FDA nod enables Magnevu to start portable MRI business

Technology could enable $100 MRI scans

After eight long years in its start-up phase, portable MRI developer Magnevu is revving its jets for commercial take-off. The Carlsbad, CA, company received Food and Drug Administration market clearance in August of its OrthoVu 1000 system for use in scanning extremities.

Magnevu is engaged in a round of venture-capital financing to fuel the start of a fee-per-scan business centering around its radically new technology. This business will target physicians' offices not traditionally served by MRI and is slated for initiation in the third quarter of 1999, according to president Dan Clark.

The eight years since the formation of Magnevu in 1990 were spent developing an MRI technology that centers around a unique capability to scan in nonhomogeneous fields (SCAN 12/29/93), Clark said. While the company's R&D stage was lengthy, OrthoVu virtually sped through the FDA, receiving 510(k) clearance in a mere 60 days. Magnevu holds a total of 17 patents worldwide on this technology.

Magnevu's extended development effort resulted in a product that could potentially create a new imaging niche in MR. The company doesn't see its portable MR system as a replacement for conventional MRI scanners, but rather as a means for extending MR technology into new applications that it hasn't penetrated because of the cost of conventional MR technology, Clark told SCAN.

Due to present technical limitations, OrthoVu 1000 scans only 2 to 3 inches into the body. The scanning is done using a handheld probe that is circulated around the body part to be imaged. But Magnevu's MR technology could eventually enable MRI examinations at a price level of around $100, he said.

"MRI (systems) are limited by their size, expense, and siting requirements mainly to hospitals and clinics," Clark said. "What the OrthoVu system brings to medical imaging is a quick way in a physician's office for looking at soft-tissue information at the price points of x-ray. We are looking at areas that typically don't do MR today, such as dermatology."

The OrthoVu system is designed to function in the future like an ultrasound scanner, with various application-specific probes running at different field strengths, Clark said. The configuration certified by the FDA for general-purpose extremity imaging operates at a 0.2-tesla field strength.

While Magnevu was funded in its early years largely with private, nonventure capital, the company has received interest and financial support from one large medical supplier, Johnson & Johnson, Clark said. J&J has taken a 4% equity stake in Magnevu and is negotiating for licensing rights to the technology in certain market segments, he said. Magnevu is also in talks with unnamed imaging vendors who might be interested in an acquisition of the company.

The company itself, however, has no intention of selling its system directly to physician offices, relying instead on fee-per-scan arrangements, according to Clark.

"Magnevu is not going to be a hardware company," he said. "We are a service company, providing MR images to physicians in their offices."