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French start-up Theraclion (Paris) won the CE mark for its Thyros high-intensity focused ultrasound (HIFU) device for non-invasive reduction of thyroid nodules and secondary hyperparathyroidism.

The company also reported receiving a €1.3 million ($1.9 million) grant from OSEO Innovation, a French state innovation agency.

Theraclion is targeting a worldwide market estimated at more than $850 million annually and expects to be ready for full commercialization of the device, or preferably a sale of the company to a larger manufacturer, by 2010.

Chief executive Ismaël Nujurally, MD, said the next two years will be dedicated to additional clinical trials to demonstrate efficacy, winning reimbursement for the outpatient procedure as an alternative to surgery or pharmaceutical therapy in Europe, and accessing new markets primarily the U.S.and Japan.

“The U.S. is the biggest market,” he told Medical Device Daily, “thanks to a concentrated population under a single regulatory authority and homogenous healthcare system.”

He said a 510(k) submission to the FDA will be filed based on an equivalent predicate HIFU device approved for InSightec (Tirat Carmel, Israel) for uterine fibroids, or for EDAP (Lyon, France) for localized prostate cancer.

Theraclion received the CE mark for head-and-neck therapies using the innovative HIFU treatment and while the initial indication is for thyroid nodules, the company can expand to other indications in the same area.

Each application of HIFU technology, which heats the targeted tumor to 176 degrees Fahrenheit, requires a specific design for a specific area of the human anatomy to control the emission device and avoid burning of skin or adjacent healthy tissues, as well as assuring a precise targeting in three dimensions.

The Thyros stereotaxic acoustic surgery device is made up of the generator for HIFU, an ultrasound imaging screen, a screen for targeting the intervention, and a stand-up station housing the computer and proprietary software for managing the procedure.

The key technology is contained in the visualization and treatment head (VTU) mounted on a robot arm that contains the ultrasound imaging sensor and the HIFU emission device in order to define the target and deliver the high-energy beam.

“The beauty of what we have done is to start with a very small focal point, targeting lesions smaller than a grain or rice (2 mm x 2 mm x 8 mm),” said Nujurally. “Having done that with precision three-dimensional targeting makes it easier to move to larger targets.”

Thecompany shares several patents with EDAP and has filed four new patents covering its proprietary developments that include the control of the energy levels at skin level and a cooling technique for the VTU.

“The cooling technique is considered a shining star in our intellectual property portfolio according to independent analysts in the U.S.,” Nujurally added.

Launched in 2004 through a technology transfer from EDAP and the Institut National de la Santé et de la Recherche Médicale to company chairman Fran ois Lacoste, Theraclion attracted €4.1 million ($6 million) in first-round financing from Truffle Capital (Paris).

First treatment in UK CHHiP trial

Clinical treatment in the UK’s large-scale trial for treating prostate cancer with intensity-modulated radiation therapy (IMRT) began at the Cancer Center of Belfast City Hospital in Northern Ireland, using the dose-shaping Oncentra device from Nucletron (Veenendaal, the Netherlands).

More than 2,000 men throughout the UK will participate in the Conventional or Hypofractionated High-Dose Intensity Modulated Radiotherapy for Prostate Cancer (CHHiP) clinical trial expected to return its first findings in 2012. The Phase III multi-center, randomized trial is being conducted by the National Cancer Research Network (NCRN) and National Cancer Research Institute (NCRI) and is sponsored by the Institute of Cancer Research.

Nucletron’s Oncentra Optimizer with Direct Step & Shoot capabilities was used for the first procedures.

Prostate cancer patients undergoing radiotherapy locally usually have up to 37 treatments, or fractions, over eight weeks. IMRT allows higher doses to be given over a shorter time period, reducing treatment time.

The CHHiP trial aims to compare the standard 37 fractions with 20 fractions given in four weeks.

Dr. Vivian Cosgrove, clinical scientist at the Cancer Center, said the conformance of dose required for the trial presents “very challenging dose-volume constraints,” and the Oncentra MasterPlan was a key to assisting the planning and targeting of treatment that combines computed axial tomography, magnetic resonance and positron emission tomography scanning.

RaySearch Laboratories (Stockholm) software for radiation therapy also was used for the treatment.

First installation of TopSpin IVMRI system

TopSpin Medical (Tel Aviv, Israel) reported the first commercial installation of its Cathamaran Intravascular MRI System at ZOL Hospital (Genk, Belgium), along with the first procedures performed using the system.

“This 6 Fr compatible technology represents a major breakthrough in our ability to detect and quantify lipid present in coronary lesions,” said Dr. M. Vrolix of ZOL Hospital. “We are [pleased] to be among the first centers to participate in the MIRACLE Study to further evaluate the clinical role for IVMRI in both diagnostic and interventional coronary catheterization procedures.”

Vrolix added, “The identification of high-risk, lipid-rich lesions that may be prone to rupture is of paramount importance, and the IVMRI System may ... help address this unmet need.”

TopSpin said it expects to install additional Cathamaran systems in the Benelux territory during the current quarter.

The multi-national prospective MIRACLE Study is designed to collect data on a widespread post-market clinical experience to evaluate how lipid quantification with the IVMRI System may be used to guide patient treatment.

Yaron Tal, company president/CEO said, “The introduction of the Cathamaran Intravascular MRI System and the initiation of the MIRACLE registry represent major milestones for our company. We are committed to advancing investigation into vulnerable plaque with the goal of improving diagnosis of these high-risk lesions and aiding development of appropriate therapeutic solutions.”