First Patient Procedure Using the ClearPoint@ Neuro Intervention System Performed at Memorial Sloan Kettering Cancer Center in Pediatric Brain Cancer Clinical Trial
MRI Interventions, Inc. (OTCBB: MRIC) and Brainlab AG announced today that the ClearPoint@ Neuro Intervention System is being used in a groundbreaking clinical trial for the treatment of pediatric brain cancer. Dr. Mark Souweidane (Professor and Vice Chairman, Department of Neurological Surgery; Director of Pediatric Neurosurgery at New York Presbyterian Hospital/Weill Cornell and Memorial Sloan Kettering Cancer Center) and a team at Memorial Sloan Kettering Cancer Center used the ClearPoint System in the delivery of a cancer-fighting agent into the tumor of a pediatric patient while viewing three-dimensional MRI images of the delivery in real-time throughout the procedure. This was the first case in a new clinical trial to administer and study the effects of the radio immunotherapy drug, 124I-8H9, on a diffuse infiltrative pontine glioma (DIPG) tumor, a rare and incurable form of pediatric brain cancer.
Brain tumors of this type are located in the brain stem, which prohibits surgical removal. Radiation is the standard treatment for DIPG, but it does not provide a cure; most patients die within months of diagnosis. Previous attempts to administer a drug therapy to significantly improve the survival of children afflicted with DIPG have failed.
Dr. Souweidane's group, in collaboration with other investigators, is using the ClearPoint System in the administration of precise amounts of the agent directly into the tumor via MRI-guided convection-enhanced delivery. The ability to view drug delivery in real-time is crucial in these cases so that the surgeon can confirm that the potent agent has reached the tumor in the correct amount, as well as to avoid hitting healthy critical structures around the tumor.
The ClearPoint System allows the surgeon to advance a drug delivery canula in a precise trajectory through the brain and into the tumor, then observe the infusion of the drug in real-time as it slowly "fills" the tumor.
It is suspected that previous attempts at drug delivery to treat pediatric brain cancers have been hindered because the drugs have not been fully administered directly into the tumor. The ClearPoint System is designed to overcome this issue.
"This trial is about renewed hope," stated Dr. Mark Souweidane. "It's a departure from the standard therapy and has the potential to create a whole new paradigm in brain tumor treatment. Delivering drugs intravenously hasn't worked because of the blood-brain barrier - to get even a small amount of medicine to the tumor we need high doses of chemotherapy, which is toxic to the rest of the body. But placing the agent outside of the blood vessels, directly into the tumor, greatly reduces that toxicity while maximizing the attack on the tumor itself." About MRI Interventions Founded in 1998, MRI Interventions (OTCBB:MRIC) is a publicly traded company 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, the company's FDA-cleared ClearPoint@ system is designed to enable a range of minimally invasive procedures in the brain. MRI Interventions has a co-development and co-distribution agreement with Brainlab, a leader in software-driven medical technology, relating to the ClearPoint system. In partnership with Siemens Healthcare, MRI Interventions is developing the ClearTraceT system to enable MRI-guided catheter ablations to treat cardiac arrhythmias, including atrial fibrillation.
Building on the imaging power of MRI, the company's interventional platforms strive to improve patient care while reducing procedure costs and times. MRI Interventions is also working with Boston Scientific Corporation to incorporate its MRI-safety technologies into Boston Scientific's implantable leads for cardiac and neurological applications. For more information, please visit www.MRIinterventions.com.
About Brainlab Founded in 1989, the privately held Brainlab group has more than 5,000 systems installed in about 80 countries. Based in Munich, Germany, Brainlab employs 1,070 people in 17 offices worldwide. Brainlab develops, manufactures and markets software-driven medical technology that supports targeted, less-invasive treatment. Core products are image-guided systems and software that provide real-time information used for surgical navigation and radiosurgical planning and delivery.
Brainlab technology drives collaboration between hospitals and clinicians from a wide variety of subspecialties-from neurosurgery and oncology to orthopedics, ENT, CMF and spine and trauma. This integration delivers better access to improved and more efficient treatment. To learn more, visit www.brainlab.com.
Forward-Looking Statements Certain matters in this press release may constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements often can be identified by words such as "anticipates," "believes," "could," "estimates," "expects," "intends," "may," "plans," "potential," "predicts," "projects," "should," "will," "would," or the negative of these words or other words of similar meaning. Forward-looking statements by their nature address matters that, to different degrees, are uncertain and involve risk. Uncertainties and risks may cause MRI Interventions' actual results and the timing of events to differ materially from those expressed in or implied by MRI Interventions' forward-looking statements. For MRI Interventions, particular uncertainties and risks include, among others: demand and market acceptance of its products; its ability to successfully complete the development of, and to obtain regulatory clearance or approval for, future products, including its current product candidates; availability of third party reimbursement; the sufficiency of its cash resources to maintain planned commercialization efforts and research and development programs; future actions of the FDA or any other regulatory body that could impact product development, manufacturing or sale; its ability to protect and enforce its intellectual property rights; its dependence on collaboration partners; the retention of its sales representatives and independent distributor; the impact of competitive products and pricing; and the impact of the commercial and credit environment on it and its customers and suppliers. More detailed information on these and additional factors that could affect MRI Interventions' actual results are described in MRI Interventions' filings with the Securities and Exchange Commission, including, without limitation, the quarterly report on Form 10-Q for the quarterly period ended June 30, 2012. Except as required by law, MRI Interventions undertakes no obligation to publicly update or revise any forward-looking statements contained in this press release to reflect any change in MRI Interventions' expectations or any change in events, conditions or circumstances on which any such statements are based.
Contact: David Carlson 901-522-9300 SOURCE MRI Interventions, Inc.
-0- 08/14/2012 /Web Site: http://www.MRIinterventions.com (OTC-BB:MRIC / OTC-QB:MRIC) / CO: MRI Interventions, Inc.; Brainlab AG ST: Tennessee Germany IN: MEQ HEA OTC SU: TRI PRN -- NE56892 -- 0000 08/14/2012 12:00:00 EDT http://www.prnewswire.c