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Florida startup develops tool to help back surgeons
March 20, 2006
By Stephen Pounds
WEST PALM BEACH, Fla. (AP) - Dr. Robert Lins knows the suffering his patients endure in back surgery.
The orthopedic surgeon at the Center for Bone and Joint Surgery in West Palm Beach typically makes a large incision and implants long screws into the vertebrae, along with a metal bar to connect them, to stabilize the back after repairing a degenerative disk.
“A traditional fusion is a big operation with significant blood loss," Lins said.
And it's painful.
It usually requires a hospital stay of three to five days, as well as strong painkillers to manage the discomfort. But with a treatment developed by a Boca Raton company that now is under review by the U.S. Food and Drug Administration, all of that could change.
U.S. Spine Inc., a privately held start-up company based at the Florida Atlantic University Research and Development Park, is looking for FDA approval in the second quarter of this year to begin marketing a less invasive surgical treatment to repair lower-back degeneration. The treatment, which uses a gun that drives stabilizing screws into the vertebrae through a small incision, promises to shorten recovery time, meaning a reduced hospital stay and less medication for postoperative pain.
It's even possible the treatment could be given on an outpatient basis.
“It will clearly be an advancement for patients," Lins said. “It should decrease the recovery time by weeks."
Recently, U.S. Spine presented its business plan to the Florida Venture Capital Conference in Ponte Vedra Beach. It is seeking $7 million to
launch its new treatment.
U.S. Spine was formed in February 2004 by Doris Blake, an executive with experience at two previous spinal device companies. The company has licensed a breakthrough surgical concept from Dr. Mark Falahee, a surgeon at the Michigan Brain and Spine Institute, a research center affiliated with the University of Michigan.
Falahee conceived of the idea of a one-shot gun to reconnect vertebrae at the facet joint after disk replacement. His aim was to eliminate the need for the large incision required to implant the screws and the metal crossing rod. “It's much like a rivet gun,” he said.
Falahee offered his invention to larger medical instrument companies, but he said they weren't interested. He then licensed the idea to U.S. Spine, which would pay him royalties.
“The big companies saw it as competition for what they were already making a lot of money off of,” he said.
Armed with Falahee's gun, Blake approached a St. Louis real estate developer with an armchair interest in bioscience and got $1.2 million in start-up capital to manufacture a prototype.
Later in 2004, Blake raised an additional $3 million from family and friends and moved out of U.S. Spine's tiny office at FAU's technology-business incubator and into a 10,000-square-foot building down the street. The company remains at the FAU research park, where it is creating a student bioengineering program while it uses FAU's cadaver lab for studies.
Last year, U.S. Spine decided to compete with 30 or so companies that sell traditional surgical implants, using its sales to finance development of the gun.
Falahee's device, called a facet-fixation gun, stabilizes the bones in a patient's lower back this way:
A two-triggered gun is loaded with a facet bolt, which resembles a screw. At the end of the barrel is a locking nut that has been inserted into an L-shaped bracket. The bracket holds the bones in place so the surgeon can position the implant.
The surgeon squeezes the first trigger, pushing an inner metal tube forward to compress and better align the bolt. The surgeon then squeezes the second trigger, which drives the screw through both vertebrae and into the nut. This locks the two vertebrae together, allowing them to fuse.
“It's less traumatic for the patient,” said Blake, who came up with the idea that the gun should be disposable to avoid the worry of infection from reuse.
U.S. Spine is co-developing the gun with Edge Product Development Inc. in Newtown, Pa. Precision Medical Products Inc. of Lancaster, Pa., will manufacture it.
Last year, U.S. Spine had $2.5 million in sales of traditional components and replacement material used in spinal surgery, pouring all its cash back into product development. It introduced the facet-fixation gun to spinal surgeons at their annual meeting in September in Philadelphia, where some saw it as a great escape from pain and agony.
With the expected launch of the facet gun this year, U.S. Spine projects $6 million in sales. It also is developing an elastic-like material to replace a damaged disk that may be available in 2010.
U.S. Spine forecasts profitability by late 2007, but it will be an uphill battle. Two giants, Medtronics Inc. and Johnson & Johnson Inc., control the spinal device market.
But Kevin Ooley, a principal of the venture capital firm Lovett Miller & Co. in Tampa who coached U.S. Spine executives for their conference presentation, said the Boca Raton
newcomer has some advantages. It has seasoned management and a strategy of entering the market in stages first with traditional spinal components followed by its own new products.
“There is some risk there because the products have to go through FDA approval,” Ooley said. “But the potential return is greater.”
Source: http://www.techjournalsouth.com