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June 11, 2014
09:15 EDTBSDMBSD Medical reports initiation of clinical study using MicroThermX system
BSD Medical announced initiation of a clinical study by the University of Utah School of Medicine using BSD’s MicroThermX Microwave Ablation System to treat liver tumors. The study is a prospective, non-randomized, single arm trial that involves 20 patients. The study objective is to clinically evaluate the size of the ablation zones produced in liver tissue by BSD’s patented Synchronous Wave Alignment technology developed for MicroThermX. Both cirrhotic and non-cirrhotic liver tissue will be evaluated in this clinical study. The study is open for patient enrollment at the University of Utah School of Medicine. The principal investigator for the study is Ryan O’Hara, M.D., Assistant Professor of Radiology, Chief, Department of Interventional Radiology, Director of Interventional Oncology, University of Utah School of Medicine, Huntsman Cancer Hospital. “This trial will allow us to study the effects of the Synchronous Wave Alignment technology in both cirrhotic and non-cirrhotic liver tissue, and to determine if there is a difference in how the energy is absorbed in the two types of tissue,” stated Dr. O’Hara.
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July 15, 2014
09:18 EDTBSDMBSD Medical initates Phase I/II study using hyperthermia
BSD Medical reported initiation of a Phase I/II study using hyperthermia, delivered using either the BSD-2000 Hyperthermia System or the BSD-500 Hyperthermia System, combined with proton radiotherapy to treat patients with unresectable soft tissue sarcoma. The clinical study has been designed in joint cooperation with Kantonsspital Aarau, Paul Scherrer Institute, Villigen, Uniklinik Balgrist, Zurich, and University Hospital, Zurich. The Phase I/II study will include 28 adult patients with primary and unresectable soft tissue sarcomas of extremities and trunk. The trial has been registered at ClinicalTrials.gov and is open for patient enrollment. The company said, "Consequently, for unresectable primary and recurrent soft tissue sarcomas, the thermoradiobiological and physical advantages of hyperthermia and proton beam radiotherapy could be expected to produce a greater tumour regression, higher tumour downstaging, superior resectability with organ and limb preservation and improved survival outcome without significant treatment related morbidity."

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