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/.
