Start-up French device maker, Theraclion, continues to break new clinical ground with its TH-One ultrasonic ablation system. Last month, the company announced early success in the noninvasive treatment of patients with breast fibroadenomas, which are benign tumors that affect about one in ten women and are especially problematic for those under 30 years old.
Theraclion reported that the first two clinical trial patients at Sofia University Medical Center in Sofia, Bulgaria had significant reduction in tumor volume. Six months after treatment, the patient’s fibroadenomas shrunk in volume by 64 and 62 percent, respectively, and had become softer on palpation. The trial is expected to treat as many as 20 patients before concluding.
The company has launched a second breast fibroadenoma study in Paris and in Lille. Set to enroll 20 patients over a 6‐month period, the feasibility study will treat women who are scheduled for a surgical resection. Patients will receive focused ultrasound treatment before undergoing surgery. The study will measure high intensity focused ultrasound-induced tissue necrosis assessed by histology of the excised gland two months after treatment.
According to Theraclion, fibroadenoma treatments are performed in a single session under sedation and on an outpatient basis. They take about 30 to 40 minutes, depending on the size of the fibroadenoma.
The TH-One previously achieved successful results in clinical trials for thyroid nodules and primary and secondary hyperparathyroidism. The system, which was originally designed to meet the high precision requirements for administering focused ultrasound to the neck, received CE-marking in 2007 for thyroid and parathyroid applications.
Theralcion’s Vice President of Marketing and Sales, David Del Bourgo, MBA, reports that a prestigious oncology center in France, the Institut Gustave Roussy, is interested in launching clinical trials to explore a fourth indication for the TH-One: metastatic bone tumors.
Del Bourgo says that, in late 2012, Theralicion will begin commercializing the TH-One as a single platform solution for multiple indications to enable hospitals and clinics to justify its acquisition cost.
Project on elastography-guided ultrasound therapy
In addition to exploring new applications of the TH-One, Theraclion is engaged in R&D efforts to improve the system’s guidance technology. In 2009, the company received a €8.5 million grant from the French state innovation agency, OSEO, to embark upon a strategic industrial innovation project on elastography-guided ultrasound therapy. The company‘s partner on the project is SuperSonic Imagine, a leader in ultrasound imaging.
When the grant was announced, Jacques Souquet, PhD, CEO of SuperSonic Imagine, said, “The added value contributed by SuperSonic Imagine and its Aixplorer product relates to how Theraclion’s therapeutic system is guided. Very high-resolution ultrasound imaging and the superposition of ShearWave elastographic information (a measure of tissue hardness) enable us to determine the site, extent and degree of necrosis created by the Theraclion device."
SuperSonic Imagine’s tissue elasticity imaging concept is quantitative, has reproducible results and works in real time.
“We believe that ultrasound-guidance is becoming a complementary tool to FUSgMR and that elastography is a smart solution to monitor and control tissue necrosis,” observes Del Bourgo.
Theraclion now in fundraising mode
Spun-off in 2004 from French medical equipment company EDAP-Technomed, Theraclion, is based in the Paris area, has ten employees and is supported by an international scientific and medical committee composed of surgeons, interventional radiologists, endocrinologists and nephrologists.
The company’s main shareholder is Truffle Capital, a leading venture capital firm in Europe. Theraclion has also received significant funding from the French Government through its Innovation and Development Fund, OSEO.
According to Del Bourgo, Theraclion is now in the midst of major fund-raising. Funding will be used to support planned clinical trials and commercialization initiatives.
TH-One System overview
TH-One ultrasonic ablation system
The TH-One is a compact, mobile machine with unique technology that combines ultrasound imaging and HIFU treatment systems. It uses diagnostic ultrasound to identify the target and then high-intensity ultrasound to heat and rapidly destroy diseased tissue - thus enabling patients to avoid burdensome drug treatment and the risks of surgery.
“Because it’s mobile and compact, the TH-One can be rolled into the treatment suite and then put back away,” says Del Bourgo.
The system consists of an ultrasound generator, a power amplifier, a computer and a Vizualisation and Treatment Unit (VTU). Currently guided by real-time echography, it offers an excellent image quality, millimeter‐scale shot accuracy and an integrated cooling device for patient safety and comfort.
A unique feature of the TH-One system is the one-use, disposable treatment pack. This treatment pack enables a high-quality, continuous coupling of the ultrasound beam and cooling of the patient skin to ensure safety.
“We believe we have the scalpel of the future. It’s a very elegant, cost-effective, and novel tool for clinicians and patients,” Del Bourgo says. “We don’t want to interrupt existing patient flow and ownership. Rather, we want to provide an additional tool to surgeons and interventional radiologists.
Sources of additional information:
Facebook Page: http://www.facebook.com/pages/Theraclion/303792825050
TH-One patient treatments: https://www.youtube.com/watch?v=xrYwFI-1Lpo
Company overview: https://www.youtube.com/watch?v=KQXDma_hHTM
Written by Ellen C., McKenna