Houston, TX, 25 July 2007:
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.
