Devices & Diagnostics

Spine fusion device startup eyes Cleveland move, more funding

A Louisville company that’s developing a medical device to help surgeons monitor the progress of […]

A Louisville company that’s developing a medical device to help surgeons monitor the progress of spinal fusion surgeries is eyeing a relocation to the Cleveland area.

OrthoData is hoping to attract some Northeast Ohio investors to help pave the way for the relocation. The company would also use a hoped-for $7 million series B round of investment to fund animal and human testing of its implantable electronic spine fusion sensor, said CEO Ric Navarro, a Northeast Ohio native who was previously an executive with Integra Spine.

Navarro says OrthoData’s technology is a more accurate and less costly means of assessing the success of spinal fusion surgeries compared with other current alternatives, typically CT scans or X-rays.

Use of OrthoData’s device would also eliminate the need for exploratory surgery on spinal fusion patients after their initial fusion procedures. Navarro says such exploratory surgeries occur in about 10 percent of spinal fusion patients.

Aside from the fundraise, one of the company’s next key milestones involves beginning animal testing. OrthoData is hoping to begin in the next few months a sheep study at Ohio State University, Navarro said.

Successful animal testing would position OrthoData for its first in-man testing, which could eventually lead to regulatory clearance of its spine fusion sensor. Navarro hopes to have the device on the market within three to five years.

OrthoData was formed in 2003 to commercialize technology developed by University of Louisville researchers and physicians. “It’s always good when a device idea comes from surgeons because that means it’s initiated from a problem they’re having,” Navarro said.

The company’s “IntelliRod” system consists of two parts. First, a small, battery-powered sensor that measures strain on spinal implants is attached to a rod-and-screw system during spinal fusion surgery. After the device is implanted, a scanning wand is used to wirelessly collect data during post-operation checkups.

The company has raised nearly $1.4 million so far, with investors including Cincinnati-based Queen City Angels and the Kentucky Seed Capital Fund.

Navarro joined the company earlier this year and is hoping to relocate OrthoData closer to his Northeast Ohio home. Plus, he’s interested in partnering with local hospitals once the company is ready for clinical trials.

As with most diagnostic tools, one of Navarro’s greatest challenges involves convincing investors that his company’s device is a “must-have” rather than just a “nice-to-have.” Navarro said he answers such concerns by touting the potential cost savings OrthoData’s technology can deliver.

“If we became a $25 million to $50 million company, we could eliminate costs to the system of $1 billion or more,” he said.

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