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VOL. 125 | NO. 125 | Tuesday, June 29, 2010

SurgiVision Gets FDA Approval

By Tom Wilemon

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Memphis-based SurgiVision Inc. has received FDA clearance to begin marketing the first of its medical imaging devices and is moving forward with its initial public offering.

SurgiVision said it expects to offer stock for $13 to $15 a share.

The new information about the IPO and the action by the Food and Drug Administration were disclosed in a filing the company made on June 25 to the U.S. Securities and Exchange Commission.

The FDA granted 510(k) clearance on June 16 for the ClearPoint system. The technology allows physicians to perform minimally invasive procedures on the brain in a MRI suite.

SurgiVision is also developing two other devices that will allow doctors to monitor their patients on a MRI while doing procedures on the brain and the heart.

“We have a significant intellectual property portfolio in the field of MRI-guided interventions,” the company said in the filing.

“In addition, we have meaningful collaborations with major industry participants and renowned academic institutions,” officials wrote. “Our technologies have been the subject of numerous peer-reviewed articles in medical and scientific journals.

“As a result of our intellectual property and collaborative relationships, we believe that we are well positioned to remain on the forefront of the emerging market for MRI-guided minimally invasive surgical procedures.”

SurgiVision has a portfolio of 40 patents and 115 patent applications.

The company was formed in 1998 and since that time has conducted research partnerships with The Johns Hopkins University, the University of Utah and the University of California, San Francisco.

Two corporate partners are Siemens and Boston Scientific.

SurgiVision announced in December its plans for the IPO, but a date has not been set for the offering. The company, which will trade on Nasdaq under the symbol SRGV, plans to offer 2.5 million shares of stock some time this year.

SurgiVision executives could not comment because it is in a “quiet period” prior to the IPO. However, a prospectus SurgiVision filed with the SEC details the company’s research and development, proposed products, finances and risk factors.

There are two more products in the pipeline: the ClearTrace Intervention System and the SafeLead Development program.

The initial target market for the ClearTrace is catheter-based ablation to treat cardiac arrhythmias. The technology could also be used for precision delivery of drugs and biologics. Siemens is a development partner on ClearTrace.

The other product in the pipeline, The SafeLead, would be used with implantable leads for cardiac and neurological applications. Boston Scientific is a partner on this program.

But there are no corporate partners on the ClearPoint technology for which the FDA granted clearance this month. SurgiVision’s current plans are to set up an internal sales force to begin marketing the ClearPoint system to physicians and hospitals.

The market for the ClearPoint is concentrated among a “few hundred hospitals,” but SurgiVision isn’t counting solely on one-time sales of the system.

This year, SurgiVision will apply for permission to also sell the ClearPoint system in the European Union.

SurgiVision lists among its risks having to achieve market acceptance, a limited commercialization history, uncertainty about FDA approval of its other product candidates and its ongoing losses.

The company remains primarily focused on research and development. It had a quarterly loss of $2.5 million for the period ending March 31. It ended its 2009 fiscal year on Dec. 31 with a $7.159 million loss.

SurgiVision has been led by CEO Kimble L. Jenkins since 2003. Prior to joining the company, Jenkins was a managing director with Morgan Keegan & Co. Inc.

The chairman of the board of directors is Paul Bottomley, a physicist and professor of radiology at The Johns Hopkins University. Bottomley worked at the GE Research and Development Center from 1980 to 1994. He played a key role in the development of GE’s MRI clinical product, according to a SurgiVision’s corporate website.

PROPERTY SALES 56 289 2,908
MORTGAGES 55 226 2,009
BUILDING PERMITS 108 1,002 6,703
BANKRUPTCIES 42 248 1,225