NLT SPINE, a company that has developed “non-linear” technology platform enabling implantation of large spinal implants and instruments through small incisions, has opened a subsidiary in the U.S.—in the Boston area in January 2013—to support the commercialization of its advanced technology platform.
With the “non-linear” technology platform, implant and instrument size is not limited by the incision size. It involves segmented devices that are inserted in a straight configuration (“linear”) into the spine by the means of a conduit and are then transformed into different (“non-linear”) shapes inside the body. The conduit provides for a pathway for introduction of instruments and implants, protecting soft tissues and nerves, allowing for predictable positioning and an accurate inflexion point within the patient, and affording a more reproducible procedure. These functional characteristics can shorten the learning curve for surgeons and may help to reduce user errors associated with spine surgery. The platform is applicable to a wide variety of surgical spine procedures representing segments that cover over 95% of the spinal implant marketplace in the U.S.
The company reports initial positive results from clinical experience with its PROW FUSION intervertebral body fusion device. Two of the company’s first generation products have already been cleared by the FDA and released into the market for initial clinical use: the PROW FUSION intervertebral body fusion device for spinal fusion in transforaminal lumbar interbody fusion (TLIF) procedures, and the eSPIN discectomy tool. Both devices can be used with traditional open procedures as well as with smaller incisions.
NLT SPINE’s non-linear technology is well suited for procedures involving small incisions and its reproducibility is expected to lead to a greater percentage of procedures being performed in outpatient, ambulatory surgical centers.
“Our focus at this time is to continue building clinical data for the PROW FUSION and eSPIN, to further demonstrate the clinical value and cost efficiencies of these devices”, stated Tom Keegan, vice president of business development and U.S. marketing, in the March 12, 2013 news release. “In parallel, we are preparing for the expanded release and ultimately full launch of our products during 2014.”
Keegan told OTW, “We have already initiated the collection of clinical use data at clinical sites in the U.S. and Europe during 2012 with good success. We have since developed the second generation of the PROW FUSION and eSPIN, and the clinical use of these products has been initiated in Europe during early 2013. We expect to initiate clinical use in the U.S. for these products by mid-year 2013, in two or three clinical study sites. We will complete a prospective study to document the clinical and cost effectiveness for these products, in preparation for commercial release in 2014.”
