FDA Clears Next-Generation Technology from NLT Spine

NLT Spine received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for two new spinal fusion products.

Prow Fusion and eSpin devices target the $1.3 billion global lumbar interbody fusion market, according to the company. Both products already are in clinical use in Europe.

The Prow Fusion Interbody Fusion device and delivery system are intended for spinal transforaminal lumbar interbody fusion procedures. The product was developed based on NLT Spine’s non-linear core technology, which allows for inserting large implants and instruments through a small incision. The FDA already has cleared the previous version of the device. The second generation, however, offers enhanced design, new material, and fewer instruments required to perform the procedure, the firm reported.

The eSpin system is intended for cutting and grinding intervertebral disc material during discectomy for fusion procedures. The previous version of eSpin also has been cleared by the FDA, and second-generation improvements include additional irrigation capability and an improved cutting tips design.

“The FDA clearance for two of our products strengthens our drive and commitment to continue and innovate to offer surgeons and patients a differentiated experience in less invasive spine procedures,” said Didier Toubia, NLT Spine’s CEO. “Alongside a strong intellectual property and FDA clearance for these two leading products, our platform becomes a solid offering in this market. With additional products in our pipeline, we plan to quickly address most of the major segments of the spinal implants business, a $7.6 billion opportunity worldwide.”

Uri Geiger, chairman and managing partner at Accelmed, the main investor in NLT Spine, added, “Prow Fusion 2.0 approvals and the strong product pipeline, strengthens NLT Spine’s positioning as a leading innovator in the minimally invasive spine landscape. Combining this kind of breakthrough platform based on Israeli innovation with a strategic partner with a solid U.S. commercial infrastructure is now a viable option, and Accelmed will support such an initiative.”

Israel-based NLT Spine develops spine surgery instrumentation and implants for treating degenerative spinal conditions through small surgical incisions. Its U.S. offices are in Dedham, Mass.