Build a better surgical tool and, voila, a new med-tech company is born. That's the story behind four-year-old CoreSpine Technologies (Minneapolis), which just received FDA 510(k) clearance for its Xtend-ST Nucleus Removal System, a device intended to replace decades-old rongeurs when used for complete or selective removal of material from the lumbar disc space.

"When we look at the potential market, we focus on discectomies as a nice potential and we also look at minimally invasive fusion procedures," CoreSpine Technologies' CEO Christine Horton told Medical Device Daily. "Minimally invasive fusion procedures is a market we could go to immediately. We're also looking down the road at nucleus replacement. Just one of those [segments] alone would be an enormous market that's available today that we could certainly start selling into."

The Xtend-ST Nucleus Removal System, which looks a bit like a handgun with a long-nosed catheter at the end, would replace the pliers-like rongeurs used in spinal surgeries, which can leave up to half of the material in the disc. Before surgeons can repair damaged spines, they have to scoop out those diseased tissues. For decades, they used two to six different rongeurs to get the job done. Xtend-ST Nucleus Removal System replaces those with one device.

"It's very different compared with what they currently use today," Horton said. "We hope it becomes the gold standard."

As surgeons continue to refine spine surgeries, company co-founders Horton and Britt Norton, saw a niche opportunity and seized it when both were laid off from jobs at another spinal device company, Raymedica (Minneapolis), in 2005. "This was invented by myself and Britt Norton our names are on the patents. We have both spent 42 years in medical devices. I started as a chemist and eventually wound up in marketing and sales. Britt is a chemical engineer and studied in engineering. We took all of this expertise and poured it into CoreSpine."

The mission: Set a new standard for preparing the spinal disc for minimally invasive interbody fusion disc nucleus replacement devices and other emerging spine technologies.

The result: Because back pain affects millions of people and with surgical techniques continuously expanding that market, CoreSpine Technologies is poised to reap huge benefits, growing the tiny, tightly funded company from a dozen employees in a relatively short period of time.

Horton said the stainless steel Xtend-ST Nucleus Removal System was designed for several uses including discectomy to total disc replacement. It can be used for open surgery as well as minimally invasive approaches.

"We've been very careful not to align ourselves with any particular procedure or approach; it's designed to be used with many different approaches," she said.

But the company isn't ready to roll out the product yet.

"We plan to do a controlled introduction of the product when the time is right," she said. "We're first going to start doing some controlled post-market studies to gather data and support the education of surgeons. There needs to be some strong data. We have studies planned, but we're not in a position to share those details yet."

Horton said the single-use device is "certainly not capital equipment and it's a disposable. From a reimbursement standpoint we're pretty pleased. If you look at minimally invasive codes, we fit nicely into that."

Horton said her company has been built on a tight budget with angel funding. "We're planning to do our first venture capital round in nine months," she said. "That's based on how things look at that time. We've been privately funded to date. We're notorious for being very lean and getting things accomplished with little money. We met at a coffee shop for the first six months when the company was formed."

When it's time to start manufacturing Xtend-ST Nucleus Removal System, Horton said the company will look to an outside partner.

Once the CoreSpine team rolls out the Xtend, they will work to expand the platform. "Our next focus is a cartilage removal device," Horton said.