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VOL. 128 | NO. 33 | Monday, February 18, 2013

Dynamic Imaging

MRI Interventions boosts ClearPoint Neuro Intervention System

By Michael Waddell

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MRI Interventions Inc. is intensifying rollout efforts for its cutting-edge ClearPoint Neuro Intervention System imaging system.

Memphis-based MRI Interventions is intensifying rollout efforts for its ClearPoint Neuro Intervention System, a next-generation platform for performing real-time, MRI-guided, minimally invasive neurosurgery. 

(Photo Courtesy of MRI Interventions)

The system is used in minimally invasive surgical procedures on the brain, such as MRI-guided deep brain stimulation (DBS) surgery, focal laser ablation, and brain tissue biopsy.

The ClearPoint system provides stable guidance for the placement and operation of instruments or devices during neurological procedures performed within MRI suites using MR imaging.

The company recently finalized a deal with a group of new and existing investors that will generate $11 million from a definitive securities purchase agreement for the private placement of approximately 9.1 million shares of its common stock and warrants to purchase approximately 4.6 million shares of its common stock. The proceeds will fund the further commercialization of ClearPoint.

“We believe that if physicians can see what they are doing, then they will do a better job and have better outcomes, and it will be easier for surgeons to perform those surgeries,” said David Carlson, MRI Interventions chief financial officer. “While a surgical procedure or a therapy is being delivered, a physician is able to see the images in real time while they are actually performing the procedure.”

Conventional or traditional procedures do not provide any kind of visualization for the physician to see inside the brain what they are doing when they are doing it.

“Our ClearPoint system is made to provide real-time visualization using MR images that are captured intra-procedurally,” Carlson said.

ClearPoint Procedures can be performed in a hospital’s existing MRI suite and can be used with both 1.5T and 3T scanners. There are approximately 4,500 1.5T MRI scanners and 550 3T MRI scanners installed in hospitals throughout the U.S.

MRI received FDA clearance for ClearPoint in mid-2010. The system, which consists of an integrated system of hardware components, disposable components and intuitive, menu-driven software, stayed at the University of California at San Francisco for the first 10 months after approval and then had a limited launch that began in the spring of 2011.

The recent $11 million move is expected to strengthen the company’s balance sheet, and it will pave the way for the completion of the commercial roll out of the system.

“The system is now in use at 18 sites inside the U.S. and two sites outside the U.S.” Carlson said. “Emory University Hospital in Atlanta is the closest in proximity to Memphis.”

MRI Interventions formed in 1998 to create innovative platforms for performing the next generation of minimally invasive surgical procedures in the brain and heart. The new ClearPoint system was co-developed and co-distributed in an agreement with Brainlab, a software-driven medical technology company.

“We are first to market for this real-time MRI-guided neuro-intervention system,” said Oscar Thomas, MRI vice president of business affairs.

MRI is also currently partnering with Siemens Healthcare to develop the ClearTrace system to enable MRI-guided catheter ablations for treatment of cardiac arrhythmias, including atrial fibrillation, and the company is also working with Boston Scientific Corporation to incorporate its MRI-safety technologies into Boston Scientific’s implantable leads for cardiac and neurological applications.

“We have shifted more focus towards the ClearPoint commercialization effort and scaled back slightly the R & D (research and development) activities for the ClearTrace system,” Carlson said. “We will continue to move forward with the R & D activities for ClearTrace, but it will simply be at a slower pace. To our knowledge there is not another system that is FDA-approved that provides a real-time visualization when performing an ablation procedure.”

MRI’s executive offices are Downtown at One Commerce Square, while the company maintains a distribution and manufacturing facility in Irvine, Calif. MRI chief executive officer Kimball Jenkins is a lifelong Memphian and had no desire to relocate the executive offices.

“Given the fact that Memphis is a hub city,” Carlson said, “it gives us some flexibility as far as flights.”

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