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Visualase, Inc. Announces Successful Completion of First Six Clinical Procedures With Its Image-Guided Thermal Therapy System for Treatment of Brain Metastases

Posted on: Thursday, 26 July 2007, 12:24 CDT

Visualase, Inc. with its research partner BioTex, Inc. and the "Assistance Publique - Hôpitaux de Paris" healthcare network have enrolled and completed treatment of the first six patients in a pilot, phase I study, with the objective to demonstrate the safety of the Visualase® magnetic resonance (MR) guided laser thermal ablation technique for the minimally invasive treatment of brain metastasis.

An independent review after the first three treatments as required by the study protocol found that the technique was safe and that the trial should be allowed to progress to the next level in which larger tumors from additional sources could be included. The results obtained from the first six treatments demonstrate that the technique is feasible and safe for all the procedures performed. Follow up of the patients over a period of up to six months also demonstrates a total or partial ablation of the treated metastasis.

Dr. Alexandre Carpentier MD, PhD, a neurosurgeon and principal investigator of the study, emphasized that "this new awake interventional MRI procedure using the Visualase system allows the physician to have a real time security control during the treatment with a high degree of precision for the ablation volume created. The procedure is achieving an immediate necrosis of the radio resistant tumor cells and allows MRI control and confirmation of the treatment efficacy. This is not possible with other brain tumor therapies in use today." He added that "the procedure is highly tolerated by the patients who are released from the hospital after only few hours of post-procedure monitoring."

Dr. Ashok Gowda PhD, President and CEO of Visualase, Inc., commented, "These initial results are extremely encouraging for the technology and its potential to help patients suffering from brain metastases. Our ability to perform these procedures safely and effectively also opens the doors to a host of other possible treatments in the neuro-cognitive and oncology areas."

The treatment is performed under local anaesthesia using an MR compatible stereotactic frame and planning software to accurately place a 1.6 millimeter diameter fiber optic laser applicator centrally inside the target tumor. The applicator delivers laser energy from a 15 Watt 980 nm diode laser through a diffusing tip to heat the tumor tissue. During treatment, the patient is positioned in a 1.5 Tesla magnetic resonance imaging system while images are acquired continuously. The Visualase computer workstation processes the MR images to provide real time temperature maps and estimates of thermal damage around the applicator. The real-time damage predictions and safety points allow the treatment to be performed with a high degree of safety and precision. Typical laser delivery lasts less than 5 minutes, and after treatment is complete, patients immediately undergo additional MR imaging which allows post-treatment confirmation of the thermal ablation zone.

About Assistance Publique - Hôpitaux de Paris (AP-HP):

The "Assistance Publique - Hôpitaux de Paris" is the largest healthcare provider in Europe including a network of 38 hospitals in the Paris region that are providing a complete and high level spectrum of treatments for a population superior to 10 million people. It also includes dedicated healthcare schools to train the various healthcare personnel to innovative new medical technologies and an important technology and clinical research platform with 354 ongoing clinical trials that include more than 34,000 patients.

About Visualase, Inc.

Visualase, Inc., a privately held company located in Houston, Texas started as a spin-off from BioTex, Inc., the original developer of the Visualase technology. Visualase, Inc. is focused on product development, clinical evaluations, marketing, and sales of advanced laser and image-guided technologies for minimally invasive thermal ablation applications. Visualase's initial products are geared toward providing physicians with a superior platform for minimally invasive thermal therapy of solid tumors and software which allows the merging of the existing diagnostic and therapeutic environments for improved patient care. For more information on the company, its products, and clinical studies visit www.visualase.net.

Source: Business Wire

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