SurgiVision Announces First Patient Procedure Using the ClearPoint System

The First Neurological Surgery Using the ClearPoint System Was Successfully Performed at the UCSF Medical Center

MEMPHIS, Tenn.--(BUSINESS WIRE)--SurgiVision, Inc. announced today that the first patient procedure using its ClearPoint™ Neuro Intervention System (ClearPoint) has been successfully performed by physicians and scientists at the University of California, San Francisco (UCSF) Medical Center. The UCSF team was led by Dr. Philip Starr, Professor of Neurological Surgery and Co-Director of the Functional Neurosurgery Program; Dr. Paul Larson, Associate Professor of Neurological Surgery; and Dr. Alastair Martin, Adjunct Professor, Department of Radiology and Biomedical Imaging.

“We are extremely pleased to announce the first patient procedure using our ClearPoint system by the team within UCSF’s Departments of Neurological Surgery and Radiology. This initial procedure is a major milestone for our company and for the field of MRI-guided interventions.”

SurgiVision’s ClearPoint system is an integrated system of reusable components, disposable components and intuitive, menu-driven software. Using the ClearPoint system, a physician sees and selects a neurological target, aims SurgiVision’s targeting device and watches via magnetic resonance imaging (MRI) as the surgical instrument is advanced to the target. In June 2010, SurgiVision received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the ClearPoint system in the United States.

The ClearPoint system provides guidance for the placement and operation of instruments or devices during the planning and operation of neurological procedures within the MRI environment and in conjunction with MR imaging. The ClearPoint system is intended to be used as an integral part of procedures, such as biopsies and catheter and electrode insertions, which have traditionally been performed using stereotactic methods, and it is designed to allow those procedures to be performed in a hospital’s existing MRI suite.

Kimble Jenkins, SurgiVision’s Chief Executive Officer, commented, “We are extremely pleased to announce the first patient procedure using our ClearPoint system by the team within UCSF’s Departments of Neurological Surgery and Radiology. This initial procedure is a major milestone for our company and for the field of MRI-guided interventions.”

“Performing minimally invasive procedures in the brain presents special challenges, including a need to reach small therapeutic targets often located deep within the brain. Utilizing the imaging power of MRI, we believe our ClearPoint system addresses these challenges and can become the platform-of-choice for performing the next generation of minimally invasive procedures in the brain,” concluded Mr. Jenkins.

Speaking on behalf of the surgical team that performed the ClearPoint system procedure, Dr. Philip Starr added, “High precision access to deep brain targets has, in the past, utilized methods that are time consuming and that can be difficult for some patients to tolerate. Among other benefits, an MRI-guided approach offers direct image guidance during the surgery and may provide the surgeon with the ability to immediately detect any complications. Interventional MRI-guided neurosurgery, conceived 15 years ago for the treatment of brain tumors, has tremendous potential for the delivery of devices to deep brain targets.”

About SurgiVision, Inc.

Founded in 1998, SurgiVision, Inc. is a leader in the emerging field of MRI-guided interventions, creating innovative platforms for performing the next generation of minimally invasive surgical procedures in the brain and heart. Utilizing a hospital’s existing MRI suite, SurgiVision’s FDA-cleared ClearPoint™ system is designed to enable a range of minimally invasive procedures in the brain. In partnership with Siemens Healthcare, SurgiVision is developing the ClearTrace™ system to enable MRI-guided catheter ablations to treat cardiac arrhythmias, including atrial fibrillation. Building on the imaging power of MRI, SurgiVision's interventional platforms strive to improve patient outcomes while reducing procedure costs and times. SurgiVision is also working with Boston Scientific Corporation to incorporate SurgiVision's MRI-safety technologies into Boston Scientific's implantable leads for cardiac and neurological applications. For more information, visit www.surgivision.com.

About University of California, San Francisco

UCSF is a leading university that advances health worldwide by conducting advanced biomedical research, educating graduate students in the life sciences and health professions, and providing complex patient care. UCSF’s neuro-interventional MRI program is based on a collaboration between the Departments of Radiology and Neurological Surgery. These departments are home to leading physicians and scientists dedicated to treating patients with neurosurgical disorders and to the search for better therapies and cures. The UCSF Department of Neurological Surgery is ranked in the top three of US News & World Report's list of best neurosurgery services in the country, and offers a full range of neurosurgical subspecialty care. Its research program is founded on a tradition of bench-to-bedside translational research, with the goal of bringing promising new treatments from the laboratory to the patient. For more information, visit http://neurosurgery.ucsf.edu.