away the dead cells and the tumor in general. The immune response is not immediate. The tumor begins to shrink after several weeks. Generally, one month out we see a 10% reduction in the tumor volume. At three months, the reduction is between 30 and 50%, At six months, 50-70%, and 80-90% after a year. In nine of 10 cases, one treatment suffices.

ME e-mag: Are you treating only benign tumors for the moment?

David Caumartin: Our CE authorization only covers benign tumors—breast fibroadenomas and benign hot and cold thyroid nodules. There are two possibilities for broadening clinical use. The first is extending treatment to other benign thyroid conditions, especially autoimmune diseases in which the thyroid overproduces hormones. A pivotal study covering this is underway at Hong Kong University.

The second, more interesting possibility is to include breast cancer. This is under study at the University of Virginia. We had to take the benign tumor treatment route to legitimize the work and to understand the operative mechanisms of tumor size reduction in order to know how to position the technology for the treatment of cancerous tumors.

ME e-mag: What are the most innovative aspects of your system compared to other ultrasound devices?

David Caumartin: Ours is the only one capable of breast and thyroid treatment. It was designed for ease of use by surgeons, without need for a radiologist or an operating room. The biggest difference compared to other systems is its remarkable precision—down to one millimeter. This is necessary to treat thyroid tumors because centimeter precision would be too risky. When treating cancerous lesions, systems like radiotherapy destroy everything around the tumor. Our system is not only non-invasive but also very precise.

ME e-mag: Are there any side-effects like burns or pain?

David Caumartin: Neither the skin nor the areas around the tumor are burned. You must be careful with nearby nerves because they are more heat-sensitive than other cells. But our instructions make it clear how to do this. There’s no need for painkillers after treatment and it’s also very rapid; a typical treatment lasts 30 to 40 minutes.

Read more about HIFU ablation systems on MedicalExpo website.