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"World first: Lasers used in keyhole surgery for brain cancer" -Agence France-Presse

Paris, France August 29th, 2008 - Visualase technology used to successfully treat brain tumors, as reported by AFP and the Telegraph (UK).

Read: AFP article here | Telegraph article here

press releases

Visualase, Inc., receives award for best elevator pitch at the 2007 Texas Life Science Conference.

Houston, Texas November 2nd, 2007 Visualase, Inc. was recognized as one of the top five presentations during the Elevator Pitch session held at the 2007 Texas Life Science Conference. The session, hosted by the Rice Alliance for Technology and Entrepreneurship, included 20 presenting life science companies with each providing a 90 second snapshot of their business. “We are extremely pleased and honored to be recognized and selected for this award,” stated Dr. Ashok Gowda, President and CEO of Visualase, and presenter of the elevator pitch at the conference. “Knowing that top venture capitalist were judging the event provides both exposure to the investment community and validation of the high commercial potential for our technology,” added Dr. Gowda. The conference hosted by BioHouston was attended by over 300 national venture capitalists, researchers, and emerging life science companies from across Texas and included a visit and speech by Governor Rick Perrry, who called for a renewed commitment to the State’s fight against cancer.

Visualase, Inc., announces receipt of a $750,000 award from the State of Texas Emerging Technology Fund.

Houston, Texas October 9th 2007 Visualase, Inc. announced receipt of a $750,000 Emerging Technology Fund Award from the State of Texas to help develop its Visualase® Thermal Therapy System, a revolutionary tool for the destructive treatment of cancer or other malignancies using patented laser and MRI-based guidance systems. Laser-induced interstitial thermal therapy (LITT) is a minimally invasive therapy for the treatment of solid tumors that uses laser light to heat and destroy the affected tissue. Combining this therapy with MRI thermal imaging feedback allows physicians a level of targeting and control previously not possible, opening a host of tumor ablation applications in neurosurgical and other vital organ systems. This therapy offers tremendous potential to minimize surgical complications, reduce recovery time and hospital stays, and decrease associated health care costs. “This investment from the Emerging Technology Fund is a partial match of a Small Business Innovation Research (SBIR) Grant from the NIH's National Cancer Institute and further validates the significant potential of our Visualase Thermal Therapy Systems,” said Ashok Gowda, Ph.D., President of Visualase, Inc. “The funds will help support ongoing clinical studies in Paris, France, and new studies that will begin soon in Houston at M.D. Anderson as well as other cancer centers in the U.S. The award will also help us attract additional financing and the high quality personnel required to accelerate the clinical deployment of our tumor ablation and image guidance technologies,” he added.

Visualase, Inc. announces article in Le Quotidien Du Medecine highlighting a clinical study of its image-guided thermal therapy system for treatment of brain metastases.

Houston, Texas September 14th, 2007 The French news journal, Le Quotidien Du Medecin presents featured article describing the ongoing clinical study taking place at hopital Lariboisiere in Paris France under the direction of Neurosurgeon, Dr. Alexander Carpentier. The article shows one of the patients enrolled in the study to demonstrate safety of the Visualase magnetic resonance guided laser thermal ablation technique. In this particular patient three Visualase cooled laser applicators are inserted into two discrete recurrent breast metastases in the brain. Both tumors in this patient were treated in a single treatment session lasting less than one hour. “Plans are currently being put in place to expand this work in Paris and in the U.S. based on the excellent results achieved to date,” commented Dr. Ashok Gowda, President and CEO of Visualase. For more information on this trial please visit the clinical trials page.

Visualase, Inc. announces successful completion of first six clinical procedures with its image-guided thermal therapy system for treatment of brain metastases.

Houston, Texas July 26th 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 tumour cells and allows MRI control and confirmation of the treatment efficacy. This is not possible with other brain tumour 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 that, “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 millions 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 focussed 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.

Visualase, Inc., named “Top 10 most promising Company” at Technology Venture Forum.

Houston, Texas June 6th 2007 Visualase, Inc. was recently named one of ten “most promising life science companies” as part of the 2007 Rice Alliance Life Science Technology Venture Forum. Over 30 medical and life science technology companies gave presentations at the forum event on the Rice University campus in Houston. A panel of audience members including venture capitalist, industry leaders, and local business people scored presentations according to commercial and technological promise in determining the ten “most promising”. “We are extremely honored to be selected for this award,” stated Dr. Roger McNichols, Chief Technology Officer for Visualase and presenter at the Forum. “The panelist judging these presentations are experts in their related fields and we are pleased that they have recognized our technology for its commercial potential,” he added. More information on this event and award can be found at:
http://www.alliance.rice.edu/alliance/LS_Overview.asp?SnID=870171268.

Visualase, Inc., announces FDA 510(k) clearance of the Visualase Thermal Therapy System.

Houston, Texas August 31st, 2007 The U.S. FDA granted 510(k) clearance (K071328) for the Visualase Thermal Therapy System (manufactured by BioTex, Inc. and owned and distributed by Visualase Inc.). This is the fourth 510(K) clearance to support marketing efforts of the company’s products and is essentially a combination of three prior approvals. “This clearance is a critical milestone in being able to exploit the features and advantages of our advanced laser ablation products,” stated Dr. Ashok Gowda, President and CEO of Visualase. “The universal imaging compatibility of our products allows their use while under MRI examination. Our proprietary software can then extract temperature information during the ablation process providing a level of targeting and control not currently possible by conventional methods,” added Dr. Gowda. The Visualase Thermal Therapy System consists of a computer workstation, laser, pump, and disposable applicator which are indicated for the coagulation of soft tissue through interstitial irradiation under MRI guidance in general and other surgical specialties. The detailed indications for use can be found at the following link: click here.

Visualase, Inc., announces FDA 510(k) clearance of the Visualase ENVISION software and workstation for real-time magnetic resonance data analysis.

Houston, Texas December 12, 2006 The U.S. FDA granted 510(k) clearance (K063505) for the Visualase ENVISION software and workstation. The Envision System can be used to analyze and compare MRI magnitude of phase difference image data as it is acquired from an MRI scanner. In particular, the software allows near real-time image visualization of temperatures derived from phase difference images during thermal therapy interventions. “This software and workstation are unique in that they can interface with a number of compatible MRIs, requiring no modification to the resident scanner software,” stated Dr. Roger McNichols, Chief Technical Officer of Visualase. “By retrieving image data through a network interface once its available, the workstation can provide information not readily available to clinicians through standard MRI exams. Data such as temperatures during an ablation process can be critical to ensure adequate treatment of the target and protection of healthy tissues,” added Dr. McNichols. The detailed indications for use can be found at the following link: click here.

Visualase, Inc., announces FDA 510(k) clearance of the PhoTex15 Diode Laser Series manufactured by BioTex, Inc. and to be distributed by Visualase, Inc.

Houston, Texas March 21st, 2006 The U.S. FDA granted 510(k) clearance (K060304) for the PhoTex15 Diode Laser Series. The PhoTex Family of Lasers are small, portable, diode lasers operating at wavelengths of between 800nm and 1064nm and can be used in a number of general surgical applications. “The 510(k) clearance on this laser system compliments the recent approval of our Visualase Cooled Applicator System, also manufactured by BioTex,“ commented Dr. Ashok Gowda, President of Visualase, Inc. “When used together, these two devices create a highly efficient and effective ablation system for creating large thermal lesions in soft tissues,” he added. The detailed indications for use can be found at the following link: click here.

Visualase, Inc., announces FDA 510(k) clearance of the Visualase Cooled Laser Applicator System.

Houston, Texas March 1st, 2006 The U.S. FDA granted 510(k) clearance (K053087) for the Visualase Cooled Laser Applicator System. The Visualase Cooled Laser Applicator System, manufactured by BioTex, Inc. and to be distributed by Visualase, Inc. received clearance for marketing with broad use in a number of medical specialties. “This family of products consists of a number of novel advancements in laser applicator systems,” stated Dr. Ashok Gowda, President and CEO of Visualase. “The laser diffusing fiber and cooling catheter system can be used together to allow use of higher laser powers and faster ablation times, while minimizing risk of applicator damage and tissue carbonization,” he added. The detailed indications for use can be found at the following link: click here.