After undergoing a discectomy, or disc removal—one of the most common spinal operations—about 30 percent of patients have experienced recurrence of back pain. A major cause has been the standard surgical practice of not closing the anulus—the soft tissue around the spinal disc—following surgery. On the other hand, using traditional surgical sutures to do so is risky and difficult, and doubles the amount of time needed to perform the surgery.
Minnetonka-based Anulex Technologies, Inc., has two products on the market designed to remedy that “unmet surgical need,” according to CEO and President Michael McCormick, who joined Anulex in 2003. The company has raised $37 million in venture capital, and recently doubled the size of its Minnetonka headquarters.
The company’s technology is based on earlier work by Joseph Cauthen, MD, a Florida neuorsurgeon who developed and patented new types of suturing techniques for closing the anulus.
Anulex’s five-member R&D team worked for more than 2 years to develop Xclose, a plastic anchor inserted on the inside of the anular wall and tethered to two sutures on each side of the hole. The tension band is pulled together and knotted, closing the hole without sewing.
The company’s other product is Inclose, a surgical-mesh implant for use in the 20 percent of cases where the hole is too large to suture closed. The mesh helps the tissue eventually grow back together.
Inclose won FDA approval for U.S. marketing in 2005. Xclose earned its approval the following year.
Anulex’s products have already been used in more than 2,000 repairs by U.S. surgeons, McCormick says. The company plans to begin European sales in the coming year.
Meanwhile, the company has initiated a post-approval “superiority study” for Xclose, hoping to gather the data needed to show that its anular repair systems should be the postsurgical standard of care. The study will include about 550 patients, with two-year follow-up.
“There’s not much margin for error when you’re dealing with delicate spinal and nerve tissue. We’ve got the strongest intellectual property in this space,” McCormick says. “In the spinal-device area, it’s rare to be the only company in a particular category, but we are.”
With approximately 450,000 discectomies performed in the U.S. annually, McCormick adds, “there’s so much opportunity.”
