NLT Spine to Release Two Next Gen Products in US

NLT Spine Ltd., a minimally invasive spine device company based in Kfar Saba, Israel, gas earned 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its 2.0 generation of devices for spinal fusion procedures.

Prow Fusion and Espin both target the lumbar interbody fusion market, which currently represents an opportunity of approximately $1.3 billion globally. Both products are already in clinical use in Europe.

The Prow Fusion interbody fusion device and delivery system are intended for spinal transforaminal lumbar interbody fusion procedures (TLIF). The product was developed based on NLT Spine’s non-linear core technology which is designed to allow for inserting large implants and instruments through a small incision. The FDA has already cleared the previous version of the device. Generation 2.0 offers enhanced design, new material, and fewer instruments required to perform the procedure.

Espin is intended for use in cutting and grinding intervertebral disc material during discectomy for fusion procedures. Similarly to Prow Fusion, the previous version of Espin has been cleared by the FDA, and generation 2.0 enhancements include an additional irrigation capability, and optimized cutting tips design.

“Alongside a strong intellectual property and FDA clearance for these two leading products, our platform becomes a solid offering in this market,” said Didier Toubia, CEO of NLT Spine. “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.”

“Prow Fusion 2.0 approvals and the strong product pipeline strengthens NLT Spine positioning as a leading innovator in the minimally invasive spine landscape,” said Uri Geiger, Ph.D., chairman and managing partner at Accelmed, the main investor in NLT Spine. “Combining this kind of break-through 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.”