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Theraclion Presents Conclusive Clinical Results At The American Society of Nephrology's 42nd Annual Meeting & Scientific Exposition


12/16/2009 12:06:41 PM

Paris, December 16, 2009 - Theraclion, the only medtech company in the world developing an innovative technology for the treatment of primary and secondary hyperparathyroidism (video), today announced that it had obtained conclusive clinical results. The device created by Theraclion, the TH-One, uses the "UNIS" method (ultrasound non-invasive surgery) based on High Intensity Focused Ultrasound. The results of a recent study were presented by Professor Roussanka Kovatcheva (University Hospital of Endocrinology, Sofia, Bulgaria) at the American Society of Nephrology's 42nd Annual Meeting & Scientific Exposition, which took place from October 27th to November 1st in San Diego, USA.

This study entitled "High intensity focused ultrasound: a novel non-invasive treatment for hyperparathyroidism" confirmed the efficacy of Theraclion's therapeutic approach. After two ultrasound treatment sessions with the Theraclion's TH-One device, a female patient suffering from primary hyperparathyroidism - caused by a non-malignant tumor (adenoma) on a parathyroid gland that results in oversecretion of parathyroid hormone - had normalized her parathyroid hormone level and her adenoma size had halved. No treatment side effects were observed.

"These results are excellent news for patients suffering from hyperparathyroidism. For the first time, a company is offering a simple, non-invasive, cost-effective alternative that can be administered on an outpatient basis to treat this pathology which is today reserved to surgery. In Q1 2010, the pre-commercialization phase of the THOne will start. We shall soon be in a position to supply our system to surgeons", commented Theraclion CEO Ismaël Nujurally.

The American Society of Nephrology (ASN)'s Annual Meeting & Scientific Exposition (also known as "Renal Week") is the world's largest nephrology meeting and was initiated in 1967. The ASN (founded in 1966) has 11,000 physician and researcher members and is the leading learned society devoted to chronic kidney disease (CKD). Between 5% and 30% of patients on long-term dialysis develop secondary hyperparathyroidism, making it the most prevalent CKD-related complication.

About hyperparathyroidism

Hyperparathyroidism corresponds to over-secretion of parathyroid hormone by the parathyroid glands in the neck. This leads to phosphocalcium dysfunction and bone demineralization. The condition is classified as primary hyperparathyroidism or secondary hyperparathyroidism, with the latter specifically affecting CKD patients.

Theraclion’s technology

At present, hyperparathyroid patients have to choose between costly, chronic drug treatment (secondary hyperparathyroidism) and surgery (primary and secondary hyperparathyroidism), with its inherent risks. By leveraging its proprietary Ultrasound Non- Invasive Surgery ("UNIS") method, Theraclion is developing medical technology which offers the first simple, non-invasive, lower-cost, outpatient-based alternative for treating this condition. The (HIFU) (High Intensity Focused Ultrasound) treatment is performed under analgesia and takes around 30 minutes. The target is identified using diagnostic ultrasound and then (thanks to the millimeter accuracy of HIFU beams) only target tissue is destroyed. After the treatment, a blood test is used to check the patient's parathyroid hormone, calcium and phosphate levels.

About Theraclion

The Paris-based medtech specialist Theraclion was spun out from Edap-Technomed in 2004. By leveraging its proprietary "Ultrasound Non-Invasive Surgery" ("UNIS" method), Theraclion develops, produces and commercializes devices for non-invasive, outpatient treatment of primary and secondary hyperparathyroidism. The technology uses diagnostic ultrasound to identify the target and then high-intensity ultrasound to coagulate the tissue - thus enabling patients to avoid burdensome drug treatment and the risks of surgery. Primary hyperparathyroidism has a potential market of over €300 million and secondary hyperparathyroidism corresponds to a potential of 1.5 million easily accessible patients on dialysis. To date, Theraclion has raised €6.1 million from Truffle Capital, one of its founding investor. Theraclion is primarily responding to the needs of clinics and hospitals in Europe, the United States and Asia. The company has initiated procedures for gaining market approval from the United States Food and Drug Administration (FDA). Indeed, the United States alone represents half of the global market. For more information on Theraclion, visit http://www.theraclion.com/.


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